therapeutic index final

Therapeutic Index

Beximco Pharmaceuticals Ltd.

T H E R A P E U T I C I N D E X

Published in March 2004

Copyright © 2004 all rights reserved

Compiled and Published byMedical DepartmentBeximco Pharmaceuticals Ltd.

Design and Computer Graphics byDTP, Medical Department

Printed byShuktara Printers, Gazipur

PTG-235/02-04/5000 SHUK

O U R M I S S I O N

OUR MISSION

Each of our activities must benefit and add value to thecommon wealth of our society. We firmly believe that, in

the final analysis we are accountable to each of theconstituents with whom we interact; namely: our employees,our customers, our business associates, our fellow citizensand our shareholders.

HistoryKey milestones

1976 Registration of the company

1980 Started manufacturing and marketing of licenseeproducts of Bayer AG of Germany and Upjohn Inc.of USA

1983 Launching its own products

1985 Listing in the Dhaka Stock Exchange (DSE) as aPublic Limited Company (PLC)

1990 Commissioning of Basic Chemical unit

1992 Started export operation with Active PharmaceuticalIngredients (APIs)

1993 First export market operation with FinishedPharmaceutical Products

1994-95 The first pharmaceutical company in the country toreceive ‘National Export Trophy (Gold)’

1996 Introduction of Sustained Release dosage form inthe market

OUR MISSION

vii

1997 Commissioning of Metered Dose Inhaler (MDI)plant and introduction of Suppository dosage form

1998 Introduction of Metered Dose Nasal Spray

1998-99 Received ‘National Export Trophy (Gold)’

1999 UNICEF approval of BPL as an enlisted supplier

1999-00 Received ‘National Export Trophy (Gold)’

2000 Contract manufacturing agreement of MeteredDose Inhaler (MDI) with Glaxo SmithKline

2001 Introduction of small volume parenteral products(Injectables) and Establishment of Analgesic-Antiinflammatory bulk-drug plant

2002 The first Bangladeshi company to supplypharmaceuticals to Raffles Hospital of Singapore

The ProfileCorporate Headquarters : 17 Dhanmondi R/A, Road No. 2,Dhaka 1205, Bangladesh

Operational Headquarter : 19 Dhanmondi R/A, Road No. 7,Dhaka 1205, Bangladesh

Factory : Auspara, Tongi, Gazipur

Business Lines : Manufacturing and marketing ofpharmaceutical finished products and Active PharmaceuticalIngredients (APIs)

Overseas Offices and Associates : UK, USA, Pakistan, Nepal,Myanmar, Singapore, Kenya, Yemen.

Export Outlets : Bhutan, Georgia, Germany, Hong Kong,Iran, Iraq, Kenya, Malaysia, Myanmar, Nepal, Pakistan,Russia, Singapore, South Korea, Taiwan, Thailand, Ukraine,Vietnam and Yemen.

viii

O U R M I S S I O N

International Marketing In BPL we are proactive in our approach to aggressivelysearch for new avenues in the international market place:Beximco Pharma is the pioneer in entering the CIS countries.BPL is the first pharmaceutical company in Bangladesh toreceive National Export Trophy Gold in 1998.

In Pakistan, BPL took proactive measures in launching itsproducts with Multimedia CD-ROM replacing the age-oldprinted promotional materials.

In Myanmar, BPL further consolidated its position bydonating Medical Information Kiosks to the MyanmarMedical Association.

Beximco Pharma is the only Bangladeshi pharmaceuticalcompany operating in Singapore market- one of the moststringent and regulated markets in Asia.

Beximco Pharma was the first company from Bangladesh toenter the African Market.

We are delighted and proud of our pioneering achievements.More than that, we have probably fulfilled a nationalaspiration of turning an import dependent country into anexporter of quality medicines. Despite the fact that there isno incentive for pharmaceutical export in Bangladesh, tilltoday, we have not deviated from our proactive andpioneering role in international marketing.

Our journey that began amidst many obstacles has nowexpanded to nineteen countries. In 2002, BPL’s majoremphasis in international marketing was to consolidate andgrow in all its existing overseas markets by ensuring

ix

O U R M I S S I O N

sustainable competitive advantage over our competitors andcompetitive brands. In 2002, we were awarded a tender orderfor our Neoceptin R for the whole year’s consumption ofRaffles Hospital- the most prestigious hospital in Singapore.We have also supplied our product in KK Women’s andChildren’s Hospital in Singapore. In order to expand ourproduct portfolio in Myanmar, we have launchedliquid/bottle items by organizing a huge scientific seminar.We have supplied our products to Shaukat KhanumMemorial Cancer Hospital & Research Center and Aga KhanUniversity Hospital- the two renowned institutions inPakistan. In Kenya, we have started supplying to Mission forEssential Drugs and Supplies (MEDS)- the largest institutionand Kenyatta Hospital -the largest hospital in Kenya.

While consolidating in all our existing overseas markets, weare determined to continue deploying our efforts andresources to develop new overseas markets in Asia, Africa,and Europe. As a part of our ongoing new marketexploration activities, in 2002 we participated in all majorexhibitions held in Russia, Ukraine, Afghanistan and Nepal.For evaluating business opportunities in new overseasmarkets, we conducted market research in various markets inAsia and Europe.

The Leading Health CareCompany in Bangladesh

Beximco PharmaceuticalsLtd. is a member of theBeximco Group- the largestprivate sector businessconglomerate of Bangladesh,

comprising 8 divisions and over 22000 employees. BPL, thelargest pharmaceutical as well as bulk drug manufacturer of

x

O U R M I S S I O N

Bangladesh started its journey back in 1980 withmanufacturing and marketing of licensee products of BayerAG, Germany and Upjohn Inc. of USA. BPL launched 6 ofits own products in 1983. We strongly believe in high qualityand cost-effective medicine. We are proud to become firstenlisted supplier to international bodies like UNICEF,UNDP, WHO and ICDDR,B.

The National Recognition for ExcellenceIn addition to local market, BPL’s exportactivities are there in nineteen countries ofthree continents- Asia, Europe and Africa. Forits outstanding export performance, BPLreceived Bangladesh’s highest award for export,the National Export Trophy, Gold in 1994-95.BPL is the first pharmaceutical company in Bangladesh toreceive such an award. BPL was also awarded NationalExport Trophy Gold for two consecutive years 1998-1999 &1999-2000. BPL is the record three times winner of thisnational highest recognition for export.

Committed to ServeBPL’s commitment is to always offer the best, both in qualityand services to its customers. Quality is the measure ofexcellence in the field of pharmaceutical products. BPL feelsthat it has an incalculable social liability of providing safe,efficacious and highest quality drugs. Equipped with thelatest & the most advanced state-of-the-art technologies BPLteam is committed to serve its customers. Through thehighest quality drugs BPL has succeeded in gaining theconfidence & trust of doctors & patients all over the country.

xi

O U R M I S S I O N

BPL- A Company with Vision forTomorrow

BPL has transformed its activities,culture, style and philosophy to meetthe demands of the new millennium.Business diversifications that arestrategically important for a sustainedgrowth are results of its vision of the

future. Several new bulk drug facilities are being developedto backward integrate their high volume products. A USFDAstandard multi-million dollar pharmaceutical formulationplant is nearing completion. This would be one of the mostmodern plants in this region.

Our Differential Edge

• World class manufacturing facilities• Highest cGMP standards• Outstanding product quality• Sophisticated formulation technology• Diversified and hightech dosage forms & products• Significant investment in R&D• Excellent customer services• Responsible care for the environment• Commitment to the people & the society

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O U R M I S S I O N

C O N T E N T S I N B R A N D N A M E

169

1114

16

18202224

2628293133363941464851535864687074

778081

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BRAND NAME GENERIC NAME


Aeronid Inhaler Budesonide BP Alendon Tablet Alendronate Sodium BP Alphin DS Tablet Albendazole USP Amdocal Tablet Amlodipine Besylate INNAnustat Ointment Cinchocaine Hydrochloride BP,

Hydrocortisone BP, Neomycin Sulphate USP and Esculin

Apresin Tablet Fluphenazine Hydrochloride BP and Nortriptyline Hydrochloride BP

Arbit Tablet Irbesartan INNAristocal Tablet Calcium Carbonate BP Aristoferon Syrup Ferrous Sulphate BPAristofol-Fe Tablet Ferrous Fumarate BP and

Folic Acid USP Aristoplex Syrup Vitamin B ComplexAristovit-B Tablet Vitamin B ComplexAristovit-M Tablet Multivitamin and MineralAristovit-X Tablet Antioxidant, Vitamin, and MineralArixon IV/IM Injection Ceftriaxone Sodium USP Arlin Tablet/Suspension Linezolid INNAscobex Tablet Ascorbic Acid USPAtova Tablet Atorvastatin Calcium INN Atrizin Tablet/Syrup Cetirizine Hydrochloride BPAvastin Tablet Simvastatin USP Avidro Tablet Pizotifen Malate BP Avifanz Tablet Efavirenz INNAvifix Tablet Nelfinavir Mesylate INNAvilam Tablet Lamivudine INN Avitron V Tablet Thiamine Hydrochloride USPAxodin Tablet Fexofenadine Hydrochloride INNAzithrocin Capsule Azithromycin USP

/Tablet/SuspensionAzmasol Inhaler Salbutamol BPBexidal Tablet Mebhydrolin Napadisylate BPCBexitrol-F Inhaler Fluticasone Propionate BP and

Salmeterol Xinafoate INN Bexitrol Inhaler Salmeterol Xinafoate INN

xv

87

89

9194

96

98

101103105107112114116119121

123

124130133136140144147

149

152155158

Bextrum Tablet High potency Multivitamin and Multimineral

Bronkolax Tablet Salbutamol Sulphate BP/Syrup

Cardopril Tablet Captopril USPCarocet Tablet Beta Carotene, Ascorbic Acid USP and

dl-alpha-Tocopheryl Acetate Carofol-Z Capsule Carbonyl Iron INN, Folic Acid BP and

Zinc Sulphate Monohydrate USPCephalen Capsule Cefalexin BP

/SuspensionCerivin Tablet Vinpocetine INNClobex Capsule/Syrup Cloxacillin Sodium BPCosmotrin Cream Tretinoin USP Cox B Capsule Celecoxib INN Curin Tablet Levocetrizine Dihydrochloride INNDecacycline Capsule Tetracycline Hydrochloride BP Decomit Inhaler Beclomethasone Dipropionate BPDecomit Nasal Spray Beclomethasone Dipropionate BPDeflux Tablet Domperidone Maleate BP/

/Suspension Domperidone BP/Paediatric Drops

Dextromethorphan Dextromethorphan Hydrobromide BPSyrup

Diactin Tablet Glipizide BP Diaglit Tablet Pioglitazone Hydrochloride INN Diapro Tablet Gliclazide BP Diaryl Tablet Glimepiride INN Diavix Tablet Lamivudine INN and Zidovudine USP Dilapress Tablet Carvedilol BP Ecotrim Cream Econazole Nitrate BP and

Triamcinolone Acetonide BPEfol-ER Capsule Ferrous Sulphate BP, Folic Acid USP

and Zinc Sulphate Monohydrate USP

Enaril Tablet Enalapril Maleate USPEpilep Tablet Carbamazepine BP Eplon Capsule Zaleplon INN

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162

166168171173

175

176178181184

186188189

191193194

196198201

204207210213215

216219222

Etrocin Tablet Erythromycin USP/Suspension

Evo Tablet Levofloxacin Hemihydrate INNFertil Tablet Clomiphene Citrate USPFibril Capsule Gemfibrozil USPFilmet Tablet Metronidazole BP/Metronidazole

/Suspension Benzoate BPFlatameal-DS Tablet Aluminium Hydroxide Gel USP,

/Suspension Magnesium Hydroxide BP and Simethicone USP

Flubex Capsule/Syrup Flucloxacillin Sodium BPFormula E Tablet Vitamin E USPFrelax Powder Polyethylene Glycol 3350 USP NFFrenxit Tablet Flupentixol Dihydrochloride BP and

Melitracen Hydrochloride INN Fungistin Suspension Nystatin BPFurasep Cream Nitrofurazone USPFusidic Plus Ointment Sodium Fusidate BP and

Hydrocortisone Acetate BPGastalfet Tablet Sucralfate USPGentosep Cream Gentamicin Sulphate BPHefolin SR Capsule Ferrous Sulphate BP and

Folic Acid BPInarzin Tablet Cinnarizine BP Informet LA Tablet Metformin Hydrochloride BP Intracef Capsule Cephradine BP

/Suspension/Paediatric Drops

Intracef Injection Cephradine USP Ipramid Inhaler Ipratropium Bromide BPIsofloxin Tablet Pefloxacin Mesilate BP Keolax Tablet Clobazam BP Lactameal Tablet Aluminium Hydroxide Gel USP and

/Suspension Magnesium Hydroxide BPLarnox LA Tablet Aminophylline BP Lucidol Capsule Tramadol Hydrochloride BP Megadox Capsule Doxycycline Hydrochloride BP

xvii



225

225

229

231234237239244

246248250

252254

256

258263269271273275277280282

286

289292

Megatrim DS Tablet Trimethoprim BP and Sulfamethoxazole BP

Megatrim Suspension Trimethoprim BP and Sulfamethoxazole BP

Melphin Tablet Pyrantel Pamoate USP/Suspension

Modipran Capsule Fluoxetine Hydrochloride BPMomento Tablet/Syrup Desloratadine INN Monate Tablet Isosorbide Mononitrate BP Monocast Tablet Montelucast Sodium INNNapa Tablet/Syrup Paracetamol BP

/Suppository/Paediatric drops

Nazolin Nasal Spray Oxymetazoline Hydrochloride USPNebactil Suspension Nalidixic Acid BPNeo Kit Clarithromycin USP, Omeprazole BP

and Metronidazole BP Neocard Tablet Diltiazem Hydrochloride USPNeoceptin R Tablet Ranitidine Hydrochloride USP

/SyrupNeodrop Simethicone USP

Paediatric DropsNeofloxin Tablet Ciprofloxacin Hydrochloride USPNeopril Tablet Lisinopril USPNeosten Cream Clotrimazole BP Neosten VT Clotrimazole BP Nightus Tablet Bromazepam BPNoscab Cream Permethrin INN Nuprafen Tablet Naproxen USPOdrel Tablet Clopidogrel Bisulfate INN Omastin Capsule Fluconazole INN

/SuspensionOpton Tablet Esomeprazole Magnesium

Trihydrate INN Pacet Tablet Amiodarone Hydrochloride BPPedeamin Syrup Diphenhydramine Hydrochloride BP

xviii



294

296300302305308310313316319321323325327

330333335339341

344345347349353355357359

361

Pregvit Capsule Ferrous Sulphate BP, Folic Acid USP, Thiamine Mononitrate USP, Riboflavin USP, Nicotinamide USP,Pyridoxine Hydrochloride USP & Ascorbic Acid USP

Premil Tablet Repaglinide USPPretin Tablet Loratadine INN Primace Capsule Ramipril BPProceptin-20 Capsule Omeprazole BP Prosan Tablet Losartan Potassium INN Prosfin Tablet Finasteride USPProtolan Capsule Lansoprazole USP Recox Tablet Rofecoxib INN Recur Tablet Finasteride USP Reflon Tablet Glucosamine Hydrochloride USPRelentus Tablet Tizanidine Hydrochloride INNResitone Tablet Spironolactone BP and Frusemide BPReumafen Tablet lbuprofen BP

/SuspensionRolacin Tablet Clarithromycin USPRostil Tablet Mebeverine Hydrochloride BP Sensipin Tablet Clozapine BPSerelose Solution Lactulose Solution BP Sibulin Capsule Sibutramine Hydrochloride

Monohydrate INNSpanil Tablet Hyoscine Butylbromide BPSparlin Tablet Sparfloxacin INN Spulyt Tablet/Syrup Bromhexine Hydrochloride BPTamona Tablet Tamoxifen Citrate BP Taverin Tablet Drotaverine Hydrochloride INN Terbex Cream/Tablet Terbinafine Hydrochloride INNTofen Tablet/Syrup Ketotifen Fumarate BP Triocim Capsule Cefixime Trithydrate USP

/SuspensionTriovix Tablet Lamivudine INN, Zidovudine USP

and Nevirapine INN

xix



364

366

366369371

374377379382386389391393395401

Tripec Syrup Guaifenesin BP, Pseudoephedrine Hydrochloride BP and TriprolidineHydrochloride BP

Tycil Capsule Amoxicillin Trihydrate BP/Suspension/Paediatric Drops

Tycil DS Suspension Amoxicillin Trihydrate BPTynisol Drops MultivitaminUltrafen Tablet Diclofenac Sodium BP/Diclofenac

/Suppository/Gel Diethylamine BPUricon Tablet Oxybutynin Chloride USPUroflo Capsule Tamsulosin Hydrochloride INNValcap Capsule Valsartan INN V-Cox Tablet Valdecoxib INNXynofen-100 SR Capsule Ketoprofen BPYamadin Tablet Famotidine USPZedex-DS Syrup Zinc Sulphate Monohydrate USP Zocil Tablet Cilostazol INN Zukast Tablet Zafirlukast INN Zymet Tablet Pancreatin BP

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C O N T E N T S I N T H E R A P E U T I C G R O U P

244

9229

105

321

17781

8489

119

207216

349

16

Analgesic & AntipyreticNapa Tablet/Syrup Paracetamol


AnthelminticAlphin DS Tablet Albendazole Melphin Tablet/Suspension Pyrantel Pamoate

Anti-acne preparationCosmotrin Cream Tretinoin

Anti-osteoarthritic preparation Reflon Tablet Glucosamine Hydrochloride

Anti-asthma preparationAeronid Inhaler Budesonide Azmasol Inhaler Salbutamol Bexitrol-F Inhaler Fluticasone Propionate and

Salmeterol Xinafoate Bexitrol Inhaler Salmeterol Xinafoate Bronkolax Tablet/Syrup Salbutamol Sulphate Decomit Nasal Spray Beclomethasone

Dipropionate Ipramid Inhaler Ipratropium Bromide Larnox LA Tablet Aminophylline

Anti-cancer preparationTamona Tablet Tamoxifen Citrate

AntidepressantApresin Tablet Fluphenazine Hydrochloride

and Nortriptyline Hydrochloride

xxiii



184

231335

124130133136198296

121

155

14

467080

112234292

300

Frenxit Tablet Flupentixol Dihydrochloride and Melitracen Hydrochloride

Modipran Capsule Fluoxetine Hydrochloride Sensipin Tablet Clozapine

Antidiabetic preparationDiactin Tablet Glipizide Diaglit Tablet Pioglitazone Hydrochloride Diapro Tablet Gliclazide Diaryl Tablet Glimepiride Informet LA Tablet Metformin Hydrochloride Premil Tablet Repaglinide

Anti-emetic preparationDeflux Tablet/Suspension Domperidone Maleate

/Paediatric Drops

Anti-epileptic preparationEpilep Tablet Carbamazepine

Anti-haemorrhoidal preparationAnustat Ointment Cinchocaine Hydrochloride,

Hydrocortisone, Neomycin Sulphate and Esculin

Anti-histamine preparationAtrizin Tablet/Syrup Cetirizine Hydrochloride Axodin Tablet Fexofenadine Hydrochloide Bexidal Tablet Mebhydrolin Napadisylate Curin Tablet Levocetrizine DihydrochlorideMomento Tablet/Syrup Desloratadine Pedeamin Syrup Diphenhydramine

Hydrochloride Pretin Tablet Loratadine

xxiv



535864

140

361

333674

98

103114162166173

176188189

193201

204210222

Anti-HIV preparationAvifanz Tablet Efavirenz Avifix Tablet Nelfinavir Mesylate Avilam Tablet Lamivudine Diavix Tablet Lamivudine and

Zidovudine Triovix Tablet Lamivudine, Zidovudine

and Nevirapine

Anti-microbial preparation

AntibacterialsArixon IV/IM Injection Ceftriaxone Sodium Arlin Tablet/Suspension Linezolid Azithrocin Capsule/Tablet Azithromycin

/SuspensionCephalen Capsule Cephalexin

/SuspensionClobex Capsule/Syrup Cloxacillin Sodium Decacycline Capsule Tetracycline Hydrochloride Etrocin Tablet/Suspension Erythromycin Evo Tablet Levofloxacin Hemihydrate Filmet Tablet/Suspension Metronidazole/

Metronidazole Benzoate Flubex Capsule/Syrup Flucloxacillin Sodium Furasep Cream Nitrofurazone Fusidic Plus Ointment Sodium Fusidate and

Hydrocortisone Acetate Gentosep Cream Gentamicin Sulphate Intracef Capsule Cephradine


Intracef Injection Cephradine Isofloxin Tablet Pefloxacin Mesilate Megadox Capsule Doxycycline Hydrochloride

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Aeronid Inhaler Budesonide BP Alendon Tablet Alendronate Sodium BP Alphin DS Tablet Albendazole USP Amdocal Tablet Amlodipine Besylate INNAnustat Ointment Cinchocaine Hydrochloride BP,

Hydrocortisone BP, Neomycin Sulphate USP and Esculin

Apresin Tablet Fluphenazine Hydrochloride BP and Nortriptyline Hydrochloride BP

Arbit Tablet Irbesartan INNAristocal Tablet Calcium Carbonate BP Aristoferon Syrup Ferrous Sulphate BPAristofol-Fe Tablet Ferrous Fumarate BP and

Folic Acid USP Aristoplex Syrup Vitamin B ComplexAristovit-B Tablet Vitamin B ComplexAristovit-M Tablet Multivitamin and MineralAristovit-X Tablet Antioxidant, Vitamin, and MineralArixon IV/IM Injection Ceftriaxone Sodium USP Arlin Tablet/Suspension Linezolid INNAscobex Tablet Ascorbic Acid USPAtova Tablet Atorvastatin Calcium INN Atrizin Tablet/Syrup Cetirizine Hydrochloride BPAvastin Tablet Simvastatin USP Avidro Tablet Pizotifen Malate BP Avifanz Tablet Efavirenz INNAvifix Tablet Nelfinavir Mesylate INNAvilam Tablet Lamivudine INN Avitron V Tablet Thiamine Hydrochloride USPAxodin Tablet Fexofenadine Hydrochloride INNAzithrocin Capsule Azithromycin USP

/Tablet/SuspensionAzmasol Inhaler Salbutamol BPBexidal Tablet Mebhydrolin Napadisylate BPCBexitrol-F Inhaler Fluticasone Propionate BP and

Salmeterol Xinafoate INN Bexitrol Inhaler Salmeterol Xinafoate INN

xv

87

89

9194

96

98

101103105107112114116119121

123

124130133136140144147

149

152155158

Bextrum Tablet High potency Multivitamin and Multimineral

Bronkolax Tablet Salbutamol Sulphate BP/Syrup

Cardopril Tablet Captopril USPCarocet Tablet Beta Carotene, Ascorbic Acid USP and

dl-alpha-Tocopheryl Acetate Carofol-Z Capsule Carbonyl Iron INN, Folic Acid BP and

Zinc Sulphate Monohydrate USPCephalen Capsule Cefalexin BP

/SuspensionCerivin Tablet Vinpocetine INNClobex Capsule/Syrup Cloxacillin Sodium BPCosmotrin Cream Tretinoin USP Cox B Capsule Celecoxib INN Curin Tablet Levocetrizine Dihydrochloride INNDecacycline Capsule Tetracycline Hydrochloride BP Decomit Inhaler Beclomethasone Dipropionate BPDecomit Nasal Spray Beclomethasone Dipropionate BPDeflux Tablet Domperidone Maleate BP/

/Suspension Domperidone BP/Paediatric Drops

Dextromethorphan Dextromethorphan Hydrobromide BPSyrup

Diactin Tablet Glipizide BP Diaglit Tablet Pioglitazone Hydrochloride INN Diapro Tablet Gliclazide BP Diaryl Tablet Glimepiride INN Diavix Tablet Lamivudine INN and Zidovudine USP Dilapress Tablet Carvedilol BP Ecotrim Cream Econazole Nitrate BP and

Triamcinolone Acetonide BPEfol-ER Capsule Ferrous Sulphate BP, Folic Acid USP

and Zinc Sulphate Monohydrate USP

Enaril Tablet Enalapril Maleate USPEpilep Tablet Carbamazepine BP Eplon Capsule Zaleplon INN

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162

166168171173

175

176178181184

186188189

191193194

196198201

204207210213215

216219222

Etrocin Tablet Erythromycin USP/Suspension

Evo Tablet Levofloxacin Hemihydrate INNFertil Tablet Clomiphene Citrate USPFibril Capsule Gemfibrozil USPFilmet Tablet Metronidazole BP/Metronidazole

/Suspension Benzoate BPFlatameal-DS Tablet Aluminium Hydroxide Gel USP,

/Suspension Magnesium Hydroxide BP and Simethicone USP

Flubex Capsule/Syrup Flucloxacillin Sodium BPFormula E Tablet Vitamin E USPFrelax Powder Polyethylene Glycol 3350 USP NFFrenxit Tablet Flupentixol Dihydrochloride BP and

Melitracen Hydrochloride INN Fungistin Suspension Nystatin BPFurasep Cream Nitrofurazone USPFusidic Plus Ointment Sodium Fusidate BP and

Hydrocortisone Acetate BPGastalfet Tablet Sucralfate USPGentosep Cream Gentamicin Sulphate BPHefolin SR Capsule Ferrous Sulphate BP and

Folic Acid BPInarzin Tablet Cinnarizine BP Informet LA Tablet Metformin Hydrochloride BP Intracef Capsule Cephradine BP


Intracef Injection Cephradine USP Ipramid Inhaler Ipratropium Bromide BPIsofloxin Tablet Pefloxacin Mesilate BP Keolax Tablet Clobazam BP Lactameal Tablet Aluminium Hydroxide Gel USP and

/Suspension Magnesium Hydroxide BPLarnox LA Tablet Aminophylline BP Lucidol Capsule Tramadol Hydrochloride BP Megadox Capsule Doxycycline Hydrochloride BP

xvii



225

225

229

231234237239244

246248250

252254

256

258263269271273275277280282

286

289292

Megatrim DS Tablet Trimethoprim BP and Sulfamethoxazole BP

Megatrim Suspension Trimethoprim BP and Sulfamethoxazole BP

Melphin Tablet Pyrantel Pamoate USP/Suspension

Modipran Capsule Fluoxetine Hydrochloride BPMomento Tablet/Syrup Desloratadine INN Monate Tablet Isosorbide Mononitrate BP Monocast Tablet Montelucast Sodium INNNapa Tablet/Syrup Paracetamol BP


Nazolin Nasal Spray Oxymetazoline Hydrochloride USPNebactil Suspension Nalidixic Acid BPNeo Kit Clarithromycin USP, Omeprazole BP

and Metronidazole BP Neocard Tablet Diltiazem Hydrochloride USPNeoceptin R Tablet Ranitidine Hydrochloride USP

/SyrupNeodrop Simethicone USP

Paediatric DropsNeofloxin Tablet Ciprofloxacin Hydrochloride USPNeopril Tablet Lisinopril USPNeosten Cream Clotrimazole BP Neosten VT Clotrimazole BP Nightus Tablet Bromazepam BPNoscab Cream Permethrin INN Nuprafen Tablet Naproxen USPOdrel Tablet Clopidogrel Bisulfate INN Omastin Capsule Fluconazole INN

/SuspensionOpton Tablet Esomeprazole Magnesium

Trihydrate INN Pacet Tablet Amiodarone Hydrochloride BPPedeamin Syrup Diphenhydramine Hydrochloride BP

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225

225

248250

258330345359366

366

147

186269271282

355

275

51

341

Anti-microbial preparation

Megatrim DS Tablet Trimethoprim and Sulfamethoxazole

Megatrim Suspension Trimethoprim and Sulfamethoxazole

Nebactil Suspension Nalidixic Acid Neo Kit Clarithromycin, Omeprazole

and Metronidazole Neofloxin Tablet Ciprofloxacin Hydrochloride Rolacin Tablet Clarithromycin Sparlin Tablet Sparfloxacin Triocim Capsule/Suspension Cefixime Trihydrate Tycil Capsule/Suspension Amoxicillin Trihydrate /Paediatric DropsTycil DS Suspension Amoxicillin Trihydrate

AntifungalsEcotrim Cream Econazole Nitrate and

Triamcinolone Acetonide Fungistin Suspension Nystatin Neosten Cream Clotrimazole Neosten VT Clotrimazole Omastin Capsules Fluconazole /SuspensionTerbex Cream/Tablet Terbinafine Hydrochloride

AntidermatophytesNoscab Cream Permethrin

Anti-migraine preparationAvidro Tablet Pizotifen Malate

Anti-obesity preparationSibulin Capsule Sibutramine Hydrochloride

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294

296300302305308310313316319321323325327

330333335339341

344345347349353355357359

361

Pregvit Capsule Ferrous Sulphate BP, Folic Acid USP, Thiamine Mononitrate USP, Riboflavin USP, Nicotinamide USP,Pyridoxine Hydrochloride USP & Ascorbic Acid USP

Premil Tablet Repaglinide USPPretin Tablet Loratadine INN Primace Capsule Ramipril BPProceptin-20 Capsule Omeprazole BP Prosan Tablet Losartan Potassium INN Prosfin Tablet Finasteride USPProtolan Capsule Lansoprazole USP Recox Tablet Rofecoxib INN Recur Tablet Finasteride USP Reflon Tablet Glucosamine Hydrochloride USPRelentus Tablet Tizanidine Hydrochloride INNResitone Tablet Spironolactone BP and Frusemide BPReumafen Tablet lbuprofen BP

/SuspensionRolacin Tablet Clarithromycin USPRostil Tablet Mebeverine Hydrochloride BP Sensipin Tablet Clozapine BPSerelose Solution Lactulose Solution BP Sibulin Capsule Sibutramine Hydrochloride

Monohydrate INNSpanil Tablet Hyoscine Butylbromide BPSparlin Tablet Sparfloxacin INN Spulyt Tablet/Syrup Bromhexine Hydrochloride BPTamona Tablet Tamoxifen Citrate BP Taverin Tablet Drotaverine Hydrochloride INN Terbex Cream/Tablet Terbinafine Hydrochloride INNTofen Tablet/Syrup Ketotifen Fumarate BP Triocim Capsule Cefixime Trithydrate USP

/SuspensionTriovix Tablet Lamivudine INN, Zidovudine USP

and Nevirapine INN

xix



94

280

6

333344353374

123

347364

158213273

239357395

111891

AntioxidantCarocet Tablet Beta Carotene, Ascorbic Acid

and dl-alpha-Tocopheryl Acetate

Anti-platelet aggregation preparation Odrel Tablet Clopidogrel Bisulphate

Anti-resorptive preparationAlendon Tablet Alendronate Sodium

Anti-spasmodicRostil Tablet Mebeverine Hydrochloride Spanil Tablet Hyoscine Butylbromide Taverin Tablet Drotaverine Hydrochloride Uricon Tablet Oxybutynin Choloride

AntitussiveDextromethorphan Syrup Dextromethorphan

Hydrobromide Spulyt Tablet/Syrup Bromhexine Hydrochloride Tripec Syrup Guaifenesin, Pseudoephedrine

& Triprolidine

Anxiolytics preparationEplon Capsule Zaleplon Keolax Tablet Clobazam Nightus Tablet Bromazepam

Asthma ProphylacticMonocast Tablet Montelukast Sodium Tofen Tablet/Syrup Ketotifen Fumarate Zukast Tablet Zafirlukast

Cardiovascular preparationAmdocal Tablet Amlodipine Besylate Arbit Tablet Irbesartan Cardopril Tablet Captopril

xxvii



364

366

366369371

374377379382386389391393395401

Tripec Syrup Guaifenesin BP, Pseudoephedrine Hydrochloride BP and TriprolidineHydrochloride BP

Tycil Capsule Amoxicillin Trihydrate BP/Suspension/Paediatric Drops

Tycil DS Suspension Amoxicillin Trihydrate BPTynisol Drops MultivitaminUltrafen Tablet Diclofenac Sodium BP/Diclofenac

/Suppository/Gel Diethylamine BPUricon Tablet Oxybutynin Chloride USPUroflo Capsule Tamsulosin Hydrochloride INNValcap Capsule Valsartan INN V-Cox Tablet Valdecoxib INNXynofen-100 SR Capsule Ketoprofen BPYamadin Tablet Famotidine USPZedex-DS Syrup Zinc Sulphate Monohydrate USP Zocil Tablet Cilostazol INN Zukast Tablet Zafirlukast INN Zymet Tablet Pancreatin BP

xx




1

Aeronid®

Inhaler

DescriptionBudesonide BP, the active ingredient of Aeronid Inhaler, is acorticosteroid designated that exhibits potent glucocorticoid activity andweak mineralocorticoid activity. Corticosteroids have been shown to havea wide range of inhibitory activities against multiple cell types (e.g., mastcells, eosinophils, neutrophils, macrophages, and lymphocytes) andmediators (e.g., histamine, eicosanoids, leukotrienes, and cytokines)involved in allergic and non-allergic-mediated inflammation. These anti-inflammatory actions of budesonide contribute to their efficacy inasthma.

IndicationsAeronid Inhaler is indicated for the maintenance treatment of asthma asprophylactic therapy in adult and paediatric patients six years of age orolder. It is also indicated for patients requiring oral corticosteroid therapyfor asthma, many of those patients may be able to reduce or eliminatetheir requirement for oral corticosteroids over time.

Aeronid Inhaler is NOT indicated for the relief of acute bronchospasm.

Dosage and AdministrationAeronid Inhaler should be administered by the orally inhaled route inasthmatic patients age 6 years and older. Individual patients willexperience a variable onset and degree of symptom relief. Generally,Aeronid Inhaler has a relatively rapid onset of action for an inhaledcorticosteroid. Improvement in asthma control following inhaledadministration of Aeronid Inhaler can occur within 24 hours of initiationof treatment, although maximum benefit may not be achieved for 1 to 2weeks, or longer. The safety and efficacy of Aeronid Inhaler whenadministered in excess of recommended doses have not been established.

The recommended starting dose and the highest recommended dose ofAeronid Inhaler, based on prior asthma therapy, are listed in the followingtable.


2

*In patients with mild to moderate asthma who are well controlled on inhaledcorticosteroids, dosing with Aeronid Inhaler 200 µg or 400 µg once daily may beconsidered. Aeronid Inhaler can be administered once daily either in the morningor in the evening.

If the once-daily treatment with Aeronid Inhaler does not provideadequate control of asthma symptoms, the total daily dose should beincreased and/or administered in divided doses.

Patients Maintained on Chronic Oral CorticosteroidsInitially, Aeronid Inhaler should be used concurrently with the patient’susual maintenance dose of systemic corticosteroid. After approximatelyone week, gradual withdrawal of the systemic corticosteroid is started byreducing the daily or alternate daily dose. The next reduction is made afteran interval of one or two weeks, depending on the response of thepatient. Generally, these decrements should not exceed 2.5 mg ofprednisone or its equivalent. A slow rate of withdrawal is stronglyrecommended. During reduction of oral corticosteroids, patients shouldbe carefully monitored for asthma instability, including objective measuresof airway function, and for adrenal insufficiency. During withdrawal,some patients may experience symptoms of systemic corticosteroid

Adults: Bronchodilators alone

200 to 400 µg twice daily

400 µg twice daily

Inhaled Corticosteroids*


800 µg twice daily

Oral Corticosteroids

400 to 800 µgtwice daily

800 µg twice daily

Children: Bronchodilators alone

200 µg twice daily 400 µg twice daily

Inhaled Corticosteroids*


400 µg twice daily

Oral Corticosteroids

The highest recommended dose in childrenis 400 µg twice daily

Previous Therapy

Recommended Starting Dose

Highest Recommended Dose


3

withdrawal, e.g., joint and/or muscular pain, lassitude and depression,despite maintenance or even improvement in pulmonary function. Suchpatients should be encouraged to continue with Aeronid Inhaler butshould be monitored for objective signs of adrenal insufficiency. Ifevidence of adrenal insufficiency occurs, the systemic corticosteroid doseshould be increased temporarily and thereafter withdrawal should becontinued more slowly. During periods of stress or a severe asthmaattack, transferred patients may require supplementary treatment withsystemic corticosteroids.

ContraindicationBudesonide inhalation aerosol is contraindicated in the primary treatmentof status asthmaticus or other acute episodes of asthma where intensivemeasures are required.

Hypersensitivity to Budesonide contraindicates the use of AeronidInhaler.

PrecautionsDuring withdrawal from oral corticosteroids, some patients mayexperience symptoms of systemically active corticosteroid withdrawal,e.g., joint and/or muscular pain, lassitude, and depression, despitemaintenance or even improvement of respiratory function.

Aeronid Inhaler will often permit control of asthma symptoms with lesssuppression of hypothalamic-pituitary-adrenal (HPA) function thantherapeutically equivalent oral doses of prednisone. Since budesonide isabsorbed into the circulation and can be systemically active at higherdoses, the full beneficial effects of Aeronid Inhaler in minimizing HPAdysfunction may be expected only when recommended dosages are notexceeded and individual patients are titrated to the lowest effective dose.Since individual sensitivity to effects on cortisol production exists,physicians should consider this fact when prescribing Aeronid Inhaler.

Because of the possibility of systemic absorption of inhaledcorticosteroids, patients treated with these drugs should be observedcarefully for any evidence of systemic corticosteroid effects. Particularcare should be taken in observing patients postoperatively or duringperiods of stress for evidence of inadequate adrenal response.

It is possible that systemic corticosteroid effects such as hypercorticismand adrenal suppression may appear in a small number of patients,particularly at higher doses. If such changes occur, Aeronid Inhalershould be reduced slowly, consistent with accepted procedures formanagement of asthma symptoms and for tapering of systemic steroids.

A reduction of growth velocity in children or teenagers may occur as aresult of inadequate control of chronic diseases such as asthma or fromuse of corticosteroids for treatment. Physicians should closely follow thegrowth of all paediatric patients taking corticosteroids by any route andweigh the benefits of corticosteroid therapy and asthma control againstthe possibility of growth suppression.

Although patients in clinical trials have received Aeronid Inhaler on acontinuous basis for periods of 1 to 2 years, the long-term local andsystemic effects of Aeronid Inhaler in human subjects are not completelyknown. In particular, the effects resulting from chronic use of AeronidInhaler on developmental or immunological processes in the mouth,pharynx, trachea, and lung are unknown.

In clinical trials with Aeronid Inhaler, localized infections with Candidaalbicans occurred in the mouth and pharynx in some patients. Iforopharyngeal candidiasis develops, it should be treated with appropriatelocal or systemic (i.e., oral) antifungal therapy while still continuing withAeronid Inhaler therapy, but at times therapy with Aeronid Inhaler mayneed to be temporarily interrupted under close medical supervision.

Inhaled corticosteroids should be used with caution, if at all, in patientswith active or quiescent tuberculosis infection of the respiratory tract,untreated systemic fungal, bacterial, viral or parasitic infections; or ocularherpes simplex.

Rare instances of glaucoma, increased intraocular pressure, and cataractshave been reported following the administration of inhaledcorticosteroids.

Side EffectsThe following adverse reactions were reported in patients treated withAeronid Inhaler.


4


5

General : Headache, flu-like syndrome, pain, back pain, fever, neck pain,asthenia; Respiratory system : Respiratory tract infections, pharyngitis,sinusitis, rhinitis, voice alteration, cough aggravation; Digestive System : Oralcandidiasis, dyspepsia, gastroenteritis, nausea, abdominal pain, dry mouth,vomiting; Metabolic and Nutritional : Weight gain; Musculoskeletal : Fracture,myalgia, arthralgia; Nervous system : Syncope, hypertonia, migraine; Skin :Ecchymosis; Psychiatric : Insomnia; Resistance Mechanisms : Infection; SpecialSenses : Taste perversion.

Paediatric Studies There were no clinically relevant differences in the pattern or severity ofadverse events in children compared with those reported in adults.

Adverse event reports from other sources : Rare adverse events reported includeimmediate and delayed hypersensitivity reactions including rash, contactdermatitis, urticaria, angioedema and bronchospasm; symptoms ofhypocorticism and hypercorticism; psychiatric symptoms includingdepression, aggressive reactions, irritability, anxiety and psychosis.

Pharmaceutical PrecautionsPressurized canister, do not puncture, break or incinerate even whenapparently empty. Avoid storage in direct sunlight or heat. Store below30o C. Keep away from eyes and children.

Commercial PackAeronid 100 Inhaler : Each canister contains 200 metered doses, eachcontaining 100 µg Budesonide BP.

Aeronid 200 Inhaler : Each canister contains 200 metered doses, eachcontaining 200 µg Budesonide BP.


6

Alendon®

Tablet

DescriptionAlendon is a preparation of Alendronic Acid, a biphosphonate used inthe treatment and prevention of osteoporosis in post-menopausalwomen.

IndicationsAlendon is indicated for:♦ Treatment and prevention of osteoporosis in post-menopausal women

♦ For the treatment of osteoporosis, Alendon increases bone mass andreduces the incidence of fractures, including those of the hip and spine(vertebral compression fractures)

♦ For the prevention of osteoporosis, Alendon may be considered inpostmenopausal women who are at risk of developing osteoporosisand for whom the desired clinical outcome is to maintain bone massand to reduce the risk of future fracture

♦ Treatment to increase bone mass in men with osteoporosis

♦ Treatment of glucocorticoid-induced osteoporosis in men and womenreceiving glucocorticoids in a daily dosage equivalent to 7.5 mg orgreater of prednisone and who have low bone mineral density. Patientstreated with glucocorticoids should receive adequate amounts ofcalcium and vitamin D

♦ Treatment of Paget’s disease of bone in men and women

Dosage and Administration Treatment of osteoporosis in postmenopausal womenThe recommended dose is one Alendon 70 tablet (70 mg) once weekly orone Alendon tablet (10 mg) once daily.

Treatment to increase bone mass in men with osteoporosisThe recommended dose is one Alendon tablet (10 mg) once daily.Alternatively, one Alendon 70 tablet (70 mg) once weekly may beconsidered.


7

Prevention of osteoporosis in postmenopausal women The recommended dose is 35 mg once weekly or 5 mg once daily. Thesafety of treatment and prevention of osteoporosis with Alendronic Acidhas been studied for up to 7 years.

Treatment of glucocorticoid-induced osteoporosis in men and womenThe recommended dose is 5 mg once daily, except for postmenopausalwomen not receiving estrogen, for whom the recommended dose is 10mg once daily.

Paget’s disease of bone in men and womenThe recommended treatment regimen is 40 mg once a day for six months.

Mode of Administration Swallow the tablet with a full glass of water at least 30 minutes beforebreakfast (and any other oral medication) on empty stomach. Patientsshould remain stand or sit upright for at least 30 minutes after taking thetablet and should not be down before eating the first meal of the day. Donot take the tablet at bedtime. Hypocalcemia should be corrected beforestarting the therapy.

PrecautionsUse in elderly : No dosage adjustment is required for elderly patients.Because in clinical study there was no evidence of age-related differencesin the efficacy or safety profiles of Alendronic Acid.

Children : It is not recommended for use.

Pregnant women : Alendronate should not be given to pregnant women.

ContraindicationHypocalcemia; Renal impairment; Vitamin D deficiency; Activegastrointestinal problem such as dysphagia, oesophago-duodenitis orulcer; Pregnancy and breast feeding and Hypersensitivity to anycomponents of the tablet.

OverdosageNo such information on overdosage with Alendronate.


8

Side EffectsThe commonest symptomatic side effects are constipation, diarrhoea,esophageal ulcer, flatulence, dysphagia, musculoskeletal pain, headache,rarely rash, erythema, transient decrease in serum calcium and phosphate,nausea, vomiting, peptic ulceration, hypersensitivity reactions includingurticaria and angioedema.

Drug InteractionsThe incidence of upper gastrointestinal side effects are increased with theconcomitant use of non-steroidal anti-inflammatory agents and aspirin.Absorption of Alendronate is reduced in the presence of antacids andcalcium supplements.

Commercial PackAlendon 70 Tablet : Box containing 30 tablets in 3 x 10’s blister strips.Each tablet contains Alendronate Sodium BP equivalent to 70 mg ofAlendronic Acid.

Alendon 10 Tablet : Box containing 30 tablets in 3 x 10’s blister strips.Each tablet contains Alendronate Sodium BP equivalent to 10 mg ofAlendronic Acid.


9

Alphin®DS Tablet

DescriptionAlphin DS (Albendazole) is a broad spectrum anthelmintic available aschewable tablets, each containing 400 mg of Albendazole USP. It is a verypotent benzimidazole carbamate anthelmintic used in the treatment ofvarious intestinal worm infestations and hydatid disease.

Indications Alphin DS (Albendazole) is indicated in- Ascariasis, Trichuriasis, Strongyloidiasis and Hookworm infestations - Enterobiasis, Capillariasis, Cysticercosis and Cutaneous larva migrans - Hydatid disease- Surgery as an adjunct therapy (either pre-or post-operatively)

Dosage and Administration The usual dose for adults and children aged 2 years or over with ascariasis(roundworm), hookworm infestations, trichuriasis (whipworm) andcutaneous larva migrans is 400 mg as a single dose. In strongyloidiasis,400 mg is given daily for 3 consecutive days. This may be repeated after 3weeks if necessary. In enterobiasis (pinworm, threadworm), children aged2 years or more have been given a single dose of 100 mg repeated after 7days; the adult dose is 400 mg repeated after 7 days. In hydatid disease, theusual dose is 400 mg twice daily for adults. This is mostly given for 28-daycycles with a 2-week interval between cycles. The number of cycles rangesfrom 1 to 12, though 3 cycles may be sufficient for most cysts.

Side Effects Gastrointestinal disturbances, headache and dizziness have been reportedduring treatment. These symptoms are usually mild and resolve withouttreatment. Rash, fever and rarely alopecia may occur during treatment.

ContraindicationAlbendazole is absolutely contraindicated during pregnancy.


10

PrecautionsElevations in hepatic enzyme levels and reversible reduction in total whitecell count have occasionally been reported. These changes appear to bemore common during treatment of E. multilocularis.

Drug Interactions Albendazole has been shown to induce liver enzymes of the cytochromeP450 system responsible for its own metabolism. There is, therefore, atheoretical risk of interaction with Theophylline, anticonvulsants,anticoagulants, oral contraceptives and oral hypoglycaemics. Care shouldtherefore be exercised during the introduction of Albendazole in patientsreceiving the above groups of compounds.

Overdosage There is no experience of overdosage. Gastric lavage may be performedin the first two to three hours after ingestion. No specific antidote isknown. However, symptomatic treatment and general supportivemeasures should be undertaken as required.

Commercial PackAlphin DS Tablet : Box containing 50 chewable tablets in 5 x 10'saluminium strips, each chewable tablet contains Albendazole USP 400 mg.


11

Amdocal®Tablet

DescriptionAmdocal (Amlodipine) is a dihydropyridine calcium antagonist, with along duration of action, used for the treatment of hypertension andangina pectoris.

IndicationsHypertensionAmdocal is indicated for the treatment of hypertension. It may be usedalone or in combination with other antihypertensive agents.

Stable AginaAmdocal is indicated for the treatment of stable angina. Amdocal may beused alone or in combination with other antianginal agents.

Vasospastic AnginaAmdocal is indicated for the treatment of confirmed or suspectedvasospastic angina. Amdocal may be used as single therapy or incombination with other antianginal drugs.

Dosage and AdministrationThe usual initial antihypertensive oral dose is 5 mg once daily with amaximum dose of 10 mg once daily. Elderly individuals or patients withhepatic insufficiency may be started on 2.5 mg once daily dose and thisdose may be used when adding Amdocal to other antihypertensivetherapy.

Dosage should be adjusted according to each patient’s need

The recommended dose for stable or vasospastic angina is 5-10 mg, withthe lower dose suggested in the elderly and in patients with hepaticinsufficiency.

ContraindicationAmlodipine is contraindicated in patients with known hypersensitivity toAmlodipine.


12

PrecautionsGeneral : Since the vasodilatation induced by Amlodipine is gradual inonset, acute hypotension has rarely been reported after oraladministration of Amlodipine. Nonetheless, caution should be exercisedwhen administering Amlodipine with any other peripheral vasodilatorparticularly in patients with severe aortic stenosis.

Use in Patient with Congestive Heart Failure : Although haemodynamicstudies and a controlled trial in Class-II-III heart failure patients haveshown that Amlodipine did not lead to clinical deterioration as measuredby exercise tolerance, left ventricular ejection fraction and clinicalsymptomatology in general, all calcium channel blockers should be usedwith caution in patients with heart failure.

β-blocker withdrawal : Amlodipine gives no protection against the dangerof abrupt β-blocker withdrawal; any such withdrawal should be gradualreduction of the dose of β-blocker.

Hepatic Failure : Since Amlodipine is extensively metabolized by the liver,so caution should be exercised when administering Amlodipine topatients with hepatic impairment.

Drug interactionsNo significant drug interaction.

Side EffectsPeripheral oedema may occasionally be severe but is fully reversible. Aswith other calcium antagonist drugs, peripheral oedema and skinerythema occur in a proportion of patients (5-10%) and facial flushing in2-5% of patients. Complaint of fatigue was also reported more frequentlythan in placebo-treated patients.

There is evidence that these effects are more common in patients treatedwith doses greater than 10 mg daily.

Overdosage In humans, experience with intentional overdosage of Amlodipine islimited. If massive overdosage occurs, active cardiac and respiratory


13

monitoring should be instituted. Frequent blood pressure measurementsare essential.

Commercial PackAmdocal-5 Tablet : Box containing 5 blister strips of 10 tablets, eachtablet contains Amlodipine Besylate INN equivalent to Amlodipine 5 mg.

Amdocal-10 Tablet : Box containing 3 blister strips of 10 tablets, eachtablet contains Amlodipine Besylate INN equivalent to Amlodipine 10 mg.


14

Anustat®

Ointment

DescriptionPale yellow coloured homogenous ointment containing in each gram :Cinchocaine Hydrochloride BP 5 mg, Hydrocortisone BP 5 mg,Neomycin Sulphate USP equivalent to Neomycin 10 mg, EsculinSesquihydrate Ger. P. equivalent to Esculin 10 mg.

ActionIt provides an excellent combination of anti-inflammatory, anti-allergicand antipruritic action of corticosteroid, antibacterial action of locallyeffective antibiotic Neomycin, local anaesthetic action of Cinchocaineand skin protective action of Esculin.

IndicationsInternal and external haemorrhoid, anal fissure, anal pruritus, perianaleczema, proctitis, pre-operative and post-operative treatment ofhaemorrhoidectomy, post-partum haemorrhoidal condition and asprophylaxis in between attacks.

Dosage and ApplicationA small quantity of the ointment should be applied with finger in thepainful pruritic area in the morning and evening and after each stool. Fordeep application nozzle should be attached to the tube and inserted to fullextent and should be squeezed gently from the lower end whilewithdrawing.

Side Effects and WarningSide effects which have been reported for individual constituents mayoccur and appropriate precautions should be taken when using Anustat.

Like most of the steroids under certain circumstances hydrocortisonemay be absorbed in sufficient amount to produce systemic effects. So,long term use should be avoided. Adrenal suppression may occur evenwithout occlusion. When used for prolonged period striae may occur.


15

Skin sensitisation may occur due to Neomycin. Absorption of theantibiotic from wound or inflamed skin may occur and this may affect thehearing irreversibly. Hence Anustat should not be given to extensivelydamaged skin.

ContraindicationSensitivity to any one of the constituents of Anustat.

PregnancyTopical steroid should not be used extensively in pregnancy.

Commercial PackAnustat Ointment : 15 g ointment in sealed aluminium tube with nozzlefor application.


16

Apresin®

Tablet

DescriptionFluphenazine Hydrochloride BP and Nortriptyline Hydrochloride BPcombination has been found as an effective preparation for the patientssuffering from "anxiety" or "depression" or both. Fluphenazine is atranquilizer of the phenothiazine type. Nortriptyline is a tricyclicantidepressant having less sedative action. This combination helps torestore functional ability without developing any drug dependence.

Dosage and AdministrationAdults : One Apresin tablet (Fluphenazine HCl 0.5 mg and Nortriptyline 10mg as Nortriptyline HCl) 2 to 3 times daily.

Indications- Mild to moderate mixed anxiety/depression- Emotional disturbance- Sleep disorder- Gastric problems

ContraindicationIt is contraindicated in :

- History of gradual epilepsy or organic brain damage- Blood dyscrasia- Severe cardiac insufficiency- Renal or liver damage- Patients taking monoamine oxidase inhibitor (MAOI) - Younger children- Hypersensitivity to any component of the preparation

Adverse Effects Tardive dyskinesias have been reported in phenothiazine therapy; usuallyafter prolonged courses given at doses adequately to control psychoticillness. Blood dyscrasia, malignant neuroleptic syndrome and suddendeath have been reported rarely. Agranulocytosis is a rare but potentiallyfatal adverse effect of Nortriptyline Hydrochloride.


17

Use in Pregnancy and Lactation The safety in human pregnancy has not been yet established. The use ofthis drug in lactation is not recommended, as it is excreted in breast-milk.

Precautions Precautions should be taken in patients with glaucoma, prostateenlargement, cardiac failure and myocardial infarction, and in concurrentadministration with CNS depressants. The drug may impair alertness andabilities to drive a car or operate machinery.

Drug InteractionsInteractions with barbiturates, alcohol, and narcotic drugs may occur, socentral depressants should be administered with caution.

Pharmaceutical Precautions Store in a cool place below 25o C. Keep out of the reach of children.

Commercial PackApresin Tablet : Box containing 10 blister strips of 10 film coated tablets.Each tablet contains Fluphenazine Hydrochloride BP 0.5 mg andNortriptyline 10 mg as Nortriptyline Hydrochloride BP.


18

Arbit®Tablet

DescriptionArbit (Irbesartan) is an antihypertensive drug. It antagonizes angiotensinII receptor (AT1 subtype).

IndicationsArbit is indicated for the treatment of hypertension. It may be used aloneor in combination with other antihypertensive agents.

Dosage and AdministrationThe recommended initial dose of Arbit is 150 mg once daily. Patientsrequiring further reduction in blood pressure should be treated to 300 mgonce daily. Arbit may be administered with or without food.

ContraindicationArbit is contraindicated in patients who are hypersensitive to anycomponent of this product.

Side EffectsIn placebo-controlled clinical trials the adverse event, which occurred inat least 1% of patients treated with Irbesartan and at a higher incidenceversus placebo, included diarrhoea, dyspepsia, trauma, fatigue, and upperrespiratory infection. Irbesartan use was not associated with an increasedincidence of dry cough, as is typically associated with ACE inhibitor use.Rare side effects are urticaria, angioedema, jaundice, hyperkalaemia, andincreased liver function tests.

Use in Special PopulationsPaediatric : There is no data on safety and effectiveness of Irbesartan inchildren.

Geriatric : In elderly subjects (age 65-80 years), no dosage adjustment isnecessary.

Renal Insufficiency : No dosage adjustment is necessary in patients withmild to severe renal impairment.


19

Hepatic Insufficiency : No dosage adjustment is necessary in patients withhepatic insufficiency.

Pregnancy and Nursing Mothers : When pregnancy is detected, Arbitshould be discontinued as soon as possible. It is not known whetherIrbesartan is excreted in human milk, so it should not be prescribedduring lactation.

Drug InteractionsNo significant drug interaction has been found in studies withHydrochlorothiazide, Digoxin, Warfarin, and Nifedipine.

OverdosageNo data is available in regard to overdosage in humans. However, dailydoses of 900 mg for 8 weeks were well-tolerated. The most likelymanifestations of overdosage are expected to be hypotension.

Pharmaceutical PrecautionsStore at temperature between 15°C and 30°C.

Commercial PackArbit 75 Tablet : Box containing 30 tablets in 3 x 10's blister strips. Eachtablet contains Irbesartan INN 75 mg.

Arbit 150 Tablet : Box containing 30 tablets in 3 x 10’s blister strips. Eachtablet contains Irbesartan INN 150 mg.


20

Aristocal®Tablet

DescriptionAristocal contains Calcium Carbonate that is used as dietary calciumsupplement, and to sequester phosphorus in the intestine to reduce totalbody phosphate accumulation in chronic renal failure. Each Aristocaltablet contains 1250 mg Calcium Carbonate BP equivalent to 500 mgelemental Calcium.

Indications♦For dietary calcium supplement when it is deficient♦As a phosphate binder in chronic renal failure

♦As an adjunct therapy in the arrest or slowing down of bonedemineralization in osteoporosis.

Dosage and AdministrationAdults and Elderly : Dietary deficiency- 2 to 3 tablets daily. As Phosphatebinder- Dose as required by the individual patient depending on serumcalcium and phosphate levels. Adjunct to osteoporosis therapy- 2 to 3tablets daily.

Contraindication♦ Hypercalcaemia and hyperparathyroidism♦ Renal calculi and nephrolithiasis♦ Zollinger-Ellision syndrome and other causes of gastric acid

hypersecretion.

Adverse EffectsMild gastrointestinal disturbances (e.g. flatulence, abdominal pain,constipation) may occur. Hypercalcaemia and alkalosis are rarelyproduced with large doses.

Precautions In mild hypercalciuria or renal failure or stone formation in urinary tract,adequate checks must be kept on urinary calcium excretion. If necessarythe dosage should be reduced or calcium therapy discontinued.


21

Use in Pregnancy and LactationCalcium containing drugs are used widely in pregnancy by way of oralcalcium supplementation. Calcium Carbonate can be used in lactatingwomen too.

Drug InteractionsCalcium Carbonate may enhance the cardiac effects of Digoxin and other cardiac glycosides if systemic hypercalcaemia occurs. It may interfere withthe absorption of concomitantly administered Tetracycline preparations.Modification of vitamin D therapy may be required to avoidhypercalcaemia when Calcium Carbonate is used as a phosphate binder inchronic renal failure. Concurrent administration of Calcium Carbonatereduces total absorption and peak serum levels of Ciprofloxacin.

Pharmaceutical PrecautionsStore in a cool and dry place. Keep out of the reach of children.

Commercial PackAristocal Tablet : Box containing 50 tablets in 5 x 10’s blister strips. Eachtablet contains Calcium Carbonate BP equivalent to 500 mg elementalCalcium.


22

Aristoferon®

Syrup

DescriptionAristoferon is a haematinic preparation of Ferrous Sulphate available asraspberry flavored syrup. Each 5 ml of syrup contains 200 mg of FerrousSulphate BP.

Ferrous Sulphate has the general properties of iron salts and is one of themost widely used iron salts in the treatment of iron deficiency anaemia.

IndicationsAristoferon is indicated in the treatment and prevention of irondeficiency anaemia and anaemia of pregnancy where routineadministration of iron is necessary.

Dosage and AdministrationAdultInitial therapeutic dose : 3-4½ teaspoonful daily in divided doses or asprescribed by the physician.

Maintenance dose : 1½ teaspoonful daily, but if needed up to 1.8g (9 teaspoonful) daily can be given.

Children♦Under 1 year : ¼ th teaspoonful thrice daily or as directed by physician♦1-5 years : 1 teaspoonful thrice daily♦6-12 years : 1½ teaspoonful twice daily

Note :i) Mix with water or fruit juice to avoid temporary staining of teeth.ii) Do not mix with milk.

Contraindication♦ Iron therapy is contraindicated in haemachromatosis and

haemosiderosis.♦ It should not be given to patients receiving repeated blood transfusion

or with anaemia not produced by iron deficiency.


23

PrecautionsShould be administered with caution when given to patients with ironstorage or iron absorption disease, haemoglobinopathies or existinggastrointestinal disease. Absorption of iron salt and Tetracycline isdiminished when taken concomitantly by mouth. If treatment with bothdrugs is required iron salt should be given 3 hours before or 2 hours afterTetracycline. Absorption of iron is also decreased in the presence ofAntacids or when taken with tea.

Side EffectsTherapeutic doses of iron may cause gastrointestinal symptoms likediarrhoea, nausea and vomiting. Although iron is better absorbed betweenmeals, side effects can be reduced by taking it with or immediately afterfood. Continuous administration may sometimes cause constipation. Ironcontaining liquid medication may cause temporary staining of teeth (thisis less likely when diluted).

Commercial PackAristoferon Syrup : Aristoferon 200 ml syrup in glass bottle, each 5 mlcontaining 200 mg of Ferrous Sulphate BP.


24

Aristofol-Fe®

Tablet

Description Each sugar coated Aristofol-Fe tablet contains 308 mg of FerrousFumarate BP (eqv. to 100 mg of elemental iron) and 350 µg of Folic AcidUSP. Iron and Folic Acid are required for normal haemopoiesis.

IndicationsProphylaxis and treatment of iron deficiency anaemia in pregnancy.Prevention of megaloblastic anaemia of pregnancy.

Dosage and Administration♦ In anaemia usual dose is one tablet daily.

♦ In severe or refractory iron deficiency anaemia, one tablet twice dailymay be given.

♦ In Pregnancy, it is recommended that Aristofol-Fe should be started atthe first antenatal consultation and continued until 3 months afterdelivery.

ContraindicationAristofol-Fe is contraindicated in megaloblastic anaemia due to vitaminB12 deficiency.

PrecautionsAdministration of Aristofol-Fe during the first trimester of pregnancymay be undesirable. Very few pregnant women are not protected byphysiological doses of folic acid. If anaemia is developed despiteprophylaxis with Aristofol-Fe, patients should be investigated further.Some postgastrectomy patients show poor absorption of iron. Care isneeded when treating patients with peptic ulcer. When Aristofol-Fe andTetracycline are taken concomitantly, absorption of both drugs arereduced. Concurrent administration of antacid may reduce absorption ofiron. Serum anticonvulsant levels may be reduced by administration offolate.


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Side EffectsGastrointestinal disorders and allergic reactions have been reported.

Treatment of OverdosageIngestion of an overdose of iron orally requires emergency treatmentalong the following lines. Vomiting should be induced immediately,followed (as soon as possible) by parenteral injection of DesferrioxamineMesylate and then gastric lavage. In the mean time it is helpful to give milkand or 5% sodium bi-carbonate solution by mouth. Intramusculardesferrioxamine injection may be given. A desferrioxamine solution (5 gin 50-100 ml) may be left in the stomach. If Desferrioxamine is notavailable, 300 ml of 1% to 5% sodium bi-carbonate solution should beleft in the stomach. Fluid replacement is essential.

Commercial PackAristofol-Fe Tablet : Box containing 100 tablets in 10 x 10’s blister strips.Each sugar coated Aristofol-Fe tablet contains 308 mg of Ferrousfumarate (eqv. to 100 mg of elemental iron) and 350 µg of Folic Acid.


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Aristoplex®

Syrup

DescriptionAristoplex is a liquid preparation of Vitamin B-Complex. Each 5 mlAristoplex syrup contains:

Thiamine Hydrochloride BP 5 mg(Vitamin B1)Riboflavin (Vitamin B2) USP 2 mgPyridoxine Hydrochloride BP 2 mg(Vitamin B6)Nicotinamide BP 20 mg

Indications♦ Prevention and treatment of Vitamin B-Complex deficiency states,

manifested by glossitis, stomatitis, cheilosis, beriberi and polyneuritis.

♦ Maintenance of normal growth and health during the early days ofchildren.

♦ Apathy and anorexia in elderly patients.

♦ Prevention of vitamin deficiencies, particularly when depletion issuspected;

- Pregnancy and lactation- Convalescence during debilitating illness- Patients on restricted diets

Dosage and AdministrationAdults and Elderly : One to two 5 ml spoonful syrup three times a day.Children : One 5 ml spoonful syrup three times a day. Infants : One 5ml spoonful syrup daily.


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ContraindicationKnown hypersensitivity to any of the active constituents.

PrecautionsPyridoxine may reduce the therapeutic efficacy of Levodopa.

Use in Pregnancy and LactationAs with all medicines, careful considerations should be given before theadministration of B-Complex preparations during the first trimester ofpregnancy. Vitamins are excreted in breast milk.

Pharmaceutical PrecautionsStore in a cool place. The syrup should be protected from light.

Commercial PackAristoplex Syrup : Aristoplex syrup is available in 100 ml and 200 mlamber glass bottle. Each 5 ml Aristoplex syrup contains multivitamin.


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Aristovit®-BTablet

DescriptionAristovit-B is a sugar coated tablet containing different B-Vitamins. Eachtablet contains 20 mg of Nicotinamide USP, 2 mg of PyridoxineHydrochloride USP, 2 mg of Riboflavin USP and 5 mg of ThiamineMononitrate USP.

IndicationsAristovit-B is indicated in the treatment and prevention of Vitamin Bdeficiencies, particularly when depletion is suspected, such as in case ofpregnancy and lactation, convalescence following debilitating illness andin restricted diet.

Dosage and AdministrationOne or two tablets three times daily.

ContraindicationContraindicated in case of hypersensitivity to any of the activeingredients of Aristovit-B.

PrecautionShould be given cautiously to patients taking Levodopa as Pyridoxinereduces the effect of Levodopa.

Commercial PackAristovit-B Tablet : Bottle containing 45 sugar coated tablets. Each sugarcoated tablet contains different B-Vitamin.


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Aristovit®-MTablet

DescriptionAristovit-M is sugar-coated multivitamin-mineral tablet.

Each tablet contains :

Vitamin A USP 1.5 mgVitamin D USP 10 µgThiamine Mononitrate (B1) USP 1.5 mgRiboflavin USP 1.7 mgAscorbic Acid USP 60 mgNicotinamide USP 20 mgPyridoxine HCl (B6) USP 2 mgFolic Acid USP 0.4 mgCalcium Pantothenate USP 10.92 mgCyanocobalamin (B12) USP 6 µgVitamin E USP 10.05mgFerrous Sulphate USP 50 mgPotassium Iodide USP 196 µgPotassium Sulphate BP 11.14 mgManganese Sulphate Monohydrate USP 1 mgCupric Sulphate Pentahydrate USP 2 mgZinc Sulphate USP 37.04 mg

Indications Deficiency states in acute and chronic disease. Conditions regardingspecific support : pregnancy, lactation, menopause, during treatment withantibiotics. The comprehensive formulae of Aristovit-M assures liberalamounts of important vitamins, minerals and trace elements needed bythe body during periods of increased energy requirements such as indisease and convalescence.

Dosage and AdministrationOne tablet daily or as advised by the physician.


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ContraindicationSupplemental vitamins and minerals should not be prescribed for patientswith haemochromatosis or Wilson’s disease.

Hypersensitivity to any of the active ingredients is a contraindication.Excessive doses of vitamin A and D can lead to hypervitaminosis. Whenmultivitamin preparations are prescribed allowance must be made forvitamins from other sources. This is particularly important during the firsttrimester of pregnancy when large doses of Vitamin A may beteratogenic.

Iron and Zinc chelate with Tetracyclines and absorption of all threeagents may be impaired.

Side EffectsMultivitamin preparation with ordinary doses of component are usuallynontoxic.

PrecautionsAristovit-M may be used in patients being treated for Parkinson’s diseasewith a Levodopa preparation which includes a dopa-decarboxylaseinhibitor (e.g. Carbidopa, Benserazide). But precautions should be takenPyridoxine acts as an antagonist of Levodopa.

Pharmaceutical PrecautionsStore in a cool and dry place at a temperature not exceeding 25°C andprotect from light.

Commercial PackAristovit-M Tablet : Bottle containing 30 sugar coated tablets. Each sugarcoated tablet contains multivitamin and mineral.


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Aristovit®-XTablet

DescriptionAristovit-X is a special formulation comprising of important vitamin,anti-oxidants and minerals. Each tablet contains:

Vitamin A 2000 IUVitamin E 50 IUVitamin K 75.00 µgVitamin C 200.00 mgZinc 15.00 mgCopper 1.00 mgManganese 3.00 mgSelenium 70.00 µg

IndicationsAristovit-X is a once-daily tablet indicated for use to develop immunesystem, help prevent the well-known deficiency diseases such as scurvy,beriberi, pellagra and others, prevent certain types of cancer by blockingthe formation of cancer causing substances in the body. It is also capableof combating cardiovascular and immunological disorders. Aristovit-Xhelps strengthen immune system, keeping free from sickness and allowinga better, harder workout.

Dosage and AdministrationAristovit-X may be administered once daily or as indicated by thephysician.

ContraindicationAristovit-X is contraindicated in patients with a known hypersensitivity toany of the ingredients.

Side EffectsGenerally well tolerated.


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PrecautionsExcess vitamin A intake may be toxic and may increase the risk of birthdefects. Pregnant women and women who may become pregnant shouldnot exceed total 5000 IU of vitamin A (retinyl palmitate) per day.

Drug InteractionsNo drug interactions have been reported.

Use in Pregnancy and LactationAristovit-X is recommended in pregnancy and lactation

Pharmaceutical PrecautionsTablets should be stored below 25οC and protected from light andmoisture.

Commercial PackAristovit-X Tablet : Plastic bottle containing 30 film coated tablets. Eachtablet contains multivitamin, antioxidants and minerals.


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Arixon®

Injection

DescriptionArixon (Ceftriaxone) is highly stable to most β-lactamase, bothpenicillinases and cephalosporinases of Gram-positive and Gram-negative bacteria. The action of Arixon is bactericidal which inhibits thecell wall synthesis. It is most effective against the followingmicroorganisms:

Gram-positive bacteria: Staphylococcus aureus (including penicillinaseproducing strains), Staphylococcus epidermis, Streptococcus, Streptococcuspneumoniae, Streptococcus bovis.

Gram-negative bacteria: Escherichia coli, Haemophilus influenzae (includingpenicillinase-producing strains), Neisseria gonorrhoeae, Neisseria meningitidis,Proteus mirabilis, Proteus vulgaris.

IndicationsIt is indicated for the treatment of sepsis; meningitis; abdominalinfections (peritonitis, infections of the biliary and gastrointestinal tracts),infections of the bones, joints, soft tissue, skin and/or wounds infectionsin patients with impaired defense mechanism; renal and urinary tractinfections; respiratory tract infections, particularly pneumonia, and ear,nose and throat infections, and genital infections including gonorrhoea.

Dosage and Administration Adults and children over twelve years : The usual dosage is 1 to 2 g of Arixonadministered once daily in 24 hours. In severe cases infections caused bymoderately sensitive organisms, the dose may be increased to 4 g once daily.

Neonates, infants and children up to 12 years : For Neonates (up to 2 weeks) adaily dose of 20-50 mg/kg body weight, not to exceed 50 mg/kg onaccount of the immaturity of the infants is advised. For children withbody weight of 50 kg or more, the usual adult dose should be used.


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Elderly patients : The dosage recommended for adults require nomodification in case of geriatric patients.

Duration of TherapyThe duration of therapy varies according to the course of the diseases. Aswith antibiotic therapy in general administration, Arixon should becontinued for a minimum of 48-72 hours after the patient has becomeafebrile or evidence of bacterial eradication has been obtained. For thetreatment of gonorrhoea, a single intramuscular dose of 250 mg Arixonis recommended.

PrecautionsAs with other cephalosporins anaphylactic shock cannot be ruled outeven if a thorough patient history is taken. Anaphylactic shock requiresimmediate counter measures.

Side EffectsDiarrhoea, nausea, vomiting, stomatitis and glossitis.

Pharmaceutical PrecautionsArixon should be stored at below 30o C.

Commercial PackArixon 250 mg IM Injection : Each box containing one vial ofCeftriaxone Sodium USP equivalent to Ceftriaxone 250 mg and oneampoule of 2 ml Lignocaine Injection BP 1%.

Arixon 500 mg IM Injection : Each box containing one vial ofCeftriaxone Sodium USP equivalent to Ceftriaxone 500 mg and oneampoule of 2 ml Lignocaine Injection BP 1%.

Arixon 1 g IM Injection : Each box containing one vial of CeftriaxoneSodium USP equivalent to Ceftriaxone 1 g and one ampoule of 3.5 mlLignocaine Injection BP 1%.

Arixon 250 mg IV Injection : Each box containing one vial ofCeftriaxone Sodium USP equivalent to Ceftriaxone 250 mg and oneampoule of 5 ml Water for Injection BP.


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Arixon 500 mg IV Injection : Each box containing one vial ofCeftriaxone Sodium USP equivalent to Ceftriaxone 500 mg and oneampoule of 5 ml Water for Injection BP.

Arixon 1 g IV Injection : Each box containing one vial of CeftriaxoneSodium USP equivalent to Ceftriaxone 1 g and one ampoule of 10 mlWater for Injection BP.


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Arlin®

Tablet/Suspension

DescriptionArlin contain Linezolid, which is a synthetic antibacterial agent of theoxazolidinone class. Arlin film coated tablets for oral administrationcontain 400 mg or 600 mg Linezolid. Arlin oral suspension is supplied aspowder for reconstitution into a suspension for oral administration.

IndicationsVancomycin-Resistant Enterococcus faecium infections, including cases withconcurrent bacteremia. Nosocomial pneumonia caused by Staphylococcusaureus (methicillin-susceptible and -resistant strains), or Streptococcuspneumoniae (penicillin-susceptible strains). Combination therapy may beclinically indicated if the documented or presumptive pathogens includeGram-negative organisms. Complicated skin and skin structure infectionscaused by Staphylococcus aureus (methicillin-susceptible and -resistantstrains), Streptococcus pyogenes, or Streptococcus agalactiae. Uncomplicated skinand skin structure infections caused by Staphylococcus aureus (methicillin-susceptible only) or Streptococcus pyogenes. Community-acquired pneumoniacaused by Streptococcus pneumoniae (penicillin-susceptible strains only),including cases with concurrent bacteremia, or Staphylococcus aureus(methicillin-susceptible strains only).

Dosage and Administration

i) Vancomycin- resistant Enterococcus faecium infections, includingconcurrent bacteremia, recommended dose is 600 mg 12 hourly for14 to 28 days.

ii) Nosocomial pneumonia, Complicated skin and skin structureinfections, and Community-acquired pneumonia, including concurrentbacteremia, recommended dose is 600 mg 12 hourly for 10 to 14 days.

iii) Uncomplicated skin and skin structure infections recommended doseis 400 mg 2 hourly for 10 to 14 days.


37

ContraindicationArlin formulations are contraindicated for use in patients who haveknown hypersensitivity to Linezolid or any of the other productcomponents.

Side EffectsMost of the adverse events reported with Arlin are mild to moderate inintensity. The most common adverse events in patients treated with Arlinwere diarrhoea, headache and nausea. Other adverse events included oralmoniliasis, vaginal moniliasis, hypertension, dyspepsia, localizedabdominal pain, pruritus, and tongue discolouration.

Use in Pregnancy and LactationThere are no adequate and well-controlled studies in pregnant women.Arlin should be used during pregnancy only if the potential benefitjustifies the potential risk to the foetus. It is not known whether Linezolidis excreted in human milk. Because many drugs are excreted in humanmilk, caution should be exercised when Arlin is administered to a lactatingwoman.

Drug InteractionsMonoamine Oxidase Inhibitors: Linezolid is a reversible, nonselectiveinhibitor of monoamine oxidase. Therefore, Linezolid has the potentialfor interaction with adrenergic and serotonergic agents.

Adrenergic Agents : Some individuals receiving Arlin may experience areversible enhancement of the pressor response to sympathomimeticagents, vasopressor or dopaminergic agents. Commonly used drugs suchas Phenylpropanolamine and Pseudoephedrine have been specificallystudied. Initial doses of adrenergic agents, such as Dopamine orEpinephrine, should be reduced and titrated to achieve the desiredresponse.

Serotonergic Agents : Co-administration of Linezolid and serotonergicagents was not associated with serotonin syndrome in studies. Since thereis limited experience with concomitant administration of Linezolid andserotonergic agents, physicians should be alert to the possibility of signsand symptoms of serotonin syndrome (e.g. hyperpyrexia and cognitivedysfunction) in patients receiving such concomitant therapy.


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OverdosageIn the event of overdosage, supportive care is advised with maintenance ofglomerular filtration. Haemodialysis may facilitate more rapid eliminationof Linezolid.

Pharmaceutical PrecautionsStore at temperature between 15oC and 30oC.

Commercial PackArlin 400 Tablet : Box containing 20 tablets in 2 x 10's blister strips. Eachfilm coated tablet contains Linezolid INN 400 mg.

Arlin 600 Tablet : Box containing 20 tablets in 2 x 10's blister strips. Eachfilm coated tablet contains Linezolid INN 600 mg.

Arlin Powder for Suspension : Dry Powder in amber glass bottle forreconstitution into 100 ml Suspension. After reconstitution each 5 mlcontains Linezolid INN 100 mg.


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Ascobex®

Tablet

DescriptionAscobex tablet contains Ascorbic Acid USP 100 mg, Sodium AscorbateUSP 168.75 mg, the combination is equivalent to 250 mg of AscorbicAcid (Vitamin C).

Ascorbic Acid (Vitamin C) is essential for synthesis of collagen andintracellular materials. It is involved in important metabolic reactions.Deficiency may arise due to decrease in absorption or increase inrequirement due to certain physiological conditions such as pregnancy,lactation, post-operative state, growing age etc.

Ascobex can be used to treat vitamin C deficiency and in those conditionswhere there is an increased requirement of vitamin C. Ascobex is alsoused as an antioxidant vitamin.

IndicationsVitamin C deficiency disorders, pregnancy, lactation, post-operative orother wound healing state, infection, growing age, thyrotoxicosis, andcommon cold. Being an antioxidant vitamin, it protects againstcardiovascular diseases, atherosclerosis, malignancy and it has been foundto delay the aging process. It has been found that in case of diabetes,there is an increase in requirement of vitamin C, Ascobex is also indicatedin that condition.

Dosage♦ In scurvy : 4 tablets 2 to 3 times daily♦ In wound healing : 2-4 tablets 2 to 3 times daily ♦ In other conditions : 1-2 tablets daily

PrecautionsShould be given with caution to patient with hyperoxaluria. Tolerance maybe induced in patients taking higher doses.


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Side EffectsAscorbic acid does not seem to have any important adverse effects atdosages less than 4 mg/day. Larger dose may cause diarrhea or formationof renal calculi of calcium oxalate in patients with renal impairment.Ingestion of more than 600 mg daily have a diuretic action.

Commercial PackAscobex Tablet : Box containing 200 tablets in 10 X 20’s blister strips,each tablet contains Ascorbic Acid USP 100 mg, Sodium ascorbate USP168.75 mg, the combination is equivalent to 250 mg of Ascorbic Acid(Vitamin C).


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Atova®

Tablet

DescriptionAtova (Atorvastatin Calcium) is a synthetic lipid-lowering agent. It is aninhibitor of 3-hydroxy-3-methyl-glutaryl-coenzyme A (HMG-CoA). Thisenzyme catalyzes the conversion of HMG-CoA to mevatonate, an earlyand rate limiting step in the synthesis of cholesterol.

IndicationsAtova is indicated as an adjunct to diet to reduce elevated totalcholesterol, low density lipoprotein-cholesterol (LDL-C), apolipoproteinB and triglyceride (TG) levels in patients with primaryhypercholesterolaemia (heterozygous familial and non familial) and mixeddyslipidaemia (Fredrickson Types lla and llb).

Atova is indicated as adjunctive therapy to diet for the treatment ofpatients with elevated serum triglyceride levels (Fredrickson Type IV).

Atova is indicated for the treatment of patients with primarydysbetalipoproteinaemia (Fredrickson Type III) who do not respondadequately to diet.

Atova is also indicated to reduce total-C and LDL-C in patients withhomozygous familial hypercholesterolaemia as an adjunct to other lipidlowering treatments (e.g. LDL apheresis) or if such treatments areunavailable.

Therapy with lipid altering agent should be a component of multiple riskfactor intervention in individuals at increased risk for atheroscleroticvascular disease due to hypercholesterolaemia. Lipid altering agentsshould be used in addition to a diet restricted in saturated fat andcholesterol only when the response to diet and other nonpharmacologicalmeasures have been inadequate (see Table 1). At the time ofhospitalization for an acute coronary event, consideration can be given toinitiating drug therapy at discharge if the LDL-C level is >130 mg/dl[National Cholesterol Education Program (NCEP) Adult TreatmentPanel II (ATP II)].


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Prior to initiating therapy with Atova, secondary causes forhypercholesterolaemia (e.g., poorly controlled diabetes mellitus,hypothyroidism, nephrotic syndrome, dysproteinaemias, obstructive liverdisease, other drug therapy, and alcoholism) should be excluded, and alipid profile performed to measure total-C, LDL-C, HDL-C, and TG. Forpatients with TG<400 mg/dl (<4.5 mmol/L), LDL-C can be estimatedusing the following equation: LDL-C=total-C (0.20 x [TG] + HDL-C).For TG levels >400 mg/dl (>4.5 mmol/L), this equation is less accurateand LDL-C concentrations should be determined by ultracentrifugation.Atorvastatin has not been studied in conditions where the majorlipoprotein abnormality is elevation of chylomicrons (Fredrickson TypesI and V).

Dosage and AdministrationAdults : The patient should be placed on a standard cholesterol-loweringdiet before receiving Atova and should continue on this diet duringtreatment with Atova.

TABLE 1 - NCEP GUIDELINES FOR LIPID MANAGEMENT

DefiniteAtherosclerotic

Diseasea

Two or MoreOther

Risk Factorsb

LDL-Cholesterol mg/dl (mmol/L)

Initiation Level Minimum Goal

No

No

Yes

No

Yes

Yes or No

>190 (>4.9)

>160 (>4.1)

>130c (>3.4)

<160 (<4.1)

<130 (<3.4)

<100 (<2.6)

a. Coronary heart disease or peripheral vascular disease (including symptomatic carotidartery disease).

b. Other risk factors for coronary heart disease (CHD) include: age (males >45 years;females >55 years or premature menopause without estrogen replacement therapy);family history of premature CHD; current cigarette smoking; hypertension;confirmed HDL-C < 35 mg/dl (< 0.91 mmol/L); and diabetes mellitus. Subtract 1risk factor if HDL-C is > 60 mg/dl (>1.6 mmol/L).

c. In CHD patients with LDL-C levels 100 to 129 mg/dl, the physician should exerciseclinical judgement in deciding whether to initiate drug treatment.


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Hypercholesterolaemia (Heterozygous Familial and Nonfamilial) andMixed Dyslipidaemia (Fredrickson Types IIa and IIb) : Therecommended starting dose of Atova is 10 mg daily. The dosage range is10 to 80 mg once daily. Atova can be administered as a single dose at anytime of the day with or without food. Therapy should be individualizedaccording to goal of therapy and response. After initiation and/or upontitration of Atova, lipid levels should be analyzed within 2 to 4 weeks anddosage adjusted accordingly.

Since the goal of treatment is to lower LDL-C, the LDL-C levels shouldbe used to initiate and assess treatment response. Only if LDL-C levelsare not available, total-C should be used to monitor therapy.

Homozygous Familial Hypercholesterolaemia : The dosage of Atova inpatients with homozygous Familial Hypercholesterolaemia is 10 to 80 mgdaily. Atova should be used as an adjunct to other lipid-loweringtreatments (e.g. LDL apheresis) in these patients or if such treatments areunavoidable.

Patients with renal insufficiency: Renal disease has no influence on theplasma concentrations or lipid effects of Atorvastatin; thus noadjustment of dose is required. Haemodialysis is not expected tosignificantly enhance the clearance of Atorvastatin since the drug isextensively bound to plasma proteins.

Patients with hepatic dysfunction: In patients with moderate to severehepatic dysfunction, the therapeutic response to Atorvastatin isunaffected but exposure to the drug is greatly increased. Cmax increases by

approximately 16 fold and AUC (0-24) by approximately 11 fold.Therefore, caution should be exercised in patients who consumesubstantial quantities of alcohol and/or have a history of liver disease.

ContraindicationHypersensitivity to any component of this medication. Active liverdisease or unexplained persistent elevations of serum transaminasesexceeding three times the upper limit of normal.

Use in Pregnancy and LactationSafety in pregnancy has not been established. Rare reports of congenital


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anomalies have been reported following intrauterine exposure to HMG-CoA reductase inhibitors.

HMG-CoA reductase inhibitors are not recommended for use duringpregnancy. An interval of 1 month should be allowed from stoppingAtorvastatin treatment to conception in the event of planning apregnancy.

Use of HMG-CoA reductase inhibitors during breast feeding is notrecommended, because of the potential for serious adverse effects innursing infants.

Use in Special PopulationChildren : Safety and efficacy of Atorvastatin have not been establishedin children.

Geriatrics : Efficacy and safety in older patients using recommendeddoses is similar to that seen in the general population.

Carcinogenicity/mutagenicityAtorvastatin was not found to be carcinogenic in rats; the maximum doseused was 63 fold higher than the highest human dose (80 mg/day) on amg/kg body weight basis.

PrecautionsRhabdomyolysis with acute renal failure secondary to myoglobinuria hasbeen reported with other drugs in this class. Atorvastatin may cause anelevation in serum creatinephosphokinase (CPK) levels. This should beconsidered in the differential diagnosis of chest pain in patients ontherapy with Atorvastatin. Uncomplicated myalgia has been reported inAtorvastatin-treated patients. Atorvastatin therapy should bediscontinued if markedly elevated CPK levels occur or myopathy isdiagnosed or suspected.

The risk of myopathy during treatment with other drugs in this class isincreased with concurrent administration of Cyclosporin, fibric acidderivatives, Erythromycin, Niacin, or azole anti-fungals. Patients shouldbe advised to report promptly any unexplained muscle pain, tenderness orweakness, particularly if accompanied by malaise or fever.


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Side EffectsAtorvastatin is generally well tolerated. Adverse effects reportedcommonly include constipation, flatulence, dyspepsia, abdominal pain,headache, nausea, myalgia, diarrhoea, asthenia and insomnia.

Dose related and reversible elevated serum alanine transaminase (ALT)levels have been reported in approximately 1.3% of patients receivingAtorvastatin.

Elevated serum CPK levels have been reported in some patients onAtorvastatin but only in rare cases patients may have muscle pain,tenderness or weakness. Other side effects reported in clinical trials (notall effects have necessarily been associated with Atorvastatin therapy)include muscle cramps, myopathy, paresthesia, peripheral neuropathy,pancreatitis, hepatitis, cholestatic jaundice, anorexia, vomiting, pruritus,rash, impotence, hyperglycaemia and hypoglycaemia. Chest pain,dizziness, angina and allergic reactions have been reported in isolatedcases.

OverdosageThere is no specific treatment available for Atorvastatin overdosage.General supportive measures should be adopted as required. Liverfunction tests and serum CPK levels should be monitored. Due toextensive drug binding to plasma proteins, haemodialysis is not expectedto significantly enhance Atorvastatin clearance.

Pharmaceutical Precautions Storage below 20o C, protected from moisture.

Commercial Pack Atova 10 Tablet : Box containing 10 tablets in 1 x 10’s blister strip, eachtablet contains Atorvastatin Calcium INN equivalent to Atorvastatin 10mg.

Atova 20 Tablet : Box containing 10 tablets in 1 x 10’s blister strip, eachtablet contains Atorvastatin Calcium INN equivalent to Atorvastatin 20 mg.


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Atrizin®

Tablet/Syrup

Description Atrizin is available in both tablet and syrup form. Each film coated tabletcontains Cetirizine Hydrochloride BP 10 mg and each 5 ml cherryflavoured syrup contains 5 mg of Cetirizine Hydrochloride BP. Cetirizineis a piperazine derivative and a potent functional antagonist of histamineH1 receptors. Atrizin is a long acting antihistamine. Central sedation or

antimuscarinic effects do not generally occur with the usual doses ofAtrizin.

IndicationsAtrizin is indicated for the prevention and symptomatic relief of allergicmanifestations, such as:

- Seasonal allergic rhinitis

- Perennial allergic rhinitis

- Chronic idiopathic urticaria

Dosage and AdministrationAtrizin tablet : Adults and children over 12 years- 10 mg (1 tablet) once daily.

Atrizin syrup: Adult and Children over 6 years- 10 mg (2 teaspoonful) daily.Child 2-6 years- 5 mg (1 teaspoonful) daily or 2.5 mg (½ teaspoonful) twicedaily.

The maximum recommended dose is 20 mg (2 tablets or 4 teaspoonful)daily. Cetirizine is safe for use in the elderly patients. Less frequent dosingis advised in patients with reduced creatinine clearance.

ContraindicationCetirizine is contraindicated in patients who have shown hypersensitivityor idiosyncrasy to it or its parent compound- Hydroxyzine.

Adverse ReactionNo potentially life threatening effects have been encountered.


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Acute OverdosageIn the occasional cases patient taking a massive intentional overdose (150-300 mg), sedation has been the only adverse effect and complete recoveryhas ensured. Like other H1 receptor antagonists, Cetirizine has no specific

antidote.

PrecautionsNeonates : The drug is not usually administered to neonates.

Children : Cetirizine is effective and well tolerated in children. No specialprecautions are required in children over 6 years of age.

Use in Pregnancy and LactationCetirizine is not teratogenic in animals. Since the animal studies are notalways predictive of human response, it should be used only if thepotential benefit justifies the potential risk to the foetus. The extent ofCetirizine excretion in human breast milk is unknown but some animalstudies have shown excretion in breast milk. Nursing mothers are advisednot to take this medication.

Drug InteractionThere are no reports of hazardous interactions with other drugs to date.Concomitant administration with alcohol or Diazepam does not impairpsychomotor performance any more than the impairment ofperformance produced by alcohol alone.

Commercial Pack Atrizin Tablet : Box containing 10 blister strips of 10 film coated tablets,each tablet contains Cetirizine Hydrochloride BP 10 mg.

Atrizin Syrup : Amber glass bottle containing 60 ml syrup. Each 5 mlsyrup contains Cetirizine Hydrochloride BP 5 mg .


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Avastin®

Tablet

DescriptionAvastin is a preparation of Simvastatin which acts as a cholesterollowering agent. Avastin inhibits 3-hydroxy-3-methylglutaryl coenzyme A(HMG-CoA) reductase, an enzyme which catalyses the biosynthesis ofcholesterol.

Mode of ActionThe main mechanism of reduction of low density lipoprotein (LDL)cholesterol is that, following inhibition of HMG-CoA reductase activity,the LDL receptor density on the liver cells is increased and this leads toan increased removal of LDL cholesterol from the plasma and increasedcatabolism of LDL cholesterol. In addition, there is a reduction in verylow-density lipoprotein (VLDL) cholesterol and reduced formation ofLDL from VLDL.

IndicationsAvastin is indicated in patients with primary hypercholesterolaemia whohave not responded adequately to diet and other appropriate measures.

To reduce incidence of clinical coronary events and slow progression ofcoronary atherosclerosis in patients with coronary heart disease andcholesterol concentration of 5.5 mmol/litre or greater.

Dosage and AdministrationThe patients should be placed on a standard cholesterol-lowering dietbefore receiving Avastin and maintained on it during treatment.

Doses should be individualized according to baseline LDL-cholesterollevels, the recommended goal of therapy and the patient’s response.Adjustment of dosage should be at intervals of 4 weeks or more. Inhypercholesterolaemia, the recommended starting dose is 5-10 mg once aday in the evening. The recommended dose range is 5-40 mg per day as asingle dose in the evening.


49

The patients with coronary heart disease and hypercholesterolaemia, thestarting dose should be 20 mg once a day in the evening.

Safety and effectiveness in children and adolescents have not beenestablished.

Contraindication Hypersensitivity to any component of the preparation; Active liverdisease; Pregnancy and lactation; women of child-bearing potential unlessadequately protected by contraception; in patients with the homozygousform of familial hypercholesterolaemia, in whom there is a completeabsence of LDL receptors.

As Simvastatin has only a moderate triglyceride-lowering effect, it is notindicated where hypertriglyceridaemia is the abnormality of mostconcern.

Side Effects Avastin is generally well tolerated, no potentially life-threatening effectshave been reported. Headache, fatigue, insomnia, gastrointestinal effectslike nausea, constipation or diarrhoea, flatulence, dyspepsia, abdominalcramps, and muscular effects like myalgia, myositis and myopathy havebeen reported. Rare cases of rhabdomyolysis with acute renal failuresecondary to myoglobinuria have been associated with Simvastatintherapy. Hepatitis, pancreatitis, rash, angioedema have also beenreported.

Drug InteractionsDigoxin : Concomitant administration of Simvastatin and Digoxin innormal volunteers resulted in a slight elevation (less than 0.3 ng/ml) indrug concentrations in plasma compared to concomitant administrationof placebo and Digoxin.

Coumarin derivatives : The administration of Simvastatin appeared toenhance slightly the anticoagulant effect of Warfarin (mean changes inprothrombin time less than two seconds) in normal volunteersmaintained in a state of low therapeutic anticoagulation.

Others : In clinical studies, Simvastatin was used concomitantly withangiotensin-converting enzyme (ACE) inhibitors, β-blockers, calciumchannel blockers, diuretics and non-steroidal


50

anti-inflammatory drugs (NSAIDs) without evidence of clinicallysignificant adverse interactions.

PrecautionsMonitor liver function before and during treatment; History of liverdisease (avoid if active); High alcohol intake; Avoid pregnancy during andfor 1 month after treatment; Advise patients to report if there is anymuscle pain. Simvastatin should be discontinued if markedly elevatedCPK levels occur or if myopathy is diagnosed.

OverdosageThere are no data available on overdose. No antidote is available. Generalmeasures should be adopted and liver function should be monitored.

Commercial PackAvastin Tablet : Box containing 30 film coated tablets in 3 x 10’s blisterstrips, each tablet contains Simvastatin USP 10 mg.


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Avidro®

Tablet

DescriptionAvidro is the brand name of Pizotifen, which is a tricyclic compoundhaving antiserotoninergic and antihistaminic effects together with a weakanticholinergic action. Pizotifen inhibit the permeability-increasing effectsof serotonin and histamine on the affected cranial vessels, therebychecking the transudation of plasmakinin so that pain threshold of thereceptors is maintained at normal levels. In the sequence of eventsleading to the migraine attack, depletion of plasma serotonin contributesto loss of tone in the extra-cranial vessels. Pizotifen inhibits serotonin re-uptake by the platelets, thus maintaining plasma serotonin and preventingthe loss of tone and passive distension of the extra-cranial arteries.

IndicationsIt is used as prophylactic treatment of vascular headaches of the migrainetypes, such as classic migraine, common migraine and cluster headache.

Dosage and AdministrationAdult : Usually 1.5 mg daily, which may be taken as a single dose at nightor in three divided doses. Dose should be adjusted to individual patient'srequirements. Up to a maximum of 4.5 mg daily and up to 3 mg may begiven as a single dose daily.

Children : Up to 1.5 mg daily, usually in divided dose, and daily 1 mg as asingle dose has been given at night using 0.5 mg tablet.

Duration of treatment : 3-6 months; minimum one month to observe thebenefit.

ContraindicationAlthough its anticholinergic activity is relatively weak, Pizotifen shouldprobably not be administered in presence of narrow angle glaucoma orprostate hypertrophy. It should not be given in patients withhypersensitivity to this drug.


52

Use in Pregnancy and LactationInformation of using Pizotifen in pregnancy is limited, so it should onlybe used during pregnancy under compelling circumstances and it is notrecommended to the nursing mother.

Side EffectsDrowsiness is the most common side effect and also increased appetite,which may lead to increase in body weight. Other side effects are,dizziness, dry mouth, nausea, constipation, which are rare. In childrencentral nervous system (CNS) stimulation may occur.

PrecautionsPatients should be cautioned about the possibility of drowsiness andinformed of its significance in driving vehicles and operation ofmachineries. Pizotifen may enhance the central effects of sedatives,hypnotic, antihistamines and alcohol. Dose adjustment may be required inpatients with renal insufficiency.

Commercial PackAvidro 0.5 Tablet : Box containing 10 x 10's tablets in blister strips. Eachfilm coated tablet contains Pizotifen Malate BP equivalent to Pizotifen 0.5mg.

Avidro 1.5 Tablet : Box containing 5 x 10's tablets in blister strips. Eachfilm coated tablet contains Pizotifen Malate BP equivalent to Pizotifen 1.5 mg.


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Avifanz®

Tablet

DescriptionAvifanz is the brand name for Efavirenz. Efavirenz, a synthetic anti-retroviral agent, is a non-nucleoside reverse transcriptase inhibitor. WhileEfavirenz is pharmacologically related to other non-nucleoside reversetranscriptase inhibitors, Efavirenz differs structurally from these drugsand also differs structurally from other currently available anti-retroviralagents.

IndicationsAvifanz in combination with other antiretroviral agents is indicated forthe treatment of human immunodeficiency virus-1 (HIV-1) infection.This indication is based on analysis of plasma HIV-RNA levels and CD4cell counts in controlled studies of up to 24 weeks in duration. At present,there are no results from controlled trials evaluating long-termsuppression of HIV- RNA with Avifanz.

Dosage and Administration Adults : The recommended dosage of Avifanz is 600 mg orally, once daily,in combination with a protease inhibitor and/or nucleoside analoguereverse transcriptase inhibitors (NRTIs). Avifanz may be taken with orwithout food; however, a high fat meal may increase the absorption ofAvifanz and should be avoided.

In order to improve the tolerability of nervous system side effects,bedtime dosing is recommended during the first two to four weeks oftherapy and in patients who continue to experience these symptoms.Avifanz must be given in combination with other antiretroviralmedications.

Paediatric Patients : The following table describes the recommended dose ofAvifanz for paediatric patients 3 years of age or older and weighingbetween 10 to 40 kg. The recommended dosage of Avifanz for paediatricpatients weighing greater than 40 kg is 600 mg, once daily.


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Paediatric Dose to be Administered Once Daily

ContraindicationEfavirenz is contraindicated in patients with known hypersensitivity tothe drug or any ingredient in formulation.

Warning and PrecautionsThe drug should not be used in pregnant women or who plan to becomepregnant, and also in lactating women. High fat foods may causeunwanted increases in drug effect, so avoid taking this drug with high-fatfoods.

Regular, periodic measurement plasma HIV-1 RNA levels and CD4+ T-cell counts is necessary to determine the risk of disease progression andto determine when to modify anti-retroviral agent regimens. Patientsshould be advised that Efavirenz has not been shown to reduce the riskof transmission of HIV to others via sexual contact or bloodcontamination and so the practices designed to prevent transmission ofHIV should be maintained during anti-retroviral therapy. Efavirenzshould always be administered in conjunction with other anti-retroviralagent and should not be used alone in the treatment of HIV infection.Although Efavirenz used in combination with other anti-retroviral agentsappears to be well tolerated, patients should be monitored closely foradverse effects during combination therapy. The usual precautions andcontraindication of the other anti-retrovirals in the regimen should beconsidered during combination therapy; Efavirenz should not be added assole agent to a failing regimen. Whenever a change in anti-retroviraltherapy is considered because of therapeutic failure, at least 2components of the previous regimen should be changed since adding a

Body Weight Avifanz

Kilogram Pound Dose (mg)

10 to < 1515 to < 2020 to < 2525 to < 32.532.5 to < 4040<

22 to < 3333 to < 4444 to < 5555 to < 71.571.5 to < 8888<

200250300350400600


55

single new agent may predispose to the development of viral resistance.Use of an entirely new regimen containing at least 3 drugs is preferred.The effect of Efavirenz therapy on subsequent therapy with other non-nucleoside reverse transcriptase inhibitors remains to be determined.Because cross-resistance occurs among non-nucleoside reversetranscriptase inhibitors, most clinicians suggest that individuals whoexperience disease progression while receiving one of the agents (e.g.,Delavirdine, Efavirenz, Nevirapine) should not be switched to anotheragent in the class. As Efavirenz has been associated with adverse CNSeffect, patients should be advised that the drug may impair their ability toperform hazardous activities requiring mental alertness or physicalcoordination such as operating machinery or driving a motor vehicle. Inaddition, patients receiving Efavirenz should be informed that there is apotential for additive CNS effects if they use Efavirenz concomitantlywith psychoactive drugs or alcohol. Patients should be advised to contacttheir clinician if they experience delusions, inappropriate behaviour, oracute depression while receiving Efavirenz; discontinuance of the drugmay be necessary in patients who experience such CNS effects. Efavirenzis metabolized in the liver; the drug should be used with caution in patentswith hepatic impairment. Serum hepatic enzyme concentrations shouldbe monitored during Efavirenz therapy in patients who have, or may have,Hepatitis B and/or C virus infection, in patients receiving concomitantRitonavir and in patients receiving concomitant therapy with hepatotoxicdrug(s). In patients with serum hepatic enzyme concentrations more than5 times the upper limit of normal, the benefits of continued Efavirenztherapy versus the risks of hepatotoxicity should be considered. Becauseincreases in serum cholesterol concentration have occurred in individualsreceiving Efavirenz, cholesterol monitoring should be considered inpatients receiving the drug. Because of the risk of foetal malformations,Efavirenz should not be used in women who are or may become pregnantunless no other therapeutic options exist.

PrecautionsEfavirenz may cause drowsiness or dizziness. Alcohol may intensify thiseffect.

Paediatric PrecautionsSafety and efficacy of Efavirenz in neonates and children younger than 3years of age or who weigh less than 13 kg have not been evaluated.


56

Adverse effects including CNS, gastrointestinal and dermatologic effectsreported in children receiving Efavirenz are similar to those reported inadults receiving the drug. Adverse CNS effects occurred in 9% ofchildren receiving Efavirenz. In clinical studies rash has been reportedmore frequently in children than adults (40 vs 27.3% ) and the incidenceof moderate to severe rash has been greater in children than adults.Because of the high incidence of dermatologic reactions in children,antihistamines may be used for the prevention of rash when initiatingEfavirenz therapy in children; however, the efficacy of such a strategy hasnot been determined.

Side EffectsCentral Nervous System (CNS) : Dizziness, impaired concentration,abnormal dreams and insomnia have been reported in about 52% ofadults receiving Efavirenz 600 mg once daily. In clinical studies theseadverse effects were reported in 26% of adults in the control groups notreceiving Efavirenz. In adults receiving Efavirenz, these CNS effects weredescribed as mild (do not interfere with daily activities) in 31.4%,moderate (may interfere with daily activities) in 17.8% or severe (interruptusual daily activities) in 2.6% cases. Adverse nervous system effectsgenerally begin during the first 1-2 days of drug therapy, improve withcontinued therapy and usually resolve after the first 1-2 days of therapy.Adverse CNS effects may be more tolerable if the daily dose of Efavirenzis administered at bedtime, especially during the first 2-4 weeks of therapyand in patients who continue to experience such effects. Fatigue has beenreported in up to 7% of adults receiving the drug in clinical studies.

Severe acute depression, sometimes accompanied by suicidal ideation/attempts, has been reported rarely in patients receiving Efavirenz inclinical studies.

Adverse CNS effects reported in less than 2% of patients receivingEfavirenz include ataxia, confusion, impaired coordination, migraineheadache, neuralgia, paresthesia, peripheral neuropathy, seizures, speechdisorder, tremor, or vertigo. In addition, aggravated depression, agitation,amnesia, anxiety, apathy, emotional liability, euphoria, hallucination, orpsychosis has occurred in less than 2% of Efavirenz-treated patients.


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Adverse CNS effects occurred in 9% of children receiving Efavirenz inclinical studies.

Dermatologic reactions : Rash has occurred in 27. 3% of adults receivingEfavirenz in clinical studies and in 17% of adults in control groups notreceiving the drug. Pruritus or increased sweating has been reported in 1-2% of patients receiving the drug. Allergic reaction, alopecia, eczema,folliculities, skin exfoliation or urticaria has occurred in lees than 2% ofpatients receiving the drug.

Gastrointestinal : Nausea or diarrhoea has been reported in up to 12% ofadults receiving the drug. Vomiting, dyspepsia, abdominal pain, orflatulence has occurred in some Efavirenz-treated adults. Dry mouth ortaste change has been reported in up to 2% of patients receiving the drug.

Hepatic : Hepatitis occurred in less than 2% of patients receiving the drug.

Cardiovascular : While the clinical importance remains to be determined,total serum cholesterol concentrations have been increased 10-20% inhealthy individuals receiving the drug. Hot flushes, flushing, palpitations,tachycardia, or thrombophlebitis has been reported in less than 2%, ofpatients receiving the drug.

Pharmaceutical PrecautionsStore in a cool dry place. Keep out of reach of children.

Commercial PackAvifanz Tablet : Each box contains 1 x 10’s tablets in blister strip. Eachtablet contains Efavirenz INN 600 mg.


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Avifix®

Tablet

DescriptionAvifix (Nelfinavir Mesylate), a human immunodeficiency virus (HIV)protease inhibitor, is available as film coated tablet in 250 mg strength (asNelfinavir free base).

IndicationsAvifix is indicated for the treatment of HIV infection when antiretroviraltherapy is warranted.

Dosage and AdministrationAdults: The recommended dose is 1250 mg (five 250 mg tablets) twicedaily or 750 mg (three 250 mg tablets) three times daily. Avifix should betaken with meal. Antiviral activity is enhanced when Avifix is administeredin combination with nucleoside analogues. Therefore, it is recommendedthat Avifix be used in combination with nucleoside analogues.

Paediatric Patients : The recommended oral dose of Avifix for paediatricpatients 2 to 13 years of age is 20-30 mg/kg per dose, three times dailywith a meal.

ContraindicationAvifix is contraindicated in patients with clinically significanthypersensitivity to any of its components.

Co-administration of Avifix is contraindicated with drugs that are highlydependent on cytochrome P450 3A (CYP3A) for clearance and for whichelevated plasma concentrations are associated with serious and/or life-threatening adverse events.

Warning and PrecautionsAvifix should not be administered concurrently with Terfenadine,Astemizole, Cisapride, Triazolam, Midazolam, ergot derivatives,Amiodarone or Quinidine because Avifix may affect the hepaticmetabolism of these drugs and create potential for serious and/or life-threatening adverse events.


59

New onset diabetes mellitus, exacerbation of pre-existing diabetesmellitus and hyperglycaemia have been reported during post-marketingsurveillance in HIV-infected patients receiving protease inhibitor therapy.Some patients required either initiation or dose adjustments of insulin ororal hypoglycemic agents for treatment of these events. In some casesdiabetic ketoacidosis has occurred. In those patients who discontinuedprotease inhibitor therapy, hyperglycaemia persisted in some cases.

Precautions for Special PopulationHepatic Impairment : Nelfinavir is principally metabolized by the liver.Therefore, caution should be exercised when administering this drug topatients with hepatic impairment.

Haemophilias : There have been reports of increased bleeding, includingspontaneous skin haematomas and haemarthrosis, in patients withhaemophilia type A and B treated with protease inhibitors. In somepatients, additional factor VIII was given. In more than half of thereported cases, treatment with protease inhibitors was continued orreintroduced. A causal relationship has not been established.

Paediatric : A similar adverse event profile was seen during the paediatricclinical trial as in adult patients. The evaluation of the antiviral activity ofNelfinavir in paediatric patients is ongoing. The safety, effectiveness andpharmacokinetics of Nelfinavir have not been evaluated in paediatricpatients below the age of 2 years.

Use in Pregnancy and LactationThere are no adequate and well-controlled studies in pregnant women. Toavoid postnatal transmission of HIV, the US Public Health ServiceCenters for Disease Control and Prevention advises HIV-infected womennot to breast feed their infants.

Side EffectsThe safety of Nelfinavir was studied in over 1500 patients who receivedthe drug either alone or in combination with nucleoside analogues. Themajority of adverse events were of mild intensity. The most frequentlyreported adverse event among patients receiving Nelfinavir wasdiarrhoea, which was generally of mild to moderate intensity.


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Adverse events occurring in less than 2% of patients receiving Nelfinavirin all phase II/III clinical trials are considered at least possibly related orof unknown relationship to treatment. They are listed below-

General : abdominal pain, accidental injury, allergic reaction, asthenia,back pain, fever, headache, malaise, pain and redistribution/accumulationof body fat.

Digestive System : anorexia, dyspepsia, epigastric pain, gastrointestinalbleeding, hepatitis, mouth ulceration, pancreatitis and vomiting.

Haematologic : anaemia, leucopenia and thrombocytopenia.

Metabolic/Nutritional : increase in alkaline phosphate, amylase, CPK,lactic dehydrogenase, asparpate transaminase (AST), ALT and gammaglutamyl transpeptidase. Hyperlipaemia, hyperuricaemia, hyperglycaemia,hypoglycaemia, dehydration, and abnormal liver function tests.

Musculoskeletal System : arthralgia, arthritis, cramps, myalgia, myastheniaand myopathy.

Nervous System : anxiety, depression, dizziness, emotional lability,hyperkinesia, insomnia, migraine, paresthesia, seizures, sleep disorder,somnolence and suicide ideation.

Respiratory System : dyspnoea, pharyngitis, rhinitis and sinusitis.

Skin/Appendages : dermatitis, folliculitis, fungal dermatitis,maculopapular rash, pruitus, sweating, and urticaria.

Special Senses : acute iritis and eye disorder.

Urogenital System : kidney calculas, sexual dysfunction and urineabnormality.

Overdosage Human experience of acute overdose with Avifix is limited. There is no


61

specific antidote for overdose with Avifix. If indicated, elimination ofunabsorbed drug should be achieved by emesis or gastric lavage.Administration of activated charcoal may also be used to aid removal ofunabsorbed drug. Since Nelfinavir is highly protein bound, dialysis isunlikely to significantly remove the drug from blood.

Drug InteractionsNelfinavir is an inhibitor of CYP3A (cytochrome P450 3A). Co-administration of Avifix and drugs primarily metabolized by CYP3A (e.g.,dihydropyridine calcium channel blockers) may result in increased plasmaconcentrations of the other drug that could increase or prolong both itstherapeutic and adverse effects. Co-administration of drugs that inhibitCYP3A may increase Nelfinavir plasma concentration.

Based on known metabolic profiles, clinically significant drug interactionsare not expected between Avifix and Dapsone,Trimethoprim/Sulfamethoxazole, Clarithromycin, Erythromycin,Itraconazole or Fluconazole.

Anti-HIV Protease InhibitorsIndinavir : Co-administration of Indinavir with Nelfinavir resulted in an83% increase in Nelfinavir plasma AUC and a 51% increase in Indinavirplasma antioxidant capacity (AC). Currently, there are no safety andefficacy data available from the use of this combination.

Drugs that Should not be Co-administered with Avifix

Class Drug Antiarrhythmics Amiodarone, QuinidineAntihistamines Astemizole, TerfenadineAntimigraine Ergot derivativesAntimycobacterial agents RifampinBenzodiazepines Midazolam, TriazolamGastrointestinal motility agents Cisapride

Drugs which Require a Dose Reduction when Co-administered with Avifix

Class DrugAntimycobacterial agents Rifabutin


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Ritonavir : Co-administration of Ritonavir with Avifix resulted in a 152%increase in Nelfinavir plasma (area under the plasma concentration x timecurve) AUC and very little change in Ritonavir plasma AC. Currently,there are no safety and efficacy data available from the use of thiscombination.

Saquinavir : Co-administration of Saquinavir (using an experimental soft-gelatin capsule formulation of Saquinavir 1200 mg) with Avifix resultedin an 18% increase in Nelfinavir plasma AUC and a 4-fold increase inSaquinavir plasma AC. If used in combination with Saquinavir hardgelatin capsules at the recommended dose of 600 mg tid, no doseadjustments are needed. Currently, there are no safety and efficacy dataavailable from the use of this combination with antifungal agents.

Anti-HIV Reverse Transcriptase InhibitorsDidanosine : It is recommended that Didanosine be administered on anempty stomach; therefore, Nelfinavir should be administered (with food)one hour after or more than two hours before Didanosine.

Zidovudine : Co-administration of Zidovudine and Lamivudine with Avifixresulted in a 35% decrease in Zidovudine plasma AC. A dose adjustmentis not needed when Zidovudine is administered with Avifix.

Little or no change in the pharmacokinetics of either drug was observedwhen Avifix was co-administered with Lamivudine or Stavudine.

Other Potentially Clinically Significant Drug Interactions with Avifix *

Anticonvulsants : Carbamazepine May decrease Nelfinavir plasma concentrations**

Anti-HIV protease inhibitors : Indinavir May increase Nelfinavir plasma concentrations

Oral contraceptives : Ethinyloestradiol Plasma concentrations may be decreased by Avifix

* This table is not all inclusive** Avifix may not be effective due to decreased Nelfinavir plasma concentrations in patients

taking these agents concomitantly


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Pharmaceutical PrecautionsStore below 30°C in a dry place. Keep out of reach of children.

Commercial PackAvifix Tablet : Each box contains 1 x 10’s tablets in blister strip. Eachtablet contains Nelfinavir Mesylate INN equivalent to 250 mg Nelfinavir.


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Avilam®

Tablet

DescriptionAvilam(formerly known as 3TC) is the brand name for Lamivudine, asynthetic nucleoside analogue with activity against HIV.

IndicationsAvilamin combination with Zidovudine is indicated for the treatment ofHIV infection.

Dosage and Administration Adults and Adolescents (12 to 16 years) : The recommended oral dose ofAvilam for adults and adolescents is 150 mg twice daily administered incombination with Zidovudine. For adults with low body weights (lessthan 50 kg or 110 lb), the recommended oral dose of Avilam is 2 mg/kgtwice daily administered in combination with Zidovudine. No data areavailable to support a dosage recommendation for adolescents with lowbody weight (less than 50 kg).

Paediatric Patients : The recommended oral dose of Avilam for paediatricpatients of age between 3 months to up to 12 years is 4 mg/kg twice daily(up to a maximum of 150 mg twice a day) administered in combinationwith Zidovudine.

Dose Adjustment It is recommended that doses of Avilam be adjusted in accordance withrenal function in patients older than age 16 years (see following table).Insufficient data are available to recommend a dosage of Avilam inpatients undergoing dialysis.

ContraindicationAvilam is contraindicated in patients with previously demonstratedclinically significant hypersensitivity to any of the components of theproduct.

Warning and PrecautionsIn paediatric patients with a history of pancreatitis or other significantrisk factors for the development of pancreatitis, the combination of


65

Avilam and Zidovudine should be used with extreme caution and only ifthere is no satisfactory alternative therapy. Treatment with Avilam shouldbe stopped immediately if there are clinical signs, symptoms, orlaboratory abnormalities suggestive of pancreatitis.

Lactic acidosis and severe hepatomegaly with steatosis, including fatalcases, have been reported with the use of antiretroviral nucleosideanalogues alone or in combination, including Lamivudine. A majority ofthese cases have been in women. Caution should be exercised whenadministering Avilam to any patient, and particularly to those with knownrisk factors for liver disease. Treatment with Avilam should be suspendedin any patient who develops clinical or laboratory findings suggestive oflactic acidosis or hepatotoxicity.

Reduction of the dosage of Avilam is recommended for patients withimpaired renal function.

In clinical trials and postmarketing experience, some patients with HIVinfection who have chronic liver disease due to hepatitis B virus infectionexperienced clinical or laboratory evidence of recurrent hepatitis upondiscontinuation of Lamivudine. Consequences may be more severe inpatients with decompensated liver disease.

Use in Pregnancy and LactationAnimal reproductive toxicity studies are not always predictive of humanresponse. There are no adequate and well-controlled studies in pregnantwomen. Lamivudine should be used during pregnancy only if thepotential benefits outweigh the risks. The US Public Health ServiceCenters for Disease Control and Prevention recommend that HIV-infected mothers should not breast feed their infants to avoid the risk ofpostnatal transmission of HIV infection.

Creatinine Clearance (mL/min) Recommended Dosage of Avilam

>5030-4915-295-14<5

150 mg twice daily150 mg once daily150 mg first dose, then 100 mg once daily 150 mg first dose, then 50 mg once daily50 mg first dose, then 25 mg once daily

Table : Adjustment of Dosage of Avilam in Accordance with Creatinine Clearance


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Side EffectsAdults : Selected clinical adverse events with a >5% frequency duringtherapy with Lamivudine 150 mg bid plus Zidovudine 200 mg tidcompared with Zidovudine are listed in the following table.

OverdosageThere is no known antidote for Lamivudine. It is not known whetherLamivudine can be removed by peritoneal dialysis or haemodialysis.

Lamivudine 150 mg bid plus Zidovudine

(n = 251)

Adverse Event Zidovudine (n = 230)

35 %27 %10 %

GeneralHeadacheMalaise and fatigueFever or chills

27 %23 %12 %

33 %18 %10%9%6%5%

DigestiveNausea and vomitingDiarrhoeaAnorexia and/or decreased appetiteAbdominal painAbdominal crampsDyspepsia

29%22%7%11%3%5%

12%11%10%9%

Nervous system NeuropathyInsomnia and other sleep disordersDizzinessDepressive disorders

10%7%4%4%

20%18%

RespiratoryNasal signs and symptomsCough

11%13%

9%SkinSkin rashes 6%

12%8%5%

Musculoskeletal Musculoskeletal painMyalgiaArthralgia

10%6%5%

Observed During Clinical Practice : The events identified during use of the drug in clinical practice include alopecia,anaphylaxis, hyperglycaemia, lactic acidosis and hepatic steatosis, peripheral neuropathy,pruritus, rash, urticaria, and weakness.

Selected Clinical Adverse Events (>5% Frequency) in Four Controlled Clinical Trials


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Pharmaceutical PrecautionsStore in a cool dry place. Protect from light.Keep out of reach of children.

Commercial PackAvilam Tablet : Each box contains 1 x 10’s tablets in blister strip. Eachtablet contains Lamivudine INN 150 mg.


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Avitron® VTablet

DescriptionAvitron V tablet contains Vitamin B1 or Thiamine Hydrochloride USP.

Thiamine Hydrochloride is a water soluble vitamin belongs to vitamin B-complex family. Thiamine in the form of Thiamine Pyrophosphate (alsoknown as cocarboxylase), is the co-enzyme for decarboxylation of α-ketoacids. Thiamine pyrophosphate also acts as the co-enzyme oftransketolase in the direct oxidation pathway of glucose metabolism. Inthiamine deficiency, pyruvic acid and lactic acid accumulate in tissues.Thiamine deficiency affects the peripheral nervous system, thegastrointestinal tract, and the cardiovascular system.

Thiamine is not stored in the body, intracellular thiamine is present almostentirely as the co-enzyme moiety of active enzymes. Thiaminerequirement is related to carbohydrate intake and the metabolic rate. Adaily intake of 400 mg thiamine per 1000 kcal is recommended. The totalrequirement increases during periods of active growth or heavy physicallabour, during pregnancy and lactation, in pathological conditions such asfever and hyperthyroidism and in other conditions causing increasedmetabolism.

Indications Avitron V is indicated in the treatment of the various manifestations ofthiamine deficiency such as beriberi (wet or dry) and Wernicke'sencephalopathy, neuritis associated with pregnancy and pellagra.Supplementary thiamine may be indicated prophylactically in conditionswhere there is low dietary intake or low gastrointestinal absorption ofthiamine, and increased thiamine requirement periods e.g. - active growth- heavy physical labour- pregnancy and lactation - in pathological conditions such as fever and hyperthyroidism and other

conditions causing increased metabolism.


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Dosage and Administration Mild chronic deficiency : 10-25 mg dailySevere deficiency : 200-300 mg daily or as advised by the physician

Contraindication Thiamine is contraindicated in patients with known hypersensitivity to it.

Side EffectsVitamin B1 does not have adverse effects when given orally. A feeling of

warmth, pruritus, urticaria, weakness, sweating, nausea, restlessness etc.may occur.

Pregnancy and Lactation Thiamine is safe in pregnant women and recommended for the treatmentof neuritis in pregnancy. Although it is not known if thiamine is excretedin breast milk, the drug may be taken safely during lactation.

Pharmaceutical Precaution Store in a cool and dry place, protected from light.

Commercial Pack Avitron V Tablet : Box containing 25 blister strips of 10 tablets. Eachtablet contains Thiamine Hydrochloride USP 100 mg.


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Axodin®

Tablet

DescriptionAxodin (Fexofenadine), a pharmacologically active metabolite ofTerfenadine, is a non-sedating antihistamine with selective peripheral H1

receptor antagonist activity.

Fexofenadine Hydrochloride is rapidly absorbed into the body followingoral administration, with Tmax occurring at approximately 1-3 hours post

dose. The mean Cmax value was approximately 427 ng/ml and 494 ng/ml

following the administration of a 120 mg and 180 mg dose (once daily)respectively.

Fexofenadine is 60-70% plasma protein bound. Fexofenadine undergoesnegligible metabolism, as it was the only major compound identified inurine and faeces of animal and human. The plasma concentration profilesof Fexofenadine follow a bi-exponential decline with a terminalelimination half-life ranging from 11 to 16 hours after multiple dosing.The single and multiple dose pharmacokinetics of Fexofenadine are linearbetween 40 mg and 240 mg taken daily. The major route of elimination isbelieved to be via biliary excretion while up to 10% of ingested dose isexcreted unchanged through the urine.

IndicationsAxodin is indicated for the relief of symptoms associated with allergicrhinitis and allergic skin conditions e.g. chronic urticaria.

Dosage and Administration♦ Allergic rhinitis

Children 6 to 11 yearsThe recommended dose of Fexofenadine Hydrochloride is 30 mg twicedaily.

Adults and children aged 12 years and over The recommended dose of Fexofenadine Hydrochloride for adults andchildren aged 12 years and over is 120 mg once daily.


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♦ Allergic skin conditions, e.g. chronic urticariaChildren 6 to 11 yearsThe recommended dose of Fexofenadine Hydrochloride is 30 mg twicedaily.

Adults and children 12 years and over The recommended dose of Fexofenadine Hydrochloride for adults andchildren aged 12 years and over is 180 mg once daily.

Children under 6 years of ageThe efficacy and safety of Fexofenadine Hydrochloride has not beenstudied in children under 6.

Use in Special Risk GroupStudies in special risk groups (elderly and patients with renal or hepaticimpairment) indicate that it is not necessary to adjust the dose ofFexofenadine Hydrochloride in these patients.

ContraindicationThe product is contraindicated in patients with known hypersensitivity toany of its ingredients.

Drug InteractionsFexofenadine does not undergo hepatic bio-transformation and istherefore unlikely to interact with drugs that rely upon hepaticmetabolism. Fexofenadine Hydrochloride at doses of 120 mg twice dailyhas been safely co-administered with Erythromycin (500 mg three timesdaily) and Ketoconazole (400 mg once daily) under steady state conditionsin healthy volunteers. A two fold increase in the level of plasmaFexofenadine was observed after co-administration of Erythromycin orKetoconazole but this was not associated with any increase in adverseevent or effects on the QT interval, compared to that seen when thedrugs were given alone.

Animal studies have shown that the increase in plasma level ofFexofenadine observed after co-administration of Erythromycin orKetoconazole appears to be due to an increase in gastrointestinalabsorption.


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Side EffectsIn placebo-controlled trials, adverse events were comparable inFexofenadine and placebo treated patients. Adverse events reported withFexofenadine include-Common : headache, Uncommon : fatigue, drowsiness, nausea, tachycardia,palpitations, dry mouth, dyspepsia and gastrointestinal disturbances(including diarrhoea), Rare : taste, disturbances, anaphylactic reactions,dyspnoea, chest tightness, increased hair loss/hair thinning,photosensitivity, dysmenorrhoea, menstrual disorders, Others : As withother non-sedating antihistamines, dizziness, nervousness, agitation, sleepdisorders, insomnia or paroniria may infrequently be reported by patients.The incidence of such reports under Fexofenadine was similar to theincidence under placebo.

Effects on ability to Drive and Use MachinesOn the basis of the pharmacodynamics profile and reported adverseevents it is unlikely that Fexofenadine Hydrochloride will produce aneffect on the ability to drive or use machines. In objective tests,Fexofenadine Hydrochloride has been shown to have no significanteffects on central nervous system function. This means that patients maydrive or perform tasks that require concentration.

OverdosageMost reports of Fexofenadine Hydrochloride overdose contain limitedinformation. However, dizziness, drowsiness and dry mouth have beenreported. Single doses up to 800 mg and doses up to 690 mg bid for 1month or 240 mg qid for 1 year were studied in healthy subjects withoutthe development of clinically significant adverse events as compared toplacebo.

Use in Pregnancy and LactationFexofenadine should be used in pregnancy only if the potential benefitoutweighs the potential risk to the foetus. There are no data on thecontent of human milk after administering Fexofenadine Hydrochloride.However, when Terfenadine was administered to nursing mothersFexofenadine was found to cross into human breast milk. ThereforeFexofenadine is not recommended for mothers breast feeding theirbabies.


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Pharmaceutical PrecautionsStore in cool and dry place. Keep away from children.

Commercial PackAxodin 60 Tablet : Each tablet contains Fexofenadine Hydrochloride 60 mg in 10 x 5 blister strips.

Axodin 120 Tablet : Each tablet contains Fexofenadine Hydrochloride120 mg in 10 x 5 blister strips.

Axodin 180 Tablet : Each tablet contains Fexofenadine Hydrochloride180 mg in 10 x 3 blister strips.


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Azithrocin®

Capsule/Tablet/Suspension

DescriptionAzithrocin contains Azithromycin USP. It is an azalide antibiotic activeagainst Gram-positive and Gram-negative organisms. Azithromycininterferes with ribosome function in susceptible bacteria by inhibiting thetranslocation of peptides.

IndicationsAzithrocin (Azithromycin) is indicated for infections caused bysusceptible organisms, in upper respiratory tract infections includingsinusitis, pharyngitis and tonsillitis, in lower respiratory tract infectionsincluding bronchitis and pneumonia, skin and soft tissue infections, andotitis media.

Azithrocin is indicated in the treatment of uncomplicated genitalinfections due to Chlamydia trachomatis.

Dosage and AdministrationAdult : Azithrocin should be given as 500 mg once-daily orally for 3 daysor as an alternative, given over 5 days with 500 mg on day 1, then 250 mgon days 2-5.

For sexually transmitted diseases caused by Chlamydia trachomatis in adults,the dose is 1 g given as a single dose.

Normal adult dose is recommended for elderly patients.

For children over 6 months recommended dose is 10 mg/kg once dailyfor 3 days; or if body weight is 15-25 kg : 200 mg once daily for 3 days, ifbody weight is 26-35 kg : 300 mg once daily for 3 days, if body weight is36-45 kg : 400 mg once daily for 3 days.

As common with many other antibiotics, Azithrocin should be taken atleast 1 hour before or 2 hours after meal and antacid.


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ContraindicationAzithromycin is contraindicated in patients hypersensitive toAzithromycin or any other macrolide antibiotic. Co-administration ofergot derivatives and Azithromycin is contraindicated. Azithromycin iscontraindicated in patients with hepatic diseases.

Side EffectsAzithromycin is well tolerated with a low incidence of side effects.Majority of the side effects were mild to moderate in nature and ofgastrointestinal in origin with nausea, abdominal discomfort, vomiting,flatulence and diarrhoea. Allergic reactions such as rash have occurredand there have also been rare reports of serious hypersensitivity reactions.Reversible elevations in liver transaminases have been seen with afrequency similar to the comparative macrolides and penicillins used inclinical trials. Transient mild reductions in neutrophil counts haveoccasionally been observed in clinical trials, although a causal relationshipto Azithromycin has not been established.

PrecautionsAs with any antibiotic, observation for signs of superinfection with non-susceptible organisms, including fungi, is recommended. No doseadjustment is needed in patients with renal impairment.

Use in Pregnancy and LactationAnimal reproduction studies have demonstrated that Azithromycincrosses the placenta, but have revealed no evidence of harm to the foetus.There are no adequate and well controlled studies in pregnant women.Since animal reproduction studies are not always predictive of humanresponse, Azithromycin should be used during pregnancy only ifadequate alternatives are not available. No data on secretion ofAzithromycin in breast milk is available, so, Azithromycin should only beused in lactating mothers where adequate alternatives are not available.

Drug InteractionsAzithromycin absorption is reduced in presence of food and antacid. So,Azithromycin should be administered 1 hour before or 2 hours aftertaking food or antacid. In patients receiving ergot alkaloids, Azithromycinshould be avoided concurrently because of the possibility of ergotismresulting from interaction of Azithromycin with the cytochrome P450


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system. However, no cases of such interaction have been reported.Macrolides have been known to increase the plasma concentration ofDigoxin and Cyclosporin. Therefore, if co-administration is necessary,caution should be exercised and serum level of Digoxin and Cyclosporinshould be checked. There have been no pharmacokinetic druginteractions between Azithromycin and Warfarin, Theophylline,Carbamazepine, Methylprednisolone and Cimetidine.

OverdosageThere is no data on overdosage with Azithromycin. Typical symptoms ofoverdosage with macrolide antibiotics include hearing loss, severe nausea,vomiting and diarrhoea. Gastric lavage and general supportive measuresare indicated.

Commercial PackAzithrocin Capsule : Box containing 1 x 10’s blister strip, each capsulecontains Azithromycin USP equivalent to 250 mg anhydrousAzithromycin.

Azithrocin 500 Tablet : Box containing 1 x 3’s blister strip, each filmcoated tablet contains Azithromycin USP equivalent to 500 mganhydrous Azithromycin.

Azithrocin Suspension : Dry powder in glass bottle for reconstitution into15 ml of suspension. After reconstitution each 5 ml containsAzithromycin USP equivalent to 200 mg anhydrous Azithromycin.


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Azmasol®

Inhaler

DescriptionSalbutamol BP, the active ingredient of Azmasol Inhaler, is a ß2-

adrenoceptor agonist used in the treatment of asthma and other forms ofdiffuse reversible airways obstruction.

IndicationsAzmasol (Salbutamol) inhaler is indicated for the treatment andprophylaxis of bronchial asthma and for the treatment of reversibleairways obstruction associated with bronchitis and emphysema. Azmasolinhaler may be used to relieve attacks of acute dyspnoea and may also betaken prophylactically before exertion or to prevent exercise-induced-asthma. It is suitable for treating bronchospasm in patients withcoexisting heart disease or hypertension, including those taking β-blockers, because of its selective action on the bronchial receptors andlack of effects on the cardiovascular system. Salbutamol is asympathomimetic agent which has a highly selective action on β-adrenergic receptors in bronchial muscle. At therapeutic levels, it has littleeffect on cardiac receptors.

Dosage and AdministrationAdultsi) For the relief of acute bronchospasm and for managing intermittent

episodes of asthma : one or two inhalation as a single dose

ii) For chronic maintenance or prophylactic therapy : two inhalationsthree or four times daily

iii) For prevention of exercise induced bronchospasm : two inhalationsbefore exertion.

ChildrenFor relief of acute bronchospasm, management of episodic asthma andfor prevention of exercise induced bronchospasm : one inhalation; forroutine maintenance and prophylaxis : one inhalation three or four timesdaily, increasing if necessary to two inhalations three or four times daily.


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ElderlyThe dosage is the same as that for adults.

ContraindicationAlthough intravenous Salbutamol, and occasionally Salbutamol tablets,are used in the management of premature labour uncomplicated byconditions such as placenta praevia, ante-partum haemorrhage ortoxaemia of pregnancy, Salbutamol inhaler preparations are notappropriate for managing premature labour. Salbutamol preparationshould not be used for threatened abortion during the first or secondtrimesters of pregnancy. Salbutamol inhaler is contraindicated in patientswith a history of hypersensitivity to any of its components.

PrecautionsIn the event of previously effective dose of Salbutamol inhaler failing togive relief for at least three hours, the patient should be advised to seekmedical advice in order that any necessary additional steps may be taken.Salbutamol should be administered cautiously to patients suffering fromthyrotoxicosis.

As with other inhalation therapy, the potential for paradoxicalbronchospasm should be kept in mind. If it occurs, the preparationshould be discontinued immediately and alternative therapy should beinstituted.

Side EffectsMild tremor and headache have been rarely reported. These usuallydisappear with continuous treatment. There have been very rare reportsof transient muscle cramp. Hypersensitivity reactions includingangioedema, urticaria, bronchospasm, hypotension and collapse havebeen reported very rarely.

Pharmaceutical PrecautionPressurized canister, do not puncture, break or incinerate even whenapparently empty.

Avoid storage in direct sunlight or heat. Store below 30°C. Keep awayfrom eyes. Keep away from children.


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Commercial PackAzmasol Inhaler : Each canister contains 200 measured doses, eachcontaining 100 µg of Salbutamol BP.

Azmasol Refill Can : Each canister contains 200 measured doses, eachcontaining 100 µg of Salbutamol BP.


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Bexidal®Tablet

DescriptionEach tablet contains Mebhydrolin 50 mg as Mebhydrolin NapadisylateBPC.

IndicationsAllergic diseases or symptoms, such as urticaria, pruritus of variousorigin, eczema, drug rash, allergic conjunctivitis, dermatitis of nutritionalorigin, hay fever, vasomotor rhinitis, allergic asthma.

Dosage and AdministrationUnless otherwise prescribed, the following doses are recommended:

Adults and children over 10 years .................. 2-6 tablets daily

Children from 5-10 years ............................. 2-4 tablets daily

Children from 2-5 years ............................ 1-3 tablets daily

Children up to 2 years ................................. 1-2 tablets daily

Treatment should be given in several single doses daily. Bexidal may beswallowed during or shortly after meals. For children, the tablets may becrushed and mixed with food.

Bexidal is essentially free from secondary sedative-hypnotic effects. Itdoes not impair psycho-physical efficiency to any appreciable degree.

Contraindication♦ Caution is required while driving or operating heavy machinery♦ Concomitant use of CNS depressant or alcohol♦ Patients to whom Mebhydrolin has previously been suspected to have

agranulocytosis or neutropenia♦ First trimester of pregnancy

Commercial PackBexidal Tablet : Box containing 20 aluminium strips of 10 tablets. Eachtablet contains Mebhydrolin 50 mg as Mebhydrolin Napadisylate BPC.


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Bexitrol-F®

Inhaler

DescriptionBexitrol-F metered dose inhaler is a combination of Salmeterol XinafoateINN and Fluticasone Propionate BP. Salmeterol Xinafoate is a selective,long acting β2 agonist used in the treatment of asthma and other forms

of diffuse airways obstruction. Fluticasone Propionate is a corticosteroidwith mainly glucocorticoid activity. Fluticasone Propionate is stated toexert a topical effect on the lungs without systematic effects at usual dose.

IndicationsBexitrol-F is indicated in the regular treatment of asthma where use of acombination product (long-acting β2 agonist and inhaled corticosteroid)

is appropriate. Other indication of Bexitrol-F is patients with frequentasthmatic episodes requiring bronchodilators or those with asthmaticepisodes at night.

Pharmacodynamic PropertiesMechanism of action : Bexitrol-F contains Salmeterol and FluticasonePropionate, which have different modes of action. Salmeterol protectsagainst symptoms, Fluticasone Propionate improves lung function andprevents exacerbations of the condition. Bexitrol-F can offer a moreconvenient regime for patients on concurrent β-agonist and inhaledcorticosteroid therapy. The mechanisms of action of both drugs arediscussed below:

Salmeterol : Salmeterol is a selective long-acting (12 hour) β2-

adrenoceptor agonist with a long side chain which binds to the exo-siteof the receptor.

Fluticasone Propionate : Fluticasone Propionate given by inhalation atrecommended doses has a potent glucocorticoid anti-inflammatoryaction within the lungs, resulting in reduced symptoms and exacerbationsof asthma, without the adverse effects observed when corticosteroids areadministered systemically.


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Recommended DosesAdults and adolescents 12 years and older-The recommended dose is two puffs of Bexitrol-F twice daily or asprescribed by the physicians.

ContraindicationBexitrol-F is contraindicated in patients with a history of hypersensitivityto any of the ingredients of the product.

Special Warning and Precautions Consideration should be given to additional corticosteroid therapies, andadministration of antibiotics if an infection is present. As with all inhaledmedication containing corticosteroids, Bexitrol-F should be administeredwith caution in patients with active or quiescent pulmonary tuberculosis.Bexitrol-F should be administered with caution in patients withthyrotoxicosis. Orally inhaled corticosteroids may cause a reduction ingrowth velocity when administered to paediatric patients. The long-termeffects of this reduction including the impact of final adult height areunknown.

Drug InteractionsBoth non-selective and selective β-blockers should be avoided in patientswith asthma, unless there are compelling reasons for their use. Due to thevery low plasma concentrations achieved after inhaled dosing clinicallysignificant drug interactions are unlikely. Care should be taken when co-administering known strong CYP3A4 (cytocrome P450 3A4) inhibitors(e.g. Ketoconazole, Ritonavir), as there is potential for increased systemicexposure to Fluticasone Propionate.

Use in Pregnancy and LactationThere is insufficient experience of the use of Salmeterol Xinafoate andFluticasone Propionate in human pregnancy and lactation. There are nodata available for human breast milk.

Administration of drugs during pregnancy and lactation should only beconsidered if the expected benefit to the mother is greater than anypossible risk to the foetus or child.


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Side EffectsAs Bexitrol-F contains Salmeterol and Fluticasone Propionate, the typeand severity of adverse reactions associated with each of the compoundsmay be expected. There is no incidence of additional adverse eventsfollowing concurrent administration of the two compounds. Adverseevents, which have been associated with Salmeterol or FluticasonePropionate, are given below.

Salmeterol : The pharmacological side effects of β2 agonist treatment, such

as tremor, subjective palpitations and headache, have been reported, buttend to be transient and reduced with regular therapy. Cardiac arrhythmia(including atrial fibrillation, supraventricular tachycardia and extrasystoles) may occur, usually in susceptible patients. There have beenreports of oropharyngeal irritation, arthralgia and hypersensitivityreactions, including rash, oedema and angioedema. There have been rarereports of muscle cramps.

Fluticasone Propionate : Hoarseness and candidiasis (thrush) of the mouthand throat can occur in some patients. Both hoarseness and incidence ofcandidiasis may be relieved by gargling with water after use of Bexitrol-FInhaler. Cutaneous hypersensitivity reactions have been reported. Rarecases of facial and oropharyngeal oedema have been reported.

OverdosageThere are no data available from clinical trials on overdosage with thiscombination drug.

Pharmaceutical PrecautionPressurized canister, do not puncture, break or incinerate even whenapparently empty. Avoid storage in direct sunlight or heat.

Store below 30oC. Keep away from eyes. Keep away from children.

Commercial PackBexitrol-F Inhaler : Each canister contains 120 metered doses, eachcontaining Salmeterol Xinafoate INN equivalent to 25 µg Salmeterol andFluticasone Propionate BP 250 µg.


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Bexitrol®

Inhaler

Description Salmeterol Xinafoate INN, the active ingredient of Bexitrol Inhaler, is aselective, long acting ß2-agonist used in the treatment of asthma and

other forms of diffuse airways obstruction. Bexitrol Inhaler is a metereddose aerosol unit containing a micro-crystalline suspension of Salmeterolin a mixture of propellant with lecithin.

Indications Bexitrol (Salmeterol) is a long-acting ß2-agonist which is considerably

more potent, selective and long-acting compared with traditionally usedbronchodilators. Bexitrol protects against asthma induced by histamine ormethacholine for a period of at least 12 hours in adults and children.Furthermore, long-acting ß2-agonist show a more than 4-fold greater

potency than short-acting agents (for example, Salbutamol) againsthistamine-induced bronchoconstriction. Bexitrol has the potential toimprove the treatment of patients with asthma; the drug providesprolonged bronchodilation and decrease asthma symptoms and the needfor short acting ß2-agonist, independently of concomitant steroid use.

Studies have consistently reported improved control of nocturnal asthmawith long-acting ß2-agonist compared with other anti-asthma drugs.

Bexitrol is indicated for the long term regular treatment of reversibleairways obstruction (including nocturnal and exercise-induced asthma)and chronic bronchitis. In paediatric asthma, the use of Bexitrol mayavoid exposure of children to Theophylline or high-dose corticosteroids,with their attendant risks.

Dosage and AdministrationThe recommended dose is 50 µg (2 puffs) twice daily, although in severedisease the dose may be increased to 100 µg twice daily. The drug shouldnot be used on an ‘as required’ basis, although on account of its efficacyin nocturnal and exercise induced asthma, single dose administration maybe considered as a treatment option.


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Contraindication Patients with thyrotoxicosis. Special caution should be exercised inpatients with cardiac problems predisposing to arrythmias. The drug isineffective in patients taking non-selective ß-blocking drugs.

PrecautionsBronchodilators should not be the only or the main treatment in patientswith severe or unstable asthma. Severe asthma requires regular medicalassessment, including lung function testing, as patients are at risk ofsevere attack or even death. Physicians should consider using oralcorticosteroid therapy and/or the maximum recommended dose ofinhaled corticosteroid in these patients. Increasing use ofbronchodilators, in particular short-acting inhaled ß2-agonist to relieve

symptoms indicates deterioration of asthma control. If patients find thatshort acting bronchodilator treatment becomes less effective or they needmore inhalation than usual, medical attention must be sought. In thissituation patients should be reassessed and consideration given to theneed for increased anti-inflammatory therapy (e.g. higher doses of inhaledcorticosteroid or a course of oral corticosteroids). Severe exacerbation ofasthma must be treated in the normal way. Salmeterol inhaler is notdesigned to relieve acute asthmatic symptoms, for which an inhaled short-acting bronchodilator is required. Patients should be advised to havesuch rescue medication available. Potentially serious hypokalaemia mayresult from ß2-agonist therapy. Particular caution is advised in acute severe

asthma as this effect may be potentiated by concomitant treatment withxanthine derivatives, steroids and diuretics. It is recommended that serumpotassium levels are monitored in such situations.

Side EffectsNo severe irreversible adverse effect is known although systemic ß2-

agonist effects of Salmeterol may last up to 12 hours. Inhaled dose ofSalmeterol up to 400 µg given to healthy volunteers produced significantsystemic side effects, the majority of which were pharmacologicallypredictable. Response observed with 100 µg Salmeterol were similar tothose observed with 400 µg Salmeterol. Hypokalaemia, tremor andpalpitations may all occur but only at doses of Salmeterol exceeding thatrecommended.


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Pharmaceutical Precaution Store below 30°C, keep out of the reach of children.

Commercial Pack Bexitrol Inhaler : Each canister contains 200 metered doses, eachcontaining Salmeterol Xinafoate INN equivalent to 25 µg Salmeterol.


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Bextrum®

Tablet

DescriptionBextrum is a special formulation comprising of important vitamins,antioxidants and minerals. Each film-coated tablet contains:

Vitamin A 2700 IUVitamin E 30 IUVitamin K 65.00 µgVitamin C 120.00 mgThiamine Mononitrate 3.40 mgRiboflavin 3.40 mgFolic Acid 800 µgNiacin 40.00 mgPantothenic Acid 20.00 mgPyridoxine Hydrochloride 10.00 mgIron 30.00 mg Zinc 25.00 mgCopper 2.00 mgManganese 1.20 µgIodine 175.00 µgSelenium 12.50 µgMolybdenum 25.00 µgChromium 25.00 µgInositol 50.00 mgQuercetin 54.00 µg

IndicationsBextrum is a once-daily tablet indicated for use to improve the nutritionalstatus of women throughout pregnancy and in the postnatal period forboth lactating and non-lactating mothers. This preparation can also bebeneficial in improving the nutritional status of women prior toconception. Bextrum tablet maintains a healthy body and active lifestyleand keeps nutrition covered for all.

Dosage and AdministrationBextrum may be administered once daily or as indicated by the physician.


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ContraindicationBextrum is contraindicated in patients with a known hypersensitivity toany of the ingredients.

Side EffectsGenerally well tolerated.

Precautions Long-term intake of high levels of vitamin A (excluding that source fromβ carotene) may increase the risk of osteoporosis in postmenopausalwomen.

Drug InteractionsNo drug interactions have been reported.

Use in Pregnancy and Lactation Bextrum is recommended in pregnancy and lactation.

Pharmaceutical PrecautionTablets should be stored below 25oC and protected from light andmoisture.

Commercial PackBextrum Tablet : Plastic bottle containing 30 tablets. Each tablet containsmultivitamin and multimineral.


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Bronkolax®

Tablet/Syrup

DescriptionBronkolax (Salbutamol) is a synthetic sympathomimetic agent having β2-adrenergic activity and selective action on receptors of bronchial smoothmuscle. It is used for the treatment of reversible obstruction of theairways.

IndicationsBronkolax is indicated for the relief of bronchospasm in bronchialasthma, bronchitis, emphysema and also in bronchospasm where heartdisease or hypertension is co-existing.

Dosage and AdministrationAdultsRecommended dose is 2-4 mg, 3-4 times daily; in some patients higherdoses up to 8 mg may be given.

ChildrenRecommended dose for age group-

2-6 years : 1 mg, 3-4 times daily6-12 years : 2 mg, 3-4 times dailyOver 12 years : 2-4 mg, 3-4 times daily

ContraindicationIt should not be prescribed with β blocking drugs.

Bronkolax should not be used for prevention of premature labourassociated with toxemia of pregnancy or antepartum hemorrhage or forthreatened abortion during the first and second trimester of pregnancy.

PrecautionsBronkolax should be given with caution to hypersusceptible patients orthose with hyperthyroidism, in patients with diabetes mellitus, seriouscardiovascular disorders or hypertension. In asthmatic patients, whosecondition deteriorates despite Salbutamol therapy, alternative oradditional therapy including corticosteroids should be instituted


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promptly. Adverse metabolic effects of high doses of Salbutamol may beexacerbated by concomitant administration of high doses ofcorticosteroids. Hypokalemia associated with high doses of Salbutamolmay result in increased susceptibility to digitalis-induced cardiacarrhythmias. Concomitant administration of Aminophylline may enhancethe effects of Salbutamol. Long term treatment may increase the risk ofdental caries and hence adequate dental hygiene should be maintained.

Side EffectsSalbutamol may cause fine tremor of skeletal muscle (particularly thehands), palpitations, and muscle cramps. Slight tachycardia, headache, andperipheral vasodilation have been reported after large doses. Salbutamolmay cause hypokalemia and hypoglycaemia. Sometimes hypersensitivityreactions including paradoxical bronchospasm, urticaria and angioedemamay occur.

Treatment of OverdosageThe preferred antidote for overdosage with Salbutamol is acardioselective beta blocking agent, but beta blocking drugs should beused with caution in patients with a history of bronchospasm.

Commercial PackBronkolax-2 Tablet : Box containing 100 tablet in 10 x 10’s blister strips,each contains Salbutamol Sulphate BP equivalent to 2 mg Salbutamol.

Bronkolax-4 Tablet : Box containing 100 tablet in 10 x 10’s blister strips,each contains Salbutamol Sulphate BP equivalent to 4 mg Salbutamol.

Bronkolax Syrup : 100 ml in glass bottle, each 5 ml contains SalbutamolSulphate BP equivalent to 2 mg Salbutamol.


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Cardopril®Tablet

DescriptionCardopril (Captopril) is the first of a new class of antihypertensive agents,a highly specific competitive inhibitor of angiotensin I convertingenzyme. Cardopril is available in 25 mg and 50 mg, as double scoredtablets for oral administration.

Indications♦ Hypertension : Mild to moderate hypertension as an adjunct to thiazide

therapy in patients who have not responded effectively to thiazidetreatment alone.

♦ Severe hypertension : Where standard therapy has failed.

Cardopril is effective alone or in combination with other antihypertensiveagents especially thiazide type of diuretics. The blood pressure loweringeffect of Cardopril and thiazides are approximately additive.

♦ Congestive heart failure : It is also used as an adjunct to the treatment ofsevere congestive heart failure.

Dosage and Administration♦ Hypertension : Treatment with Cardopril should be at the lowest

effective dose, which should be titrated according to the need of thepatient.

Mild to moderate hypertension- In mild to moderate hypertensionCardopril therapy should be used as an adjunct to thiazide therapy.Starting dose is 12.5 mg twice daily. The usual maintenance dose is 25mg twice daily.

Severe hypertension- Starting dose is 12.5 mg twice daily and can beincreased incrementally to a maximum of 50 mg thrice daily.

♦ Heart failure : In congestive heart failure an initial dose of 6.25 mg to12.5 mg is given under close medical supervision.


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The usual maintenance dose is 25 mg thrice daily and should not exceed50 mg thrice daily.

Side EffectsHaematological : neutropenia, anaemia and thrombocytopenia.

Renal : proteinuria, elevated blood urea and creatinine, elevated serumpotassium and acidosis.

Cardiovascular : hypotension, tachycardia.

Skin : rashes usually pruritic, may occur.

Gastrointestinal : Reversible and usually self limiting taste impairmenthas been reported. Stomatitis resembling aphthous ulcers has also beenreported.

Drug Interactions♦ Diuretics: Diuretics potentiate the antihypertensive effect of

Captopril. Potassium sparing diuretics (Triamterene, Amiloride andSpironolactone) or potassium supplements may cause significantincrease in serum potassium.

♦ Vasodilators: Captopril has been reported to act synergistically withperipheral vasodilators such as Minoxidil.

♦ Non-steroidal anti-inflammatory agents: Concomitant therapy withIndomethacin and possibly other anti-inflammatory drugs may reducethe antihypertensive effect of Captopril.

♦ Others: Caution should be exercised in prescribing Captopril forpatients receiving concomitant therapy with immuno-suppressant,procainamide, allopurinol and other drugs known to causeneutropenia especially in patients with impaired renal function.

ContraindicationA history of previous hypersensitivity to Captopril.


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PrecautionsCaptopril should be used with great caution in patients with impairedrenal function particularly if reno-vascular disease is present or suspectedand in patient with collagen vascular disorders such as systemic lupuserythematosus or scleroderma. Captopril should not be used duringpregnancy.

Commercial PackCardopril-25 Tablet : Box containing 100 tablets in 10 x 10’s blister strip,each tablet contains 25 mg of Captopril USP.

Cardopril-50 Tablet : Box containing 100 tablets in 10 x 10’s blister strip,each tablet contains 50 mg of Captopril USP.


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Carocet®

Tablet

DescriptionCarocet is a chewable tablet which contains a combination of threeantioxidant vitamins. Each tablet contains β Carotene (pharma grade) 6mg, Ascorbic Acid USP and Sodium Ascorbate USP equivalent toAscorbic Acid (Vitamin C) 200 mg and Vitamin E preparation USPequivalent to dl-alpha-Tocopheryl Acetate (Vitamin E) 50 mg.

IndicationsAntioxidant vitamins are used in a wide range of conditions where freeradical damage is playing a role. Antioxidant vitamin combination is usedin the prevention of coronary heart diseases, certain types of cancer,aging as well as free radical damage caused by excessive exercise, illness,certain medications, air pollution, smoke, radiation and pesticides. Themain role of the antioxidant vitamins is as follows:

β-carotene prevents free radical formation by quenching singlet oxygen, ahighly reactive form of oxygen. Vitamin C is another free radicalscavenger which deactivates free radicals. It works specially in the plasma,lung fluid, aqueous humour and interstitial fluid. It can increase whiteblood cell activity; play important roles in the biochemistry of antibodies,prostaglandin E1, B- and T-lymphocytes, and interferon. Vitamin E also

scavenges free radicals in the blood along with β-carotene and vitamin C.Moreover, vitamin E is essential to protect us against some of the illeffects of smog and smoke. In relation to other nutrients vitamin Eprotects vitamin A from being destroyed in the body.

Dosage and AdministrationDosage varies according to individual’s need. The usual recommendeddose is two tablets daily or as advised by the physician. The dose can beincreased up to four tablets daily.

Side Effectsβ carotene is comparatively safe even at high and prolonged exposure.Individuals who routinely ingest large amounts of carotenoids candevelop hypercarotenosis, which is characterized by a yellowish


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colouration of the skin and a very high concentration of carotenoids inthe plasma. This benign condition, although resembling jaundice,gradually disappears upon correcting the excessive intake of carotenoids.Vitamin C is generally a safe drug for human use in normal doses. Largerdoses may lead to gastrointestinal tract upset and renal stone formation.Vitamin E is considered safe even in large doses. Doses over 800 mg maycause diarrhoea, abdominal pain or cramps, fatigue and reduced resistanceto bacterial infection and transiently raised blood pressure.

ContraindicationThere is no absolute contraindication.

Warning and PrecautionsThere are some evidences that β-carotene may cause harm to heavysmokers and alcoholics. Therefore, caution should be exercised in thesecases. Vitamin C should be given with caution to patients withhyperoxaluria. Vitamin E should be used with caution in patients takinganticoagulant drugs, because vitamin E may enhance the anticoagulantactivity of these drugs.

Use in Pregnancy and Lactationβ carotene, vitamin C and vitamin E have no teratogenic effects inhumans. However, like any other drugs caution should be taken inprescribing to pregnant women.

Drug InteractionsCholestyramine, Colestipol, Neomycin cause decreased absorption of βcarotene. Circulating vitamin C levels have been shown to be reducedduring prolonged administration of certain drugs including oralcontraceptives containing Oestrogen, Tetracycline and Aspirin. Thedecrease in vitamin C level may be due to drug-induced impairedabsorption or increased utilization of the vitamin for drug metabolism.Vitamin E may enhance the anticoagulant activity of anticoagulant drugs.High doses of vitamin E can impair intestinal absorption of vitamins Aand K.

OverdosageNo cases have been reported.

Commercial PackCarocet Tablet : Bottle containing 20 tablets.


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Carofol®-ZCapsule

DescriptionCarofol-Z capsule contains Carbonyl Iron INN 50 mg, Folic Acid BP0.50 mg and Zinc Sulphate Monohydrate USP 61.80 mg. Most ordinaryiron products contain iron salts that may cause gastric irritation. ButCarofol-Z capsule contains pure iron micro particles called carbonyl iron.This advanced formula is specially designed to be well absorbed, gentleon the stomach and offers enhanced safety in case of an accidentaloverdose. Folic Acid and Zinc supplementation are also important duringpregnancy as because Folic Acid helps to prevent the risk of birth defectslike neural tube defects (NTDs) and low birth weight (LBW). Zinc is animportant factor to maintain a healthy immune system.

IndicationsThe capsule is indicated for the treatment of iron deficiency or irondeficiency anemia, folic acid and zinc deficiency. It is also indicated forprophylactic use when inadequate diet calls for supplementary Zinc, FolicAcid and Iron specially during pregnancy.

Dosage and AdministrationTreatment 2 to 4 capsules a day or as prescribed by the physician.

Prophylaxis Adult and elderly : Usually once daily. In severe cases, two capsules a daymay be required as prescribed by the physician.

Children aged over one year: One capsule a day, the capsule may beopened and the pellets may be mixed with soft, cool food but they mustnot be chewed.

ContraindicationIt is contraindicated in patients with haemolytic anaemia and in conditionwith increased hypersensitivity to any of its components and increasedbody iron content.


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Side EffectsSide effects of Iron, Folic Acid and Zinc supplementation are mild andtransient. These include epigastric pain, nausea, constipation, vomiting,diarrhoea etc. The capsule is specially designed to reduce the possibilityof gastrointestinal irritation.

Drug InteractionsIron chelates with Tetracycline. Since oral Iron products interfere withabsorption of oral Tetracycline antibiotics, these products should not betaken within hours of each other. Occasional gastrointestinal discomfortmay be minimized by taking it with meals. Absorption of Iron may beimpaired by concurrent administrations of Penicillamine and antacid.

OverdosageOverdosage of Iron is dangerous, particularly in children and requiresimmediate attention. Gastric lavage should be carried out in the earlystages, vomiting may also be induced. Zinc Sulphate in gross overdosageis corrosive. Symptoms are those of gastrointestinal irritation, leading insevere cases to haemorrhagic corrosion of the mucosa and possible laterstricture formation. Demulcent such as milk should be given. Chelatingagents such as Dimercaprol, Penicillamine or Edetic acid have beenrecommended. The extended release capsule presentation may delayexcessive absorption of Iron and Zinc and allow more time for initiationof appropriate counter measures.

PrecautionsCare should be taken in patients who may develop Iron overload, such asthose with haemochromatosis, haemolytic anaemia or red cell aplasia. Inpatients with renal failure, a risk of Zinc accumulation may exist.

Pharmaceutical PrecautionStore capsules in cool and dry place. Keep out of reach of children.

Commercial PackCarofol-Z capsule : Box containing 50 capsules in 5 x 10's blister strips.Each capsule contains Carbonyl Iron INN 50 mg, Folic Acid BP 0.05 mgand Zinc Sulphate Monohydrate USP 61.80 mg.


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Cephalen®

Capsule/Suspension

DescriptionCephalen (Cefalexin) is a semisynthetic antibiotic of the cephalosporingroup, intended for oral administration which has a bactericidal activityagainst a wide range of Gram-positive and Gram-negative organisms.Cephalen is acid stable and may be given regardless of meal. It is rapidlyabsorbed after oral administration and peak serum level is obtained afterone hour. It is mainly excreted in the urine.

IndicationsCephalen is indicated for the treatment of the following infections whencaused by susceptible organisms.

Respiratory tract infections : Acute and chronic bronchitis and infectedbronchiectasis.

Genito-urinary tract infections : Acute and chronic nephritis, cystitis, urethritisand prostatitis, prophylaxis of recurrent urinary tract infections.

Skin and soft tissue infections : Caused by staphylococci and/or streptococci.

Ear, Nose and Throat infections : Otitis media, mastoiditis, sinusitis, folliculartonsillitis and pharyngitis.

Bone infections : Caused by staphylococci and/or P. mirabilis.

Dosage and AdministrationAdult : The usual dose is 250 mg to 500 mg every 6 hour. For skin andsoft tissue infections, streptococcal pharyngitis and uncomplicatedcystitis, in patients over 15 years of age, 500 mg of the drug may beadministered every 12 hour. In severe or deep seated infections the dosecan be increased up to 3 g to 6 g daily.

Children : The dosage range is 25-100 mg/kg/day in divided doses to amaximum of 4 g daily (please note the table below ).


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For streptococcal pharyngitis, skin and soft tissue infections and inpatients over 1 year of age the total daily dose may be divided andadministered every 12 hour. In the therapy of otitis media 75-100mg/kg/day in four divided doses may be required. In the treatment ofbeta haemolytic streptococcal infections a therapeutic dosage of the drugshould be given at least for 10 days.

ContraindicationCephalen is contraindicated in patients with known hypersensitivity to thecephalosporin group of antibiotics.

Side EffectsSide effects include nausea, vomiting, diarrhoea and abdominaldiscomfort. Symptoms of pseudomembranous colitis may appear eitherduring or after antibiotic treatment. Skin rash, angioedema, rise in serumaminotransferases, eosinophilia, neutropenia have been reported veryrarely. Superinfection with resistant micro-organisms, particularly candidamay follow the treatment.

PrecautionsCefalexin should be given with caution in patients with renal impairment.Under such condition, careful clinical observation should be madebecause safe dosage may be lower than the usually recommended. Theurine of patients receiving Cefalexin may give a false positive reaction forglucose with copper reduction reagent. Positive results to Coombs’ testhave been reported.

Although there is no evidence of teratogenicity in animal tests, Cefalexinmay be used during pregnancy when it is considered essential. Cefalexinis found in the milk of nursing mothers, hence caution should be takenwhen it is administered to nursing mothers.

Children’s weight Recommended Dose

10 kg ( 22 Ibs)

20 kg ( 44 Ibs)

40 kg ( 88 Ibs)

62.5 mg to 125 mg qid or 125 mg to 250 mg bid

125 mg to 250 mg qid or 250 mg to 500 mg bid

250 mg to 500 mg qid or 500 mg to 1 g bid


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Commercial PackCephalen-250 Capsule : Box containing 10 x 10’s blister strips. Eachcapsule contains Cefalexin BP equivalent to anhydrous Cefalexin 250 mg.

Cephalen-500 Capsule : Box containing 5 x 10’s blister strips. Eachcapsule contains Cefalexin BP equivalent to anhydrous Cefalexin 500 mg.

Cephalen Suspension : Dry powder in amber glass bottle forreconstitution into 100 ml suspension. After reconstitution each 5 mlcontains Cefalexin BP equivalent to anhydrous Cefalexin 125 mg.


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Cerivin®

Tablet

DescriptionCerivin (Vinpocetine) increases cerebral metabolism: it increases theglucose and O2 consumption; improves cerebral hypoxia tolerance; shifts

glucose metabolism to the energetically more favourable aerobic pathway,but it increases the anaerobic pathway as well; it elevates the ATPconcentration and the ATP/AMP ratio in the brain, and elevates thecerebral norepinephrine, dopamine and serotonin levels.

Vinpocetine considerably improves cerebral microcirculation byinhibiting platelet aggregation, reducing the pathologically increasedblood viscosity, and increases erythrocyte derformability; it also promotesO2 transport into the tissues by reducing the O2 affinity of erythrocytes.

It selectively and intensely increases cerebral blood flow and the share ofthe brain in cardiac output, it reduces cerebral vascular resistance withoutaffecting systemic circulation (blood pressure, heart rate, cardiac output,total peripheral resistance), it does not elicit steal phenomenon, on thecontrary, it primarily improves the blood supply of the injured, ischaemicarea while it remains unchanged in the intact areas (inverse steal effect), itfurther increases blood flow which is already increased as a result ofhypoxia.

IndicationsAll forms of acute and chronic cerebral circulatory insufficiency: TIA(Transient Ischaemic Attack), reversible ischaemic neurological deficiency,progressive stroke, completed stroke, post-apoplectic conditions, multi-infarct dementia, cerebral arteriosclerosis, post traumatic, hypertensiveencephalopathy etc.

For the reduction of psychic or neurological symptoms of cerebralinsufficiency (e.g. memory disturbances, dizziness, headache, aphasia,apraxia, locomotor disorders etc.).


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Ophthalmology: It can be used for the treatment of vascular disorders ofthe choroid and retina due to arteriosclerosis, vasospasm, maculardegeneration, arterial or venous thrombosis or embolism, and glaucomasecondary to the above mentioned disorders.

Otology: For the treatment of impaired hearing of vascular or toxic(iatrogenic) origin, presbyacusis, Meniere’s disease, cochleovestibularneuritis, tinnitus and dizziness of labyrinth origin.

For the treatment of vasovegetative symptoms of climacteric syndrome.

Dosage and AdministrationCerivin is taken 1-2 tablets three times daily with meals. The maintenancedose is 1 tablet three times daily over long periods.

Side EffectsCerivin is well tolerated. In some cases transient fall of blood pressureand tachycardia may occur.

ContraindicationCerivin is contraindicated in pregnancy and lactation.

Precautions Because Cerivin can reduce the ability of blood to clot, those individualswith a tendency to bleed should avoid Vinpocetine.

Drug InteractionsSlight changes in prothrombin time have been noted in those addingVinpocetine to Warfarin dosing. The changes appear minimal. There areno other interactions reported so far. Therefore, it can be applied incombinations.

Commercial PackCerivin Tablet : Box containing 100 tablets in 10 x 10’s blister strips. Eachtablet contains Vinpocetine INN 5 mg.


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Clobex®

Capsule/Syrup

DescriptionClobex (Cloxacillin) is a beta-lactamase resistant antibacterial agent withbactericidal activity against most Gram-positive organisms and Neisseriaspp. It is also effective against beta-lactamase producing Gram-negativeorganisms when given with Ampicillin.

IndicationsClobex is indicated for the treatment of infections caused by Gram-positive organisms including infections caused by beta-lactamaseproducing Staphylococci such as :

♦ Skin and soft tissue infections : Boils, Abscesses, Carbuncles,Furunculosis, Cellulitis, Infected wounds, Infected burns, Otitis mediaand externa, Protection of skin graft and Skin infections like ulcer,eczema, acne, etc.

♦ Respiratory tract infections : Pneumonia, Lung abscess, Empyema,Sinusitis, Pharyngitis and Tonsillitis.

♦ Other infections caused by sensitive organisms : Osteomyelitis,Enteritis, Endocarditis, Urinary tract infection, Meningitis andSepticaemia.

Dosage and AdministrationAdult : Usual dose is 500 mg 6 hourly daily

Children (2-10 years) : 250 mg 6 hourly daily

Children (up to 2 years) : 125 mg (i.e. 1 measuring spoonful of Clobex Syrup) 6 hourly daily

Dose may be doubled in severe infection and should be taken at least 30minutes before food.


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ContraindicationClobex should not be given to patients known to be hypersensitive topenicillin.

PrecautionsClobex should be given with caution to patients with known history ofallergy.

Side EffectsCommon side effects are skin rash, transient diarrhoea, nausea,heartburn, pruritus and disturbance of blood electrolyte. Rarelyanaphylactic shock.

Commercial PackClobex Capsule : Box containing 100 capsules in 10 x 10’s foil strips, eachcapsule containing Cloxacillin Sodium BP equivalent to 500 mgCloxacillin.

Clobex Syrup : Dry powder in glass bottle for reconstitution into 100 mlsyrup. After reconstitution each 5 ml contains Cloxacillin Sodium BPequivalent to 125 mg Cloxacillin.


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Cosmotrin®

Cream

Description Cosmotrin cream is a topical anti-acne preparation containing TretinoinUSP 0.025%. Each gram Cosmotrin cream contains Tretinoin USP 0.25 mg.

PharmacologyAlthough the exact mode of action of Tretinoin is unknown, but currentevidence suggests that topical Tretinoin decreases cohesiveness offollicular epithelial cells with decreased microcomedo formation.Additionally Tretinoin stimulates mitotic activity and increases turnoverof follicular epithelial cells, causing extrusion of the comedones, papulesand pustules.

IndicationsFor topical application in the treatment of acne vulgaris in whichcomedones, papules and pustules predominate.

Dosage and Application Cosmotrin cream should be applied sparingly to the whole affected areaonce or twice daily. The skin should be thoroughly cleaned and driedbefore application. Patient should be advised that 6 to 8 weeks oftreatment may be required before a therapeutic effect is observed.Moisturisers and cosmetics may be used during treatment with Cosmotrincream but should not be applied to the skin at the same time. Astringenttoiletries should be avoided.

ContraindicationTretinoin is contraindicated to those who are highly sensitive to any ofthe ingredients. This cream should not be used in patients with a personalor family history of cutaneous epithelioma (skin cancer).

Use in Pregnancy and LactationThere is an inadequate evidence of the safety of topically appliedTretinoin cream during pregnancy. Tretinoin has been associated withteratogenicity in human when administered systemically. So, the creamshould not be used during pregnancy and lactation.


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Side EffectsInitial external application of Tretinoin generally may cause burning orslight irritation. Erythema and peeling at the site of application. Ifirritation becomes severe and persists, discontinue application and consultphysician, if necessary.

Drug InteractionsOther topical acne treatments should be used with caution duringtreatment with Tretinoin. Particular caution should be exercised whenusing preparation containing a peeling agent for example benzoylperoxide. It is also possible to apply Tretinoin and benzoyl peroxidealternately. The suggested regimens are either Tretinoin in the morningand benzoyl peroxide in the evening or the preparations should be usedon alternate days.

PrecautionsAvoid contact of Tretinoin with lips, mouth, eyes, eyelids, nostrils orother mucous membrane. If contact in these areas occur, careful washingwith water is recommended. Apply the cream to sensitive areas of skin,such as the neck, with caution. Do not use it on broken, eczematous orsun burned skin.

Pharmaceutical PrecautionKeep out of the reach of children. Keep in a cool and dry place, protectfrom light.

Commercial PackCosmotrin Cream : Tube containing 10 g cream, each gram containsTretinoin USP 0.25 mg.


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Cox®BCapsule

DescriptionCox B (Celecoxib) is a selective cyclooxygenase-2 (COX-2) inhibitor, non-steroidal anti-inflammatory drug (NSAID). It exhibits anti-inflammatory,analgesic and antipyretic properties. The mechanism of action ofCelecoxib is believed to be due to the inhibition of prostaglandinsynthesis, via the inhibition of cyclooxygenase-2 (COX-2) enzyme. Attherapeutic concentration, Celecoxib does not inhibit cyclooxygenase-1(COX-1) isoenzyme.

Indications♦ For the relief of the signs and symptoms of osteoarthritis.♦ For the relief of the signs and symptoms of rheumatoid arthritis.♦ For the regression and prevention of colorectal adenomatous polyps

in patients with familial adenomatous polyposis (FAP).

Dosage and AdministrationOsteoarthritis : The recommended oral dose is 200 mg per dayadministered as a single dose or as 100 mg twice daily.

Rheumatoid arthritis : The recommended oral dose is 100 to 200 mgtwice daily.

Familial adenomatous polyposis (FAP) : Usual medical care for FAPpatients should be continued while on Cox B. To reduce the number ofadenomatous colorectal polyps in patients with FAP, the recommendedoral dose is 400 mg (2 x 200 mg capsules) twice daily to be taken withfood.

ContraindicationCox B is contraindicated in patients with known hypersensitivity toCelecoxib. It should not be given to patients who have demonstratedallergic-type reactions to Sulfonamides (Celecoxib contains a sulfonamideside chain). Celecoxib should not be given to patients who havedemonstrated asthma, urticaria or allergic-type reactions after takingAspirin or other


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NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs havebeen reported in such patients.

Adverse ReactionsAdverse events occurring in ≥ 2% of patients at recommended doses- Abdominalpain 4.1%, diarrhoea 5.6%, dyspepsia 8.8%, flatulence 2.2%, nausea 3.5%,back pain 2.8%, peripheral oedema 2.1%, accidental injury 2.9%,dizziness 2.0%, headache 15.8%, insomnia 2.3%, pharyngitis 2.3%,rhinitis 2.0%, sinusitis 5.0%, upper respiratory tract infections 8.1%, rash2.2%.

The following adverse events occurred in 0.1-1.9% of patients-General : Allergy aggravated, allergic reaction, asthenia, chest pain,oedema generalized, face oedema, fatigue, fever, hot flushes, influenza-like symptoms, pain, peripheral pain.

Gastrointestinal : Constipation, diverticulitis, dysphagia, oesophagitis,gastritis, gastroenteritis, gastro-oesophageal reflux disease, haemorrhoids,hiatal hernia, melaena, dry mouth, stomatitis, tenesmus, tooth disorder,vomiting.

Cardiovascular : Aggravated hypertension, angina pectoris, coronaryartery disease, myocardial infarction.

Nervous system : Leg cramps, hypertonia, hypoesthesia, migraine,neuralgia, neuropathy, paresthesia, vertigo.

Female reproductive system : Breast fibroadenosis, breast neoplasm,breast pain, dysmenorrhoea, menstrual disorder, menorrhagia, vaginitis.

Male reproductive system : Prostatic disorder.

Resistance mechanism disorders : Herpes simplex, herpes zoster, bacterialinfection, fungal infection, infection of soft tissue, viral infection,moniliasis, moniliasis genital, otitis media.

Hearing and vestibular : Deafness, ear abnormality, earache, tinnitus.


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Heart rate and rhythm : Palpitation, tachycardia.

Respiratory : Bronchitis, bronchospasm, bronchospasm aggravated,coughing, dyspnoea, laryngitis, pneumonia.

Liver and biliary system : Peptic function abnormal, increased AST andALT.

Musculoskeletal : Arthralgia, arthrosis, accidental fracture, myalgia, neckstiffness, synovitis, tendinitis.

Urinary system : Albuminuria, cystitis, dysuria, haematuria, micturitionfrequency, renal calculus, urinary incontinence, urinary tract infection.

Metabolic and nutritional : Blood urea nitrogen (BUN), CPK, creatinine,alkaline phosphatase, are increased. Hypercholesterolaemia,hyperglycaemia, hypokalaemia. Body weight is also increased.

Psychiatric : Anorexia, anxiety, increased appetite, depression,nervousness, somnolence.

Haemic : Anaemia, ecchymosis, epistaxis, thrombocythaemia.

Skin and appendages : Alopecia, dermatitis, photosensitivity reaction,pruritus, rash erythematous, rash maculopapular, skin disorder, dry skin,increased sweating, urticaria.

Application site disorders : Cellulitis, contact dermatitis, skin nodule.

Special senses : Taste perversion.

Vision : Blurred vision, cataract, conjunctivitis, eye pain, glaucoma.

Use in Special PopulationGeriatric : Dose adjustment in the elderly is not generally necessary.

However, for patients of less than 50 kg in body weight, initiate therapyat the lowest recommended dose.


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Paediatric : The safety and efficacy of Celecoxib is not established inpaediatric patients.

Hepatic Insufficiency : Cox B capsules should be introduced at a reduceddose in patients with moderate hepatic impairment. The use of Celecoxibin patients with severe hepatic impairment is not recommended.

Pregnancy : Cox B should be used during pregnancy only if the potentialbenefit justifies the potential risk of the foetus. In late pregnancy (thirdtrimester), Celecoxib should be avoided because it may cause prematureclosure of the ductus arteriosis.

Precautions Cox B, at doses up to 200 mg bid, can be administered without regard totiming of meal. Higher doses (400 mg bid) should be administered withfood.

Co-administration of Cox B with an aluminium and magnesium-containing antacid should be avoided, because they may reduce theamount of Celecoxib that the body absorbs.

Drug InteractionsACE inhibitors : Reports suggest that NSAIDs may diminish theantihypertensive effect of ACE inhibitors. This interaction should begiven into consideration in patients taking Cox B concomitantly withACE inhibitors. Frusemide : NSAIDs can reduce the natriuretic effect offrusemide and thiazides in some patients. Aspirin : Cox B can be used withlow dose Aspirin. However, concomitant administration of Aspirin withCox B may result in an increased rate of gastrointestinal ulceration orsimilar complications, compared to the use of Cox B alone. Fluconazole :Concomitant administration of Fluconazole at 200 mg qid resulted in atwo-fold increase in Celecoxib plasma concentration. Cox B should beintroduced at the lowest recommended dose in patients receivingFluconazole. Lithium : Patients on Lithium treatment should be closelymonitored when Cox B is introduced or withdrawn. Warfarin : Cautionshould be used when administering Cox B with Warfarin since thesepatients are at increased risk of bleeding complications.


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OverdosageSymptoms following NSAID overdoses are usually limited to lethargy,drowsiness, nausea, vomiting, and epigastric pain, which are generallyreversible with supportive care. Gastrointestinal bleeding can occur.Hypertension, acute renal failure, respiratory depression and coma mayoccur, but are rare. Anaphylactoid reactions have been reported withtherapeutic ingestion of NSAIDs, and may occur following an overdose.Patients should be managed by symptomatic and supportive carefollowing an NSAID overdose. There are no specific antidotes. Emesisand/or activated charcoal (60 to 100 g in adults, 1 to 2 g/kg in children)and/or osmotic cathartic may be indicated in patients seen within 4 hoursof ingestion with symptoms or following a large overdose.

Pharmaceutical Precaution

Store at temperature between 15οC and 30οC.

Commercial PackCox B-100 Capsule : Box containing 50 capsules in 5 x 10’s blister strips.Each capsule contains Celecoxib INN 100 mg.

Cox B-200 Capsule : Box containing 50 capsules in 5 x 10’s blister strips.Each capsule contains Celecoxib INN 200 mg.


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Curin®

Tablet

DescriptionCurin tablet is a preparation of Levocetrizine Dihydrochloride.Levocetrizine is the active (levo) isomer of Cetrizine. It is a new highlyeffective and well-tolerated non-sedating antihistamine with potentantiallergic properties. It has a two-fold higher affinity for H1-receptors

than Cetirizine. Levocetirizine has a rapid and long-lasting action,allowing once-a-day administration.

IndicationsCurin is indicated in the treatment of symptoms associated with allergicconditions such as seasonal allergic rhinitis, perennial allergic rhinitis andchronic idiopathic urticaria.

Dosage and AdministrationAdults & children over 6 years of age : One Curin tablet (LevocetrizineDihydrochloride 5 mg) once daily.Patients with renal impairment : The recommended dose in patients withmoderate renal impairment is one Curin tablet every two days. In thosewith sever renal impairment, the dose interval should be increased toevery three days. Patients with end-stage renal disease should not be givenLevocetirizine.

Side EffectsGenerally Levocetirizine is well tolerated. However, a few side effects likeheadache, dry mouth, fatigue and skin rash have been reported rarely.

ContraindicationsCurin is contraindicated in patients who are hypersensitive to thismedication or to any of its ingredients.

Use in Pregnancy and Lactation:The safety of Levocetirizine in pregnancy has not been established.Therefore, it should be used with caution during pregnancy and only ifthe potential benefits to the mother outweigh any risks to the fetus.


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Levocetirizine passes into breast milk. So, it should be used with cautionin nursing mothers and only if the expected benefit to the mother isgreater than the positive risk to the nursing infant.

Pediatric UseNot recommended for use in children less than 6 years of age.

OverdosageNo clinically relevant adverse events have been reported in case ofoverdosage. However, in the event of overdosage, symptomatic andsupportive treatment is recommended.

Pharmaceuticals PrecautionsKeep out of reach of children. Keep in a cool dry place.

Commercial PackCurin Tablet : Each box contains 10 blister strips of 10 tablets. Each filmcoated tablet contains Levocetrizine Dihydrochloride INN 5 mg.


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Decacycline®

Capsule

DescriptionDecacycline contains Tetracycline Hydrochloride BP. TetracyclineHydrochloride is a broad spectrum antibiotic. It is active against a widerange of Gram-positive and Gram-negative bacteria and even some thatare resistant to penicillins. It is primarily bacteriostatic in activity. Due toincreasing bacterial resistance, Tetracycline use has been decreased.However, it remains the treatment of choice for infections caused byChlamydia, Rickettsiae, Mycoplasma and Brucella. When penicillin iscontraindicated, Tetracycline is an alternative drug in treatment ofinfections caused by Neisseria gonorrhoeae, Treponema pallidum and Treponemapertenue.

IndicationsDecacycline is indicated in the infections caused by Tetracycline sensitivemicroorganisms.

Respiratory tract infections: Acute and chronic bronchitis, lobar andbronchopneumonia, atypical pneumonia, lung abscess.

Gastro-intestinal infections: Amoebic dysentery, bacillary dysentery, enteritis,hepatic infections, cholangitis, and cholecystitis.

Genito-urinary infections: Pyelonephritis (acute and chronic), cystitis,urethritis, and epididymitis, non-gonococcal urethritis, gonorrhoea.

Soft tissue infections : Mild to moderate acne, typhus fever.

Other infections: Trachoma, psittacosis, whooping cough, brucellosis (incombination with other antibacterial drugs), rickettsial fevers,actinomycosis, anthrax, Rocky Mountain spotted fever etc.

Dosage and AdministrationAdults : Usual dose is 250 mg every 6 hours and can be increased in severeinfection to 500 mg every 6-8 hours. In case of primary, secondary or


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latent syphilis : 500 mg every 6 hours for 14-21 days. Non-gonococcalurethritis : 500 mg every 6 hours for 7-14 days. Brucellosis : 500 mg 4times/day for 3 weeks (accompanied by other antibacterial drugs). Severeacne (long term therapy) : Initially, 1 g/day in divided doses. Formaintenance 125-500 mg/day should be given.

Children (over 12 years of age) : Daily dose is 10-20 mg/lb (25-50mg/kg) in 4 equal doses.

ContraindicationDecacycline is contraindicated in renal impairment, during pregnancy andlactation, children under 12 years of age, systemic lupus erythematosusand hypersensitivity to any other Tetracyclines.

Side EffectsGastrointestinal side effects especially nausea, vomiting and diarrhoea aremost frequently reported. Glossitis, stomatitis, vaginitis or Staphylococcalenterocolitis may occur. Anaphylaxis may occur on rare occasions.

Pharmaceutical PrecautionStore in a cool and dry place. Keep out of the reach of children.

Use in Pregnancy and LactationTetracycline should be avoided in pregnant women, because of the risk ofboth staining of teeth and effect on bone growth in the foetus.Tetracycline has been found in the breast milk of lactating mothers. Thereis probably negligible absorption of Tetracycline by breasted infants,because of chelation by the calcium in milk.

Commercial PackDecacycline Capsule : Box containing 10 blister strips of 10 capsule, eachcapsule contains Tetracycline Hydrochloride BP 250 mg.


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Decomit®

Inhaler

DescriptionThe active ingredient of Decomit Inhaler (Beclomethasone DipropionateBP) is a synthetic halogenated corticosteroid with anti-inflammatoryactivity.

IndicationsDecomit Inhaler (Beclomethasone Dipropionate BP) given by inhalationhas a potent anti-inflammatory action within the lungs without the sideeffects observed when steroids are administered systemically.

Decomit inhaler is indicated for the management of patients withbronchial asthma including :

♦ Patients whose asthma is becoming worse and is inadequatelycontrolled by bronchodilator therapy alone

♦ Patients whose asthma is not controlled by the combined use ofbronchodilator and Sodium Cromoglycate

♦ Patients with severe asthma being treated with systemic corticosteroidsor synthetic or actual adrenocorticotrophic hormone (ACTH)

Dosage and AdministrationIt may take 1-3 months to achieve maximum therapeutic benefit from anycorticosteroid inhalation therapy. Patients should be given a starting doseof inhaled Beclomethasone Dipropionate that is appropriate for theseverity of their disease. The dose may then be adjusted until control isachieved or reduced to the minimum effective dose according toindividual response.

Adults : The usual recommended maintenance dose is 100-250 µg giventhree or four times a day. Alternatively, 200-500 µg given twice daily hasbeen effective in some patients. In patients with severe asthma, it isadvisable to start with 600 to 1000 µg a day and reduce the dose according


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to the response of the patients. High dose (up to 2000 µg daily) maycontrol asthmatics not adequately controlled with more conventionaldoses. In patients receiving doses of 1500 µg or more, adrenalsuppression (though may not be clinically significant) may occur whichshould be balanced against the therapeutic advantages.

Children : The usual starting dose is 100 µg twice daily. Some patients mayrequire 100 µg three to four times daily (or 200 µg twice daily). Total dosefor children should not exceed 500 µg daily.

ContraindicationHypersensitivity to Beclomethasone is a contraindication; and special careis necessary in patients with active or quiescent pulmonary tuberculosis.

PrecautionsPatients should be instructed about proper use of the inhalers to ensurethat the drug reaches the target areas within the lungs. They should alsobe made aware that Beclomethasone inhaler has to be used regularly foroptimum benefit. Patients should be made aware of the prophylacticnature of therapy with Beclomethasone inhaler and that it should betaken regularly, even when they are asymptomatic.

The maximum daily administration of Beclomethasone inhaler shouldnot exceed 1 mg. Significant reduction in plasma cortisone levels has beenreported in patients who receive twice this amount.

Side EffectsCandidiasis of the mouth and throat (thrush) occurs in some patients, theincidence of which is increased with doses greater than 400 µgBeclomethasone Dipropionate per day. Patients with high blood levels ofCandida precipitins, indicating a previous infection, are most likely todevelop this complication. Some patients may find it helpful to rinse theirmouth thoroughly with water after using the inhaler. Symptomaticcandidiasis can be treated with topical antifungal therapy whilst stillcontinuing the Beclomethasone inhaler.

In some patients, inhaled Beclomethasone Dipropionate may causehoarseness or throat irritation. It may be helpful to rinse mouth withwater immediately after inhalation.


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As with other inhalation therapy, the potential for paradoxicalbronchospasm should be kept in mind. If it occurs, the preparationshould be discontinued immediately and alternative therapy instituted.

Pharmaceutical PrecautionStore below 30°C, keep out of the reach of children.

Commercial Pack Decomit 100 Inhaler : Each canister contains 200 metered doses, eachcontaining 100 µg of Beclomethasone Dipropionate BP.

Decomit 250 Inhaler : Each canister contains 200 metered doses, eachcontaining 250 µg of Beclomethasone Dipropionate BP.


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Decomit®

Nasal Spray

DescriptionBeclomethasone Dipropionate BP, the active ingredient of Decomit nasalspray, is an anti-inflammatory steroid having the chemical name 9-chloro-11,17,21-tr ihydroxy-16-methylpregna-1,4-diene-3,20-dione21-dipropionate. Decomit nasal spray is a metered dose manual pump sprayunit containing a microcrystalline suspension of BeclomethasoneDipropionate in a mixture of suspending agents.

IndicationsDecomit nasal spray is indicated for the prophylaxis and treatment ofperennial and seasonal allergic rhinitis including hay fever and vasomotorrhinitis. Beclomethasone Dipropionate nasal spray is also indicated for theprevention of recurrence of nasal polyps following surgical removal.


Decomit nasal spray is for administration by the intranasal route only

Adults and children : The recommended dosage is two applications intoeach nostril twice daily. For some patients, a dosage regimen of a singleapplication into each nostril three or four times daily may be preferred.Total daily administration should not normally exceed eight applications.For full therapeutic benefit, regular usage is essential. The cooperation ofthe patient should be sought to comply with the regular dosage scheduleand it should be explained that maximum effect may not be obtainedwithin the first few applications.

For children under six years, there are insufficient clinical data torecommend its use.

ContraindicationDecomit nasal spray is contraindicated in patients with a history ofhypersensitivity to any of its components.


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PrecautionsInfections of the nasal passages and paranasal sinuses should beappropriately treated but do not constitute a specific contraindication totreatment with Decomit nasal spray.

Care must be taken while transferring patients from systemic steroidtreatment to Decomit nasal spray if there is any reason to suppose thattheir adrenal function is impaired.

Systemic effects may rarely occur. These include hypothalamic-pituitary-adrenal (HPA) suppression and growth retardation in children.

Although Decomit nasal spray will control seasonal allergic rhinitis inmost cases, an abnormally heavy challenge of summer allergens may, incertain instances, necessitate appropriate additional therapy particularly tocontrol eye symptoms.

Side EffectsAs with other nasal sprays, dryness and irritation of the nose and throat,unpleasant taste and smell and epistaxis have been reported rarely.

Rare cases of raised intra-ocular pressure or glaucoma in association withintranasal formulations of Beclomethasone Dipropionate have beenreported.

Pharmaceutical PrecautionDecomit nasal spray should be stored at a temperature below 30°C.Protect from frost and direct sunlight.

Commercial PackDecomit Nasal Spray : Each bottle contains 200 metered doses, eachcontaining 50 µg of Beclomethasone Dipropionate BP.


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Deflux®

Tablet/Suspension/Paediatric Drops

DescriptionDeflux (Domperidone) is a dopamine antagonist. As it does not enter thecentral nervous system, its effect is confined to the periphery and actsprincipally at the receptor in the chemoreceptor trigger zone.

Indications♦ Stimulation of gut motility in

- Non-ulcer dyspepsia- Oesophageal reflux, reflux oesophagitis and gastritis- Diabetic gastroparesis- Functional dyspepsia- Speeding barium transit in follow through radiological studies

♦ Prevention and symptomatic relief of acute nausea and vomiting fromany cause including cytotoxic therapy, radiotherapy and anti-parkinsonism therapy

♦ In the prophylactic treatment of migraine

Dosage and AdministrationThe recommended oral dose for Adults: 10-20 mg every 4-8 hours daily;Children: 0.2-0.4 mg/kg every 4-8 hours daily. Note that Domperidoneshould be taken 15-30 minutes before meal. For acute vomiting andnausea, maximum period of treatment is 12 weeks. Use in children isrestricted to nausea and vomiting following cytotoxic drugs orradiotherapy.

ContraindicationDeflux is contraindicated to the patients who have hypersensitivity to thisdrug and in case of neonates.

PrecautionsDeflux should be used with absolute caution in case of children becausethere may be an increased risk of extra-pyramidal reactions in youngchildren because of an incompletely developed blood brain barrier.


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Side EffectsDomperidone may produce hyperprolactinaemia (1.3% frequency). Thismay result in galactorrhoea, breast enlargement, soreness and reducedlibido. Dry mouth (1.9%), thirst, headache (1.2%), nervousness,drowsiness (0.4%), diarrhoea (0.2%), skin rash and itching (0.1%) mayoccur during treatment with Domperidone. Extra-pyramidal reactions areseen in 0.05% of patients in clinical studies.

Use in Pregnancy and LactationThe safety of Domperidone has not been proven and it is therefore notrecommended during pregnancy. Animal studies have not demonstratedteratogenic effects on the foetus.

Domperidone may precipitate galactorrhoea and improve post-natallactation. It is secreted in breast milk but in very small quantities,insufficient to be considered harmful.

Drug InteractionsDomperidone may reduce the hypoprolactinaemic effect ofbromocriptine. Anti-muscarinics and opioid analgesics may antagonizethe action of Domperidone on gastrointestinal function.

OverdosageThere is no reported case of overdosage.

Commercial PackDeflux Tablet : Box containing 10 x 10’s blister strips. Each tabletcontains Domperidone Maleate BP equivalent to 10 mg Domperidone.

Deflux Suspension : Bottle containing 100 ml of suspension. Each 5 mlcontains Domperidone BP 5 mg.

Deflux Paediatric Drops : Bottle containing 15 ml of drops. Each mlcontains Domperidone BP 5 mg.


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Dextromethorphan®

Syrup

DescriptionDextromethorphan Syrup is cherry flavoured liquid, containing in each 5ml, 10 mg Dextromethorphan Hydrobromide BP. Dextromethorphan (d-3-methoxy-N-methylmorphinan) is the d-isomer of the codeine analogueof levorphanol. It is a cough suppressant.

IndicationsAs antitussive.

Dosage1-3 teaspoonful 1-4 times daily or as advised by the physician.

WarningNot for children use.

ContraindicationLiver disease.

PrecautionsShould be administered with caution to asthmatic patient.

Side EffectsOccasionally Dextromethorphan hydrobromide may cause drowsiness,dizziness, excitation, mental confusion and gastrointestinal disturbance.Very high doses may produce respiratory depression. Abuses ofDextromethorphan have been reported in few cases, but there does notappear to be any evidence of dependence of the morphine type.

Commercial Pack Dextromethorphan Syrup: 100 ml syrup in glass bottle, each 5 mlcontains 10 mg of Dextromethorphan Hydrobromide BP.


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Diactin®

Tablet

DescriptionDiactin (Glipizide) is an oral blood glucose lowering drug of thesulfonylurea class which causes hypoglycaemia by stimulating release ofinsulin from pancreatic β cells and by increasing the sensitivity ofperipheral tissues to insulin.

IndicationsDiactin (Glipizide) is indicated as an adjunct to diet for the control ofhyperglycaemia and its associated symptomatology in the treatment ofnon-insulin-dependent diabetes mellitus (NIDDM type II) when dietmodification has not been proved effective on its own. In certain patientswho are receiving insulin, the concurrent use of Glipizide would allow areduction in the daily dose of insulin.

Use of Glipizide must be viewed by both the physician and patient as atreatment in addition to diet and not as a substitute for diet or as aconvenient mechanism for avoiding dietary restraint. Furthermore, shortterm administration may be required if diet control alone results intransient control of blood glucose level.

During maintenance, if satisfactory lowering of blood glucose is nolonger achieved, use of Glipizide should be discontinued.

Dosage and Administration Like any other oral hypoglycaemic agent, dosage of Diactin is not fixedand may be adjusted through periodic monitoring of blood glucose level.

Short term administration of Glipizide may be sufficient during periodsof transient loss of control of blood glucose in patients, usuallycontrolled well on diet.

In general, Diactin should be given approximately 30 minutes before ameal to achieve the maximum reduction in postprandial hyperglycaemia.


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Initial dose : The recommended starting dose is 5 mg, given beforebreakfast. Geriatric patients or those with liver disease may be started on2.5 mg.

Dosage adjustments : Dosage adjustment may be done at intervals ofseveral days by an increment of 2.5-5 mg, as determined by blood glucoseresponse. If response to a single dose is not satisfactory, dividing thatdose might prove effective. The maximum recommended once daily doseis 15 mg. Doses above 15 mg should ordinarily be divided and givenbefore meals of adequate caloric content. The maximum recommendedtotal daily dose is 40 mg.

Maintenance : Some patients may be effectively controlled on a once dailyregimen, while others show better response with divided dosing. Totaldaily dose above 30 mg have been safely given on bid basis to long-termpatients. Patients can usually be stabilized on a dosage ranging from 2.5to 30 mg daily.

In elderly, debilitated or malnourished patients, and patients with impairedrenal or hepatic function, the initial and maintenance dosing should beconservative to avoid hypoglycaemic reactions.

Patients Receiving Insulin : Many stable non-insulin-dependent diabetic patients receiving Insulinmay be safely placed on Glipizide if the physician decides to do so.

Patients receiving other oral hypoglycaemic agents : As with other sulfonylurea, no transition period is necessary whiletransferring patients to Glipizide. Patients should be observed carefullyfor any possible hypoglycaemic effect due to overlapping of drug effects.

Contraindication Diactin is contraindicated in the following conditions :

♦ Patients who are hypersensitive to Glipizide or any component of theproduct

♦ Juvenile onset diabetes

♦ Severe or unstable ‘brittle’ diabetes


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♦ Diabetes complicated by ketosis and acidosis, major surgery, severesepsis or severe trauma

♦ Severe renal, hepatic or thyroid impairment, co-existent renal andhepatic disease

Precautions Hypoglycaemia : All sulfonylurea drugs are capable of producing severehypoglycaemia. Proper patient selection, dosage and instructions areimportant to avoid hypoglycaemic episodes. Renal or hepatic insufficiencymay cause elevated blood levels of Glipizide and the latter may alsodiminish gluconeogenic capacity, both of which increase the risk ofserious hypoglycaemic reactions. Elderly, debilitated or malnourishedpatients and those with adrenal or pituitary insufficiency are particularlysusceptible to the hypoglycaemic actions of glucose lowering drugs.

Renal and Hepatic Disease : The metabolism and excretion of Glipizide maybe slowed in patients with impaired renal and/or hepatic function. Thesepatients may suffer from prolonged hypoglycaemia and appropriatemeasures should be instituted.

Loss of Control on Blood Glucose : When a patient stabilized on anyantidiabetic regimen is exposed to stress such as fever, trauma, infectionor surgery, a loss of control on blood glucose may occur. At that time itmay be necessary to discontinue Glipizide and administer Insulin.

The effectiveness of any oral hypoglycaemic drug including Glipizide, inlowering blood glucose to a desired level, decreases in many patients overa period of time, which may be due to secondary failure, i.e., progressionof the severity of the diabetes or diminished responsiveness to the drug.

Side Effects The majority of side effects have been dose-related, transient, andresponded to dose reduction or withdrawal of the medication.

Hypoglycaemia : See "Precautions" and "Overdosage" section.

Gastrointestinal : Gastrointestinal complaints were reported with thefollowing approximate incidences like nausea, diarrhoea, constipation and


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gastralgia. They appear to be dose related and usually disappear ondivision or reduction of dosage.

Cholestatic jaundice may occur rarely with these kind of drugs andGlipizide should be discontinued if this occurs.

Dermatological : Allergic skin reactions including erythema, morbilliformor maculopapular eruption, urticaria, pruritus and eczema have beenreported. They frequently disappear with continued therapy. However, ifthey persist, the drug should be discontinued.

Haematologic : Leucopenia, agranulocytosis, thrombocytopenia,haemolytic anaemia, aplastic anaemia and pancytopenia have beenreported with sulfonylureas.

Metabolic : Hepatic porphyria and disulfiram like reactions have beenreported with sulfonylurea.

Endocrine Reactions : Cases of hyponatraemia and the syndrome ofinappropriate antidiuretic hormone (SIADH) secretion have beenreported with this and other sulfonylureas.

Miscellaneous : Dizziness, drowsiness and headache have been reportedin patients treated with Glipizide. They are usually transient and seldomrequire discontinuation of therapy.

Warning The administration of oral hypoglycaemic drugs has been reported to beassociated with increased cardiovascular mortality as compared totreatment with diet alone or diet plus Insulin. Although the study reportwas based on use of Tolbutamide only, but from a safety point of viewthis warning may also be applied for other oral hypoglycaemic agents.Patients should be instructed to take their meals regularly and not toexercise excessively without additional calorie intake.

Overdosage Overdosage of sulfonylurea including Glipizide can producehypoglycaemia. Mild hypoglycaemic symptoms without loss ofconsciousness or neurologic findings should be treated aggressively withoral glucose and adjustments in drug dosage and/or meal patterns. Closemonitoring should be continued until the physician is assured that


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the patient is out of danger. Severe hypoglycaemic reactions with coma,seizure, or other neurological impairment occur infrequently, butconstitute medical emergencies requiring immediate hospitalization. Ifhypoglycaemic coma is diagnosed or suspected, the patient should begiven a rapid intravenous injection of concentrated (50%) glucosesolution. This should be followed by a continuous infusion of a moredilute (10%) glucose solution at a rate that will maintain the bloodglucose at a level above 100 mg/dl.

Patients should be closely monitored for a minimum of 24 to 48 hourssince hypoglycaemia may recur after apparent clinical recovery. Clearanceof Glipizide from plasma would be prolonged in persons with liverdisease. Because of the extensive protein binding of Glipizide, dialysis isunlikely to be of benefit.

Drug Interactions The hypoglycaemic action of sulfonylurea may be potentiated by certaindrugs including non-steroidal anti-inflammatory agents and other drugsthat are highly protein bound e.g. Salicylates, Sulfonamides,Chloramphenicol, Probenecid, Coumarins, Monoamine OxidaseInhibitors, and β-adrenergic blocking agents. When such drugs areadministered to a patient receiving Glipizide, the patients should beobserved closely for hypoglycaemia. When such drugs are withdrawnfrom a patient receiving Glipizide, the patient should be observed closelyfor loss of control on blood glucose.

Certain drugs tend to produce hyperglycaemia and may lead to loss ofcontrol on blood glucose. These drugs include the thiazides and otherdiuretics, corticosteroids, phenothiazines, thyroid products, oestrogens,oral contraceptives, Phenytoin, nicotinic acid, sympathomimetics, calciumchannel blocking drugs and Isoniazid. When such drugs are administeredto or withdrawn from a patient receiving Glipizide, the patient should beclosely observed for loss of control on blood glucose. Diabetic controlmay be altered also in patients treated with cyclophosphamide.

Use in Pregnancy and Lactation Glipizide was found to be mildly foetotoxic in rat reproductive studies atall dose levels (5-50 mg/kg) like other sulfonylureas. There are noadequate and well controlled studies in pregnant women. Glipizide should


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be used during pregnancy only if the potential benefit justifies thepotential risk to the foetus. Because recent information suggests thatabnormal blood glucose levels during pregnancy are associated with ahigher incidence of congenital abnormalities, many experts recommendto use Insulin during pregnancy to maintain blood glucose levels as closeto normal as possible.

Although it is not known whether Glipizide is excreted in human milk,some sulfonylurea drugs are known to be so. Breast feeding is nottherefore recommended while taking this medication.

PrecautionsProlonged severe hypoglycaemia (4-10 days) has been reported inneonates born to mothers who were receiving sulfonylurea (e.g. Glipizide)at the time of delivery. So, if Glipizide is used during pregnancy, it shouldbe discontinued at least one month before the expected delivery date.

In children safety and effectiveness have not been established.

Information for Patients Patients should be informed of the potential risks and advantages ofGlipizide and of alternative modes of therapy. They should also beinformed about the importance of adhering to dietary instructions, of aregular exercise programme, and of regular testing of urine and/or bloodglucose.

The risks of hypoglycaemia, its symptoms and treatment, and conditionsthose predispose to its development should be explained to patients andresponsible family members. Primary and secondary failure should also beexplained.

Pharmaceutical Precaution Store below 25°C.

Commercial PackDiactin Tablet : Box containing 10 aluminium strips of 10 tablets. Eachtablet contains Glipizide BP 5 mg.


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Diaglit®Tablet

DescriptionDiaglit (Pioglitazone) is a member of the newest class of oral antidiabeticagent called thiazolidinediones. It depends on the presence of Insulin forits mechanism of action. Pioglitazone decreases Insulin resistance in theperiphery and in the liver, resulting in increased Insulin-dependentglucose disposal and decreased hepatic glucose output. It also improvesabnormality in lipid metabolism by activating peroxisome proliferator-activated receptor gamma (PPAR-γ).

IndicationsDiaglit is indicated as an adjunct to diet and exercise to improve glycaemiccontrol in patients with type II diabetes (NIDDM). Diaglit is indicated formonotherapy and also indicated for use in combination with sulfonylurea,Metformin or Insulin when diet and exercise plus the single agent doesnot result in adequate glycaemic control.

Dosage and AdministrationDiaglit can be taken once daily without regard to meals. The managementof antidiabetic therapy should be individualized. Diaglit monotherapymay be initiated at 15 mg or 30 mg once daily dosages in patients notadequately controlled with diet and exercise alone. For patients whorespond inadequately to the initial dose of Pioglitazone, the dose can beincreased up to 45 mg once daily. For patients not responding adequatelyto monotherapy, combination therapy should be considered.

Maximum recommended daily dose of Diaglit should not exceed 45 mgsince doses higher than 45 mg have not been studied in placebo-controlled clinical studies. Besides, no placebo-controlled clinical studiesof more than 30 mg once daily have been conducted in combinationtherapy.

Side EffectsThe overall incidence and types of adverse events reported in placebocontrolled clinical trials of Pioglitazone monotherapy at doses of 7.5 mg,


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15 mg, 30 mg or 45 mg once daily are upper respiratory tract infection(13.2%), headache (9.1%), sinusitis (6.3%), myalgia (5.4%), tooth disorder(5.3%), and pharyngitis (5.1%).

PrecautionsPioglitazone exerts its antihyperglycaemic effect only in the presence ofInsulin. Therefore, it should not be used in Type-1 diabetes or for thetreatment of diabetic ketoacidosis. Pioglitazone should be used withcaution in case of combination antidiabetic therapy and hepaticinsufficiency. Liver enzyme should be monitored regularly.

Use in Pregnancy and LactationThere are no adequate and well controlled studies in pregnant women.Pioglitazone should be used during pregnancy only if the potentialbenefit justifies the potential risk to the foetus. It is not known whetherPioglitazone is secreted in human milk. As many drugs are excreted inhuman milk, it should not be administered to a lactating women.

ContraindicationDiaglit is contraindicated in patients with known hypersensitivity to anyof its components.

Drug InteractionsAdministration of thiazolidinediones with an oral contraceptivecontaining ethinyl estradiol and norethindrone reduces the plasmaconcentration of both hormones by approximately 30% which couldresult in loss of contraception.

OverdosageIn the event of overdosage, appropriate supportive treatment should beinitiated according to patient’s clinical signs and symptoms.

Pharmaceutical PrecautionStore at 25o C. Keep in a cool and dry place, away from direct sunlight.Keep out of the reach of children.


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Commercial PackDiaglit 15 Tablet : Box containing 30 tablets in 3 x 10’s blister strips, eachtablet contains Pioglitazone Hydrochloride INN equivalent toPioglitazone 15 mg.

Diaglit 30 Tablet : Box containing 30 tablets in 3 x 10’s blister strips, eachtablet contains Pioglitazone Hydrochloride INN equivalent toPioglitazone 30 mg.


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Diapro®

Tablet

DescriptionDiapro (Gliclazide) is a second generation sulfonylurea that hashypoglycaemic and potentially useful haemobiological properties. Itstimulates the influx of calcium ions into pancreatic β cells and as a resultincreases Insulin secretion. Moreover, in vivo studies have demonstratedchanges in thrombin-induced platelet aggregation in NIDDM patientstreated with gliclazide.

IndicationsNon-insulin dependent diabetes mellitus (type-II) when dietarymodification has failed.

Dosage and AdministrationInitially 40-80 mg daily, adjusted according to response; up to 160 mg asa single dose, with breakfast; higher doses divided; maximum 320 mgdaily.

Adverse ReactionsPotentially life-threatening effects- All hypoglycaemic agents have thepotential to cause severe hypoglycaemia and may cause severe braindamage or death. Gliclazide used in standard dose is less likely thanGlyburide to cause hypoglycaemia. Hypoglycaemia may be favoured byconcurrent conditions such as hepatic and renal disease, malnutrition,anorexia, senility, alcohol intoxication or adrenal and pituitaryinsufficiency.

Severe or irreversible adverse effects- Approximately 2% of patients havebeen withdrawn from therapy because of adverse reactions, namelyhypoglycaemia (overdose effect), gastrointestinal disturbances anddermatological reactions.

Symptomatic adverse effects- Headache, gastrointestinal upsets, nauseaand dizziness have been reported and skin reactions, including rash,


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pruritus, erythema and bullous eruptions may occur. Abnormalities ofliver function are not uncommon.

High Risk Group♦ Neonates- The drug is not used in neonates.

♦ Nursing mothers- The drug should not be used by lactating mothers.

♦ Children- Gliclazide is contraindicated in children.

♦ Pregnant women- Gliclazide, as other sulfonylurea, is contraindicatedfor use in pregnant women. No teratogenic changes have been foundin animals or human, but diabetes can be controlled more effectively inpregnancy by Insulin than by oral hypoglycaemic agents.

♦ Elderly- All sulfonylureas should be used with caution in the elderlybecause of the greater likelihood of their missing meals and the moresevere outcome of significant hypoglycaemia.

♦ Concurrent disease- Definite hepatic disease should contraindicate theuse of Gliclazide, since it is almost completely metabolized in the liver.Renal disease does not appear significantly to alter thepharmacokinetics, although it may be wise to limit the maximum dosewhen serum creatinine starts to rise.

Drug InteractionsPotentially hazardous interactions- These may be divided into thosewhich will tend to increase the hypoglycaemic effect and those tending tooppose it. In the first category come drugs which displace thesulfonylurea from protein binding, such as Aspirin, non-steroidal anti-inflammatory drugs, Phenylbutazone, Clofibrate, Sulfonamides andCoumarin anticoagulants; or which inhibit, hepatic microsomal enzymes,for example Cimetidine, sulfonamides, imidazole antifungal agents andthe Monoamine Oxidase Inhibitors (MAOI), which may increase thehypoglycaemic effect of Gliclazide. Any effects, which result fromprotein-binding displacement, are transient, lasting from 12-24 h. Regularconcomitant doses of these agents together with a constant dose ofGliclazide would not cause problems.

The hypoglycaemic action of sulfonylureas may be opposed by theinduction of hepatic enzymes, which metabolize the drug causing lowerplasma concentrations and less hypoglycaemic effect. Common inducersinclude Rifampicin, barbiturates, Phenytoin and alcohol, or by drugs that


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inhibit the release or action of Insulin, e.g. thiazide diuretics, dizoxide,glucocorticoids, oestrogens or sympathomimetic drugs. Early symptomsof hypoglycaemia such as tremor, sweating and tachycardia may bemasked by β-adrenoreceptor blocking drugs, such as Propranololallowing severe hypoglycaemic episodes without preceding warningsymptoms. If β-adrenoreceptor blocking drugs are required the moreselective types, such as Metoprolol or Atenolol, are preferred in thediabetic patient.

Pharmaceutical PrecautionStore below 250 C.

Commercial PackDiapro Tablet : Box containing 50 tablets in 5 x 10’s blister strips. Eachtablet contains Gliclazide BP 80 mg.


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Diaryl®Tablet

DescriptionDiaryl (Glimepiride) tablets are an oral blood-glucose-lowering drug ofthe sulfonylurea class. Chemically, glimepiride is identified as 1-[[p-[2-(3-ethyl-4-methyl-2-oxo-3-pyrroline-1-carboxamido) ethyl]phenyl]sulfonyl]-3-(trans-4-methylcyclohexyl) urea.

PharmacologyThe primary mechanism of action of Glimepiride is lowering of bloodglucose by stimulating the release of insulin from functioning pancreaticβ cells. In addition, extra-pancreatic effects may also play vital role in theactivity of Glimepiride. Administration of Diaryl can lead to increasesensitivity of peripheral tissues to insulin. After oral administration.Glimepiride is completely (100%) absorbed from gastrointestinal tract.When Glimepiride is given with meals, the mean Tmax is slightly increased

(12%) and the mean Cmax and AUC are slightly decreased. Glimepiride is

completely metabolized by oxidative biotransformation after oral dose.When 14 C-Glimepride is given orally, approximately 60% of the totalradioactivity is recovered in the urine in 7 days and 80-90% of themetabolites are recovered in the urine.

IndicationsNon-insulin dependent (type-III) diabetes, whenever blood sugar levelscannot be controlled adequately by diet, physical exercise and weightreduction.

Diaryl is also indicated for use in combination with Insulin to lower bloodglucose in patients whose hyperglycaemia can not be controlled by dietand exercise or in conjunction with an oral hypoglycaemic agent.

Dosage and AdministrationIn principle, the dosage of Diaryl is governed by the desired blood sugarlevel. The dosage of Diaryl must be the lowest which is sufficient toachieve the desired metabolic control.


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The initial and the maintenance doses are set based on the results ofregular checking of glucose in blood and urine. Monitoring of glucoselevels in blood and urine also serves to detect either primary or secondaryfailure of therapy.

Initial dose and dose titration : Usual initial dose is 1 mg once daily. Ifnecessary, the daily dose can be increased. Any increase can be based onregular blood sugar monitoring, and should be gradual, i.e., at intervals ofone to two weeks and carried out stepwise at follows: 1 mg-2 mg-3 mg-4mg-6 mg.

Dose range in patients with well controlled diabetes: Usual dose range inpatients with well controlled diabetes is 1 to 4 mg daily.

Distribution of doses : Timing and distribution of doses are decided bythe physician, in consideration of the patient's current life style. Normally,a single daily dose is sufficient. This should be taken immediately beforea substantial breakfast or - if none is taken - immediately before the firstmain meals. It is very important not to skip meals after taking the drug.

Secondary dosage adjustment : As the control of diabetes improves,sensitivity to insulin increases; therefore, Diaryl requirement may fall astreatment proceeds. To avoid hypoglycaemia, timely dose reduction orcessation of Glimepiride therapy must be considered.

A dose adjustment must also be considered whenever the patient's weightor life style changes, or other factors arise which cause an increasedsusceptibility to hypo- or hyperglycaemia.

Changeover from other oral antidiabetics to Diaryl : There is no exactdosage relationship between Glimepiride and other oral blood sugarlowering agents. When substituting Glimepride for other such agents, theinitial daily dose is 1 mg; this applies even in changeover from themaximum dose of other oral blood sugar lowering agents. Any doseincrease should be in accordance with guideline given above in initial doseand dose titration.


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Consideration must be given to the potency and duration of action of theprevious blood sugar lowering agent. It may be necessary to interrupttreatment to avoid additive effects which would increase the risk ofhypoglycaemia.

Administration : Diaryl tablet must be swallowed without chewing andwith sufficient amount of liquid (approximately ½ glass).

ContraindicationGlimepiride is not suitable for the treatment of insulin dependent (type-I) diabetes mellitus, or of diabetic pre-coma or coma. Glimepiride mustnot be used in patients hypersensitive to Glimepiride or othersulphonylureas.

PrecautionsIn the initial weeks of treatment, the risk of hypoglycaemia may beincreased and necessitates careful monitoring. If such risk is present itmay be necessary to adjust the dosage of Glimepiride. Hypoglycaemiacan almost always be promptly controlled by immediate intake ofcarbohydrates (glucose or sugar, e.g. sugar sweetened fruit juice or sugarsweetened tea).

Side EffectsHypoglycaemia, temporary visual impairment, nausea, vomiting,diarrhoea, abdominal pain, urticaria, fall in blood pressure.

Drug InteractionsPotentiation of the blood-sugar-lowering effect may occur with Insulinand other oral anti-diabetics, ACE inhibitors, Allopurinol, anabolicsteroids and male sex hormones, Chloramphenicol, coumarin derivatives,Fluoxetine, MAO inhibitors, Miconazole, Para-aminosalicyclic acid,Pentoxifylline (high dose parenteral), Phenylbutazone, Oxyphenbutazone,quinolones, salicylates, Sulfonamides, tetracyclines, β blockers.

Weakening of the blood-sugar-lowering effect may occur withAcetazolamide, barbiturates, corticosteroids, Diazoxide, diuretics,Epinephrine and other sympathomimetic agents, laxative, oestrogens andprogestogens, phenothiazines, Phenytoin, Rifampicin, and thyroidhormones.


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H2 -receptor antagonists, Clonidine and Reserpine may lead to either

potentiation or weakening of the blood-sugar-lowering effect.

Both acute and chronic alcohol intake may potentiate or weaken theblood-sugar-lowering action of Glimepiride unpredictably.

Use in Pregnancy and LactationGlimepiride must not be taken during pregnancy; a changeover to Insulinis necessary. Patients planning a pregnancy must inform their physician,and should changeover to Insulin.

Ingestion of Glimepiride with breast milk may harm the child. Therefore,Glimepiride must not be taken by lactating women. Either a changeoveror a complete discontinuation of breast-feeding is necessary.

Commercial PackDiaryl 1 Tablet : Each box contains 3 x 10’s tablets in blister strips. Eachtablet contains Glimepiride INN 1 mg.

Diaryl 2 Tablet : Each box contains 3 x 10’s tablets in blister strips. Eachtablet contains Glimepiride INN 2 mg.

Diaryl 1 Tablet : Each tablet contains Glimepiride INN 1 mg. Diaryl 2:Each tablet contains Glimepiride INN 2 mg


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Diavix®

Tablet

DescriptionDiavix Tablets are combination tablets containing Lamivudine INN 150mg and Zidovudine USP 300 mg.

IndicationsDiavix is indicated for the treatment of HIV infection.

Dosage and AdministrationThe recommended oral dose of Diavix for adults and adolescents (at least12 years of age) is one tablet (containing 150 mg of Lamivudine and 300mg of Zidovudine) twice daily.

Dose Adjustment : As it is a fixed-dose combination, Diavix should not beprescribed for patients requiring dosage adjustment such as those withreduced renal function (creatinine clearance <50 ml/min), those with lowbody weight (<50 kg or 110 lb), or those experiencing dose-limitingadverse events.

Diavix is not recommended for patients with impaired hepatic function,as Diavix is a fixed-dose combination that cannot be adjusted for thispatient population.

ContraindicationDiavix Tablets are contraindicated in patients with previouslydemonstrated clinically significant hypersensitivity to any of thecomponents of the product.

General : Reduction of doses of Lamivudine is recommended for patientswith low body weight (less than 50 kg or 110 lb); therefore, patients withlow body weight should not receive Diavix.

Warning and PrecautionsZidovudine, one of the two active ingredients in Diavix, has beenassociated with haematologic toxicity including neutropenia and severe


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anaemia, particularly in patients with advanced HIV disease. Prolongeduse of Zidovudine has been associated with symptomatic myopathy.

Post-treatment Exacerbations of Hepatitis : In clinical trials in non-HIV-infected patients treated with Lamivudine for chronic hepatitis B, clinicaland laboratory evidence of exacerbations of hepatitis have occurred afterdiscontinuation of Lamivudine. These exacerbations have been detectedprimarily by serum ALT elevations in addition to re-emergence ofhepatitis B viral DNA (HBV DNA). Although most events appear tohave been self-limited, fatalities have been reported in some cases. Similarevents have been reported from post-marketing experience after changesfrom Lamivudine-containing HIV treatment regimens to non-Lamivudine-containing regimens in patients infected with both HIV andHBV. Patients should be closely monitored with both clinical andlaboratory follow-up for at least several months after stopping treatment.There is insufficient evidence to determine whether re-initiation ofLamivudine alters the course of post-treatment exacerbations ofhepatitis.

Ordinarily, Diavix should not be administered concomitantly with eitherLamivudine or Zidovudine.

Bone Marrow Suppression : Diavix should be used with caution in bonemarrow compromised patients evidenced by granulocyte count <1,000

cells/mm3 or haemoglobin <9.5 g/dl.

Frequent blood counts are strongly recommended in patients withadvanced HIV disease who are treated with Diavix. For HIV-infectedindividuals and patients with asymptomatic or early HIV disease, periodicblood counts are recommended.

Lactic Acidosis/Severe Hepatomegaly with Steatosis : Lactic acidosis and severehepatomegaly with steatosis, including fatal cases have been reported withthe use of antiretroviral nucleoside analogues alone or in combination,including Zidovudine and Lamivudine. A majority of these cases havebeen in women. Caution should be exercised when administering Diavixto any patient, and particularly to those with known risk factors for liverdisease. Treatment with Diavix should be suspended in any patient who


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develops clinical or laboratory findings suggestive of lactic acidosis orhepatotoxicity.

Patients with HIV and Hepatitis B Virus Co-infection : Safety and efficacy ofLamivudine have not been established for treatment of chronic hepatitisB in patients dually infected with HIV and HBV. In non-HIV-infectedpatients treated with Lamivudine for chronic hepatitis B, emergence ofLamivudine-resistant HBV has been detected and has been associatedwith diminished treatment response. Emergence of hepatitis B virusvariants associated with resistance to Lamivudine has also been reportedin HIV-infected patients who have received Lamivudine-containingantiretroviral regimens in the presence of concurrent infection withhepatitis B virus. Post-treatment exacerbations of hepatitis have also beenreported.

Side EffectsGeneral : Headache, malaise, fatigue, fever or chills, weakness.Gastrointestinal : Nausea and vomiting, diarrhoea, anorexia and/ordecreased appetite, abdominal pain or cramps, dyspepsia. Nervous system :Neuropathy, insomnia and other sleep disorders, dizziness, depressivedisorders. Respiratory : Nasal signs and symptoms, cough. Skin : Skinrashes. Musculoskeletal : Musculoskeletal pain, myalgia, arthralgia.

The following events have been chosen for inclusion due to theirseriousness, frequency of reporting, causal connection to Lamivudineand/or Zidovudine or a combination of these factors. Cardiovascular :Cardiomyopathy, vasculitis. Endocrine and Metabolic : Gynaecomastia,hyperglycaemia. Gastrointestinal : Oral mucosal pigmentation, stomatitis.Haemic and Lymphatic : Aplastic anaemia, anaemia, lymphadenopathy, purered cell aplasia, spleenomegaly. Hepatic and Pancreatic : Lactic acidosis andhepatic steatosis, steatosis, pancreatitis, post-treatment exacerbation ofhepatitis B infection. Hypersensitivity : Sensitisation reactions (includinganaphylaxis), urticaria. Musculoskeletal : Muscle weakness, elevation ofcreatinephosphokinase (CPK), rhabdomyolysis. Nervous system :Paraesthesia, peripheral neuropathy, seizures. Respiratory system : Abnormalbreath sounds/wheezing. Skin : Alopecia, erythema multiforme, Stevens-Johnson syndrome.


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Overdose There is no experience of overdosage with Lamivudine and Zidovudinecombination. However, there are limited data available on theconsequences of ingestion of acute overdoses of Lamivudine andZidovudine in humans. No fatalities occurred, and all patients recovered.No special signs or symptoms have been identified following suchoverdosage.

If overdosage occurs the patients should be monitored for evidence oftoxicity, and standard supportive treatment applied as necessary. SinceLamivudine is dialysable, continuous haemodialysis could be used in thetreatment of overdosage, although this has not been studied.Haemodialysis and peritoneal dialysis appear to have a limited effect onelimination of Zidovudine, but enhance the elimination of theglucuronide metabolite.

Pharmaceutical PrecautionStore in a cool dry place. Protect from light.Keep out of reach of children.

Commercial PackDiavix Tablets : Each tablet contains Lamivudine INN 150 mg andZidovudine USP 300 mg. Each box contains 1 x 10’s tablets in blisterstrip.


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Dilapress®

Tablet

DescriptionDilapress (Carvedilol) is a cardiovascular drug which mainly acts asneurohormonal antagonist consisting of non-selective β-blockade, α1-

blockade and antioxidant properties.

IndicationsDilapress is indicated for the treatment of essential hypertension. It canbe used alone or in combination with other antihypertensive agents,especially thiazide type of diuretics.

Dilapress is also indicated for the treatment of mild to moderate heartfailure, to reduce the progression of disease, to reduce mortality andcardiovascular hospitalization.

Dilapress may be used in patients unable to tolerate an ACE inhibitor.

Dilapress may be used in patients who are not receiving digitalis,hydralazine or nitrate therapy.

Dosage and AdministrationIn essential hypertension initially 12.5 mg once daily for 2 days isrecommended. Thereafter the recommended dose is 25 mg once daily. Ifnecessary the dose may be further increased at intervals of at least 2weeks to maximum 50 mg daily in single or divided doses. In elderlypatients the initial dose of 12.5 mg daily may provide satisfactory control.

In heart failure, initially 3.125 mg twice daily may be given for 2 weeks,dose may be increased at intervals of at least 2 weeks to 6.25 mg twicedaily, then to 12.5 mg twice daily, then to 25 mg twice daily. The dose maybe increased to highest dose tolerated, maximum 25 mg twice daily inpatients less than 85 kg body weight and 50 mg twice daily in patients over85 kg.


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In angina pectoris the recommended dose for initiation of therapy is 12.5mg twice daily for the first 2 days. Thereafter, the recommended dose is25 mg twice daily. For elderly patients, the maximum daily dose is 50 mgdaily in divided doses.

ContraindicationDilapress must not be used in patients with New York Heart Association(NYHA) class IV decompensated heart failure requiring intravenousinotropic support, Asthma, Chronic obstructive pulmonary disease(COPD) with a bronchospastic component, 2nd or 3rd degree AV block,sick sinus syndrome (unless a permanent pacemaker is in place),cardiogenic shock or severe bradycardia. Therapy is not to be initiated insevere heart failure.

Side EffectsDizziness, headache, fatigue, gastrointestinal disturbances, posturalhypotension, peripheral oedema, bradycardia, dry mouth, dry eyes, eyeirritation or disturbed vision, impotence, disturbances of micturition,influenza-like symptoms. Rarely angina, AV block, exacerbation ofintermittent claudication or Raynaud’s phenomenon, allergic skinreactions, nasal stuffiness, wheezing, depressed mood, sleep disturbances,paresthesia, heart failure, changes in liver enzymes, thrombocytopenia,leucopenia are also reported.

PrecautionsTake precaution in hepatic impairment, and in heart failure monitorclinical status for 2-3 hours after initiation and after increasing each dose.Before increasing dose ensure that the renal function and heart failure arenot deteriorating.

Use in Pregnancy and LactationCarvedilol should not be used during pregnancy as no studies have beenperformed in this group. Carvedilol and its metabolites are excreted inbreast milk. Therefore, breastfeeding is not recommended duringadministration of Carvedilol.

Drug InteractionsAs with other anti-hypertensive, there is a potential for pronouncedhypotension during general anaesthesia.


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As with other agents with β-blocking activity, Carvedilol may potentiatethe effect of other concomitant administered drugs that are anti-hypertensive in action or have hypotension as part of their adverse effectprofile. As with other drugs with β-blocking activity, caution should beexercised when administered Class I anti-arrhythmic drugs or calciumantagonists such as Verapamil. These drugs should be administeredintravenously.

Plasma Digoxin levels may be increased in patients to whom Carvediloland Digoxin are co-administered. Increased monitoring of Digoxin levelsis recommended when initiating, adjusting or discontinuing Carvedilol.

Care should be required in those receiving inducers of mixed functionoxidase e.g. Rifampicin, as serum levels of Carvedilol may be reduced.

Pharmaceutical Precaution Store at temperature between 150 C to 300 C.

Commercial PackDilapress 6.25 Tablet : Box containing 30 tablets in 3 x 10’s blister strips.Each tablet contains Carvedilol BP 6.25 mg.

Dilapress 12.5 Tablet : Box containing 30 tablets in 3 x 10’s blister strips.Each tablet contains Carvedilol BP 12.5 mg.

Dilapress 25 Tablet : Box containing 30 tablets in 3 x 10’s blister strips.Each tablet contains Carvedilol BP 25 mg.


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Ecotrim®

Cream

Description Ecotrim cream is a soft white cream containing 1% Econazole Nitrate BPand 0.1% Triamcinolone Acetonide BP.

IndicationsEconazole Nitrate is a broad spectrum antifungal agent. It is effectiveagainst various dermatophytes, yeasts and moulds. Moreover, it hasactivity against Gram-positive bacteria. Triamcinolone Acetonide is apotent corticosteroid with anti-inflammatory, antipruritic and antiallergicactivity.

The more important indications of Ecotrim are dermatomycosis causedby dermatophytol yeast and fungus with clear inflammatory and allergicsymptoms such as various eczematous mycosis, diaper dermatitis, eczemamarginatum, intertrigo, folliculitis, tricophytica and sycosis barbae.Ecotrim is also indicated for the treatment of mycosis present in variousfolds of the body.

Dosage and ApplicationThe cream should be applied by gently rubbing into the skin with thefinger once or twice daily for 14 days or as directed by a registeredphysician.

ContraindicationLike all preparations containing corticosteroids, Ecotrim cream shouldnot be used on tubercular skin infections or in viral diseases (e.g. herpes,vaccinia, and varicella).

Use in PregnancyThe use of corticosteroids during pregnancy has not been established.Topical steroids should not be used extensively in pregnancy, i.e. in largeamounts or for prolonged periods.


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PrecautionsLong term continuous steroid therapy should be avoided since adrenalsuppression can occur, particularly when infants or children are treated orwhen occlusive dressings are applied. Discontinuation of the medicationis advised if hypersensitivity occurs.

Side EffectsEcotrim cream is well tolerated, even to sensitive skin. Burning sensation,pruritis and redness of skin have rarely been reported.

Additional Information♦ The infected area should be kept clean and dry during treatment

♦ Keep the medication out of reach of children

♦ To be dispensed only upon the prescription of a registered physician

Commercial PackEcotrim Cream : Tube containing 10 g cream, each gram containsEconazole Nitrate BP 10 mg and Triamcinolone Acetonide BP 1 mg.


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Efol®ERCapsule

DescriptionEach Efol extended release capsule contains 150 mg of Dried FerrousSulphate BP equivalent to 47 mg Iron, 500 µg Folic Acid USP and 61.8mg of Zinc Sulphate Monohydrate USP equivalent to 22.5 mg Zinc. It isa clear, transparent capsule filled with a mixture of red, pale yellow, pinkand white pellets. This capsule is especially formulated for extendedrelease of iron over a period of several hours and that of zinc over oneto two hours.

IndicationsEfol ER is indicated for the treatment of iron, folic acid and zincdeficiency. Efol ER is also indicated on prophylaxis of iron deficiencyespecially when inadequate diet calls for supplementary zinc and ironduring pregnancy.

Dosage and AdministrationProphylaxis♦ AdultOne capsule a day. In more severe cases, two capsules a day may berequired as prescribed by the physician.

♦ ElderlyDosage as above.

♦ Children aged over 1 yearOne capsule a day, the capsule may be opened and the pellets can bemixed with soft cool food but they must not be chewed.

TreatmentRecommended dose is 2 to 4 capsules a day or as prescribed by thephysician.

ContraindicationIt is contraindicated in patients with haemolytic anaemia and in conditions


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with increased hypersensitivity to any of its components and increasedbody iron content.

Use in PregnancyAdministration in first trimester of pregnancy should be avoided unlessdefinite evidence of iron deficiency is observed. Prophylaxis of irondeficiency is justified during the remainder of pregnancy specificallywhen zinc supplementation is required.

Side EffectsSide effects of iron, folic acid and zinc supplementation are mild andtransient. These include epigastric pain, nausea, constipation, vomiting,diarrhoea etc. The blended Efol ER capsule is especially designed toreduce the possibility of gastrointestinal irritation.

Drug Interactions Iron chelates with Tetracycline. Since oral iron products interfere withabsorption of oral Tetracycline, these products should not be takenwithin two hours of each other. Occasional gastrointestinal discomfortmay be minimized by taking with meals. Absorption of iron may beimpaired by concurrent administrations of penicillamine and antacid. Inpatients with renal failure, a risk of zinc accumulation may exist.

OverdosageOverdosage of iron is dangerous, particularly in children and requiresimmediate attention. Gastric lavage should be carried out in the earlystages, vomiting may also be induced. Zinc Sulphate in gross overdosageis corrosive. Symptoms are those of gastrointestinal irritation, leading insevere cases to haemorrhagic corrosion of the mucosa and possible laterstricture formation. Demulcent such as milk should be given. Chelatingagents such as Dimercaprol, Penicillamine or Edetic acid have beenrecommended. The extended release capsule presentation may delayexcessive absorption of iron and zinc and allow more time for initiationof appropriate counter measures.

PrecautionsCare should be taken in patients who may develop iron overload, such asthose with haemochromatosis, haemolytic anaemia or red cell aplasia.


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Failure to respond to treatment may indicate other causes of anaemia andshould be further investigated.

Pharmaceutical PrecautionStore in a dry place below 25ºC and protect from sunlight. Keep out ofthe reach of children.

Commercial PackEfol ER Capsule : Box containing 50 capsules in 5 x 10's blister strips.Each capsule contains Dried Ferrous Sulphate BP 150 mg equivalent toIron 47 mg, Folic Acid USP 500 µg and Zinc Sulphate Monohydrate USP61.8 mg equivalent to Zinc 22.5 mg.


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Enaril®Tablet

DescriptionEnaril (Enalapril Maleate) is the maleate salt of Enalapril, the ethyl esterof a long-acting angiotensin-converting enzyme (ACE) inhibitor,enalaprilat. It is highly effective in the management of hypertension andheart failure.

IndicationsEnaril is indicated for the treatment of all grades of essentialhypertension, renovascular hypertension and heart failure.

Dosage and administrationEssential and Renovascular Hypertension : Treatment should be initiated with5 mg once a day. Where concomitant therapy is a diuretic, therecommended initial dose of Enaril is 2.5 mg. The dose should be titratedto give optimum control of blood pressure. The usual maintenance doseis 10-20 mg given once daily. In severe hypertension, the dosage may beincreased incrementally to a maximum of 40 mg once daily.

Heart Failure : Enaril can be used as an adjunctive therapy with non-potassium-sparing diuretics and/or digitalis. The recommended startingdose of Enaril is 2.5 mg once daily. The dose of Enaril should begradually increased depending upon tolerability to the recommendedmaintenance dose (10-20 mg) given as a single or twice daily dose.

The absorption of Enaril is not affected by food. The maximum dailydose is 40 mg.

Use in the elderly (over 65 years) : The starting dose should be 2.5 mg. Enarilis effective in the treatment of hypertension in the elderly. The doseshould be titrated according to need for the control of blood pressure.

Contraindication Pregnancy : Enalapril is contraindicated in pregnancy and treatmentshould be stopped if pregnancy is suspected, because it has been foundto be foetotoxic in rabbits.

Hypersensitivity : Enaril is also contraindicated in patients who are


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hypersensitive to any component of this product and in patients with ahistory of angioneurotic oedema relating to previous treatment with anACE inhibitor.

Precautions Hypotension : Symptomatic hypotension has been reported mainly inpatients with severe heart failure. In these patients, by discontinuingdiuretic therapy or significantly reducing the diuretic dose for two to threedays prior to initiating Enalapril, the possibility of this occurrence isreduced. By initiating therapy with a small dose (2.5 mg), the duration ofany hypotensive effect may be lessened.

If hypotension develops, the patient should be placed in a supineposition. Volume repletion with oral fluids or intravenous normal salinemay be required.

Impaired renal function : Enalapril should be used with caution inpatients with renal insufficiency as they may require reduced or lessfrequent doses. Renal failure has been reported in association withEnalapril and has been mainly in patients with severe congestive heartfailure or underlying renal disease, including renal artery stenosis. Ifrecognized promptly and treated appropriately, renal failure is usuallyreversible.

Angioneurotic oedema : Angioneurotic oedema has been reported withACE inhibitors including Enalapril. In such cases, Enaril should bediscontinued immediately and appropriate monitoring should beinstituted to ensure complete resolution of symptoms prior to dismissingthe patient. Where swelling is confined to the face, lips and mouth, thecondition will usually resolve without further treatment, althoughantihistamines may be useful in relieving symptoms. However, wherethere is involvement of the tongue, glottis or larynx, likely to causeairways obstruction, appropriate therapy such as subcutaneous adrenaline1:1000 (0.5 ml) should be administered promptly.

Cough : Cough has been reported with the use of ACE inhibitors.

Surgery/Anaesthesia : In patients undergoing major surgery or duringanaesthesia with agents that produce hypotension, Enalapril blocks


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angiotensin II formation secondary to compensatory renin release. Thismay lead to hypotension which can be corrected by volume expansion.

Lactating mothers : Enalapril and Enalaprilat are excreted in breast milk;caution should be exercised if Enaril is given to lactating mothers.

Drug Interactions Combination with other antihypertensive agents such as β-blockers,Methyldopa, calcium antagonists and diuretics may increase theantihypertensive efficacy. Adrenergic-blocking drugs should only becombined with Enalapril under careful supervision. ConcomitantPropranolol may reduce the bioavailability of Enalapril, but this does notappear to be of any clinical significance. Concomitant therapy withLithium may increase the serum Lithium concentration.

Side Effects The commonly reported side effects are dizziness and headache. Otherside effects occurring less frequently include orthostatic hypotension,nausea, rash, cough etc.

Cardiovascular : Myocardial infarction or cerebrovascular accident,possibly secondary to severe hypotension in high-risk patients.Palpitation, rhythm disturbances. Gastrointestinal : Abdominal pain,dyspepsia, hepatitis, jaundice. Nervous system : Confusion, nervousness,insomnia, somnolence. Respiratory : Sore throat, hoarseness of voice.Skin : Urticaria, pruritus. Special senses : Blurred vision. Renal : Oliguria,renal dysfunction, renal failure are reported in rare cases.

OverdosageLimited data are available for overdosage in humans. The most prominentfeature of overdosage is hypotension, for which the usual treatmentwould be intravenous infusion of normal saline solution. Enaril can beremoved from general circulation by haemodialysis.

Pharmaceutical PrecautionStore in a dry place below 25°C, protected from light.

Commercial Pack Enaril Tablet : Box containing 10 blister strips of 10 tablets, each tabletcontains 5 mg of Enalapril Maleate USP.


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Epilep®

Tablet

DescriptionCarbamazepine is an iminodibenzyl derivative with anticonvulsantproperties and its structure is related to the tricyclic antidepressants. It isa white or yellowish-white, crystalline, almost odourless powder which istasteless or with a slightly bitter taste.

Indications Carbamazepine is indicated in all forms of epilepsy except myoclonic andabsence seizures, trigeminal neuralgia, mood disorder, aggression anddiabetes insipidus.

Dosage and AdministrationEpilepsy :Dosage in adults : 100-200 mg once or twice daily and this is thengradually increased by 200 mg daily every week. The best response isoften obtained with doses of 800-1200 mg daily. In some instances 1600mg or even 2000 mg daily may be necessary.

Dosage in children : The dose in children is determined on the basis ofbody weight (10-20 mg/kg) and age. Children up to 1 year of age : 100-300 mg daily in two to four divided doses. Children between 1 to 5 yearsof age: 200-400 mg daily in two to four divided doses. Children between6 to 10 years of age : 400-600 mg daily in two to four divided doses.Children between 11 to 15 years of age : 600-1000 mg daily in two to fourdivided doses.

Trigeminal neuralgia : The initial dose is usually 200 mg daily. In someinstances a dose of 1600 mg daily is necessary.

Mood disorder : In patients unresponsive to Lithium therapy, a starting doseof 400-600 mg daily is used.

Diabetes insipidus : 200 mg two to three times daily. In children the doseshould be determined according to body weight (10-20 mg/kg).


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Side Effects

PrecautionsCarbamazepine should be used with caution in cardiovascular disease,hepatic or renal disorders, changing treatment from Carbamazepine toanother antiepileptic drug, haematological disorder, glaucoma etc.

Drug Interactions

ContraindicationPrevious sensitivity to Carbamazepine or structurally related drugs,atrioventricular conduction abnormalities, history of previous bonemarrow depression or of intermittent porphyria.

Drugs Effects

Reduced anticoagulant effectIncreased contraceptive effectInterference with the metabolism and clearance of Carbamazepine Provoked symptomatic Carbamazepine toxicityIncreased incidence of cardiac arrhythmiasInduction of hepatic microsomal enzymeCNS side effects of Carbamazepine possibly increasedShorter half-life of DoxycyclineIncreased free Carbamazepine concentrationin plasmaInterference with the metabolism of Vitamin D Neurotoxic reactions have been occurred.

AnticoagulantsOral contraceptivePropoxyphene

FluvoamineMAO InhibitorsAnticonvulsantsAlcohol

DoxycyclineSalicylic Acid

Vitamin DLithium

Potentially life-threatening Severe or irreversible Symptomatic

Aplastic anaemia,Agranulocytosis, Fatal hepatitis,Severe exfoliative dermatitis,

Toxic epidermal necrolysis,Stevens-Johnson syndrome,Lupus erythematosus

Generalized erythematousskin rashes, Transientleucopenia,

Thrombocytopenia,Oliguria, Haematuria,Proteinuria, Renal failure,

Bradycardia, Heart failure

Dizziness, Ataxia,Headache, Diplopia,Drowsiness, Nausea,Vomiting, Asthenia


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Use in Pregnancy and LactationThere is definite evidence of risk to the human foetus, but this may beoverweighed by the therapeutic benefit for the mother. Pregnant womenwith epilepsy should be kept under close surveillance. Pregnancydecreased the plasma concentration of Carbamazepine. This is largely theresult of an increase in the rate of metabolism. It may therefore benecessary to increase the dose of Carbamazepine during pregnancy inorder to maintain a satisfactory clinical response. Carbamazepine and itsmain metabolite, Carbamazepine-10, 11-epoxide, are both present inbreast milk of nursing mothers in concentrations of between 30-60% ofthose in plasma. Breast-feeding is not contraindicated, however, becausethe amount of drug ingested by the breasted infant is too small to causeany adverse pharmacological effects.

Acute OverdosageDoses of up to 20 g are known to have been taken but no deaths havebeen reported. The symptoms of overdosage include erythema of theface, tremor, ataxia, psychomotor restlessness, changes in blood pressure,muscle hypotonia, and dilatation of the pupils, unconsciousness andconvulsions.

Pharmaceutical PrecautionStore at 25oC. Keep in a cool and dry place, away from direct sunlight.

Commercial PackEpilep Tablet : Each box contains 5 x 10’s tablets in blister strips. Eachtablet contains Carbamazepine BP 200 mg.

Epilep CR Tablet : Each box contains 5 x 10’s tablets in blister strips.Each CR tablet contains Carbamazepine BP 200 mg.


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Eplon®

Capsule

DescriptionEplon (Zaleplon) is a newer non-benzodiazepine hypnotic from thepyrazolopyrimidine class. So, its chemical structure is unrelated tobenzodiazepines, barbiturates, or other drugs with known hypnoticproperties. It interacts with the gamma aminobutyric acid-benzodiazepine(GABA-BZ) receptor complex.

IndicationEplon is indicated for the short-term treatment of insomnia. Eplon hasbeen shown to decrease the time to sleep onset for up to 30 days incontrolled clinical trials.

Dosage and administration The dose of Eplon should be individualized. The recommended dose ofEplon for most non-elderly adults is 10 mg. For certain low weightindividuals, 5 mg may be a sufficient dose. Although the risk of certainadverse events associated with the use of Eplon appears to be dosedependent, the 20 mg dose has been shown to be adequately tolerated andmay be considered for occasional patient who does not benefit from atrial of lower dose. Dosage above 20 mg has not been adequatelyevaluated and is not recommended.

Eplon should be taken immediately before bedtime. Taking Eplon with orimmediately after a heavy, high-fat meal results in slower absorption andwould be expected to reduce the effect of Eplon on sleep latency. Elderlypatients and debilitated patients appear to be more sensitive to the effectsof hypnotic, and respond to 5 mg of Eplon. The recommended dose forthese patients is therefore 5 mg. Doses over 10 mg are not recommended.

For patients with mild to moderate renal impairment no dose adjustmentis necessary.

An initial dose of 5 mg should be given to patients concomitantly takingCimetidine because Zaleplon clearance is reduced in this population.


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Contraindication None known.

Side EffectsSide effects of Eplon appear to be dose related. So, it is important to usethe lowest possible effective dose, specially in the elderly. The side effectsare usually mild and transient, the most common are diarrhoea, nausea,vomiting, vertigo, headache, asthenia, nightmare etc.

PrecautionsTiming of drug administration : Eplon should be taken immediately beforebedtime or after the patient has gone to bed.

Use in the elderly and/or debilitated patients : Impaired motor and/or cognitiveperformance after repeated exposure or unusual sensitivity tosedative/hypnotic drugs is a concern in the treatment of elderly and/ordebilitated patients. A dose of 5 mg is recommended for elderly patientsto decrease the possibility of side effects. Elderly and/or debilitatedpatients should be monitored closely.

Use in patients with concomitant illness : Eplon should be used with caution inpatients with diseases or conditions that could affect metabolism orhaemodynamic responses.

Although preliminary studies did not reveal respiratory depressant effectsat hypnotic doses of Zaleplon in normal subjects, caution should beobserved if Zaleplon is prescribed to patients with compromisedrespiratory function, because sedative/hypnotic have the capacity todepress respiratory drive. However, patients with compromisedrespiration due to preexisting illness should be monitored carefully. Thedose of Eplon should be reduced to 5 mg in patients with mild tomoderate hepatic impairment. It is not recommended for use in patientswith severe hepatic impairment.

No dose adjustment is necessary in patients with mild to moderate renalimpairment. Zaleplon has not been adequately studied in patients withsevere renal impairment.


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Use in patients with depression : As with other sedative/hypnotic drugs,Eplon should be administered with caution to patients exhibiting signs orsymptoms of depression.

Use in Pregnancy and LactationThere are no studies of Zaleplon in pregnant women; therefore, it is notrecommended for use in women during pregnancy. Eplon has noestablished use in labour and delivery.

A study in lactating mothers indicated that the clearance and half-life ofZaleplon is similar to that in young normal subjects. A small amount ofZaleplon is excreted in breast milk, with the highest excreted amountoccurring during a feeding at approximately 1 hour after Zaleplonadministration. Since the small amount of the drug from breast milk mayresult in potentially important concentrations in infants, and because theeffects of Zaleplon on a nursing infant are not known, it is notrecommended in nursing mothers.

Paediatric UseThe safety and effectiveness of Zaleplon in paediatric patients have notbeen established.

OverdosageIt is usually manifested by degrees of central nervous system depressionranging from drowsiness to coma. In mild cases, symptoms includedrowsiness, mental confusion, and lethargy; in more serious cases,symptoms may include ataxia, hypotonia, hypotension, respiratorydepression, rarely coma, and very rarely death.

Drug InteractionsZaleplon has been shown to have minimal effects on the kinetic ofWarfarin, Imipramine, Ethanol, Ibuprofen, Diphenhydramine,Thioridazine, and Digoxin.

Pharmaceutical PrecautionStore at controlled room temperature, 20οC-25οC.


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Commercial PackEplon 5 Capsule : Box containing 3 x 10’s capsule in blister strips. Eachcapsule contains 5 mg Zaleplon INN.

Eplon 10 Capsule : Box containing 3 x 10’s capsule in blister strips. Eachcapsule contains 10 mg Zaleplon INN.


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Etrocin®

Tablet/Suspension

DescriptionEtrocin suspension is a preparation of Erythromycin Ethylsuccinate.After reconstitution each 5 ml contains Erythromycin EthylsuccinateUSP equivalent to 125 mg Erythromycin. Enteric-coated Etrocin tablet isa preparation of Erythromycin USP and is available in potencies of 250and 500 mg.

Antimicrobial Actions Its range of antimicrobial action is similar to that of penicillin. It is activeagainst most Gram-positive and some Gram-negative bacteria includingNeisseria species, Haemophilus influenzae and Bordetella pertussis, againstspirochete and some rickettsiae and chlamydia. Micoplasma pneumoniae isvery sensitive to Erythromycin, Streptococcus pneumoniae and haemolyticstreptococci are highly sensitive but streptococci (including thoseresistant to penicillin) are rather less sensitive. Although theEnterobacteriaceae are generally resistant to Erythromycin, some strainsof Escherichia coli and Klebsiella species have been reported to be sensitiveat an alkaline pH. The Gram-negative bacterium responsible forlegionnaire’s disease known as Legionella pneumophila is reported to besensitive to Erythromycin.

Indications Etrocin is highly effective in the treatment of a great variety of clinicalinfections caused by Erythromycin sensitive organisms. Upper RespiratoryTract infections : Tonsillitis, peritonsillar abscess, pharyngitis, laryngitis,sinusitis, secondary infections in cold and influenza. Lower Respiratory Tractinfections : Tracheitis, acute and chronic bronchitis, pneumonia (lobarpneumonia, broncho-pneumonia, primary atypical pneumonia),bronchiectasis, legionnaire’s disease. Ear infection : Otitis media and otitisexterna, mastoiditis. Oral infection : Gingivitis, Vincent’s angina. Eyeinfection: Blepharitis. Skin and Soft Tissue infections : Boils and carbuncles,paronychia, abscesses, pustular acne, impetigo, cellulitis, erysipelas. Gastro-intestinal infections : Cholecystitis, staphylococcal enterocolitis. Prophylacticuse : Pre- and post-operative trauma, burns, rheumatic fever. Other


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infections: Osteomyelitis, urethritis, gonorrhoea, syphilis, lymphogranulomavenereum, diphtheria, prostatitis, scarlet fever.

Dosage and Administration In case of suspension, optimum blood levels are obtained, when dosesare given on an empty stomach. Etrocin tablet can be given before, duringor after meal.

Adults and children over 8 years : 250-500 mg every 6 hours or 0.5 -1 gevery 12 hours. This may be increased up to 4 g per day according to theseverity of infection.

Elderly : Same as for adults.

Children : Age, weight and severity of infection are important factors indetermining the correct dosage.

The usual regimen is 30-50 mg/kg/day in divided doses or as directed bythe physician. For more severe infections this dosage may be doubled. Ifadministration on a twice daily schedule is desirable, one half of the totaldaily dose may be given every 12 hours, one hour before meal.

Amoebic dysentery : Adult- 250-500 mg four times daily for 10 to 14 days.Children- 30-50 mg/kg/day in divided doses for 10-14 days.

Pertussis : Although optimum dosage and duration of treatment have notbeen established, doses of Erythromycin utilized in reported clinicalstudies were 40-50 mg/kg/day given in divided doses for 5-14 days.

Streptococcal infections : In the treatment of group A beta haemolyticstreptococcal infections, therapeutic dosage of Erythromycin should beadministered for at least 10 days.

Prophylaxis : In continuous prophylaxis of streptococcal infections inpersons with a history of rheumatic heart disease, the dosage is 250 mgtwice daily.

When Etrocin is used prior to surgery to prevent endocarditis caused byα-haemolytic streptococci, a recommended schedule for children- 20


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mg/kg 1.5-2 hours pre-operatively and 10 mg/kg every six hours foreight doses post-operatively. For adults the dose is 1 g, 1.5-2 hours pre-operatively and 500 mg every six hours for eight doses post-operatively.

Contraindication It is contraindicated in patients hypersensitive to Erythromycin.

Warning Since Erythromycin is metabolized principally by the liver, caution shouldbe exercised in administering the antibiotic to patient with impairedhepatic function. There have been reports of hepatic dysfunction with orwithout jaundice occurring in patients taking oral Erythromycin.

Use in Pregnancy and Lactation Clinical and laboratory studies have no evidence of teratogenecity ortoxicity. However, caution should be exercised when prescribing for thepregnant women. Erythromycin is readily excreted in breast milk.

PrecautionsThe use of Erythromycin in patients who are receiving concomitant highdoses of Theophylline may be associated with Theophylline toxicity dueto increase level of Theophylline in the serum. If symptoms of toxicitydevelop, the dose of Theophylline should be reduced.

Side Effects Serious side effects are rare. The most frequent side effects ofErythromycin preparation are gastrointestinal (e.g. abdominal crampingand discomfort) and these are dose related. Nausea, vomiting anddiarrhoea occur infrequently with usual oral doses.

Mild allergic reactions such as urticaria and other skin rashes, haveoccurred. Serious allergic reactions, including anaphylaxis have beenreported.

Overdosage Symptoms are mainly confined to nausea, vomiting and diarrhoea.General management may consist of supportive therapy.


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Pharmaceutical Precaution Keep the container tightly closed and protected from light. Store in a cooland dry place. Suspension should be shaken well before use.

Commercial Pack Etrocin Tablet : Box containing 100 enteric-coated tablets in 10 x 10’sblister strips, each tablet contains 250 mg Erythromycin USP.

Etrocin-500 Tablet : Box containing 50 enteric-coated tablets in 5 x 10’sblister strips, each tablet contains 500 mg Erythromycin USP.

Etrocin Suspension : Bottle containing dry powder for 100 mlsuspension. After reconstitution each 5 ml contains ErythromycinEthylsuccinate USP equivalent to 125 mg Erythromycin.


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Evo®

Tablet

DescriptionEvo (Levofloxacin) is a synthetic, broad-spectrum antibacterial agent.Chemically Levofloxacin is a chiral fluorinated carboxyquinolone.

IndicationsAcute maxillary sinusitis due to Streptococcus pneumoniae, Haemophilusinfluenzae, or Moraxella catarrhalis. Acute bacterial exacerbation of chronicbronchitis due to Staphylococcus aureus , Streptococcus pneumoniae, Haemophilusinfluenzae, Klebsiella pneumoniae or Moraxella catarrhalis. Community acquiredpneumoniae due to Staphylococcus aureus , Streptococcus pneumoniae,Haemophilus influenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydiapneumoniae, Legionella pneumophila or Mycoplasma pneumoniae. Complicatedurinary tract infections due to E. coli, Klebsiella pneumoniae or Staphylococcussaprophyticus. Acute pyelonephriits caused by E. coli. Uncomplicated andcomplicated skin and skin structure infections including abscesses,cellulitis, furuncles, impetigo, pyoderma, wound infections, due toStaphylococcus aureus, Streptococcus pyogenes, Proteus mirabilis or Enterococcusfaecalis.

Dosage and AdministrationAcute sinusitis : 500 mg once daily for 10-14 days. Exacerbation ofchronic bronchitis : 250-500 mg daily for 7-10 days. Community acquiredpenumonia : 500 mg once or twice daily for 7-14 days. Complicatedurinary- tract infections and acute pyelonephritis : 250 mg daily for 7-10days. Uncomplicated skin and soft-tissue infections : 500 mg once dailyfor 7-10 days. Complicated skin and soft-tissue infections : 750 mg oncedaily for 7-14 days.

ContraindicationLevofloxacin is contraindicated in patients with a history ofhypersensitivity to levofloxacin, quinolone antimicrobial agents, or anyother components of this products.

PrecautionWhile taking Levofloxacin adequate amount of water should be drunk toavoid risk of crystalluria. Dose adjustment should be taken during


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Levofloxacin ingestion in presence of renal insufficiency and hepaticinsufficiency.

Side EffectsLevofloxacin is generally well tolerated. However, a few side effects canusually be seen. Side effects include nausea, vomiting, diarrhoea,abdominal pain, flatulence and rare occurrence of phototoxicity (0.1%).Side effects that may be seen very rarely include tremors, depression,anxiety, confusion etc.

Use in Pregnancy and LactationLevofloxacin is not recommended for use during pregnancy or duringlactation, as the effects on the unborn child or nursing infant areunknown.

Use in ChildrenNot recommended for children.

Drug InteractionsAntacids, Iron and multivitamin preparations with Zinc- reduceabsorption of Levofloxacin. NSAIDs may increase the risk of CNSstimulation and convulsive seizures. Warfarin may increase the risk ofbleeding.

OverdosageLevofloxacin exhibits a low potential for acute toxicity. However, in theevents of an acute overdosage, the stomach should be emptied. Thepatients should be kept under observation and appropriate hydrationshould be maintained.

Pharmaceutical PrecautionStore in a cool and dry place, away from sunlight.

Commercial PackEvo 250 Tablet : Box containing 30 tablets in 3 x 10’s blister strips. Eachfilm coated tablet contains Levofloxacin Hemihydrate INN equivalent toLevofloxacin-250 mg.

Evo 500 Tablet : Box containing 20 tablets in 2 x 10’s blister strips. Eachfilm coated tablet contains Levofloxacin Hemihydrate INN equivalent toLevofloxacin 500 mg.


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Fertil®Tablet

DescriptionFertil (Clomiphene Citrate USP) is an orally administered, non-steroidal,ovulatory stimulant. Each tablet contains Clomiphene Citrate USP 50 mg.Clomiphene Citrate is the first non-steroid preparation that in manypatients induces ovulation which has failed. Clomiphene Citratestimulates the increased secretion of both gonadotropins (FSH and LH),which induce the maturation of the ovarian follicle, ovulation and thesubsequent normal function of the corpus luteum. It is most probablythat Clomiphene Citrate stimulates the production of the releasing factorfor gonadotropins in the hypothalamus, that induce the increasingsecretion of FSH and LH. After oral administration, Clomiphene Citrateis readily absorbed from the gastrointestinal tract. Biological half-life inthe plasma is 5-7 days. It is partly metabolized in the liver, and throughthe bile is excreted in the faeces. A part is reabsorbed and enters theenterohepatic recirculation pool.

IndicationsFertil is indicated for the treatment of ovulatory failure in women desiringpregnancy whose partners are fertile and potent. The followingsyndromes are most commonly associated with ovulatory failure:polycystic ovary syndrome, amenorrhoea with galactorrhoea, psychogenicamenorrhoea, some forms of secondary amenorrhoea of undeterminedetiology, and post-oral-contraceptive amenorrhoea. Other possible causesof infertility should be excluded before giving Clomiphene Citrate. Fertilis indicated in the treatment of menorrhagia caused by hyperplasticendometrium.

Dosage and AdministrationThe usual dose for the first course of Fertil is 50 mg (1 tablet) a day for5 days in the early follicular phase of the cycle, following normalmenstruation or a progestagen-induced withdrawal bleeding. Manyregimes have been used, but most common begin either on day 2 or day5. If this dose induces ovulation, there is no need to increase the dose inthe following courses. If this dose induces ovulation, but pregnancy does


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not occur, stimulation with Clomiphene Citrate is to be continued, but upto 6 stimulative courses. If the first course does not induce ovulation, thesecond course should be started with 100 mg a day (2 tablets of 50 mgtaken in a single dose) for 5 days. If ovulation is not induced, 2 morestimulative courses of the same dose should be given. If the next threestimulative courses do not produce a successful result, the therapeutic trialis considered to be finished. If ovulation is induced, but pregnancy doesnot occur, maximum 6 courses with Fertil are recommended. However, ifmenstrual bleeding does not occur, the patient should be examinedcarefully for the possible pregnancy, and the next course of therapyshould be delayed until the correct diagnosis has been determined.

ContraindicationFertil is contraindicated during pregnancy, in patients with liver disease,ovarian cysts, bleeding of undetermined origin, and in patients withneoplasms of endometrium.

Side EffectsClomiphene Citrate is well tolerated. However a few side effects likedizziness, headache, nausea, vomiting, depression, fatigue, insomnia,vasomotor flushing, and allergic reaction may occur. Rarely ovarianenlargement and cyst formation may occur. All these effects disappearpromptly after the treatment is discontinued.

PrecautionsClomiphene Citrate is not to be used for longer maintenance therapy. Ifovarian enlargement occurs, the next Fertil course is not to be given untilthe ovaries return to their pretreatment size and the dosage of the nextcourse may be reduced. Fertil should be used with caution with alcoholicdrinks and antidepressants. There is a minimal chance of multiplepregnancies, about which the patient should be warned.

Drug InteractionsThere are no significant drug interactions with Clomiphene Citrate.

Use in Pregnancy and LactationFertil should not be administered during pregnancy. It is not knownwhether Fertil is excreted in human milk. Because many drugs are


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excreted in human milk, caution should be exercised if Fertil isadministered to a nursing woman. In some patients, Fertil may reducelactation.


Commercial PackFertil Tablet : Box containing 50 tablets in blister strip. Each tabletcontains Clomiphene Citrate USP 50 mg.


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Fibril®Capsule

DescriptionFibril containing Gemfibrozil is an antilipemic agent. Gemfibrozildecreases serum triglycerides in healthy individuals and in patients withhypertriglyceridemia. It decreases very low density lipoprotein (VLD)-triglyceride concentration. HDL-triglyceride usually decreases slightly.Gemfibrozil usually increases the HDL-cholesterol fraction in healthyindividuals and in patients with hyperlipoproteinemia, an action that maybe beneficial in slowing the progression of atherosclerosis and inreducing the risk of coronary heart disease.

Gemfibrozil also inhibits synthesis of VLDL carrier apolipoprotein B,leading to a decrease in VLDL production. The drug inhibits lipolysis offat in adipose tissue and decreases the hepatic uptake of plasma free fattyacids, thereby reducing hepatic triglyceride production.

Gemfibrozil is rapidly and completely absorbed from the Gastro-intestinal tract. Peak concentration in plasma occurs within 1 to 2 hours;the half-life is about 1.5 hours. About 70% of a dose is excreted in theurine little is excreted in the faeces.

IndicationsFibril is used as a hypolipidaemic agent in conjunction with dietarymodification. It is recommended in the treatment of type IIa, type III,type IV, and type V hyperlipoproteinaemia.

Dosage and AdministrationThe usual dose, by mouth is 1.2g daily in 2 divided doses given 30 minutesbefore morning and evening meal. The dosage range may vary between0.9-1.5g daily or as advised by the physician.

ContraindicationIt is contraindicated in case of alcoholism, hepatic impairment, gallstone,pregnancy and in patients hypersensitive to Gemfibrozil.


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PrecautionRisk benefit must be considered in case of lactating mother. Beforeinitiating long term treatment lipid profile, blood counts, renal activity,annual eye examination and liver function test should be done.

Side EffectsThe most frequent adverse effect involves the Gastro-intestinal tract.Abdominal pain and epigastric pain or dyspepsia are common adverseGastro-intestinal effects. Other adverse reactions include pruritus, rash,headache, dizziness, blurred vision, painful extremities and rarely myalgia.

Commercial PackFibril Capsule : Box containing 3x10 capsules in strip pack. Each capsulecontains Gemfibrozil USP 300 mg.


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Filmet®

Tablet/Suspension

DescriptionFilmet is the brand of Metronidazole in 200, 400 and 800 mg film coatedtablets and lemon flavoured suspension. The special film coating is tomask the characteristic bitterness of Metronidazole which maysometimes cause nausea. Filmet has antiprotozoal action and is effectiveagainst Trichomonas vaginalis, Entamoeba histolytica, Giardia intestinalis andanaerobic bacteria.

Indications- Urogenital trichomoniasis in the female and male- Intestinal and extra-intestinal amoebiasis- Giardiasis- Anaerobic bacterial infections- Non-specific vaginitis- Anaerobically-infected ulcers and pressure sores

Dosage and AdministrationIndications

Amoebic dysentery

Asymptomaticamebiasis

Hepatic andextraintestinalamebiasis

Giardiasis

Trichomoniasisconsort treatmentsrecommended

Vincent’s infection

Anaerobic infection

Non-specificvaginitis

Leg ulcer and pressure sore

Durationin days

5 to 10or 2

5 to 10

5 to 10or 2

3

7or 2or 1

3

7

7

17

Adults and Childrenover 10 years

800 mg tid2 g once daily

400-800 mg tid

400-800 mg tid2-2.4 g once daily

2 g once daily

200 mg tid800 mg-morning and1.2 g-evening2 g single dose

200 mg tid or400 mg bid400 mg tid

400 mg tid

2 g single dose400 mg tid

Children7-10 yrs.

400 mg tid

200-400 mg tid

200-400 mg tid

1 g once daily

100 mg t.id

100 mg tid

Children3-7 yrs.

200 mg qid

100-200 mg qid.

100-200 mg tid

600 mg once daily100 mg bid

100 mg tid

Children1-3 yrs.

200 mg tid

100-200 mg t.i.d

100-200 mg t.id

500 mg once daily50 mg tid

50 mg tid

7.5 mg/kg body weight in divided doses


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Side EffectsSide effects of Metronidazole include gastrointestinal discomfort, nausea,coated tongue, dryness of mouth and unpleasant metallic or bitter taste,headache, pruritus and skin rashes and less frequently, vertigo, depression,insomnia, drowsiness, urethral discomfort, and darkening of the urine.Occasionally there may be temporary moderate leucopenia. Peripheralneuropathy has been reported in patients on prolonged therapy.

PrecautionsMetronidazole should not be used in patients with blood dyscrasia. It issuggested that it should not be given in the first three months ofpregnancy. When given in conjunction with alcohol, Metronidazole mayprovoke a disulfiram like effect.

ContraindicationFilmet is contraindicated in patients with prior history of hypersensitivityto Metronidazole or other Nitroimidazole derivatives.

Commercial PackFilmet 200 Tablet : 10 blister strips of 10 film coated tablets, each tabletcontains 200 mg Metronidazole BP.

Filmet 400 Tablet : 10 blister strips of 10 film coated tablets, each tabletcontains 400 mg Metronidazole BP.

Filmet DS Tablet : 10 blister strips of 10 film coated tablets, each tabletcontains 800 mg Metronidazole BP.

Filmet Suspension : 60 ml suspension in amber glass bottle, each 5 mlcontains Metronidazole Benzoate BP 320 mg equivalent to 200 mgMetronidazole.


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Flatameal®-DSTablet/Suspension

DescriptionFlatameal -DS is an antacid and antiflatulent containing a combination ofAluminium Hydroxide Gel USP, Magnesium Hydroxide BP andSimethicone USP.

IndicationsFlatameal-DS is indicated for dyspepsia, hyperacidity, gastric andduodenal ulcer, gastritis; also indicated for the relief of flatulence,abdominal distention and windy colic.

Dosage and Administration1-2 tablets of Flatameal-DS to be chewed or 1-2 teaspoonful ofFlatameal-DS Suspension to be taken one hour after meals and at bedtime or as directed by the physician.

Precautions- Drugs containing Aluminium Hydroxide should not be taken

concomitantly with any form of Tetracycline, as the absorption of thelater may be affected.

- Aluminium Hydroxide may also reduce the absorption of Digoxin.

Commercial PackFlatameal-DS Tablets : Box containing 20 blister strips of 10 tablets, eachtablet contains 400 mg dried Aluminium Hydroxide Gel USP, 400 mgMagnesium Hydroxide BP and 30 mg Simethicone USP.

Flatameal-DS Suspension : 200 ml suspension in glass bottle, each 5 mlcontains Aluminium Hydroxide Gel USP equivalent to 200 mgAluminium Oxide, 400 mg Magnesium Hydroxide BP and 30 mgSimethicone USP.


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Flubex®

Capsule/Syrup

DescriptionFlubex is a preparation of Flucloxacillin. It acts in similar way to Penicillinby inhibiting bacterial cell wall synthesis.

IndicationsFlubex is indicated for the treatment of infections due to Gram-positiveorganisms, including infections caused by β-lactamase producingstaphylococci. Typical indications include:

Respiratory tract infections : Pneumonia, lung abscess, empyema, sinusitis,pharyngitis, tonsillitis.

Skin and soft tissue infections : Boils, abscesses, carbuncles, furunculosis,infected skin conditions e.g. ulcer, eczema, acne, cellulitis, infectedwounds, infected burns etc.

Other infections caused by Flucloxacillin-sensitive organisms : Osteomyelitis,enteritis, endocarditis, urinary tract infection, meningitis, septicaemia.

Flucloxacillin is also indicated for use as a prophylactic agent during majorsurgical procedures where appropriate; for example, cardiothoracic andorthopaedic surgery.

Dosage and Administration Doses should be administered half an hour before meals.

Adult (including elderly patients) : 250 mg four times daily. Dose may beincreased in severe infections. In osteomyelitis, endocarditis- up to 8 gdaily, in divided doses six to eight hourly.

Children : 2-10 years- half of adult dose; Under 2 years- one fourth ofadult dose.


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ContraindicationFlucloxacillin is contraindicated for those who have hypersensitivity topenicillins.

Use in Pregnancy and LactationAnimal studies with Flucloxacillin have shown no teratogenic effects. Theuse of Flucloxacillin in pregnancy should be reserved for cases consideredessential by the clinician.

Side EffectsSide effects, as with other penicillins, are uncommon and mainly of mildand transitory in nature. Gastrointestinal upsets (e.g. nausea, diarrhoea)and skin rashes have been reported. If a skin rash occurs, treatmentshould be discontinued. Hepatitis and cholestatic jaundice have beenrarely reported.

OverdosageProblems of overdosage with Flucloxacillin are unlikely to occur. In caseof overdosage patient should be treated symptomatically.

Pharmaceutical Precaution Store in a cool and dry place.Keep out of the reach of children.

Commercial PackFlubex-250 Capsule : Box containing 5 strips of 10 capsules. Each capsulecontains Flucloxacillin Sodium BP equivalent to Flucloxacillin 250 mg.

Flubex-500 Capsule : Box containing 3 strips of 10 capsules, each capsulecontains Flucloxacillin Sodium BP equivalent to Flucloxacillin 500 mg.

Flubex Powder for Syrup : Dry powder in amber glass bottle forreconstitution into 100 ml syrup. After reconstitution, each 5 ml containsFlucloxacillin Sodium BP equivalent to Flucloxacillin 125 mg.


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Formula®E Tablet

DescriptionFormula-E (Vitamin E) is a crackable tablet with chocolate taste. Eachtablet contains Vitamin E USP (dl-alpha tocopheryl acetate) 200 mg.

IndicationsAs a dietary supplement and for prophylactic use : ♦ To meet raised requirements (e.g. pregnancy and lactation period, high

dietary intake of polyunsaturated fatty acids, etc).

♦ For prevention of vitamin E deficiency due to malabsorptionsyndromes caused by pancreatic, hepatobiliary and gastrointestinaldisorders.

Therapeutic use : ♦ Haemolytic anaemia due to vitamin E deficiency (in premature

infants).

♦ Intermittent claudication.

Also Formula-E has been found to be effective in preventing andalleviating the symptoms of the following conditions :-

In internal medicine : Thromboangiitis obliterans, varicose ulcers, myocardialinsufficiency, fibrositis, Dupuytren’s contracture, Peyronie’s disease, maleinfertility, dyslipoproteinaemia with low HDL cholesterol and high LDLcholesterol.

In gynaecology and obstetrics : Habitual abortion, tendency to prematuredelivery, habitual stillbirth, threatened abortion, menopausal disorders,pruritus vulvae, kraurosis vulvae.

In dermatology : Lupus erythematosus, granuloma annulare, acrodermatosis,atrophicans progressiva, scleroderma.

Dosage and AdministrationDosage varies according to individual’s need. The following dosages arerecommended in different indications.


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As a supplement or prophylactic use:-

♦ Increased requirements: 100-300 mg daily

♦ Malabsorption syndromes: 100-300 mg daily

♦ Haemolytic anaemia in premature infants: 100-200 mg/kg body weight

♦ Intermittent claudication: 300-600 mg daily.

Other indications and dosages are the following:-

♦ Thromboangiitis obliterans, varicose ulcers, myocardial insufficiency :300-600 mg daily

♦ Fibrositis, Dupuytren’s contracture, Peyronie’s disease,dyslipoproteinaemia with low HDL cholesterol and high LDLcholesterol. : 200-300 mg daily

♦ Male infertility : 100-200 mg daily

♦ Habitual abortion, tendency to premature delivery, habitual stillbirth :100 mg daily from the beginning of pregnancy as a prophylaxis, withhormone therapy if required

♦ Threatened abortion : 100 mg every 6 hours until the crisis is over

♦ Menopausal disorders, pruritus vulvae, kraurosis vulvae : 100-200 mgdaily

♦ Lupus erythematosus, granuloma annulare, acrodermatosis, dermatitisatrophicans diffuse progressiva, scleroderma : 100-300 mg daily.

Side EffectsVitamin E is very well tolerated. As a rule, daily doses of up to 800 mgdo not induce any adverse reactions. Only a dose approaching 1 g maygive rise to transient gastrointestinal symptoms like nausea, flatulence,diarrhoea, etc. There have so far been no reports of any changes inlaboratory parameters as a result of vitamin E administration.

ContraindicationThere is no absolute contraindication.

Warning and PrecautionsVitamin E may enhance the anticoagulant activity of anticoagulant drugs.

Use in Pregnancy and Lactation Vitamin E may be used in pregnancy in the normally recommended dose,


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but the safety of high-dose therapy has not been established. Thereappears to be no contraindication to breast feeding by mothers taking thenormally recommended dose.

Drug InteractionsIn animal studies very high doses of vitamin E were shown to limit theabsorption of vitamin A and K.

OverdosageVitamin E hypervitaminosis is unknown.

Commercial Pack Formula-E Tablet : Bottle containing 15 tablets. Each tablet containsVitamin E USP (dl-alpha tocopheryl acetate) 200 mg.


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Frelax®

Powder

DescriptionFrelax (Polyethylene Glycol USP) is a powder for solution and is asynthetic polyglycol having an average molecular weight of 3350. Below55°C it is a free flowing white powder freely soluble in water. It is anosmotic agent for the treatment of constipation.

IndicationsFrelax is indicated for the treatment of constipation. This product shouldbe used for 2 weeks or less or as directed by a physician.

Dosage and AdministrationThe usual dose of Frelax is 17 g (about 1 heaping tablespoon) of powderper day (or as directed by physician) in 8 ounces (approximately 240 ml,one glass) of water, juice, coke, coffee, or tea.

Side EffectsNausea, abdominal bloating, cramping and flatulence may occur. Highdoses may produce diarrhoea and excessive stool frequency, particularlyin elderly patients. Patients taking other medications containingpolyethylene glycol have occasionally developed urticaria suggestive of anallergic reaction.

ContraindicationFrelax is contraindicated in patients with known or suspected bowelobstruction and patients known to be allergic to polyethylene glycol.

PrecautionsGeneral: Patients presenting with complaints of constipation should havea thorough medical history and physical examination to detect associatedmetabolic, endocrine and neurogenic conditions, and medications. Adiagnostic evaluation should include a structural examination of thecolon. Patients should be educated about good defaecating and eatinghabits (such as high fiber diets) and lifestyle changes (adequate dietary


182

fiber and fluid intake, regular exercise) which may produce more regularbowel habits.

Polyethylene glycol should be administered after being dissolved inapproximately 8 ounces of water, juice, coke, coffee, or tea.

Pediatric : Safety and effectiveness in pediatric patients has not beenestablished.

Geriatric : There is no evidence for special considerations whenPolyethylene glycol is administered to elderly patients. In geriatric nursinghome patients a higher incidence of diarrhoea occurred at therecommended 17 g dose. If diarrhoea occurs Polyethylene glycol shouldbe discontinued.

Use in Pregnancy and LactationPregnancy Category C : Animal reproductive studies have not beenperformed with polyethylene glycol. It is also not known whether Frelaxcan cause fetal harm when administered to a pregnant woman, or caneffect reproductive capacity. Frelax should only be administered to apregnant woman if clearly needed. There is no information on the use ofpolyethylene glycol while nursing. Consultation with a physician isnecessary in case of breast feeding.

Drug InteractionsNo specific drug interactions have been demonstrated.

OverdosageThere have been no reports of accidental overdose. In the event ofoverdose diarrhoea would be the expected major event. Dehydration mayoccurred. Medication should be terminated immediately and plenty offluids should be administered.

Information to the PatientFrelax is a prescription only laxative that has been prescribed by physicianto treat constipation. The person for whom it is prescribed should onlyuse this product.


183

How to take?The dose of Frelax is 17 g each day or as directed by physician. It shouldalways be taken by mouth. Measure the dose using the supplied cap, stirand dissolve in a glass (8 ounces or 240 ml) of water, juice, coke, coffeeor tea. Taking more than the prescribed dose may cause loss of fluid dueto severe diarrhoea. Each bottle is supplied with a measuring cap that isused to measure 17 g or 8.5 g of laxative powder when filled up to theindicated line.

How long should it be taken?Frelax achieves its best results when used between one and two weeks. Itmay be discontinued after several satisfactory bowel movements. Shouldunusual cramps, bloating or diarrhoea occur, consultation with physicianis needed. Frelax is intended for up to a two-week course of therapy. Itshould not be used for a longer time unless directed by a physician.

After successfully completing the Frelax therapy (usually between one andtwo weeks) discussion with a physician is needed to change lifestyle thatmay produce more regular bowel habits (adequate dietary and fluid intake,regular exercise).

Commercial PackFrelax Powder : Each bottle contains 85 g of Polyethylene Glycol 3350USP NF powder for solution. The cap on each bottle is marked with ameasuring line and may be used to measure a single dose of 17 g or 8.5 gof powder for reconstitution into solution. After reconstitution 240 mlsolution contains 17 g of Polyethylene Glycol.


184

Frenxit®

Tablet

DescriptionFrenxit is a preparation of Flupentixol and Melitracen. Flupentixol- is aneuroleptic with anxiolytic and antidepressant properties when given insmall doses, and Melitracen- a bipolar thymoleptic with activatingproperties in low doses. In combination the compound renders apreparation with antidepressant, anxiolytic and activating properties.

Indications♦ Anxiety ♦ Depression ♦ Apathy. Others are- Psychogenic depression,Depressive neuroses, Masked depression, Psychosomatic affectionsaccompanied by anxiety and apathy, Menopausal depression. Dysphoriaand depression in alcoholics and drug addicts.

Dosage and AdministrationAdults: Usually 2 tablets daily (morning and noon). In severe cases themorning dose may be increased to 2 tablets. Elderly patients: 1 tablet inthe morning. Maintenance dose: Usually 1 tablet in the morning. In casesof insomnia or severe restlessness additional treatment with a sedative inthe acute phase is recommended. Second dose should not be taken after4 pm.

ContraindicationThe immediate recovery phase after myocardial infarction. Defects inbundle-branch conduction. Untreated narrow angle glaucoma. Acutealcohol, barbiturate and opiate intoxication. Flupentixol and Melitracenshould not be given to patients who have received a MAO-inhibitorwithin two weeks. Not recommended for excitable patient since itsactivating effect may lead to exaggeration of these characteristics.

PrecautionsIf previously the patient has been treated with tranquilizers with sedativeeffects these should be withdrawn gradually.


185

Use in Pregnancy and LactationFlupentixol and Melitracen should preferably not be given duringpregnancy and lactation.

Side EffectsIn the recommended doses side effects are rare. These could be transientrestlessness and insomnia.

Drug InteractionsFlupentixol and Melitracen may enhance the response to alcohol,barbiturates and other CNS depressants. Simultaneous administration ofMAO-inhibitors may cause hypertensive crisis. Neuroleptics andthymoleptics reduce the antihypertensive effect of guanethidine andsimilar acting compounds and thymoleptics enhance the effects ofadrenaline and noradrenaline.

OverdosageSymptoms : In cases of overdosage the symptoms of intoxication byMelitracen, especially of anticholinergic nature, dominate. More rarelyextrapyramidal symptoms due to Flupentixol occur.

Treatment : It should be symptomatic and supportive. Gastric lavageshould be carried out as soon as possible and activated charcoal may beadministered. Measures aimed at supporting the respiratory andcardiovascular systems should be instituted. Epinephrine (adrenaline)must not be used for such patients. Convulsions may be treated withDiazepam and extrapyramidal symptoms with Biperiden.

Commercial Pack Frenxit Tablet : Box containing 100 tablets in 10 x 10’s blister strips. Eachfilm coated tablet contains Flupentixol Dihydrochloride BP equivalent to0.5 mg Flupentixol and Melitracen Hydrochloride INN equivalent to 10mg Melitracen.


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Fungistin®

Suspension

DescriptionFungistin oral suspension is an antifungal antibiotic which is bothfungistatic and fungicidal in vitro against a wide variety of yeasts and yeastlike fungi.

Fungistin oral suspension is banana flavoured, ready to use suspensioncontaining 100,000 units of Nystatin BP per ml.

IndicationsSuspension for the prevention and treatment of candidal infection of theoral cavity, oesophagus and intestinal tract caused by Candida albicans(monilia) it provides effective prophylaxis against oral candidiasis in thoseborn of mothers with vaginal candidiasis.

Dosage and AdministrationAdults:Dosage range: 1-6 ml four times daily.

For the treatment of denture sores, and oral infections, in adults causedby C. albicans, 1-2 ml of the suspension should be dropped into the mouthfour times daily, it should be kept in contact with the affected area as longas possible.

Older people with intestinal candidiasis may be given 5 ml of thesuspension four times a day.

Children:Dosage range: 1-6 ml four times daily in children

1-2 ml four times daily infants

In intestinal and oral candidiasis (thrush) in infants and children, 1-2 mlshould be dropped into the mouth four times a day. The longer thesuspension is kept in contact with the affected area in the mouth beforeswallowing, the greater will be its effect.


187

For prophylaxis of oral candidiasis in the newborn the suggested dose is1 ml once daily.

Administration should be continued for 48 hours after clinical cure toprevent relapse.

ContraindicationThere are no known contraindication to the use of Nystatin excepthypersensitivity to the drug.

PrecautionsUse in pregnancy: Absorption of Fungistin from the gastrointestinal tractis negligible, therefore no special precautions apply in pregnancy.

Side EffectsNausea, vomiting and diarrhoea have occasionally been reported withdoses of Nystatin exceeding 4 to 5 million units daily. No systemic effectsor allergic reactions have been associated with its oral use.

OverdosageSince the absorption of Nystatin from the gastro-intestinal tract isnegligible, overdosage causes no systemic toxicity.

Pharmaceutical PrecautionDilution : Not recommended as this may reduce therapeutic efficacy.

Commercial PackFungistin Oral Suspension : 12 ml suspension in amber glass bottle withgraduated dropper, each ml contains 100,000 units of Nystatin BP.


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Furasep®

Cream

DescriptionFurasep cream is a preparation of 0.2% Nitrofurazone. Nitrofurazone isa broad spectrum topical antibacterial agent indicated for the treatment ofmixed skin infections of superficial wounds and diseases of the skin.

IndicationsFurasep is indicated in the infectious conditions of the skin such as burns,wounds, ulcers, skin infections and skin grafting.

Dosage and ApplicationTo be applied directly to the lesion or on gauze first; 2-3 times daily or asadvised by the physician.

Side EffectsSensitization and generalized allergic skin reactions may be produced afterfew days of initial application. Cross sensitization to other Nitrofurazonederivatives may occur. Intolerance to Nitrofurazone necessitatingwithdrawal has been encountered.

Contraindication and WarningFurasep is contraindicated to patients with known sensitivity toNitrofurazone. It is not advisable to use Furasep after the infection iscured. It should be used with caution in patients with known or suspectedrenal impairment.

Commercial PackFurasep Cream : Tube containing 20 g cream, each gram containsNitrofurazone USP 2 mg.


189

Fusidic Plus®

Ointment

DescriptionFusidic Plus is a topical steroid-antibiotic ointment. It contains SodiumFusidate BP 2% and Hydrocortisone Acetate BP 1%.

IndicationsEczema and dermatitis with secondary bacterial infections, includingatopic eczema, primary irritant dermatitis and allergic and seborrhoeicdermatitis where the organisms are known to be or believed to besensitive to Fusidic Acid.

Dosage and ApplicationAdults and Children :Uncovered lesions- apply gently 3 to 4 times daily.Covered lesions - less frequent applications may be adequate.

Contraindication Contraindicated in patients with hypersensitivity to Fusidic Acid or itssalts. Also contraindicated in cases of primary bacterial, viral and fungalinfections.

PrecautionsAs with all topical antibiotics, bacterial resistance and contact sensitizationmay occur. These risks may increase with extended or recurrentapplication. Caution should be exercised when used near the eye. Steroid-antibiotic combinations should not be used for more than seven dayswithout clinical improvement since in this situation occult extension ofthe infection may occur due to the masking of the steroid. Similarly,steroids may also mask hypersensitivity reactions. Long-term continuoususe should be avoided in infants, and adrenal suppression can occur.

Use in Pregnancy and LactationThere is inadequate evidence of safety in pregnancy and nursing mothers.Use requires benefit to be weighed against possible hazards to the foetus.


190

Side EffectsHypersensitivity reactions in the form of skin rashes and mild stingingirritation on application have been reported rarely.

Commercial PackFusidic Plus Ointment : It is supplied in aluminium tube of 10 g and 20g capacity. Each gram of Fusidic Plus ointment contains Sodium FusidateBP 20 mg and Hydrocortisone Acetate BP 10 mg.


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Gastalfet®

Tablet

DescriptionGastalfet tablet contains 500 mg of Sucralfate (basic aluminium salt ofsucrose octa sulphate).

IndicationsFor the treatment of duodenal ulcer, gastric ulcer and chronic gastritis.

Dosage and AdministrationAdult: Usual dose 1 gram 4 times daily to be taken 1 hour before mealsand at bed time. Maximum daily dose is 8 grams. Four to six weekstreatment is usually needed for ulcer healing but up to twelve weeks maybe necessary in resistant cases. Antacids may be used as required for reliefof pain, but should not be taken half an hour before or after Gastalfet.

Elderly: There are no special dosage requirements for elderly patients butas with all medicines the lowest effective dose should be used.

Safety and efficacy in children have not been established.

ContraindicationThere are no known contraindication.

PrecautionsThe product should only be used with caution in patients with renaldysfunction.

Use in Pregnancy and LactationAlthough animal studies show no evidence of foetal malformation, safetyin pregnant women has not been established and Gastalfet should be usedin pregnancy only if clearly needed.

It is not known whether this drug is excreted in human milk. Cautionshould be taken when Sucralfate is administered to nursing mothers.


192

Drug InteractionConcomitant use of Sucralfate may reduce the bioavailability of certaindrugs as has been observed in animal studies with Tetracycline, Phenytoinand Cimetidine and in human studies with Digoxin. Administration ofGastalfet with any of these drugs should be separated by two hours. SinceSucralfate may hinder Warfarin absorption, caution should be taken whenthese two drugs are used together.

Side EffectsThe incidence and severity of side effects from Sucralfate are very low.Mild side effect like constipation has been reported in some patients.

OverdosageThere is no experience in human with overdosage.

Commercial PackGastalfet Tablet : Box containing 10 blister strips of 10 tablets, each tabletcontains Sucralfate USP 500 mg.


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Gentosep®

Cream

DescriptionGentosep is a preparation of Gentamicin Sulphate which is a watersoluble antibiotic of the aminoglycoside group, active against a widevariety of pathogenic Gram-positive and Gram-negative microorganisms.

IndicationsGentosep cream is indicated for the topical treatment of the primary andsecondary bacterial infections of the skin caused by the organismssensitive to Gentamicin. Gentosep may clear infections that have notresponded to other topical antibiotics.

Dosage and ApplicationA small amount of Gentosep should be applied gently to the affectedareas three to four times daily. The area treated may be covered with agauze dressing if desired. Before applying the medication the affectedarea should be properly cleaned.

Side EffectsGentosep cream is well tolerated. There has been no evidence ofirritation and sensitization after using Gentosep cream.

ContraindicationGentosep is contraindicated in individuals with a history ofhypersensitivity to any of its components.

PrecautionsUse of topical antibiotics occasionally cause overgrowth ofnonsusceptible organisms including fungi. If this occurs or if irritation,sensitisation or super infection develops, treatment with Gentosep shouldbe discontinued and appropriate therapy should be instituted.

Commercial PackGentosep Cream : Each gram contains Gentamicin Sulphate BPequivalent to 3 mg Gentamicin base in sealed tubes of 15 grams.


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Hefolin®SR Capsule

DescriptionEach Hefolin sustained release capsule contains 150 mg Ferrous SulphateBP equivalent to 47 mg Iron and 500 µg of Folic Acid BP. Hefolin SR isa transparent capsule filled with colourful pellets. The iron is speciallyformulated for sustained release over a period of several hours.

IndicationsHefolin SR capsule is a haematinic preparation indicated in the treatmentof iron and folic acid deficiency states. Hefolin SR is used as a prophylaxisof iron deficiency in pregnancy and after subtotal or total gastrectomy.

Dosage and AdministrationAs a ProphylaxisAdult : One capsule daily. In more severe cases, two capsules a day maybe required or as prescribed by the physician. In Elderly patient same asadult dose. Children aged over 1 year : One capsule a day, the capsule maybe opened and the pellets mixed with soft cool food but they must not bechewed.

As a Treatment2 to 4 capsules a day or as prescribed by the physician.

ContraindicationIt is contraindicated in patients with hypersensitivity to any of itscomponents.

PrecautionsCaution should be taken in patients with haemochromatosis, haemolyticanaemia or red cell aplasia as they may cause high blood ironconcentrations. In case of pregnant women and lactating mothers, it isbetter to seek the advice of a health professional before using thisproduct.


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Drug InteractionsIron chelates with Tetracycline. Since oral Iron products interfere withabsorption of oral tetracycline antibiotics, these product should not betaken within two hours of each other. Occasional gastrointestinaldiscomfort may be minimized by taking with meals. Absorption of ironmay be impaired by concurrent administrations of penicillamine andantacid.

Side EffectsAlthough Hefolin SR capsule is designed to minimize gastrointestinal sideeffects, in some cases anorexia, nausea, abdominal discomfort,constipation may be encountered.

OverdosageGastric lavage should be carried out in the early stages and vomiting mayalso be induced if needed. Oral Desferrioxamine (2 g for a child and 5 gfor an adult) should be given. If the patient is in shock or comaDesferrioxamine should be administered by IV or IM route.

Pharmaceutical PrecautionKeep in a cool and dry place below 25oC and protect from sunlight. Keepout of reach of children.

Commercial PackHefolin SR Capsule : Box containing 10 x 10’s blister strips. Each capsulecontains 150 mg Ferrous Sulphate BP equivalent to 47 mg Iron and 500µg Folic Acid BP.


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Inarzin®

Tablet

DescriptionInarzin is a preparation of Cinnarizine which acts as an antihistamine,labyrinthine sedative and a peripheral antivasoconstrictor. Each tabletcontains Cinnarizine BP 15 mg.

Mode of ActionInarzin (Cinnarizine) is a selective calcium antagonist, inhibiting the influxof Ca2+ intracellularly. It prevents the Ca2+-dependent contraction ofarterial smooth muscle by inhibiting Ca2+ influx through smooth musclecalcium channels and thereby, improves vestibular symptoms andprevents peripheral arterial disease.

IndicationsInarzin is indicated for : - The control of vestibular symptoms such as vertigo, tinnitus, nausea

and vomiting as seen in Meniere’s disease- The prophylaxis and control of motion sickness- The long-term treatment of peripheral arterial disease

Dosage and AdministrationThe recommended dose for treatment of vestibular symptoms in adultsand children over 12 years is 30 mg (2 tablets) three times daily. Forchildren from 5 to 12 years half the adult dose is recommended, i.e. 15 mg (1 tablet) three times daily.

For prophylaxis of motion sickness, 30 mg (2 tablets) should be taken 2hours before travel and then 15 mg (1 tablet) every 8 hours during thejourney. Children from 5 to 12 years, should take half the adult dose.

In the management of peripheral arterial disease, the recommendedstarting dose is 75 mg (5 tablets) three times daily. Maintenance dose is 75mg (5 tablets) two to three times daily depending upon the therapeuticresponse. Inarzin should preferably be taken after meals.


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Contraindication- Known hypersensitivity to Cinnarizine- Parkinson’s disease- Hypotension

Side EffectsDrowsiness and gastrointestinal disturbances may occur. These areusually transient. In rare cases, headache, dry mouth, etc. may occur.

Drug InteractionConcurrent use of alcohol, CNS depressants or tricyclic antidepressantsmay potentiate the sedative effects of either these drugs or ofCinnarizine. Therefore, it is advisable to avoid these drugs while takingCinnarizine.

Use in Special PopulationNeonates : Cinnarizine is not indicated in neonates

Pregnant women : The safety of Cinnarizine in human pregnancy has notbeen established. Therefore, it is not advisable to administer Cinnarizinein pregnancy.

Nursing mothers : It is not known if Cinnarizine is excreted in humanbreast milk. Use of Cinnarizine during breast-feeding is not advised.

OverdosageVomiting, drowsiness, tremor, etc. may occur. There is no specificantidote to Cinnarizine, but in the event of overdosage, gastric lavage andthe administration of activated charcoal may help.

Pharmaceutical PrecautionStore at room temperature.

Commercial PackInarzin Tablet : Box containing 100 tablets in 10 x 10’s blister strips, eachtablet containing Cinnarizine BP 15 mg.


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Informet®LATablet

DescriptionInformet LA (Metformin Hydrochloride) belongs to biguanide class oforal antidiabetic drugs. It decreases hepatic glucose production, decreasesintestinal absorption of glucose and improves insulin sensitivity. Unlikesulfonylureas, Metformin does not produce hypoglycaemia. It is the drugof first choice in obese patients.

Indications Metformin Hydrochloride, as monotherapy, is indicated as an adjunct todiet to lower blood glucose in patients with non-insulin-dependentdiabetes mellitus (NIDDM) whose hyperglycaemia cannot besatisfactorily managed on diet alone. Metformin Hydrochloride may useconcomitantly with a sulfonylurea when diet and MetforminHydrochloride or sulfonylureas alone do not result in adequate glycaemiccontrol.

Dosage and AdministrationThe usual starting dose of Informet LA (Metformin Hydrochloride longacting) is 500 mg once daily with the evening meal. Dose incrementsshould be made 500 mg weekly, up to a maximum of 2000 mg once dailywith the evening meal. If glycaemic control is not achieved on InformetLA 2000 mg once daily, a trial of Informet LA 1000 mg twice daily shouldbe considered.

When transferring patients from standard oral hypoglycaemic agentsother than Chlorpropamide to Metformin HCl, no transition periodgenerally is necessary. When transferring patients from Chlorpropamide,care should be exercised during the first two weeks because of theprolonged retention of Chlorpropamide in the body, leading tooverlapping drug effects and possible hypoglycaemia.

Side EffectsDiarrhoea, nausea, vomiting, abdominal bloating, flatulence, and anorexiaare the most common side effects to Metformin Hydrochloride. Lacticacidosis also rarely occurs.


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ContraindicationMetformin Hydrochloride is contraindicated in patients with renal diseaseor renal dysfunction, congestive heart failure, known hypersensitivity,acute or chronic metabolic acidosis, including diabetic ketoacidosis, withor without coma.

PrecautionsMetformin Hydrochloride therapy should be temporarily suspended forany surgical procedure (except minor procedures not associated withrestricted intake of food and fluids) and should not be restarted until thepatient’s oral intake has resumed and renal function has been evaluated asnormal. It should be used with caution in case of excessive alcohol intakeand hepatic insufficiency. It should be temporarily discontinued inpatients undergoing radiologic studies involving intravascularadministration of iodinated contrast materials, because use of suchproducts may result in acute alteration of renal function.

Use in Special PopulationPregnancy : Safety in pregnant women has not been established. Anydecision to use this drug should be balanced against the benefits and risks.

Nursing Mothers : It is not known whether Metformin Hydrochloride issecreted in human milk.

Paediatric and Geriatric use : Safety and effectiveness in paediatricpatients have not been established. Dosage adjustment should be basedon a careful assessment of renal function in elderly patients.

Drug InteractionsNifedipine : Nifedipine appears to enhance the absorption of Metformin.Metformin has minimal effects on Nifedipine.

Others : Certain drugs tend to produce hyperglycaemia and may lead toloss of glycaemic control. These drugs include thiazide and otherdiuretics, corticosteroids, phenothiazines, oestrogens, oral contraceptives,Phenytoin, Nicotinic acid, sympathomimetics, calcium channel blockingdrugs, and Isoniazid. When such drugs are administered to a patientreceiving Metformin HCl, the patient should be closely observed tomaintain adequate glycaemic control.


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Overdosage Hypoglycaemia has not been seen even with ingestion of up to 85 gramsof Metformin HCl, although lactic acidosis has occurred in suchcircumstances. Haemodialysis may be useful for removal of accumulateddrug from patients in whom Metformin overdosage is suspected.

Pharmaceutical PrecautionStore at 150-250 C. Keep in a cool and dry place. Keep out of the reachof children.

Commercial PackInformet LA Tablet : Box containing 100 tablets in 10 x 10’s blister strips.Each long acting tablet contains Metformin Hydrochloride BP 500 mg.


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Intracef®Capsule/Suspension/Paediatric Drops

Description Intracef (Cephradine) is a semisynthetic first generation cephalosporinantibiotic that works in a similar way to penicillin by inhibiting bacterialcell wall synthesis. The chemical name of Cephradine is [6R-[6α,7β(R*)]]7-[(Amino- 1,4-cyclohexadien-l-yl)-acetyl) amino-3-methyl-8-oxo-5-thia-1-azabicyclo[4.2.0]-oct-2 -ene-2-carboxylic acid.

Indications Intracef is a broad spectrum bactericidal antibiotic active against bothGram-positive and Gram-negative bacteria. It is also highly active againstmost strains of penicillinase-producing staphylococci.

Intracef is indicated for the treatment of the following infections whencaused by susceptible organisms.

♦ The upper and lower respiratory tract infections - pharyngitis, sinusitis,otitis media, tonsillitis, laryngo-tracheo-bronchitis, acute and chronicbronchitis, lobar pneumonia

♦ Gastrointestinal tract infections

♦ Urinary tract infections- cystitis, urethritis, pyelonephritis

♦ Skin and soft tissue infections- abscess, cellulitis, furunculosis andimpetigo

♦ Prophylaxis for surgical procedures associated with high risk ofdisastrous consequences of infection.

Intracef is also of value where postoperative infections would bedisastrous and where patients have a reduced host resistance to bacterialinfection. Protection is best ensured by achieving adequate local tissueconcentrations at the time of contamination is likely to occur. Thus,Intracef should be administered immediately prior to surgery andcontinued during the postoperative period.


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Dosage and Administration Intracef may be given regardless of meals.

Adults : For urinary tract infections the usual dose is 500 mg four timesdaily or 1 g twice daily; severe or chronic infections may require largerdose. Prolonged intensive therapy is needed for complications such asprostatitis and epididymitis. For respiratory tract infections and skin andsoft tissue infections the usual dose is 250 mg or 500 mg four times dailyor 500 mg or 1g twice daily depending on the severity and site ofinfection.

Children : The usual dose is from 25 to 50 mg/kg/day total, given in twoor four equally divided doses.

For otitis media daily dose from 75 to 100 mg/kg body weight in divideddoses every 6 to 12 hours are recommended. Maximum dose is 4 g perday.

Elderly : There are no specific dosage recommendations or precautionsfor use in the elderly except as with other drugs to monitor those patientswith impaired renal or hepatic function.

Dosage in renal impairment : A modified dosage schedule is necessary inpatients with decreased renal function. Each patient should be consideredindividually; the following modified dosage schedule is recommended asa guideline, based on the creatinine clearance (ml/min/1.73m2). In adults,the initial loading dose is 750 mg of Intracef and the maintenance doseis 500 mg at the time intervals listed below :

Creatinine clearance Time interval

More than 20 ml/min 6-12 hours15-19 ml/min 12-24 hours10-14 ml/min 24-40 hours 5-9 ml/min 40-50 hoursLess than 5 ml/min 50-70 hours

Further modification of the dosage schedule may be necessary in children.


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Side Effects Rarely Cephradine may induce a hypersensitivity reaction and gastro-intestinal disturbances which include nausea, vomiting, diarrhoea,glossitis, heartburn, dizziness, abdominal pain, candidal overgrowth,vaginitis, urticaria, skin rashes, joint pain and oedema. As with othercephalosporins, mild transient eosinophilia, leucopenia and neutropenia,rarely positive direct Coombs’ test and pseudomembraneous colitis havebeen reported.

Drug Interactions The cephalosporins are potentially nephrotoxic (particularlyCephaloridine) and may enhance the nephrotoxicity of aminoglycosideantibiotics such as Gentamicin and Tobramycin. One should be cautiousabout the use of any cephalosporin with Frusemide and Ethacrynic Acid.

Use in Pregnancy and Lactation No teratogenicity has been demonstrated in animals, but safety inpregnancy has not been established. Cephradine is excreted in breast milkand should be used with caution in lactating mothers.

Contraindication Patients with known hypersensitivity to cephalosporin antibiotics.

Warning and Precautions There is evidence of partial cross-allergenicity between penicillins and thecephalosporins. Therefore Cephradine should be used with caution inpatients with known hypersensitivity to penicillins.

Commercial PackIntracef 250 Capsule : Box containing 5 x 10’s blister strips. Each capsulecontains Cephradine BP 250 mg.

Intracef 500 Capsule : Box containing 4 x 10’s blister strips. Each capsulecontains Cephradine BP 500 mg.

Intracef Suspension : Each amber glass bottle contains dry powder for100 ml suspension. After reconstitution each 5 ml contains CephradineBP 125 mg.

Intracef Paediatric Drops : Each amber glass bottle contains dry powderfor 15 ml paediatric drops. After reconstitution each 1.25 ml containsCephradine BP 125 mg.


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Intracef®Injection

Description Intracef (Cephradine) is a semisynthetic first generation cephalosporinantibiotic that works in a similar way to penicillin by inhibiting bacterialcell wall synthesis. The chemical name of Cephradine is [6R-[6α,7β(R*)]]7-[(Amino- 1,4-cyclohexadien-l-yl)-acetyl) amino-3-methyl-8-oxo-5-thia-1-azabicyclo[4.2.0]-oct-2 -ene-2-carboxylic acid.

Indications Intracef is indicated for use primarily in the treatment of infections ofthe respiratory tract, genitourinary tract, soft tissue and skin, bloodstream, and bones, caused by susceptible organisms as listed below:

Staphylococcus aureus (penicillin sensitive and penicillinase producingstrains); Group-A Beta-haemolytic streptococci; Pneumococci;Haemophilus influenzae; Escherichia coli and other coliform bacteria;Klebsiella species; Proteus mirabilis.

Intracef is also effective in cases of peritonitis.

Bacteriology studies to determine the causative organisms and theirsensitivity to Cephradine should be performed. Therapy may be institutedprior to receiving the results of the sensitivity test.

Intracef is effective prophylactically, to avoid infections due to susceptibleorganisms in patients about to undergo ceasarian section or vaginalhysterectomy.

Intracef is primarily indicated for those patients unable to tolerate oralmedication. It is also indicated for intravenous use either by directintravenous injection or by intravenous infusion for the treatment ofserious and life threatening infections.

Intracef is also of value where postoperative infections would bedisastrous and where patients have a reduced host resistance to bacterialinfection. Thus, Intracef should be administered immediately prior tosurgery and continued during the postoperative period.


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Dosage and Administration Adults: The usual dose of Intracef for injection is 2 to 4 g daily in fourequally divided doses intramuscularly or intravenously (e.g. 500 mg to 1 gfour times daily). A dosage of 500 mg four times a day is adequate inuncomplicated pneumonia, furunculosis with cellulitis, and most urinarytract infections. In severe infections, the dose may be increased by givinginjections every four hours or by increasing the dose.

The maximum dose should not exceed 8 g per day.

The recommended dose for surgical prophylaxis is either a single 2 g dosegiven 1 hour before surgery or a regimen of 1 g given one hour beforesurgery followed by a second dose 4 hours later. Additional doses of 1 gmay be given every 4 hours until vital signs are stabilized.

Infants and Children: The usual dose range is 50 to 100 mg/kg/day inequally divided doses four times a day and should be regulated by age,mass of the patient, and severity of the infection being treated.

Elderly : There are no specific dosage recommendations or precautionsfor use in the elderly except as with other drugs to monitor those patientswith impaired renal or hepatic function.

Dosage in renal impairment : A modified dosage schedule is necessary inpatients with decreased renal function. Each patient should be consideredindividually; the following modified dosage schedule is recommended asa guideline, based on the creatinine clearance (ml/min/1.73m2). In adults,the initial loading dose is 750 mg of Intracef (Cephradine) and themaintenance dose is 500 mg at the time intervals listed below :

Creatinine clearance Dose Time interval

More than 20 ml/min 500 mg 6 hours5-20 ml/min 250 mg 6 hours

Less than 5 ml/min 250 mg 12 hours

Further modification of the dosage schedule may be necessary in children


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Side Effects Rarely Cephradine may induce a hypersensitivity reaction and gastro-intestinal disturbances which include nausea, vomiting,diarrhoea,glossitis, heartburn, dizziness, abdominal pain, candidalovergrowth, vaginitis, urticaria, skin rashes, joint pain and oedema. Aswith other cephalosporins, mild transient eosinophilia, leucopenia andneutropenia, rarely positive direct Coombs test and pseudomembraneouscolitis have been reported.

Drug Interactions The cephalosporins are potentially nephrotoxic (particularlycephaloridine) and may enhance the nephrotoxicity of aminoglycosideantibiotics such as gentamicin and tobramycin. One should be cautiousabout the use of any cephalosporin with frusemide and ethacrynic acid.Use in pregnancy and lactation

No teratogenicity has been demonstrated in animals, but safety inpregnancy has not been established. Cephradine is excreted in breast milkand should be used with caution in lactating mothers.

Contraindication Patients with known hypersensitivity to cephalosporin antibiotics.

Warning and Precautions There is evidence of partial cross-allergenicity between penicillins and thecephalosporins. Therefore Cephradine should be used with caution inpatients with known hypersensitivity to penicillins.

Commercial PackIntracef 250 Injection: Each box contains 10 combipacks. Eachcombipack contains 1 vial of Cephradine with Arginine equivalent toCephradine USP 250 mg and 1 ampoule of 5 ml Water for Injection BP.

Intracef 500 Injection: Each box contains 10 combipacks. Eachcombipack contains 1 vial of Cephradine with Arginine equivalent toCephradine USP 500 mg and 1 ampoule of 5 ml Water for Injection BP.


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Ipramid®

Inhaler

DescriptionIpratropium Bromide BP, the active ingredient in Ipramid Inhaler, is ananticholinergic (parasympatholytic) agent that appears to inhibit vagally-mediated reflexes by antagonizing the action of acetylcholine, thetransmitter agent released from the vagus nerve.

Anticholinergics prevent the increases in intracellular concentration ofcyclic guanosine monophosphate (cyclic GMP) that are caused byinteraction of acetylcholine with the muscarinic receptor on bronchialsmooth muscle.

The bronchodilation following inhalation of Ipratropium Bromide isprimarily a local, site-specific effect and not a systemic one.

IndicationsIpratropium Bromide inhaler administered either alone or with otherbronchodilators, especially beta adrenergics, is indicated as abronchodilator for maintenance treatment of bronchospasm associatedwith chronic obstructive pulmonary disease (COPD), including chronicbronchitis and emphysema.

Dosage and AdministrationAdults : 20-40 µg, in early treatment up to 80 µg at a time, 3-4 times daily.

Children : up to 6 years 20 µg 3 times daily, 6-12 years 20-40 µg 3 timesdaily.

ContraindicationIpratropium Bromide inhalation aerosol is contraindicated in patientswith a history of hypersensitivity to soya lecithin or related food productssuch as soya bean and peanut.

Ipratropium Bromide is contraindicated in known or suspected cases ofhypersensitivity to Ipratropium Bromide, or to atropine and itsderivatives.


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PrecautionsIpratropium Bromide should be used with caution in patients withnarrow-angle glaucoma, prostatic hypertrophy or bladder-neckobstruction.

Use in Pregnancy and LactationPregnancy Category B : Because animal reproduction studies are notalways predictive of human response, Ipratropium Bromide should beused during pregnancy only if clearly needed.

Nursing Mothers : It is not known whether Ipratropium Bromide isexcreted in human milk. Although lipid-insoluble quaternary bases passinto breast milk, it is unlikely that Ipratropium Bromide would reach theinfant to a significant extent, especially when taken by inhalation sinceIpratropium Bromide is not well absorbed systematically after inhalationor oral administration. However, because many drugs are excreted inhuman milk, caution should be exercised when Ipratropium Bromide isadministered to a nursing woman.

Pediatric Use : Safety and effectiveness in children below the age of 12have not been established.

Side EffectsGeneral : Headache, pain, influenza-like symptoms, back pain, chest pain;Cardiovascular : Hypertension may be aggravated; Central and PeripheralNervous System: Dizziness, insomnia, tremor, nervousness;Gastrointestinal : Mouth dryness, nausea, constipation; Musculo-skeletalSystem : Arthritis; Respiratory System (Upper) : pharyngitis, rhinitis,sinusitis; Respiratory System (Lower) : Coughing, dyspnoea, bronchitis,bronchospasm.

Additional adverse reactions reported in less than three percent of thepatients treated with Ipratropium Bromide include tachycardia,palpitations, eye pain, urinary retention, urinary tract infection andurticaria. A single case of anaphylaxis thought to be possibly related toIpratropium Bromide has been reported. Cases of precipitation orworsening of narrow-angle glaucoma and acute eye pain have beenreported.


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Lower respiratory adverse reactions (bronchitis, dyspnoea andbronchospasm) were the most common events leading to discontinuationof Ipratropium Bromide therapy in the 12-week trials. Headache, mouthdryness and aggravation of COPD symptoms are more common whenthe total daily dose of Ipratropium Bromide equals or exceeds 2,000 µg.

Pharmaceutical PrecautionPressurized canister, do not puncture, break or incinerate even whenapparently empty. Avoid storage in direct sunlight or heat. Store below 300

C. Keep away from eyes. Keep away from children.

Commercial PackIpramid Inhaler : Each canister contains 200 metered doses, eachcontaining 20 µg Ipratropium Bromide BP.


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Isofloxin®

Tablet

Description Isofloxin is a film coated tablet. Each tablet contains Pefloxacin MesilateBP equivalent to 400 mg Pefloxacin.

Indications Isofloxin is indicated for the treatment of single or mixed infectionscaused by two or more susceptible organisms. It can also be used forinfections caused by organisms resistant to other antibiotics includingaminoglycoside, penicillin and cephalosporin.

Isofloxin is indicated for the treatment of the following infections causedby sensitive bacteria-

Severe systemic infection : Septicaemia, bacteraemia, peritonitis, infections inimmunosuppressed patients with haematological or solid tumors and inpatients in intensive care unit with specific problems such as infectedburns.

Urinary tract infection : Uncomplicated and complicated urethritis, cystitis,pyelonephritis, prostatitis, epididymitis.

Respiratory tract infection : Lobar and bronchopneumonia, acute andchronic bronchitis, acute exacerbation of cystic fibrosis, bronchiectasis,empyema.

Gastrointestinal infection : Enteric fever, infective diarrhoea.

Infections of the biliary system : Cholangitis, cholecystitis, empyema of the gallbladder.

Skin and soft tissue infection : Infected ulcers, wound infections, abscesses,cellulitis, otitis externa, erysipelas, infected burns.

Eye, ear, nose and throat infection : Otitis media, sinusitis, mastoiditis,tonsillitis.


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Intra abdominal infection : Peritonitis, intra abdominal abscesses.

Bone and joint infection : Osteomyelitis, septic arthritis.

Pelvic infection : Salpingitis, endometritis, pelvic inflammatory diseases.

Gonorrhoea : Including urethral, rectal and pharyngeal gonorrhoea causedby β-lactamase producing organisms or organisms moderately sensitive topenicillin.

Dosage and Administration The usual dose is 400 mg twice daily (morning and evening) by mouth inmost infections. Dosage should be adjusted for adults with hepaticinsufficiency. Patients should take the drug with meals to avoidgastrointestinal disturbances.

Contraindication Pefloxacin is contraindicated in patients who have shown hypersensitivityto Pefloxacin or other quinolones. Pefloxacin is also contraindicated inchildren and growing adolescents except where the benefits of treatmentexceed the risks, in pregnant women, nursing mothers and in patients withglucose-6-phosphate dehydrogenase deficiency.

Side Effects Gastrointestinal disturbances e.g. nausea, diarrhoea, vomiting, dyspepsia,abdominal pain. Disturbance of the central nervous system (CNS) e.g.dizziness, headache, tiredness, confusion, convulsions. Hypersensitivityreactions e.g. skin rashes, pruritus. The other reactions have also beenreported are joint pain, mild photosensitivity and thrombocytopenia (atdoses of 1600 mg daily).

Drug Interactions Antacids may interfere with absorption of Pefloxacin resulting in serumand urine levels lower than desired, so concurrent administration of theseagents with Pefloxacin should be avoided.


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Precautions Avoid exposure to sunlight and ultraviolet radiation during treatment withPefloxacin because of the risk of photosensitivity reactions. Dosagereadjustment is required in severe hepatic insufficiency.

Commercial Pack Isofloxin Tablet : Box containing 5 aluminium strips of 10 film coatedtablets. Each tablet contains Pefloxacin Mesilate BP equivalent toPefloxacin 400 mg.


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Keolax®

Tablet

DescriptionKeolax contains Clobazam, an active ingredient which is abenzodiazepine derivative with actions and uses similar to those ofDiazepam. Each tablet contains Clobazam BP 10 mg.

IndicationsKeolax is indicated for the relief of acute or chronic anxiety, tension andagitation. Physical symptoms associated with an underlying anxiety state,phobias and psychosomatic disorders may all respond to treatment withClobazam. Keolax may be used together with antidepressants in thetreatment of anxiety associated with depression. Keolax has also beenshown to have a beneficial effect in the treatment of sleep disturbancesassociated with anxiety and may be used as adjunctive therapy in epilepsy.

Dosage and AdministrationThe usual anxiolytic dose for adult is 20-30 mg daily in divided doses oras a single dose given at night. Doses of up to 60 mg daily have been usedin the treatment of adult in patients with severe anxiety.

Elderly : Doses of 20 mg daily may be used in the elderly patients withanxiety.

Children : In children aged 3 years or over, doses should not exceed halfthe recommended adult dose. There is insufficient experience of the useof Clobazam under three years of age to enable any dosesrecommendation to be made.

ContraindicationClobazam should not be used in patients known to be hypersensitive tobenzodiazepines.

PrecautionsClobazam is a benzodiazepine derivative and in common with othermembers of this group, may potentiate the effect of central nervous


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system depressant drugs such as alcohol, analgesics, hypnotic andneuroleptics.

Addition of Clobazam to anticonvulsant medication may cause a changein plasma levels of these drugs. The ability to drive or operate machinerymay be impaired in individuals who are particularly sensitive to the effectsof Clobazam or in patients taking high doses of the drug. Clobazamshould be used in reduced doses in patients with impaired renal or hepaticfunction.

Use in Pregnancy and LactationThere is a little information on the use of Clobazam in early pregnancybut no untoward effects have been found in animal studies. However,there are reports of a possible malformations in infants due to theadministration of other benzodiazepines in early pregnancy.

Clobazam has been detected in the breast milk of nursing mothers, butthe effect on the neonate is not known.

Overdosage Muscle weakness, ataxia, drowsiness and sedation may occur afteringestion of very high doses, the patient may lose consciousness. Thetreatment of overdosage is symptomatic, stomach should be emptied assoon as possible by gastric lavage and general supportive measures shouldbe undertaken as necessary.

Side EffectsKeolax is generally well tolerated. Side effects such as drowsiness ordryness of mouth have been reported. These are more likely to occur atthe beginning of treatment or a reduction in dose.

Pharmaceutical PrecautionKeolax should be stored in a cool and dry place.

Commercial PackKeolax Tablet : Box containing 100 tablets in 10 x 10’s blister strips. Eachtablet contains Clobazam BP 10 mg.


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Lactameal®Tablet/Suspension

DescriptionLactameal is an antacid containing a combination of AluminiumHydroxide Gel USP and Magnesium Hydroxide BP.

IndicationsHyperacidity, gastric and duodenal ulcer, gastritis.

Dosage and Administration2 Lactameal tablets or 2 teaspoonful of Lactameal suspension one hourafter meals and at bed time or as directed by the physician.

Commercial PackLactameal Tablet : Box containing 20 blister strips of 10 tablets, eachtablet contains 250 mg Dried Aluminium Hydroxide Gel USP and 400 mgMagnesium Hydroxide BP.

Lactameal Suspension : 200 ml suspension in glass bottle, each 5 mlcontains Aluminium Hydroxide Gel USP equivalent to 175 mgAluminium Oxide and 225 mg Magnesium Hydroxide BP.


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Larnox®LATablet

DescriptionLarnox LA (Aminophylline) is a stable mixture or combination ofTheophylline and Ethylenediamine. Ethylenediamine confers greatersolubility in water.

IndicationsIt is indicated for the treatment and prophylaxis of bronchospasmassociated with asthma, emphysema and chronic bronchitis. Alsoindicated in adults for the treatment of cardiac asthma and left ventricularor congestive cardiac failure.

Dosage and Administration Larnox LA tablet possess a slow release mechanism, in whichAminophylline is released to give an effective therapeutic blood levels,lasting up to 12 hours. The recommended initial dose is 1 tablet (350 mgAminophylline) every 12 hours. The dosage may be gradually increased toa maximum of 2 tablets (700 mg Aminophylline) twice a day dependingon the patient’s response.

Note: Tablets should be swallowed whole and not chewed because of thestructure of the tablet.

ContraindicationAminophylline should not be administered to patients withhypersensitivity to xanthines or ethylenediamine. It should not beadministered to patients with active peptic ulcer, since it may increase thevolume and acidity of gastric secretions.

Side EffectsThe most common adverse effects are gastric irritation, nausea, vomiting,epigastric pain and tremor. These are usually early signs of toxicity;however, with high doses, ventricular arrhythmias or seizures may be thefirst signs to appear. Adverse reactions include: Gastrointestinal- nausea,vomiting, epigastric pain, haematemesis, diarrhoea, anorexia, intestinal


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bleeding and reactivation of peptic ulcer. Central Nervous System- headache,irritability, restlessness, insomnia, twitching, convulsion and reflexhyperexcitability. Cardiovascular- palpitation, tachycardia, hypotension,circulatory failure, ventricular arrhythmias, and flushing. Renal-albuminuria, diuresis and haematuria. Others- hyperglycaemia, tachypnoeaand inappropriate ADH syndrome.

Precautions Aminophylline should be given with caution to patients with pepticulceration, hyperthyroidism, hypertension, cardiac arrhythmias or othercardiovascular disease, or epilepsy, as these conditions may beexacerbated. They should also be given with caution to patients with heartfailure, hepatic dysfunction, chronic alcoholism, acute febrile illness,neonates and the elderly.

Use in Pregnancy and LactationTheophylline crosses the placental barrier and also passes freely intobreast milk, where concentrations are similar to plasma levels. Safe use inpregnancy has not been established. Therefore, use of Aminophylline inpregnant women should be balanced against the risk.

Drug Interactionsβ-blockers (e.g., Propranolol) may oppose the effects of Aminophylline.barbiturates, Phenytoin and smoking may decrease Theophylline levels inblood or circulation.

OverdosageToxic effects of overdosage are frequent vomiting, anorexia, unusualthirst, maniacal agitation leading in the most severe cases to convulsions,shock and death. After Aminophylline overdosage by mouth the stomachmay be emptied by lavage if within 2 hours of the overdose. Eliminationmay be enhanced by repeated oral doses of activated charcoal regardlessof the route of Theophylline overdose. An osmotic laxative may also beconsidered, especially if modified-release preparations have been taken.Treatment should be symptomatic and supportive. Serum Theophyllineconcentrations should be monitored, and if modified release preparationshave been taken monitoring should be prolonged.


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Pharmaceutical PrecautionStore at 25oC. Keep in a cool and dry place, away from direct sunlight.Keep out of the reach of children.

Commercial Pack

Larnox LA Tablet : Box containing 50 tablets in 5 x10’s blister strips; eachtablet contains Aminophylline BP 350 mg.


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Lucidol®Capsule

DescriptionLucidol (Tramadol Hydrochloride) is a centrally acting analgesic.Tramadol is a synthetic analog of codeine. However, Tramadol has alower affinity for opioid receptor than codeine. It is less potential forabuse or respiratory depression than other opiate agonist, but both mayoccur.

IndicationsLucidol is indicated for the management of moderate to severe pain.

Dosages and AdministrationFor the treatment of painful conditions, Lucidol 50 mg to 100 mg can beadministered as needed for relief every four to six hours, not to exceed400 mg per day. For moderate pain, Lucidol 50 mg may be adequate as theinitial dose, and for more severe pain, Lucidol 100 mg is usually moreeffective as the initial dose.

ContraindicationLucidol should not be administered to patients who have previouslydemonstrated hypersensitivity to tramadol, any other component of thisproduct, or opioids. It is also contraindicated in cases of acuteintoxication with alcohol, hypnotic, centrally acting analgesics, opioids orpsychotropic drugs.

Side EffectsMost common side effects (Incidence 1% to less than 5% in clinical trails)are malaise, vasodilatation, anxiety, confusion, coordination disturbance,euphoria, nervousness, sleep disorder, abdominal pain, anorexia,flatulence, hypertonia, skin rash, visual disturbance, urinary retention,urinary frequency, and menopausal symptoms.

Other infrequently reported side effects are abnormal ECG,hypertension, myocardial ischaemia, palpitations, migraine,gastrointestinal bleeding etc.


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PrecautionsLucidol should be administered cautiously in patients at risk forrespiratory depression. When large doses of Lucidol are administeredwith anesthetic medications or alcohol, respiratory depression may result. Lucidol should be used with caution in patients with increased intracranialpressure or head injury. Pupillary changes (miosis) from Tramadol mayobscure the existence, extent, or course of intracranial pathology.

Lucidol is not recommended for patients who are dependent on opioids.Patients who have recently taken substantial amounts of opioids mayexperience withdrawal symptoms.

Impaired renal function results in a decreased rate and extent of excretionof Tramadol and its active metabolite. In patients with creatinineclearances of less than 30 ml/min, dosing reduction is recommended

OverdosageSerious potential consequences of overdosage are respiratory depressionand seizure. In treating an overdose, primary attention should be given tomaintaining adequate ventilation along with general supportive treatment.Haemodialysis is not expected to be helpful in an overdose because itremoves less than 7% of the administered dose in a 4-hour dialysisperiod.

Use in Pregnancy and LactationTramadol should not be used in pregnant women prior to or during laborunless the potential benefits outweigh the risks. Safe use in pregnancy hasnot been established. Chronic use during pregnancy may lead to physicaldependence and post-partum withdrawal symptoms in the newborn.

Tramadol is not recommended for obstetrical preoperative medication orfor post-delivery analgesia in nursing mothers because its safety in infantsand newborns has not been studied.

Paediatric UseThe paediatric use of Tramadol is not recommended because safety andefficacy in patients under 16 years age have not been established.


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Commercial PackLucidol Capsule : Box containing 3 x 10’s capsules in blister strips. Eachcapsule contains Tramadol Hydrochloride BP 50 mg.


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Megadox®

Capsule

DescriptionMegadox contains Doxycycline Hydrochloride BP. DoxycyclineHydrochloride is a semisynthetic tetracycline antibiotic with broadspectrum activity. It is primarily a bacteriostatic antibiotic. It has a similarspectrum of activity to other tetracyclines but in particular is more activeagainst Staphylococcus aureus and Nocardia. The drug is often active againstpenicillin-resistant strains of Staphylococcus aureus and against strains ofthose organisms that are resistant to other Tetracyclines.

Certain gram-negative strains of E. coli, Proteus mirabilis and Klebsiella,which are often resistant to Tetracycline, may be sensitive to Doxycycline.In addition, 70-90% of the various anaerobes are sensitive to Doxycyclineand Bacteroides fragilis is more likely to be sensitive to Doxycycline than toother tetracyclines.

Doxycycline is active against most strains of Haemophilus influenzae and isparticularly useful for infections with H. ducreyi, Actinomyces, Brucellaand Vibrio cholerae. It is also active against Nocardia, Chlamydia,Mycoplasma and a wide range of Rickettsiae. Doxycycline is active againstspirochetes such as Borellia recurrentis, Treponema pallidum and Treponemapertenue. It is also active against Plasmodium falciparum.

IndicationsMegadox is indicated in the following infections caused by susceptiblemicroorganisms:

♦ Pneumonia and other respiratory tract infections caused by Klebsiella,Pneumococci and Mycoplasma pneumoniae

♦ Gastrointestinal infections

♦ Genitourinary tract infections

♦ Soft tissue infections

♦ Ophthalmic infections (trachoma) caused by Chlamydia trachomatis

♦ Acne


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♦ Prophylaxis of Plasmodium falciparum malaria

♦ Miscellaneous group of infections : Prostatitis, Psittacosis, Trigonitis,Louse borne typhus, Plague etc.

Dosage and Administration Adults : Usual dose is 200 mg on first day, then 100 mg daily for 7-10 days.Severe infections (including refractory urinary tract infections) 200 mgdaily for 10 days. Acne : 100 mg daily. Uncomplicated genital chlamydia,non-gonococcal urethritis : 100 mg twice daily for 7-21 days (14-21 daysin pelvic inflammatory disease).

Contraindication Doxycycline Hydrochloride is contraindicated in pregnancy, nursingmother, children under 12 years of age and in patients with knownhypersensitivity to any of the Tetracyclines.

Side EffectsSince Megadox is virtually completely absorbed, side effects of the lowerbowel particularly diarrhoea have been infrequent. Gastrointestinaleffects e.g., anorexia, nausea, diarrhoea, vomiting, glossitis, dysphagia,enterocolitis and anogenital inflammatory lesions have been reportedoccasionally. Hypersensitivity reactions e.g., urticaria, angioneuroticoedema, anaphylactic purpura, pericarditis and exacerbation of systemiclupus erythematosus may occur. Haemolytic anaemia, thrombocytopenia,neutropenia and eosinophilia have also been reported. On rare occasions,anaphylaxis may occur. In case of overdose, discontinue medication, treatsymptomatically and institute supportive measures.

Pharmaceutical Precaution Store in a cool and dry place. Keep out of the reach of children.

High Risk GroupsNeonates and children : Tetracycline may cause permanent discolorationof the teeth and so is contraindicated for neonates and children under 12years.

Nursing Mother : Tetracyclines enter breast milk, and mothers takingthese drugs should not breastfeed their child.


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Pregnant women : Tetracycline should be avoided in pregnant women,because of the risk of both staining and effect on bone growth in thefoetus.

Elderly : No special precautions are necessary in the elderly.

Commercial PackMegadox Capsule : Box containing 10 blister strips of 10 capsules, eachcapsule contains Doxycycline Hydrochloride BP equivalent to 100 mgDoxycycline.


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Megatrim®DSTablet

Megatrim®

Suspension

DescriptionMegatrim is a broad spectrum antibacterial drug containingTrimethoprim BP and Sulfamethoxazole BP in a 1:5 fixed combination.

Each Megatrim DS tablet contains 160 mg Trimethoprim BP and 800 mgSulfamethoxazole BP.

Each 5 ml of Megatrim Suspension contains 40 mg Trimethoprim BPand 200 mg Sulfamethoxazole BP.

IndicationsMegatrim is bactericidal in vitro to a wide range of Gram-positive andGram-negative organisms, including Streptococcus, Staphylococcus,Pneumococcus, Neisseria, B. catarrhalis, Escherichia coli, Klebsiella, Proteusspp., Haemophilus, Salmonella, Shigella, Vibrio cholerae, Brucella,Pneumocystis carinii, Nocardia and Bordetella. A particularly high degree ofactivity is exhibited against Haemophilus influenzae, E. coli and Proteus spp.,making Megatrim particularly suitable for the treatment of chronicbronchitis and urinary tract infections.

Megatrim exerts its bactericidal action by the sequential blockade of twobacterial enzyme systems in the biosynthesis of folinic acid in the micro-organisms. The synergy thus produced accounts for the high degree ofbactericidal activity.

IndicationsRespiratory tract infections, including acute and chronic bronchitis(treatment and prophylaxis), bronchiectasis, lung abscess, lobar andbroncho-pneumonia, Pneumocystis carinii pneumonitis, sinusitis and otitismedia.


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Genito-urinary tract infections, including urethritis, acute and chroniccystitis, pyelonephritis, prostatitis and gonorrhoea.

Gastro-intestinal tract infections, caused by Salmonella typhi and Salmonellaparatyphi , including the chronic carrier state.

Other infections, caused by a wide range of organisms confirmed to besusceptible to Megatrim and where the therapeutic benefits areconsidered to outweigh the possible occurrence of adverse events. Suchinfections include acute and chronic osteomyelitis, acute brucellosis, skininfections including pyoderma, abscesses and wound infections,septicaemia, bacillary dysentery and cholera (as an adjuvant to fluid andelectrolyte replacement), nocardiosis and mycetoma.


Usual dosage

Minimum dosage for long-term treatment (>14 days)

One Megatrim-DS tablet twice daily

High dosage for severeinfections and septicaemia

Uncomplicated gonorrhoea

1½ Megatrim-DS tablets, twice daily

2 Megatrim-DS tablets 12 hourly for 2 days or 2½Megatrim DS tablets with 8-12 hours’ intervalsbetween the doses

½ Megatrim-DS tablet twice daily

Megatrim Suspension

Children

6-12 years

2-5 years

up to 2 years

1-2 teaspoonful twice daily

½-1 teaspoonful twice daily

½ teaspoonful twice daily

Adults and children over 12 years

Dosage Guideline

Megatrim-DS tablet :


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Duration of therapy : In acute infections, apart from gonorrhoea,Megatrim DS should be given for at least 5 days or until the patient hasbeen symptom-free for 2 days. Treatment for prostatitis and acutebrucellosis should be maintained for a period of at least 4 weeks, whilstin nocardiosis and mycetoma, dosage guideline requires long-termtherapy.

Contraindication- Hypersensitivity to Trimethoprim or Sulphonamides.

- Patients with documented megaloblastic anaemia due to folatedeficiency.

- Patients showing marked liver parenchymal damage, blood dyscrasia,severe renal insufficiency, glucose 6-phosphate dehydrogenasedeficiency.

- Pregnancy and during the nursing period, because sulphonamides passthe placenta and are excreted in the breast milk and may causekernicterus.

Side EffectsThe side effects like crystalluria, allergic reactions, haemolysis,thrombocytopenia, neutropenia, agranulocytosis etc. have been reportedrarely with Sulfamethoxazole-Trimethoprim combination. Other sideeffects are less serious in nature such as malaise, headache, nausea andvomiting. These are normally transient and do not require withdrawal oftreatment.

PrecautionsProlonged full dose treatment with Sulfamethoxazole-Trimethoprimcombination is associated with the risk of macrocytic anaemia due to thedrug’s interference in the conversion of folic acid into folinic acid. If thisoccurs, it can be reversed by giving folinic acid.

Care should be taken when giving this combination to diabetic patientsreceiving sulphonylurea drug for possible potentiation of action ofsulphonylurea.


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Commercial PackMegatrim-DS Tablet : Box containing 10 blister strips of 10 tablets. EachMegatrim DS tablet contains 160 mg Trimethoprim BP and 800 mgSulfamethoxazole BP.

Megatrim Suspension : 60 ml suspension in amber glass bottle. Each 5ml of Suspension contains 40 mg Trimethoprim BP and 200 mgSulfamethoxazole BP.


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Melphin®

Tablet/Suspension

DescriptionMelphin contains Pyrantel Pamoate USP. It is an anthelmintic effectiveagainst Ascaris lumbricoides (roundworm). Enterobius vermicularis (pinworm),Ancylostoma duodenale/Necator americanus (hookworm) andTrichostrongylus.

Indications Melphin is specifically indicated for the treatment of infestations causedby Ascaris lumbricoides, Enterobius vermicularis, Ancylostoma duodenale/Necatoramericanus and Trichostrongylus.

Melphin may be used for the treatment of infestations with one or moreof these parasites in both adults and children.

Dosage and AdministrationMelphin is given orally at anytime without regard to ingestion of food orbeverages. A single dose of 11 mg/kg body weight, to a maximum of 1 g,should be given to treat infestations caused by the parasites mentionedabove. In the case of Pinworm, it is often wise to repeat the dose after aninterval of 2 weeks.

ContraindicationSince Pyrantel Pamoate has not been studied in pregnant women, use ofMelphin in such patients is normally contraindicated. Melphin is notrecommended for children below 1 year of age.

Side EffectsMelphin is well tolerated in recommended dosage. When given in largedosage, Melphin may cause gastrointestinal upset such as anorexia,nausea, vomiting and diarrhoea. Other side effects that may occur in rareoccasions are headache, dizziness and rash.

PrecautionsSince Pyrantel Pamoate and Piperazine appear to be mutuallyantagonistic, Melphin should not be given together with Piperazine.Melphin should be kept out of the reach of children.


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Commercial PackMelphin Tablets : Box containing 100 tablets in 10 x 10’s aluminium strips,each tablet contains Pyrantel Pamoate USP equivalent to 125 mg Pyrantel.

Melphin Suspension : 10 ml suspension in amber glass bottle, each mlcontains Pyrantel Pamoate USP equivalent to 50 mg Pyrantel.


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Modipran®

Capsule

DescriptionModipran is a preparation of Fluoxetine Hydrochloride BP containing 20mg of Fluoxetine per hard gelatin capsule.

Fluoxetine Hydrochloride is a selective inhibitor of serotonin reuptake inpresynaptic neurons and is used as an antidepressant with very long halflife.

IndicationsModipran (Fluoxetine Hydrochloride) is indicated for the treatment ofdepressive illness, bulimia nervosa and obsessive compulsive disorder.

Dosage and AdministrationInitial treatment :Recent studies suggest that 20 mg/day of Fluoxetine may be sufficient toobtain satisfactory antidepressant response. Consequently, a dose of 20mg/day administered in the morning is recommended as the initial dose.

A dose increase may be considered after several weeks if no clinicalimprovement is observed. Dosage above 20 mg/day, should beadministered on a bid schedule (i.e. morning and noon) and should notexceed a maximum dose of 80 mg/day. As with other antidepressants, thefull antidepressant effect may be delayed until 4 weeks of treatment orlonger. As with many other medications, a lower or less frequent dosageshould be used in patients with renal and/or hepatic impairment.

A lower or less frequent dosage should also be considered for patients,such as elderly, with concurrent disease or on multiple medication. Arecommended maximum dose for elderly patients is 60 mg per day.

Maintenance Treatment :It is generally agreed among expert psychopharmacologists that acuteepisode of depression requires several months or longer sustainedpharmacologic therapy.


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Fluoxetine is also used in dosage of 60 mg daily for the management ofbulimia nervosa.

ContraindicationModipran (Fluoxetine Hydrochloride) is contraindicated in patientsknown to be hypersensitive to it.

Monoamine Oxidase Inhibitors : There have been reports of serious,sometimes fatal reactions (including hyperthermia, rigidity, myoclonus,autonomic instability with possible rapid fluctuations of vital signs andchanges of mental status that include extreme agitation progressing todelirium and coma) in patients receiving fluoxetine in combination withmonoamine oxidase inhibitors (MAOIs), and in patients who haverecently discontinued fluoxetine and are then started on an MAOIs. Somecases presented with features resembling neuroleptic malignantsyndrome. Therefore, Modipran should not be used in combination witha MAOI, or within 14 days of discontinuing therapy with an MAOI. Sincefluoxetine and its major metabolites have very long elimination half-lives,at least 5 weeks should be allowed after stopping fluoxetine and beforestarting an MAOI.

WarningA small percentage (4%) of patients have been found to develop rashand/or urticaria associated with fever, leukocytosis, arthralgia, oedema,carpal tunnel syndrome, respiratory distress, lymphadenopathy,proteinuria and mild transaminase elevation. Most patients improvedpromptly with discontinuation of the drug and/or adjunctive treatmentwith antihistamines or steroids.

There were also rare cases of serious cutaneous systemic illness andserum sickness. Other events include bronchospasm, angioedema,fibrosis, vasculitis with rash, and involvement of lung, kidney and liver.

Use in Pregnancy and LactationIn animal studies, no teratogenicity or harmful effect was found. Becauseanimal reproductive studies are not always predictive of humanresponses, fluoxetine should be used in pregnancy only if clearly needed.


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As Fluoxetine is excreted in human milk, caution should be exercisedwhen Fluoxetine is administered to nursing women.

PrecautionsAs Fluoxetine undergoes hepatic metabolism and renal excretion, itshould be used with caution and in reduced doses in patients withimpaired hepatic or renal function. Because of its epileptogenic effect, itshould be used with caution in patients with epilepsy or a history of suchdisorders. Fluoxetine may alter glycaemic control and therefore caution isalso warranted in diabetic subjects.

Depressed patients with suicidal tendencies should be carefullysupervised during treatment. Fluoxetine is not usually considered asuitable form of therapy for the depressive component of bipolar (manicdepressive) illness as mania may be precipitated.

Use in Children: Safety and effectiveness in children have not beenestablished.

Side EffectsGastrointestinal : Nausea, vomiting, dyspepsia, dry mouth, and diarrhoea.

Neurological : Anxiety, nervousness, insomnia/drowsiness and fatigue.

Others : Excessive sweating, pruritus, skin rashes associated with liver,kidney and lung involvement. It has therefore been advised that fluoxetinetherapy should be discontinued in any patient who develops a skin rash.

OverdosageIn overdosage nausea, vomiting and excitation of the central nervoussystem are considered to be prominent features; death has been reported.Treatment involves emesis induction or gastric lavage followed bysymptomatic and supportive therapy. Forced diuresis, dialysis,haemoperfusion and exchange transfusion are unlikely to be of benefit.

Commercial PackModipran Capsule : Box containing 10 aluminium strips of 10 capsules.Each capsule contains Fluoxetine Hydrochloride BP equivalent toFluoxetine 20 mg.


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Momento®

Tablet/Syrup

DescriptionMomento (Desloratadine) is a potent, rapidly effective, long-acting, non-sedative antihistamine with selective H1 receptor histamine antagonist

activity. It is an orally administered drug. Each film-coated Momentotablet contains Desloratadine INN 5 mg. Each 5 ml Syrup containsDesloratadine INN 2.5 mg.

Indications Allergic Rhinitis : Momento is indicated for the relief of the nasal andnon-nasal symptoms of allergic rhinitis (Both seasonal and perennial) inpatients 12 years of age and older.

Chronic Idiopathic Urticaria : Momento is also indicated for thesymptomatic relief of pruritus, reduction in the number of hives, and sizeof hives, in patients with chronic idiopathic urticaria 12 years of age andolder.

Dosage and Administration Adult and Children over 12 years :One 5 mg tablet or 2 teaspoonful once daily

Child 6-11 years :½ tablet or 1 teaspoonful once daily

Child 2-5 years :½ teaspoonful daily

In patients with liver or renal impairment, a starting dose of one 5 mgtablet every other day is recommended based on pharmacokinetic data.

Adverse EffectsIn general it is well tolerated. Clinical trials suggest a very low rate ofadverse effects associated with Desloratadine administration. Among thevery few adverse effects commonly reported by small percentage of


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patients are dry mouth, fatigue, myalgia, and somnolence. Less commonside effects may include headache, nausea, dizziness, dyspepsia,pharyngitis etc.

Contraindication Momento is contraindicated in patients who are hypersensitive to thismedication or to any of its ingredients.

Precautions Pregnancy Category C : Desloratadine was not teratogenic in rats or rabbitsat doses higher enough to produce an AUC, which is 210-230 times theAUC in human at the recommended daily oral dose. There are, however,no adequate and well-controlled studies of Desloratadine in pregnantwomen. Because animal reproduction studies are not always predictive ofhuman response, Desloratadine should be used during pregnancy only ifclearly needed.

Nursing Mothers : Desloratadine passes into breast milk, therefore adecision should be made whether to discontinue nursing or to discontinueMomento, taking into account the importance of the drug to the mother.

Paediatric Use : The safety and effectiveness of Desloratadine in pediatricpatients under 12 years of age have not been established.

Geriatric Use : In general, dose selection for an elderly patient should becautious, taking into account of the greater frequency of decreasedhepatic, renal, or cardiac function, and of concomitant disease or otherdrug therapy.

Drug InteractionConcomitant administration of Erythromycin, Ketoconazole,Azithromycin, Fluoxetine, and Cimetidine with Desloratadine increasedthe plasma concentration of Desloratadine. But there were no clinicallyrelevant changes in the safety profile of Desloratadine.

OverdosageNo clinically relevant adverse events were reported. In the event ofoverdose, consider standard measures to remove any unabsorbed drug.


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Symptomatic and supportive treatment is recommended. Desloratadineand 3-hydroxydesloratadine are not eliminated by haemodialysis.

Pharmaceutical PrecautionStore at a temperature between 2°C and 25°C. It is heat sensitive, so avoidexposure at or above 30°C.

Commercial Pack Momento Tablet : Each box contains 10 blister strips of 10 tablets. Eachtablet contains Desloratadine INN 5 mg.

Momento Syrup : 60 ml syrup in amber glass bottle, each 5 ml containsDesloratadine INN 2.5 mg.


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Monate®

Tablet

DescriptionIsosorbide Mononitrate is an organic nitrate. It is a vasodilator, active onboth arteries and veins. Each tablet contains Isosorbide Mononitrate BP20 mg.

Dosage and AdministrationAdults : The recommended dosage is from 20 to 120 mg daily in divideddoses. The majority of patients will require a dosage in the range of 40 to60 mg daily in divided doses. The tablets should be taken with fluid andswallowed whole without chewing.

Elderly : There is no evidence to suggest an adjustment of dose. However,caution may be required in elderly patients who are known to besusceptible to the effects of hypotensive medication.

Children : The safety and efficacy of Isosorbide Mononitrate in childrenhas not been established.

IndicationsMonate tablets are indicated for prophylaxis of angina pectoris and as anadjunct to treatment of heart failure.

ContraindicationIsosorbide Mononitrate is contraindicated in patients with a knownhypersensitivity to Isosorbide Mononitrate or Isosorbide Dinitrate. It isalso contraindicated in cases of marked low blood pressure, shock andacute myocardial infarction with low left ventricular filling pressure.

Adverse ReactionsA number of nitrate-related adverse effects may occur during treatmentincluding headache and feelings of dizziness. The incidence of sucheffects is normally highest at the commencement of treatment and tendsto decline with time. In highly sensitive patients hypertension may occur,especially after a high dose. Other reactions, including feelings of


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weakness, nausea or vomiting may occur occasionally. Side effects thathave been associated with Isosorbide Dinitrate (e.g. flushing, posturalhypotension, dry rash, exfoliative dermatitis) may also occur.

PrecautionsIsosorbide Mononitrate tablet is not indicated for the relief of an acuteattack when sublingual or buccal Glyceryl Trinitrate tablets or sprayshould be used. In the case of acute myocardial infarction, IsosorbideMononitrate tablets should be continued only under strict medicalsupervision. Since a rebound phenomenon cannot be excluded, therapywith Isosorbide Mononitrate should be terminated gradually rather thanstopping abruptly.

Use in Pregnancy and LactationNo data have been reported which would indicate the possibility ofadverse effects resulting from the use of organic nitrates in pregnancy.However, safety in pregnancy has not been established. There is noinformation on excretion of Isosorbide Mononitrate in breast milk. Usein pregnancy and lactation is not recommended unless consideredessential by the physician.

Drug InteractionsOrthostatic hypotension may occur with combined use of calciumchannel blockers, antihypertensive agents, phenothiazines or tricyclicantidepressants. Use of alcohol with Isosorbide Mononitrate mayproduce severe hypotension and collapse.

Pharmaceutical PrecautionStore at a temperature between 15o and 30oC.

Commercial PackMonate Tablet : Box containing 100 tablets in 10 x 10’s blister strips. Eachtablet contains Isosorbide Mononitrate BP 20 mg.


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Monocast®Tablet

DescriptionThe active ingredient of Monocast tablet is Montelukast Sodium INN.Montelukast is a selective and orally active leukotriene receptor antagonistthat inhibits the cysteinyl leukotriene CysLT1 receptor. Each Monocast 10film coated tablet contains Montelukast Sodium INN equivalent to 10 mgMontelukast. Each Monocast 5 chewable tablet contains MontelukastSodium INN equivalent to 5 mg Montelukast. Each Monocast 4 chewabletablet contains Montelukast Sodium INN equivalent to 4 mgMontelukast.

Mechanism of ActionThe cysteinyl leukotrienes (LTC4, LTD4, LTE4) are products ofarachidonic acid metabolism and are released from various cells, includingmast cells and eosinophils. These eicosanoids bind to cysteinyl leukotriene(CysLT) receptors. The CysLT type-1 (CysLT1) receptor is found in thehuman airway (including airway smooth muscle cells and airwaymacrophages) and on other pro-inflammatory cells (including eosinophilsand certain myeloid stem cells). CysLTs have been correlated with thepathophysiology of asthma and allergic rhinitis. In asthma, leukotriene-mediated effects include airway oedema, smooth muscle contraction, andaltered cellular activity associated with the inflammatory process. Inallergic rhinitis, CysLTs are released from the nasal mucosa after allergenexposure during both early and late-phase reactions and are associatedwith symptoms of allergic rhinitis. Intranasal challenge with CysLTs hasbeen shown to increase nasal airway resistance and symptoms of nasalobstruction.

Montelukast is an orally active compound that binds with high affinityand selectivity to the CysLT1 receptor (in preference to otherpharmacologically important airway receptors, such as the prostanoid,cholinergic, or β-adrenergic receptors). Montelukast inhibits physiologicactions of LTD4 at the CysLT1 receptor without any agonist activity.


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IndicationsMonocast is indicated for the prophylaxis and chronic treatment ofasthma in adults and paediatric patients 12 months of age and older.

Monocast is indicated for the relief of symptoms of seasonal allergicrhinitis in adults and paediatric patients 2 years of age and older.

Dosage and AdministrationGeneral Information : Monocast should be taken once daily. For asthma,the dose should be taken in the evening. For seasonal allergic rhinitis, thetime of administration may be individualized to suit patients’ needs.Patients with both asthma and seasonal allergic rhinitis should take onlyone tablet daily in the evening.

Adults and Adolescents 15 years of age and older with asthma or seasonalallergic rhinitis : The dosage is one 10 mg tablet daily.

Paediatric patients 6 to 14 years of age with asthma or seasonal allergicrhinitis : The dosage is one 5 mg chewable tablet daily. No dosageadjustment within this age group is necessary.

Paediatric patients 2 to 5 years of age with asthma or seasonal allergicrhinitis : The dosage is one 4 mg chewable tablet daily.

Paediatric patients 12 to 23 months of age with asthma : The dosage isone 4 mg chewable tablet daily to be taken in the evening. Safety andeffectiveness in paediatric patients younger than 12 months of age havenot been established.

ContraindicationHypersensitivity to any component of this product.

Side EffectsAdolescents and Adults 15 years of age and older : In placebo-controlledclinical trials, Montelukast has been evaluated for safety in approximately2600 adolescent and adult patients of 15 years and older, the followingadverse experiences reported with Montelukast occurred in greater thanor equal to 1% of patients. General : Asthenia/fatigue, Fever, Pain;


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Gastrointestinal: Dyspepsia, Gastroenteritis; Nervous System/Psychiatric :Dizziness, Headache; Respiratory System: Congestion, Cough, Influenza;Skin: Rash; Laboratory adverse experiences : ALT increase, AST increase,Pyuria.

Paediatric patients 6 to 14 years of age : In paediatric patients receivingmontelukast, the following events occurred with a frequency ≥ 2% arediarrhoea, laryngitis, pharyngitis, nausea, otitis, sinusitis, and viralinfection. With prolonged treatment, the adverse profile did not changesignificantly.

PrecautionsGeneral : Montelukast is not indicated for use in the reversal ofbronchospasm in acute asthma attacks, including status asthmaticus.Patients should be advised to have appropriate rescue medicationavailable. Therapy with Montelukast can be continued during acuteexacerbation of asthma.

While the dose of inhaled corticosteroid may be reduced gradually undermedical supervision, montelukast should not be abruptly substituted forinhaled or oral corticosteroids. Montelukast should not be used asmonotherapy for the treatment and management of exercise-inducedbronchospasm. Patients who have exacerbation of asthma after exerciseshould continue to use their usual regimen of inhaled ß-agonist asprophylaxis and have available for rescue a short-acting inhaled ß-agonist.Patients with known Aspirin sensitivity should continue avoidance ofaspirin or non-steroidal anti-inflammatory agents while takingMontelukast. Although montelukast is effective in improving airwayfunction in asthmatics with documented aspirin sensitivity, it has not beenshown to truncate bronchoconstrictor response to aspirin and other non-steroidal anti-inflammatory drugs in aspirin-sensitive asthmatic patients.

Eosinophilic Conditions : In rare cases, patients on therapy withMontelukast may present with systemic eosinophilia, sometimespresenting with clinical features of vasculitis consistent with Churg-Strauss syndrome, a condition which is often treated with systemiccorticosteroid therapy. These events usually, but not always, have beenassociated with the reduction of oral corticosteroid therapy. Physicians


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should be alert to eosinophilia, vasculitic rash, worsening pulmonarysymptoms, cardiac complications, and/or neuropathy presenting in theirpatients. A causal association between montelukast and these underlyingconditions has not been established.

Paediatric UseSafety and efficacy of Montelukast has been established in adequate andwell-controlled studies in paediatric patients with asthma and allergicrhinitis between age 1 to 14 years. Long-term trials evaluating the effectof chronic administration of Montelukast on linear growth in paediatricpatients have not been conducted.

Geriatric UseOf the total number of subjects in clinical studies of Montelukast, 3.5%were 65 years of age and over and 0.4% were 75 years of age and over.No overall differences in safety or effectiveness were observed betweenthese subjects and younger subjects, and other reported clinicalexperience has not identified differences in responses between the elderlyand younger patients. But greater sensitivity of some older individualscannot be ruled out.

Use in Pregnancy and LactationMontelukast crosses the placenta following oral dosing in rats and rabbits.There are, however, no adequate and well-controlled studies in pregnantwomen. Because animal reproduction studies are not always predictive ofhuman response, Montelukast should be used during pregnancy only ifclearly needed.

It is not known if Montelukast is excreted in human milk. Because manydrugs are excreted in human milk, caution should be exercised whenMontelukast is given to a nursing mother.

Drug InteractionsMontelukast has been administered with other therapies routinely used inthe prophylaxis and chronic treatment of asthma with no apparentincrease in adverse reactions. In drug-interaction studies, therecommended clinical dose of montelukast did not have clinically


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important effects on the pharmacokinetics of the following drugs:Theophylline, Prednisolone, oral contraceptives (norethindrone 1mg/ethinyl estradiol 35 µg), Terfenadine, Digoxin, and Warfarin.

Although additional specific interaction studies were not performed,Montelukast was used concomitantly with a wide range of commonlyprescribed drugs in clinical studies without clinically evident adverseinteractions. These medications included thyroid hormones, sedativehypnotic, non-steroidal anti-inflammatory agents, benzodiazepines, anddecongestants.

Phenobarbital, which induces hepatic metabolism, decreased the AUC ofMontelukast approximately 40% following a single 10 mg dose ofMontelukast. No dosage adjustment for Montelukast is recommended. Itis reasonable to employ appropriate clinical monitoring when potentcytochrome P450 enzyme inducers, such as Phenobarbital or Rifampin,are co-administered with Montelukast.

OverdosageThere were no adverse experiences reported in the majority ofoverdosage reports. The most frequent adverse experiences observedwere thirst, somnolence, hyperkinesia, and abdominal pain. It is notknown whether Montelukast is removed by peritoneal dialysis orhaemodialysis.

Commercial PackMonocast 10 Tablet : Box containing 1 blister strip of 10 film coatedtablets. Each tablet contains Montelukast Sodium INN equivalent to 10mg Montelukast.

Monocast 5 Tablet : Box containing 2 blister strips of 20 chewable tablets.Each tablet contains Montelukast Sodium INN equivalent to 5 mgMontelukast.

Monocast 4 Tablet : Box containing 2 blister strips of 20 chewable tablets.Each tablet contains Montelukast Sodium INN equivalent to 4 mgMontelukast.


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Napa®

Tablet/Syrup/Drops/Suppository

Description Napa (Paracetamol) is a fast acting and safe analgesic with markedantipyretic property. It is specially suitable for patients who, for anyreason, can not tolerate aspirin or other analgesics.

IndicationsAll conditions requiring relief from pain and fever such as neuritis,neuralgia, headache, earache, toothache, pain due to rheumatic disorder,cold, influenza, dysmenorrhoea, post-vaccination pain and fever ofchildren etc. Napa suppositories are used for rapid symptomaticmanagement of pain and fever. It is given as rectal suppository for mildto moderate pain and for pyrexia.

Dosage and Administrations Tablets : Adults- 1-2 tablets 3-4 times daily; Syrup : Adults- 4-8 measuringspoonful 3-4 times daily; Children- 6-12 years- 2-4 measuring spoonful 3-4 times daily, 1-5 years- 1-2 measuring spoonful 3-4 times daily. Up to 1year- ½-1 measuring spoonful 3-4 times daily. Paediatric drops : Neonatesand children- 0-3 months- 0-5 ml, 4-11 months- 1 ml, 12-23 months- 1.5ml, 2-3 years- 2 ml 4-5 years- 3 ml four times daily or as directed byphysicians. Suppositories : Children- 1-5 years- 125-250 mg, 6-12 years- 250-500 mg, up to 4 times daily.

Contraindication Paracetamol is contraindicated in patients with severe renal functionimpairment and hepatic disease (Viral Hepatitis).

Precautions Paracetamol should be given with care to patients with impaired kidney orliver function. Paracetamol should be given with care to patients takingother drugs that affect the liver.

Side Effects Side effects of paracetamol are usually mild, though haematologicalreactions including thrombocytopenia, leucopenia, pancytopenia,


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neutropenia, and agranulocytosis have been reported. Pancreatitis, skinrashes, and other allergic reactions occur occasionally.

Overdosage Symptoms of paracetamol overdose in the first 24 hours are pallor,nausea, vomiting, anorexia and abdominal pain. Liver damage maybecome apparent 12 to 40 hours after ingestion. Abnormalities of glucosemetabolism and metabolic acidosis may occur.

Commercial Pack Napa Tablet : Box containing 50 blister strips of 10 tablets, each contains500 mg Paracetamol BP.

Napa Syrup : Bottle containing 60 ml syrup, each 5 ml contains 120 mgParacetamol BP.

Napa Paediatric Drops : Bottle containing 15 ml drops, each ml contains80 mg Paracetamol BP.

Napa 125 Suppository : Box containing 4 foils of 5 suppositories (4 x 5’s),

each containing 125 mg Paracetamol BP.

Napa 250 Suppository : Box containing 4 foils of 5 suppositories (4 x 5’s),each contains 250 mg Paracetamol BP.


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Nazolin®

Nasal Spray

DescriptionOxymetazoline Hydrochloride, the active ingredient of Nazolin nasalspray, is a sympathomimetic amine of the imidazoline class. The chemicalname of the active ingredient is 3-[(4,5-Dihydro-1H-imidazole-2-yl)methyl]-6-(1,1-dimethylethyl)-2,4-dimethylphenol hydrochloride.

Indications♦ As a nasal decongestant in allergic rhinitis, with or without the addition

of topical antihistamines or sodium cromoglycate.♦ As a nasal decongestant in sinusitis where there is evidence of

obstruction of osteal opening to the sinuses.

♦ As nasal decongestant in otitis media where there is evidence ofobstruction of eustachian tube, especially in subacute serous otitis media ('glue ear') and otitic barotrauma.

♦ As a decongestant in an infective rhinitis(e.g. an acute viral upperrespiratory tract infection). Where there is a secondary bacterialinfection, there is no evidence of benefit.

Dosage and AdministrationFor nasal use, 2-3 sprays should be instilled into each nostril twice daily.The nasal spray can be used with the patient in the upright position.Sprays are generally unsuitable for young children because of the smallsize of their nostril. A treatment course should not normally exceed threeto five days, and on no account should it be continued for longer than twoweeks because of the risk of developing ‘rhinitis medicamentosa'.

Contraindication♦ As a sympathomimetic, oxymetazoline should not be used in patients

being simultaneously treated with monoamine oxidase inhibitortherapy.

♦ Narrow-angle glaucoma.♦ The safety of use in pregnancy has not fully been established and

administration of oxymetazoline during that time should be avoidedunless absolutely essential.


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PrecautionsThe drug should be used with caution in patients suffering fromCoronary artery disease, Hypertension, Hyperthyroidism and Diabetesmellitus.

Side EffectsUsed correctly (as an intranasal application), the local vasoconstrictionproduced by the drug inhibits the absorption and a systemic action isunlikely. If, however, some of the drops are swallowed, they can beabsorbed from the gastrointestinal tract and a systemic effect can beproduced. In children an overdose, if swallowed and absorbed, has beenreported to cause sedation. As oxymetazoline is an α2 adrenergic agonist,

it might be expected to produce effects similar to those of clonidine, witha short-lived rise in pressure caused by a peripheral action, followed bymore prolonged hypotension and sedation as a result of inhibition ofsympathetic outflow from brain.

Overuse is associated with a more persistent rhinitis related to therebound phenomenon- the condition known as ‘rhinitis medicamentosa’.It is claimed that, because of its more prolonged action, oxymetazoline isless likely to cause rebound congestion than other decongestants.

Stinging, discomfort or a dryness locally in the nose or eye is encounteredinfrequently. If the symptoms persist, the discomfort from the use of thedrops probably outweighs any advantage they may confer. Headache hasbeen reported, albeit infrequently, as has tachycardia.

Pharmaceutical PrecautionNazolin nasal spray should be stored at a temperature below 30o C.Protect from frost and direct sunlight.

Commercial PackNazolin Nasal Spray : Each bottle contains 200 metered doses of 0.05%aqueous nasal preparation of Oxymetazoline Hydrochloride USP in atotal volume of 10 ml. Each actuation delivers 0.05 ml containing 25 µgof Oxymetazoline Hydrochloride.


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Nebactil®Suspension

DescriptionNebactil contains Nalidixic Acid BP. Nebactil is available in suspensionform. Each 5 ml suspension contains 300 mg of Nalidixic Acid BP. It isa bactericidal DNA gyrase inhibitor.

Indications Nalidixic Acid is indicated in-w Urinary tract infections caused by susceptible Gram-negative

microorganisms, including the majority of Proteus strains, Klebsiella,Enterobacter spp . and E. coli.

w Gastrointestinal infections caused by Salmonella and Shigella.

Dosage and Administration Adult : Initial therapy : 1 g 4 times/day (Total dose 4 g/day) for 1 or 2weeks. Prolonged therapy : May be reduced to 2 g/day after the initialtreatment period.

Children : 3 months to 12 years of age: Initial therapy : 55 mg/kg/day in4 equally divided doses.

Prolonged therapy : May be reduced to 33 mg/kg/day

ContraindicationNebactil is contraindicated to known hypersensitivity to Nalidixic Acid, history of convulsive disorders and patients with porphyria.

Relative ContraindicationShould be used with caution in patients with liver and renal disease. Alsoin glucose 6-phosphate dehydrogenase deficiency.

Side EffectsCentral Nervous System : Drowsiness, weakness, headache, dizziness,vertigo, toxic psychosis, brief convulsion (rare). Ophthalmic : Reversiblesubjective visual disturbances occur infrequently (generally with each doseduring the first few days) and over brightness of lights, change in colour


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perception, focusing difficulty, decrease in visual acuity and double vision.Gastrointestinal : Abdominal pain, nausea, vomiting, diarrhoea.Hypersensitivity : Rash, pruritus, urticaria, angioedema, arthralgia withjoint stiffness and swelling, anaphylactoid reaction (rare). Haematologic :Thrombocytopenia, leucopenia or haemolytic anaemia, sometimesassociated with glucose 6-phosphate dehydrogenase deficiency (rare).Miscellaneous : Cholestatic jaundice, cholestasis, paraesthesia, metabolicacidosis (rare), photosensitivity reactions (eg. erythema and painful bullaeon exposed skin surfaces).

PrecautionsGeneral : Should be used with caution in liver disease, epilepsy or severecerebral arteriosclerosis patients. Periodic blood counts and renal andliver function test should be performed if treatment is continued for >2weeks. If bacterial resistance emerges, rapid change of drug should bemade.

Children : Should not be used to infants <3 months of age.

Use in Pregnancy and Lactation Nalidixic Acid is DNA-gyrase inhibitor which is capable of causing DNAdamage, and there is possibility that it may cause cartilage damage. Thus,it is best to avoid using in pregnancy.

Commercial PackNebactil Suspension : Bottle contains 50 ml of oral suspension. Each 5ml contains 300 mg of Nalidixic Acid BP.


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Neo Kit®

DescriptionHelicobacter pylori is implicated in the etiology of gastritis and pepticulceration in humans. It is found in 90% cases of duodenal ulcer, 90%cases of chronic antral gastritis and 70% cases of gastric ulcer.

Conventional H2 receptor antagonists do not suppress or eradicate

H. pylori and has a high rate of ulcer recurrence. The standard tripletherapy regimens have proved to be effective for eradicating H. pylori.

Each Neo Kit contains-Clarithromycin USP 500 mg : 1 Tablet Omeprazole BP 20 mg : 1 Capsule Metronidazole BP 400 mg : 1 Tablet

Indications Neo Kit is indicated in the eradication of H. pylori in active chronicgastritis, duodenal and gastric ulcers.

Dosage and AdministrationOne Neo Kit (2 tablets and 1 capsule in one blister strip) twice daily (12hourly) for 7 days.

ContraindicationNeo Kit is contraindicated in patients with known hypersensitivity toClarithromycin, Omeprazole and Metronidazole.

Side EffectsThe drugs of the Neo Kit are well tolerated. Side effects may be that ofClarithromycin, Omeprazole and Metronidazole which include nausea,vomiting, diarrhoea and abdominal pain. Other side effects includeunpleasant metallic or bitter taste, headache, drowsiness, vertigo,constipation, abdominal colic and flatulence but are rare.


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PrecautionsCaution should be exercised in administering Clarithromycin in patientswith impaired hepatic and renal functions. Prolonged or repeated use ofClarithromycin may result in an overgrowth of non-susceptible bacteriaor fungi. Proton pump inhibitors should be used in caution in patientswith liver disease, during pregnancy and lactation. Metronidazole shouldnot be used in patients with blood dyscrasia. It is suggested thatMetronidazole should not be given in the first three months ofpregnancy.

Use in Pregnancy and LactationNeo Kit should be used with caution during pregnancy and lactation onlyif the potential benefit justifies the risk.

Use in ChildrenSafety and effectiveness in children have not been established.

Drug InteractionsClarithromycin: Concomitant administration with Theophylline has beenassociated with increased serum Theophylline level. Effects of Digoxinand Warfarin may be potentiated with concomitant administration ofClarithromycin.

Omeprazole: Effects of Warfarin enhanced and absorption ofKetoconazole reduced by Omeprazole.

Metronidazole: The effect of Warfarin enhanced by Metronidazole.

Commercial PackNeo Kit : Box containing 14 kits. Each kit contains one tablet ofClarithromycin USP 500 mg , one capsule of Omeprazole BP 20 mg andone tablet of Metronidazole BP 400 mg.


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Neocard®

Tablet

DescriptionNeocard (Diltiazem Hydrochloride) tablet is available in potencies of 30mg and 60 mg for oral administration.

IndicationsNeocard is a calcium antagonist. It is indicated for the prophylaxis andtreatment of classical and vasospastic angina pectoris and hypertension,myocardial infarction, coronary artery spasm, hypertension, cardiacarrhythmias, Raynaud’s phenomenon, oesophagal motility disorder, andmigraine.

Dosage and AdministrationGeneral: Usual dose is 60 mg three times daily. However patient responsesmay vary and dosage requirements can differ significantly betweenindividual patients. If necessary the divided dose may be increased to 180-360 mg/day. Dosage may also be started as 30 mg four times daily andincreasing at 1 to 2 days intervals until the optimum response is achieved.Higher doses up to 480 mg/day have been used with benefit in somepatients especially in unstable angina. There is no evidence of anydecrease in efficacy at these high doses. Neocard has not been reportedto precipitate angina.

Elderly and patients with impaired hepatic or renal function: Therecommended starting dose is 60 mg twice daily. The heart rate should bemeasured regularly in these groups of patients and the dose should notbe increased if the heart rate falls below 50 beats per minute.

Children: Not recommended.

ContraindicationDiltiazem Hydrochloride is contraindicated in pregnant women or thoseof child bearing potential, patients with sick sinus syndromes, patientswith second or third degree AV block, patients with severe bradycardiaand patients who demonstrated hypersensitivity to the drug.


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PrecautionsPatients with mild bradycardia or a prolonged PR interval should beobserved closely. Neocard does not have a significant myocardialdepressant effect and is well tolerated in patients with poor left ventricularfunction. The drug should be used with caution in patients with impairedhepatic or renal function.

Drug InteractionsDiltiazem Hydrochloride should be carefully administered in case ofconcomitant use with the following drugs.♦ Anti-hypertensive agents : effects of anti-hypertensive agents are

enhanced

♦ Propranolol : concentration of propranolol may be increased

♦ Carbamazepine : plasma level of Carbamazepine may be increased andit may cause Carbamazepine induced toxic symptoms such assleepiness, nausea, vomiting, vertigo etc.

♦ Digoxin preparations : plasma level of Digoxin is increased

♦ Cyclosporin: may increase serum cyclosporin concentration by 75% ormore.

Side EffectsDiltiazem Hydrochloride produces few side effects and these are usuallymild. Oedema, nausea, headache, finger swelling, skin rash, dizziness andasthenia have been reported. Other adverse effects include bradycardia,AV block, hypotension, gastrointestinal symptom, hyperactivity withassociated psychiatric symptoms and mild elevation of liver functiontests.

OverdosageExperience of overdosage in man is limited and spontaneous recoveryhas been seen in reported cases. However, observation in coronary careunit (CCU) is advisable with corrective measures available for possiblehypotension and conduction disturbances.

Commercial PackNeocard-30 Tablet : Box containing 10 blister strips of 10 tablets, eachtablet contains Diltiazem Hydrochloride USP 30 mg.

Neocard-60 Tablet : Box containing 10 blister strips of 10 tablets, eachtablet contains Diltiazem Hydrochloride USP 60 mg.


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Neoceptin®RTablet/Syrup

DescriptionThe active ingredient of Neoceptin R is Ranitidine. Neoceptin R is ahistamine H2 receptor antagonist. It inhibits basal and stimulated

secretion of gastric acid. Neoceptin R is rapidly absorbed after oraladministration. Food or antacid does not interfere its absorption.

IndicationsNeoceptin R is indicated for the treatment of duodenal ulcer, benigngastric ulcer, post-operative ulcer, reflux oesophagitis, Zollinger-EllisonSyndrome and in other conditions where reduction of gastric acidity isbeneficial.

Dosage and Administration Duodenal and Gastric Ulcer : The usual dosage is 150 mg twice daily takenin the morning and evening or 300 mg as a single daily dose at night for4 to 8 weeks.

Reflux Oesophagitis : 150 mg twice daily or 300 mg at bed time for up to 8weeks.

Zollinger-Ellison Syndrome : 150 mg 3 times daily and increased if necessaryup to 6 g daily in divided doses. Dosage should be continued as long asclinically indicated.

Episodic Dyspepsia : 150 mg twice daily or 300 mg at bed time for up to 6weeks.

Maintenance : 150 mg at night for preventing recurrences.

Child (peptic ulcer) : 2-4 mg/kg twice daily, maximum 300 mg daily.

Side EffectsNeoceptin R is well tolerated and side effects are usually uncommon.Altered bowel habit, dizziness, rash, tiredness, reversible confusionalstates, headache, decreased blood counts, muscle or joint pain have rarelybeen reported.


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PrecautionsRanitidine should be given in reduced dosage to patients with impairedrenal and hepatic function.

Use in Pregnancy and LactationRanitidine crosses the placenta. But there is no evidence of impairedfertility or harm to the foetus due to Ranitidine. Like other drugs,Neoceptin R should only be used during pregnancy if consideredessential. Ranitidine is excreted in human breast milk. Caution should beexercised when the drug is administered to a nursing mother.

Pharmaceutical PrecautionStore in a cool and dry place. Protect from light.

Commercial PackNeoceptin R-150 Tablet : Box containing 100 tablets in 10 x 10’s Alu-Aluform packs. Each round, bi-convex, film coated tablet contains RanitidineHydrochloride USP equivalent to Ranitidine 150 mg.

Neoceptin R-300 Tablet : Box containing 100 tablets in 10 x 10’saluminium strips. Each round, bi-convex, film coated tablet containsRanitidine Hydrochloride USP equivalent to Ranitidine 300 mg.

Neoceptin R Syrup : Bottle containing 100 ml sugar free syrup. Each 5 mlcontains Ranitidine Hydrochloride USP equivalent to Ranitidine 75 mg.


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Neodrop®

Drops

DescriptionNeodrop (Simethicone) is used as an antiflatulent to relieve symptomscommonly referred to gas including upper gastrointestinal bloating,fullness or stuffed feeling. The clinical use of Neodrop is based on itsantifoam properties. Its defoaming action relieves flatulence bydispensing and preventing the formation of mucous surrounded gaspockets in the gastrointestinal tract. Neodrop acts in the stomach andintestines to change the surface tension of gas bubbles, enabling them tocoalesce; thus gas is freed and eliminated more easily by belching orpassing flatus. Neodrop aids in the elimination of gas from thegastrointestinal tract and can be used to reduce postoperative gas pains.Neodrop can also be used prior to gastroscopy to enhance visualizationand prior to radiography of the intestine to reduce gas shadows.

Indications Flatulence, abdominal distention, fullness, gas and windy colic : Neodrop(Simethicone) is an excellent and effective antiflatulent. It is used forrelief of the painful symptoms of excess gas in the digestive tract. Suchgas is frequently caused by excessive swallowing of air or by eating foodsthat disagree. Neodrop is especially acts in the stomach and intestines ofinfants and child. Thus Neodrop enables freeing and eliminating the gasmore easily by belching or passing flatus.

Large bowel preparation : Addition of Neodrop to a polyethylene glycolbowel preparation produces symptomatic improvement prior toinvestigation in patients undergoing colonoscopy.

Treatment of poisoning : Neodrop has an anecdotal use as an antifoamingagent in the management of accidental ingestion of foaming detergents.

Dosage and AdministrationTake after meals and at bedtime. Can be given with infant’s feeds.Children less than 2 years of age- 20 mg (0.3 ml Neodrop drops) 4 times


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daily up to 240 mg (3.6 ml Neodrop drops)/day. Children: 2-12 years ofage- 40 mg (0.6 ml Neodrop drops) 4 times daily. Adults: 40-80 mg (0.6ml-1.2 ml Neodrop drops) 4 times daily, up to 500 mg (7.5 ml Neodropdrops)/day.

Side EffectSimethicone is physiologically inert and no adverse effect has been notedafter oral ingestion.

PrecautionsDo not exceed 12 doses per day except under the advice and supervisionof a physician.

Drug InteractionThere is no evidence that simethicone modifies the effect of other drugs.The defoaming effect of simethicone is reduced by antacids such asAluminium Hydroxide and Magnesium Carbonate, which absorb theSilicone.

Use in Pregnancy and LactationNo data are available to suggest any harmful effects on pregnant women.

Pharmaceutical PrecautionShould be stored in well-closed bottle, protected from light, and at a

temperature not exceeding 30oC. Keep the medicine out of the reach ofchildren.

Commercial PackNeodrop Paediatric Drops : Bottle containing 15 ml Simethicone dropswith a plastic dropper. Each ml drop contains Simethicone USP 67 mg.


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Neofloxin®

Tablet

DescriptionCiprofloxacin, a fluoroquinolone, is an extremely broad spectrum DNAgyrase inhibitor antimicrobial agent. The active ingredient of Neofloxinis Ciprofloxacin Hydrochloride USP.

Indications Neofloxin is indicated for the treatment of single infection or mixedinfections caused by two or more susceptible organisms. It can also beused for infections caused by organisms resistant to other antibioticsincluding aminoglycosides, penicillins and cephalosporins. Asantibacterial concentrations of Ciprofloxacin are obtained in serum andbody tissues as well as in the urine following administration by mouth,Ciprofloxacin has been suggested for use in the treatment of a wide rangeof infections caused by susceptible organisms including infections of theurinary, respiratory and gastrointestinal tracts, gonorrhoea andsepticaemia. The extensive tissue penetration of Neofloxin combinedwith its enhanced antibacterial activity (including antipseudomonalactivity), enables Ciprofloxacin to be used alone (pending sensitivityresults) or in combination with an aminoglycoside or with beta-lactamantibiotics for instance when severe neutropenia is present or with anantibiotic active against anaerobes where the presence of Bacteroides fragilisis suspected. Neofloxin is indicated for the treatment of the followinginfections caused by sensitive bacteria :

Severe systemic infections : Septicaemia, bacteraemia, peritonitis, infections inimmunosuppressed patients with haematological or solid tumors and inpatients in intensive care unit with specific problems such as infectedburns.

Respiratory tract infections : Lobar and bronchopneumonia, acute, andchronic bronchitis, acute exacerbation of cystic fibrosis, bronchiectasis,empyaema.

Urinary tract infections : Uncomplicated and complicated urethritis, cystitis,pyelonephritis, prostatitis, epididymitis.


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Skin and soft tissue infections : Infected ulcers, wound infections, abscesses,cellulitis, otitis externa, erysipelas, infected burns.

Gastro-intestinal infections : Enteric fever, infective diarrhoea.

Infection of the biliary tract : Cholangitis, cholecystitis, empyaema of the gallbladder.

Intra abdominal infections : Peritonitis, intra-abdominal abscesses.

Bone and joint infections : Osteomyelitis, septic arthritis.

Pelvic infections : Salpingitis, endometritis, pelvic inflammatory diseases.

Eye, ear, nose and throat infections : Otitis media, sinusitis, mastoiditis,tonsillitis.

Genito-urinary tract infection : Gonorrhoea (urethral, rectal and pharyngeal)caused by beta-lactamase producing organisms or organisms moderatelysensitive to penicillin.

In vitro studies have shown that the antibacterial action of Ciprofloxacinresults from the inhibition of bacterial DNA gyrase. This mode of actiondiffers from that of penicillins. Organisms resistant to cephalosporins,aminoglycosides and tetracyclines are generally sensitive to Ciprofloxacin.

Dosage and Administration General dosage recommendationsThe dosage of Ciprofloxacin is determined by the severity and type ofinfection, the sensitivity of the causative organism(s) and the age, weightand renal function of the patient.

Adults : The dosage range for adults is 100-750 mg twice daily. Ininfections of the urinary tract : 250-500 mg twice daily. In respiratory tractinfections : 250-750 mg twice daily for both upper and lower respiratorytract infections. For the treatment of known Streptococcal pneumoniaeinfection, the recommended dosage is 750 mg twice daily. In gonorrhoea: a single dose of 250 or 500 mg. In the majority other infections, 500-750mg twice daily should be administered. Cystic fibrosis : In adults withpseudomonal infections of the lower respiratory tract, the normal dose is750 mg twice


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daily. As the pharmacokinetics of Ciprofloxacin remain unchanged inpatients with cystic fibrosis, the low body weight of these patients wouldbe fallen into consideration when determining dosage. Impaired renalfunction : Dosage adjustment are not usually required except in patientswith severe renal impairment (serum creatinine >265 µmol/l orcreatinine clearance <20 ml/minute). If adjustment is necessary, this maybe achieved by reducing the total daily dose by half, although monitoringof drug serum levels provide the most reliable basis for dose adjustment.

Dose adjustmentElderly : Although higher Ciprofloxacin serum levels are found in theelderly, no adjustment of dosage is necessary. Adolescents and children :As with other drugs in its class, Ciprofloxacin has been shown to causearthropathy in weight bearing joints of immature animals. Although therelevance of this to man is unknown, its use in children, growing childrenand growing adolescents is not recommended. However, where thebenefit of using Ciprofloxacin is considered to out weigh this potentialrisk, the dosage should be 7.5-15 mg/kg/day depending upon the severityof infection, administered in two divided doses.

Duration of treatmentThe duration of treatment depends upon the severity of infection, clinicalresponse and bacteriological findings. For acute infections the usualtreatment period is 5 to 10 days with Neofloxin tablets. Generallytreatment should be continued for 3 days after the signs and symptoms ofthe infection have disappeared.

Contraindication Ciprofloxacin is contraindicated in patients who have shownhypersensitivity to Ciprofloxacin or other quinolones. Ciprofloxacin isalso contraindicated in children and growing adolescents except where thebenefits of treatment exceed the risks.

Warning and Precautions Ciprofloxacin should be used with caution in patients with a history ofconvulsive disorders. Crystalluria related to the use of Ciprofloxacin hasbeen observed only rarely. Patients receiving Ciprofloxacin should be wellhydrated and excessive alkalinity of the urine should be avoided.


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Drug interactions Concurrent administration of Ciprofloxacin with Theophylline may leadto elevated plasma concentrations of Theophylline and prolongation ofits elimination half-life. This may result in increased risk of Theophyllinerelated adverse reactions. If concomitant use cannot be avoided plasmalevels of Theophylline should be monitored and dosage adjustmentsmade as appropriate.

Antacids containing Magnesium Hydroxide or Aluminium Hydroxidemay interfere with the absorption of Ciprofloxacin resulting in serum andurine levels lower than desired, concurrent administration of these agentswith Ciprofloxacin should be avoided. Probenecid interferes with renaltubular secretion of Ciprofloxacin and produces an increase in the levelof Ciprofloxacin in the serum. This should be considered if patients arereceiving both drugs concomitantly. As with other broad spectrumantibiotics prolonged use of Ciprofloxacin may result in overgrowth ofnonsusceptible organism. Repeated evaluation of the patient’s conditionand microbial susceptibility testing is essential. If superinfection occursduring therapy, appropriate measures should be taken.

Information for Patients Patients should be advised that Ciprofloxacin may be taken with orwithout meals. The preferred time of dosing is two hours after a meal.Patients should also be advised to drink fluids liberally and not takeantacids containing magnesium or aluminium concomitantly or withintwo hours after dosing. Ciprofloxacin may cause dizziness and light-headedness, therefore patients should know how they react to this drugbefore they operate an automobile or machinery or engage in activitiesrequiring mental alertness or coordination.

Use in Pregnancy and Lactation Reproduction studies performed in mice, rats and rabbits using parenteraland oral administration did not reveal any evidence of teratogenicity,impairment of fertility or impairment of peri/post natal development.However as with other quinolones, Ciprofloxacin has been shown tocause arthropathy in immature animals and therefore its use duringpregnancy is not recommended. Studies in rats have indicated thatCiprofloxacin is secreted in milk, administration to nursing mothers isthus not recommended.


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Overdosage No information on overdosage is available. Routine measures such asgastric lavage should be performed as soon as possible after ingestion ofNeofloxin tablets. Serum levels of Ciprofloxacin are reduced by dialysis.

Side Effects Gastrointestinal : Nausea, diarrhoea, vomiting, dyspepsia, abdominalpain. Central nervous system : Dizziness, headache, tiredness, confusion,convulsions. Hypersensitivity reactions : Skin rashes, pruritus and possiblesystemic reactions. The following other reactions have also been reported,joint pain, mild photosensitivity and transient increase in liver enzymes(particularly in patients with previous liver damage) serum bilirubin, ureaor creatinine levels.

Commercial PackNeofloxin Tablet : Box containing 5 blister strips of 10 film coatedtablets, each tablet contains Ciprofloxacin Hydrochloride USP equivalentto Ciprofloxacin 250 mg.

Neofloxin-500 Tablet : Box containing 4 blister strips of 10 film coatedtablets, each tablet contains Ciprofloxacin Hydrochloride USP equivalentto Ciprofloxacin 500 mg.

Neofloxin-750 Tablet : Box containing 3 blister strips of 10 film coatedtablets, each tablet contains Ciprofloxacin Hydrochloride USP equivalentto Ciprofloxacin 750 mg.


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Neopril®Tablet

DescriptionNeopril is a preparation of Lisinopril USP. Neopril is available inpotencies of 5 mg and 10 mg tablet.

Indications Neopril (Lisinopril) is indicated for treatment of all grades of essentialhypertension and renovascular hypertension, where standard therapy isineffective or inappropriate because of adverse events. Neopril may beused alone or with other antihypertensive agents.

Neopril is also indicated in the treatment of congestive heart failure asadjunctive therapy with non-potassium sparing diuretics and, whereappropriate, with digitalis.

Dosage and Administration Since absorption of Lisinopril is not affected by food, Neopril may beadministered before, during or after meal.

Essential Hypertension The usual recommended starting dose is 10 mg once a day. Dosageshould be adjusted according to blood pressure response. The usualeffective maintenance dose is 20 mg administered in a single daily dose.The maximum dose used in long term, controlled clinical trial was 80mg/day, but does not appear to give a greater effect.

A lower starting dose is required in presence of renal impairment, inpatients in whom diuretic therapy cannot be discontinued, patients whoare volume and/or salt-depleted for any reason, and in patients withrenovascular hypertension.

Diuretic Treated Patients Symptomatic hypotension may occur occasionally following initial doseof Neopril. The diuretic should be discontinued, if possible, for two orthree days before starting therapy with Lisinopril to reduce the likelihoodof hypotension.


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If the diuretic cannot be discontinued, an initial dose of 5 mg should beused under medical supervision for at least 2 hours and until the bloodpressure has stabilized for at least an additional hour.

Use in ElderlyBlood pressure response and adverse experiences were similar in youngerand older patients. Pharmacokinetic studies, however, indicate thatmaximum blood levels and area under the plasma concentration timecurve (AUC) are doubled in older patients, so that dosage adjustmentshould be made with particular caution.

Dosage Adjustment in Renal Impairment :

Dosage adjustment should be based on creatinine clearance in case ofrenal impairment " -

Renal status Creatinine clearance Initial dose ml/min mg/day

Normal Renal Function 30 ml/min 10 mgto mild impairment

Moderate to severe 10-30 ml/min 5 mgimpairment

Dialysis Patients <10 ml/min 2.5 mg

Renovascular Hypertension Some patients with renovascular hypertension, especially those withbilateral renal artery stenosis or stenosis of the artery to a solitary kidney,may develop an exaggerated response to the first dose of Neopril.Therefore, a lower starting dose of 2.5 or 5 mg is recommended.Thereafter, the dosage may be adjusted according to the blood pressureresponse.

Congestive Heart Failure In patients, not adequately controlled by digitalis and/or diuretics,Neopril may be added with a starting dose of 2.5 mg once a day. The


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usual effective dosage range is 5 to 20 mg per day administered in a singledaily dose.

Contraindication Neopril is contraindicated in pregnancy and treatment should be stoppedif pregnancy is suspected, because it has been shown to be foetotoxic inrabbits.

Neopril is also contraindicated in patients who are hypersensitive to anycomponent of this product and in patients with a history ofangioneurotic oedema relating to previous treatment with an angiotensin-converting enzyme (ACE) inhibitor.

Precautions Hypotension : Excessive hypotension was rarely seen in uncomplicatedhypertensive patients. However, because of the potential fall in bloodpressure in patients with severe congestive heart failure with or withoutassociated renal insufficiency, therapy should be started under very closemedical supervision. Such patients should be followed closely for the firsttwo weeks of treatment and whenever the dose of Neopril and/ordiuretic is increased. Similar considerations should be applied to patientswith ischaemic heart disease or cerebrovascular disease in whom anexcessive fall in blood pressure could result in a myocardial infarction orcerebrovascular accident.

If hypotension occurs, the patient should be placed in supine positionand if necessary receive an intravenous infusion of normal saline. Atransient hypotensive response is not a contraindication to further doseswhich usually can be given without difficulty once the blood pressure hasincreased after volume expansion.

Renal Function Impairment : In patients with congestive heart failure,hypotension following the initiation of therapy with ACE inhibitors maylead to some further impairment in renal function. Reversible acute renalfailure has been reported in this situation.

Reversible increase of blood urea and serum creatinine have beenreported in some patients with bilateral renal artery stenosis or stenosis ofthe artery to a solitary kidney.


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Hypersensitivity/Angioneurotic Oedema : Angioneurotic oedema of the face,extremities, lips, tongue, glottis and/or larynx has been reported rarely inpatients treated with ACE inhibitors, including Neopril. In such caseslisinopril should be discontinued promptly and appropriate monitoringshould be instituted to ensure complete resolution of symptoms prior todismissal of the patient. In those instances where swelling is confined tothe face and lips, the condition generally resolves without treatment,although antihistamines have been useful in relieving symptoms.

Angioneurotic oedema associated with laryngeal oedema may be fatal.Where there is involvement of the tongue, glottis and larynx, likely tocause airway obstruction, appropriate therapy such as subcutaneousadrenaline solution 1:1000 (0.3 ml to 0.5 ml) should be administeredpromptly.

Cough : Cough has been reported with the use of ACE inhibitors.

Surgery/Anaesthesia : In patients undergoing major surgery or duringanaesthesia with agents that produce hypotension, Neopril may blockangiotensin II formation, secondary to compensatory renin release. Ifhypotension occurs and is considered to be due to this mechanism, it canbe corrected by volume expansion.

Paediatric Use : Safety and effectiveness of Lisinopril have not beenestablished.

Diuretics : When a diuretic is added to the therapy of a patient receivingLisinopril, the antihypertensive effect is usually additive.

Patients already on diuretics and especially those in whom diuretic therapywas recently instituted may occasionally experience an excessive reductionof blood pressure when Lisinopril is added. The possibility ofsymptomatic hypotension with Lisinopril can be minimized bydiscontinuing the diuretic prior to initiation of treatment with Lisinopril.

Other Agents : Indomethacin may diminish the antihypertensive efficacy ofconcomitantly administered Lisinopril.


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Lisinopril has been used concomitantly with nitrates without evidence ofclinically significant adverse interactions.

Use in Pregnancy and LactationThere is no adequate and well controlled studies of Lisinopril in pregnantwomen. However, data are available that indicate that ACE inhibitors cancause foetal and neonatal morbidity and mortality when administered topregnant women; therefore, the use of Lisinopril during pregnancy is notrecommended unless needed in a situation where other drugs cannot beused or are ineffective.

Lisinopril crosses the human placenta. Infants whose mothers have takenLisinopril should be closely observed. It is not known whether exposure,limited to the first trimester, can adversely affect foetal outcome.However, complications including foetal hypotension, renal failure andoligohydramnios have been reported when Lisinopril was used during thelater stages of pregnancy. Hyperkalaemia and/or skull hypoplasia hasoccurred with the use of other ACE inhibitors during the second andthird trimesters. Maternal oligohydramnios, presumably representingdecreased renal function in the foetus may result in limb contracture andcraniofacial deformations. If oligohydramnios is observed Lisinoprilshould be discontinued unless it is considered life saving for the mother.

It is not known whether Lisinopril is secreted in human milk. Becausemany drugs are secreted in human milk, caution should be exercised ifLisinopril is given to nursing mother.

Overdosage There is no data on overdosage in human. The most likely manifestationof overdose would be hypotension, for which the usual treatment wouldbe intravenous infusion of normal saline. Lisinopril may be removedfrom the general circulation by haemodialysis.

Side Effects The most frequent clinical side-effects of Lisinopril in controlled trialswere dizziness, headache, diarrhoea, fatigue, cough and nausea. Other sideeffects occurring less frequently were orthostatic effects (includinghypotension), rash etc.


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Cardiovascular : Myocardial infarction or cerebrovascular accident possiblysecondary to excessive hypotension in high risk patients. Palpitation andtachycardia may be developed.

Gastrointestinal tract : Abdominal pain, dry mouth, hepatitis, jaundice.

Nervous system : Mood alteration, mental confusion.

Respiratory tract : Bronchitis, pharyngeal pain.

Special senses : Blurred vision.

Urogenital tract : Uraemia, oliguria/anuria renal dysfunction, acute renalfailure in rare cases.

A symptom complex with Lisinopril has been reported which mayinclude fever, vasculitis, myalgia, arthralgia/arthritis, a positive ANA,elevated ESR, eosinophilia, and leukocytosis. Rash, photosensitivity orother dermatological manifestations may also occur.

Pharmaceutical Precaution Store at room temperature.

Commercial PackNeopril-5 Tablet : Box containing 10 blister strips of 10 tablets, eachtablet contains Lisinopril USP equivalent to 5 mg anhydrous Lisinopril.

Neopril-10 Tablet : Box containing 5 blister strips of 10 tablets, eachtablet contains Lisinopril USP equivalent to 10 mg anhydrous Lisinopril.


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Neosten®

Cream

DescriptionNeosten (Clotrimazole) has a reliable action on dermatophytes, yeasts andother fungi. Neosten cream contains 1.0% Clotrimazole BP.

IndicationsThe confirmed indications for Neosten include :♦ all dermatomycoses due to dermatophytes (e.g. Trichophyton species)

♦ all dermatomycoses due to yeasts (Candida species)

♦ dermatomycoses due to moulds and other fungi

♦ skin diseases showing superinfections with these fungi.

The above mentioned dermatomycoses include interdigital mycoses (e.g.Athlete’s foot), paronychias (associated with nail mycoses), mycoses inskin folds, candida vulvitis, candida balanitis, pityriasis versicolour,erythrasma.

Application and UsageWash skin with soap and water and dry thoroughly. Apply a thin layer ofthe cream 2-3 times daily and gently massage over affected area asdirected by the doctor. For Athlete’s foot, pay special attention to thespaces between the toes. Best results in Athlete’s foot and ringworm areusually obtained with 4 weeks use of this product. The cream should beapplied two or three times daily for one month or for at least two weeksafter the disappearance of all signs of infection. If satisfactory resultshave not occurred within these times consultation with doctor is essential.

For best results, follow directions and continue treatment for length oftime indicated.

The duration of treatment varies; it depends among other factors on theextent and localization of the disease.

Recommended duration of treatment :

Dermatomycoses : 3-4 weeks

Candida vulvitis and candida balanitis : 1-2 weeks

Erythrasma and pityriasis versicolor (approx.) : 3 weeks


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In fungal infection of the feet, to prevent relapses, treatment should becontinued for about 2 weeks beyond the disappearance of all signs ofdisease.

Neosten cream is odourless, can be washed off and does not stain.

Tolerance When applied topically Neosten cream is well tolerated. With externalapplication systemic effects are not observed. Local irritation or burningsensation may occur in a very few cases but these symptoms are notconsidered harmful.

Commercial PackNeosten Cream : Tube containing 20 g cream, each gram containsClotrimazole BP 10 mg.


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Neosten®VTVaginal Tablet

DescriptionNeosten VT acts reliably on dermatophytes, yeasts and other fungi; it isalso effective against Trichomonas vaginalis and Gram-positivemicroorganisms (streptococci/staphylococci) and Gram-negativemicroorganisms (Bacteroides/Haemophilus vaginalis). Each Neosten vaginaltablet contains Clotrimazole BP 0.2 g. It has broad-spectrum antimycoticwith fungicidal and trichomonacidal action.

Indications♦ Infectious vaginal discharge

♦ Vaginitis due to fungi (mainly Candida and/or Trichomonas)

♦ Superinfections with Neosten VT-sensitive bacteria

Dosage and Application In general, a 3-day treatment is sufficient for candida vaginitis. On threeconsecutive nights, one Neosten vaginal tablet is inserted as deeply aspossible into the vagina. This is best achieved when lying on one’s backwith the knees slightly bent. If necessary, one Neosten vaginal tablet dailycan be used unhesitatingly for 6-12 days.

Treatment should be timed so as to avoid the menstrual period and befinished before the onset of menstruation.

To avoid reinfection, the partner should undergo local treatment withNeosten cream at the same time.

Tolerance Since there is practically no Neosten absorption through the vaginal skin,no systemic effects are expected. The local tolerance of Neosten vaginaltablets is generally good. Local irritation or burning sensation may occurin a very few cases but these symptoms are not considered harmful.

Experimental and clinical studies on the use of Neosten vaginal tabletsduring pregnancy gave no indication of harmful effect on mother and


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child. The use of Neosten VT during the last 4-6 weeks of pregnancy isrecommended for the purpose of sanitation of the birth canal.

Commercial PackNeosten VT : Pack containing 3 vaginal tablets of Clotrimazole BP 0.2 g,each sealed in aluminium strip with applicator.


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Nightus®

Tablet

DescriptionNightus tablet contains Bromazepam BP 3 mg. It is a global anxiolyticwith smooth and superior efficacy. Unlike other benzodiazepines it hasleast side effects. Bromazepam reaches peak plasma concentrations withintwo hours after oral administration. Bromazepam is metabolized in theliver. It effectively removes anxiety and anxiety related variousphysiological problems.

IndicationsNightus is indicated for the following indications :

♦ Emotional disturbance such as anxiety and tension states, for anxiety indepressed patients, nervous tension, restlessness anxiety and tensionrelated insomnia.

♦ Functional disturbances of the cardiovascular and respiratory systemssuch as pseudo angina pectoris, tachycardia, hypertension,hyperventilation.

♦ Functional disturbances of the gastrointestinal tract such as irritablebowel syndrome, ulcerative colitis, epigastric pain, spasm.

♦ Other psychosomatic disturbances such as psychogenic headache.

Dosage and AdministrationRecommended dose is 1.5-12 mg three times daily. The dose depends onaccording to condition or patient response, and also side effect profile.Average outpatient dosage : 1.5-3 mg three times a day. Severecases/hospital 5-12 mg two to three times daily. Reduce dose in half forelderly.

ContraindicationBromazepam is contraindicated in patients with known hypersensitivity tobenzodiazepines. It is also contraindicated in severe respiratory failure,myasthenia graves and severe liver failure.


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PrecautionsBromazepam should be used cautiously in respiratory diseases, muscleweakness, and history of alcohol or drug abuse.

Side Effects Drowsiness, lightheadedness in the next day, confusion, ataxia andamnesia may occur.

Use in Pregnancy and Lactation The administration of Bromazepam is rarely justified in women and childbearing potential. Bromazepam should be avoided during breast feeding.

Drug InteractionPhenothiazines, barbiturates, MAO inhibitors and psychoactive drugsmay potentiate the action of Bromazepam and should not be givenconcurrently.

Commercial PackNightus Tablet : Box containing 10 x 10 tablets in a blister pack. Eachtablet contains Bromazepam BP 3mg.


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Noscab®

Cream

DescriptionNoscab cream is a preparation of 5% (w/w) Permethrin INN.Permethrin is a photo stable synthetic pyrethroid that possesses a broadspectrum of insecticidal activity and is generally rated as the safestinsecticide because of its low primary toxicity.

Along with the pediculicidal activity Permethrin has ovicidal andscabicidal activity. The insect rapidly absorbs Permethrin via mouth,respiratory tract or the intact cuticle. Although the primary target tissue isthe nervous system, insects are killed by a complex series of reactions invarious organs such as metabolic exhaustion and paralysis of the nervoussystem. Permethrin induces electrochemical abnormalities across themembranes of excitable cells, leading to sensory hyperexcitability incoordination and prostration.

IndicationsNoscab is indicated for the treatment of scabies.

Dosage and Application♦ Adults and children (over 12 years)- A full tube

♦ Children aged 6-12 years- up to half of a tube

♦ Children aged 1-5 years- up to one fourth of a tube

♦ Children aged 2 months to 1 year- up to one eighth of a tube

Patients of >2 months of age can use Noscab cream. Cream should beapplied to clean, dry and cool skin. If the body is hot due to warm bathor any other reason, skin should be allowed to cool down. It should beapplied to the whole body excluding head. The whole body should bewashed thoroughly 8-12 hours after treatment. Adults and children above12 years will use a full tube as a single dose. If necessary maximum twotubes can be used as a single dose.

The cream should not be applied to the vicinity of mouth and areas closeto the eyes.


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ContraindicationPermethrin is contraindicated in patients with known hypersensitivity tothe product, its components, other pyrethroids or pyrethrins.

Precautions Noscab is not an eye irritant, but the cream itself may cause markedirritation. Nursing staff who routinely apply Noscab, may wear gloves toavoid any possible irritation to the hands.

Side Effects In scabies patients, skin discomfort, usually described as burning, stingingor tingling occurs in a few individuals soon after the cream is applied.Other transient effects are erythema, numbness, rash and pruritus.

OverdosageThere is no reports of overdosage with Permethrin. It is possible thatexcessive application of Permethrin might result in localized adversereactions or more severe skin reactions.

Drug InteractionsThe treatment of eczematous like reactions with corticosteroids shouldbe withheld prior to treatment with Permethrin, as there is a risk ofexacerbating the scabies infestation by reducing the immune response tothe mite.

Use in Pregnancy and LactationThere are limited data on the use of Permethrin in pregnancy whichprovide no indication of any risk to the foetus. Furthermore, the amountof Permethrin absorbed systemically following a whole body applicationis extremely low. The negative mutagenicity tests and the very lowmammalian toxicity would suggest that any risk to the foetus followingtreatment with Permethrin is minimal. Consideration should be given todiscontinuing nursing temporarily or to withholding the drug while themother is nursing, although drug levels in breast milk following topicalapplication are likely to be very low.

Commercial PackNoscab Cream : Each pack has a tube containing 25 g of Noscab cream.Each gram contains Permethrin INN 50 mg.


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Nuprafen®

Tablet

DescriptionNuprafen (Naproxen), a non-steroidal anti-inflammatory agent, is apreparation of (+)-6-Methoxy-a-methyl-2-naphthalene acetic acid. It hasanalgesic, anti-inflammatory and antipyretic properties. It is an inhibitorof prostaglandin synthetase.

IndicationsNuprafen is indicated in mild to moderate pain such as dysmenorrhoea,migraine and for the treatment of rheumatoid arthritis, osteoarthritis(degenerative arthritis), ankylosing spondylitis, juvenile rheumatoidarthritis, acute gout, and acute musculoskeletal disorders.

Dosage and Administration Adults : For rheumatoid arthritis, osteoarthritis and ankylosingspondylitis, the usual dose is 500 mg to 1 g per day taken in two divideddoses at 12 hour intervals. For mild to moderate pain such as primarydysmenorrhoea, acute tendinitis and bursitis, the usual initial dose is 500mg followed by 250 mg every 6 or 8 hours. The total daily dose shouldnot exceed 1250 mg.

In acute gout an initial dose of 750 mg followed by 250 mg every 8 hourshas been suggested until the attack subsides.

For juvenile arthritis : A dose of 10 mg/kg body weight daily in 2 divideddoses in children over 5 years of age has been recommended.

In the acute phase of the following cases a loading dose of 750 mg perday is recommended.

♦ In patients reporting severe night time pain and morning stiffness.♦ In patients being switched to Nuprafen (Naproxen) from a high dose

of another anti-rheumatic compound.

♦ In osteo-arthrosis where pain is the predominant symptom.


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ContraindicationThe drug is contraindicated in patients who are allergic to Naproxen orNaproxen Sodium. It is also contraindicated in patients in whom Aspirinor other non-steroidal anti-inflammatory/analgesic drug induce thesymptoms of asthma, rhinitis and nasal polyps.

Drug Interactions Due to the high plasma protein binding of Naproxen, patientssimultaneously receiving Hydantoin, anti-coagulants or a highly proteinbound sulphonamide should be observed for signs of overdosage ofthese drugs. Naproxen and other non-steroidal anti-inflammatory drugs(NSAIDs) can reduce the antihypertensive effect of Propranolol andother β- blockers. Probenecid given concurrently, increases the plasmalevel of Naproxen and extends its plasma half life considerably.

Side Effects Occasional skin rashes and angioedema have been reported. Thefollowing additional occurrences have been reported with Naproxen :nausea, vomiting, abdominal discomfort, epigastric distress, headache,inability to concentrate, insomnia, tinnitus and vertigo.

Thrombocytopenia, jaundice, aplastic anaemia, haemolytic anaemia,peptic ulceration, fatal hepatitis, hearing impairment, cognitivedysfunction, anaphylactic reactions to Naproxen and Naproxen sodiumformulations and nephropathy may occur rarely.

Mild peripheral oedema has been observed in a few patients receivingNaproxen. Although sodium retention has not been reported inmetabolic studies, it is possible that patients with questionable orcompromised cardiac function may be at a greater risk when takingNaproxen.

Use in Pregnancy and LactationThere are no adequate and well-controlled studies in pregnant women.Because animal reproduction studies are not always predictive of humanresponse, Naproxen should be used during pregnancy only if thepotential benefits justify the potential risks to the foetus. The Naproxenanion has been found in the milk of lactating women. Because of thepossible adverse effects of prostaglandin-inhibiting drugs on neonates,use in nursing mothers should be avoided.


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OverdosageSignificant overdosage of the drug may be characterized by drowsiness,heartburn, indigestion, nausea or vomiting.

No evidence of toxicity has been reported 5-15 months after ingestion ofthe drug for three to seven days with doses up to 3 g/day.

Pharmaceutical PrecautionProtect from heat and direct sunlight.

Commercial PackNuprafen 250 Tablet : Box containing 10 blister strips of 10 tablets, eachtablet contains 250 mg of Naproxen USP.

Nuprafen 500 Tablet : Box containing 5 blister strips of 10 tablets, eachtablet contains 500 mg of Naproxen USP.


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Odrel®

Tablet

DescriptionOdrel (Clopidogrel) is an inhibitor of ADP-induced platelet aggregationacting by direct inhibition of adenosine diphosphate (ADP) binding to itsreceptor and of the subsequent ADP-mediated activation of theglycoprotein GPIIb/IIIa complex. Each tablet contains ClopidogrelBisulfate INN equivalent to 75 mg Clopidogrel.

IndicationsOdrel is indicated for the reduction of atherosclerotic events (myocardialinfarction, stroke and vascular death) in patients with atherosclerosisdocumented by recent stroke, recent myocardial infarction or establishedperipheral arterial disease.

Dosage and AdministrationThe recommended dose of Odrel is 75 mg once daily with or withoutfood. No dosage adjustment is necessary for elderly patients or patientswith renal disease.

ContraindicationThe use of Odrel is contraindicated in the following conditions :i) Hypersensitivity to any component of the product and ii) Activepathological bleeding such as peptic ulcer or intracranial haemorrhage.

Side EffectsThe most common clinically important side effects are pruritus, purpura,diarrhoea and rash. Infrequent events include intracranial haemorrhage(0.4%) and severe neutropaenia (0.04%).

Use in Special PopulationHepatic impaired patients : Odrel should be used with caution in thispopulation.

Paediatric patients : Safety and effectiveness in the paediatric populationhave not been established.


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Pregnancy : Animal studies revealed no evidence of impaired fertility orfoetotoxicity due to Clopidogrel. There are, however, no adequate andwell-controlled studies in pregnant women. Because animal studies arenot always predictive of a human response, Odrel should be used duringpregnancy only if clearly needed.

PrecautionsAs with other antiplatelet agents, Odrel should be used with caution inpatients who may be at risk of increased bleeding from trauma, surgeryor other pathological conditions. If a patient is to undergo surgery and anantiplatelet effect is not desired, Odrel should be discontinued 7 daysprior to surgery.

Odrel prolongs the bleeding time. Patients should be told that it mighttake them longer than usual to stop bleeding when they take Odrel andthat they should report any unusual bleeding to their physician.

Drug InteractionsConcomitant administration of Clopidogrel with NSAIDs, Warfarin orHeparin should be undertaken with caution.

OverdosageNo adverse events were reported after single oral administration of 600mg (equivalent to 8 standard 75 mg tablets) of Clopidogrel in healthyvolunteers. The bleeding time was prolonged by a factor of 1.7, which issimilar to that typically observed with the therapeutic dose of 75 mg ofClopidogrel per day. If quick reversal is required, platelet transfusion maybe appropriate to reverse the pharmacological effects.

Pharmaceutical PrecautionStore at temperature between 15oC and 30oC.

Commercial PackOdrel Tablet : Box containing 10 tablets in 1 x 10’s blister strip. Eachtablets contains Clopidogrel Bisulfate INN equivalent to 75 mg ofClopidogrel.


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Omastin®

Capsule/Suspension

Description Omastin (Fluconazole) is a triazole antifungal agent. It is a potent andselective inhibitor of fungal cytochrome P450 dependent enzymesnecessary for the synthesis of ergosterol.

Indications ♦ Vaginal Candidiasis

♦ Oropharyngeal Candidiasis

♦ Oesophageal Candidiasis

♦ Systemic Candidiasis and Cryptococcal infection

♦ Tinea corporis/Tinea cruris/Tinea pedis/Other Tinea

♦ Kerion

♦ Pityriasis versicolor

♦ Onychomycosis

Dosage and Administration Recommended dosages are given below, and this regimen isrecommended from early infection to severe infections.→→ 150 mg as a single dose or 200 mg in 1st day followed by 100 mg daily

for 14 days

→→ 200 mg in 1st day followed by 100 mg daily for 14-30 days.

→→ 400 mg in 1st day followed by 200 mg daily for 28 days or longer basedon clinical response

→→ 150 mg weekly for 4-6 weeks

→→ 50 mg daily for 20 days

→→ 400 mg as a single dose

→→ 150 mg weekly for 12 months.

Child over 1 year♦ In Superficial Candidiasis- 1-2 mg/kg daily

♦ In Systemic Candidiasis and Cryptococcal infection- 3-6 mg/kg daily


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In serious life threatening infections up to 12 mg/kg daily has been givento children aged 5-13 years (Maximum 400 mg daily)

Age Average weight Dose/Day1 year 9 kg ½ spoonful1-2 years 12 kg 1 spoonful2-3 years 14 kg 1½ spoonful3-4 years 16 kg 2 spoonful4-6 years 20 kg 2½ spoonful

The daily dose of Omastin should be based on the nature and severity ofthe fungal infection. Most cases of fungal infections require multiple dosetherapy. Treatment should be continued until clinical parameters orlaboratory tests indicate that active fungal infection has subsided. Aninadequate period of treatment may lead to recurrence of activeinfection. Immuno-compromised patients usually require maintenancetherapy to prevent relapse.

Other indications ♦ Fungal urinary tract infections♦ Disseminated candidiasis♦ Prophylaxis for fungal infection in neutropenic cancer patients.♦ Acute treatment of other systemic fungal infections such as

coccidioidomycosis and histoplasmosis

Use in the ElderlyThe normal dose should be used if there is no evidence of renalimpairment.

Use in Renal ImpairmentNo adjustment in single dose therapy is required. In multiple dose therapyof patients with renal impairment, normal doses should be given on days1 and 2 of treatment and thereafter the dosage intervals should bemodified as follows:Creatinine clearance Dosage interval(ml/min) (hours)>41 24 21-40 4810-20 72Patients receiving regular One dose after every dialysis dialysis session


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Paediatric UseFew formal studies have been done in children. Doses of 3-6 mg/kg dailyhave been used without serious adverse reactions being reported. Renalclearance in children may be proportionately more rapid than in adultsand doses up to 12 mg/kg is recommended.

Effects on LiverFor the liver as a potential target organ, the available data indicate that,Fluconazole is not predictable hepatotoxic drug in man. In man, includingthose with existing hypercholesterolaemia, serum cholesterol is notadversely affected by Fluconazole.

Use in Pregnancy and Lactation Adverse foetal effects have been seen in animals only at doses rangingfrom 80 mg/kg to 320 mg/kg with maternal toxicity. These levels are 20-60 times the recommended therapeutic use. Still Fluconazole should beused in pregnancy only if the potential benefit justifies the possible riskto the foetus.

Fluconazole is secreted in human milk at concentrations similar toplasma. Therefore, the use of fluconazole in nursing mother is notrecommended.

ContraindicationFluconazole should not be used in patients with known hypersensitivityto Fluconazole or to related triazole compounds.

Drug InteractionsFluconazole acts by inhibiting fungal cytochrome P450 enzymes. It ismuch less active against mammalian P450 enzymes, still potential existsfor interaction with drugs that are metabolized by P450.♦ Cyclosporin

Some data suggest that Fluconazole increases cyclosporin levels. ♦ Phenytoin

Fluconazole significantly increases Phenytoin levels.♦ Anticoagulants

Fluconazole has shown to prolong prothrombin time in subjects receiving Warfarin.


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♦ Oral hypoglycaemics Fluconazole has been shown to prolong the serum half life of concomitantly administered Tolbutamide. However no adverse effect on serum glucose levels was seen.

♦ Rifampicin Decreases levels of Fluconazole.

♦ Oral contraceptivesNo clinically significant interactions have been seen.

Side EffectsTherapy with Fluconazole is well tolerated. In 4000 patients receivingFluconazole for various indications and for durations of 7 days or more,the incidence of side effects were 16% . Only 1.5% of subjects requireddiscontinuation of medication. The most common adverse events wererelated to the gastrointestinal system : nausea (3.7%), abdominal pain(1.17%), vomiting (1.7%) and diarrhoea (1.5%). Headache (1.9%) andskin rash (1.8%) were also seen. It should be noted that approximatelyone third of this group were patients with acquired immunodeficiencysyndrome (AIDS) and severe systemic disorders. Therefore the data maynot be applicable to patients receiving Fluconazole for the treatment ofsuperficial mycoses.

OverdosageIn the case of overdose, supportive measures and gastric lavage should beinstituted. If deemed necessary, a 3 hours haemodialysis will decreaseplasma levels by about 50%.

Pharmaceutical Precaution Omastin should be stored below 30°C.

Commercial PackOmastin-50 Capsule : Box containing 5 aluminium strips of 10 capsules,each capsule contains Fluconazole INN 50 mg.

Omastin-150 Capsule : Box containing 2 blister strips of 10 capsules, eachcapsule contains Fluconazole INN 150 mg.

Omastin Suspension : Dry powder in glass bottle for reconstitution into35 ml of suspension. After reconstitution, each 5 ml contains FluconazoleINN 50 mg.


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Opton®

Tablet

DescriptionEsomeprazole is the S-isomer of Omeprazole. It reduces gastric acidsecretion through a specific targeted mechanism of action. It is a specificinhibitor of the acid pump in the parietal cell. Each enteric coated tabletcontains 20 mg Esomeprazole INN (as Magnesium Trihydrate).

Indications♦ Healing of erosive oesophagitis♦ Long-term management of Oesophagitis

♦ Symptomatic gastro-oesophageal reflux disease (GERD)

♦ H. pylori Eradication for treatment of duodenal ulcer. (Triple Therapywith Esomeprazole, Clarithromycin and Amoxicillin).

Dosage and AdministrationHealing of erosive oesophagitis : 20 mg or 40 mg once daily for 4 to 8Weeks. For those patients who have not healed after 4-8 weeks oftreatment, an additional 4-8 week course of Esomeprazole may beconsidered.

Long-term management of oesophagitis : 20 mg once daily.

Symptomatic GERD : 20 mg once daily for 4 weeks.

H. pylori eradication for treatment of duodenal ulcer : Triple Therapy- 20mg Esomeprazole once daily with 500 mg Clarithromycin twice daily, and1 g Amoxicillin twice daily for 7-10 days.

ContraindicationPatients with known hypersensitivity to any component of theformulation.

Side EffectsIn general, Esomeprazole is well tolerated in both short and long-termuse. Common adverse events are headache and diarrhoea. Other side


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effects include nausea, flatulence, abdominal pain, constipation, and drymouth.

Use in Special PopulationGeriatric : Dosage adjustment is not necessary.

Pediatric : Safety and effectiveness in paediatric patients have not beenestablished.

Hepatic Insufficiency : No dosage adjustment is recommended forpatients with mild to moderate hepatic insufficiency. However, in patientswith severe hepatic insufficiency a dose of 20 mg once daily should notbe exceeded.

Renal Insufficiency : Dosage adjustment is not necessary.

Use in Pregnancy and LactationThere are no adequate and well-controlled studies in pregnant women.This drug should be used during pregnancy only if clearly needed. Theexcretion of Esomeprazole in human milk has not been studied. BecauseEsomeprazole is likely to be excreted in human milk, a decision should bemade whether to discontinue the drug.

OverdosageThere is no experience to date with deliberate overdose. Data are limitedbut single doses of 80 mg Esomeprazole were uneventful. Esomeprazoleis extensively plasma protein bound and is therefore not readily dialysable.As in any case of overdose, treatment should be symptomatic and generalsupportive measures should be utilized.

Drug InteractionsEsomeprazole inhibits gastric acid secretion. Therefore, Esomeprazolemay interfere with the absorption of drugs where gastric pH is animportant determinant of bioavailability (eg, Ketoconazole, Iron salts andDigoxin).

Pharmaceutical Precaution Store at temperature between 15οC and 30οC.


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Commercial PackOpton Tablet : Box containing 3 x 10 tablets in aluminium form pack.Each tablet contains 20 mg Esomeprazole INN as (MagnesiumTrihydrate).


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Pacet®

Tablet

DescriptionPacet (Amiodarone Hydrochloride) is used to correct abnormal rhythmsof the heart. Amiodarone is considered a "broad spectrum"antiarrhythmic medication. The most important electrical effects of thedrug includes : a delay in the rate at which the heart’s electrical system"recharges" after the heart contracts (repolarization); a prolongation inthe electrical phase during which the heart’s muscle cells are electricallystimulated (action potential); a slowing of the speed of electricalconduction (how fast each individual impulse is conducted through theheart’s electrical system); a reduction in the rapidity of firing of thenormal generator of electrical impulses in the heart (the heart’spacemaker); and a slowing of conduction through various specializedelectrical pathways (called accessory pathways). In addition to being anantiarrhythmic medication, Amiodarone also causes blood vessels todilate. Because of this effect it also may be of benefit in patients withcongestive heart failure. This effect can result in drop of blood pressure.

IndicationsAmiodarone is used for many serious arrhythmias of the heart includingventricular fibrillation, ventricular tachycardia, atrial fibrillation, and atrialflutter.

DosageOral dose is 200 mg 3 times daily for 1 week reduced to 200 mg twicedaily or the minimum required to control arrhythmia. Amiodarone isusually given in several daily doses to minimize stomach upset which isseen more frequently with higher doses. For this same reason, it is alsorecommended that Amiodarone should be taken with meals.

Side EffectsThe most severe side effects of Amiodarone therapy are related to thelungs. These reactions can be fatal. Patients should report any symptomsof cough, fever, or painful breathing. Although quite rare, fatal livertoxicity may occur with Amiodarone therapy.


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Reversible corneal microdeposits (sometimes with night glare), rarelyimpaired vision due to optic neuritis; peripheral neuropathy andmyopathy (usually reversible on withdrawal); bradycardia and conductiondisturbances; phototoxicity and rarely persistent skin discolouration;hypothyroidism, hyperthyroidism; raised serum transaminases; jaundice,hepatitis and cirrhosis are reported.

Other rare complaints are nausea, vomiting, metallic taste, tremor,sweating, vertigo, headache, sleeplessness, fatigue, alopecia, benign raisedintracranial pressure, ataxia, rashes, vasculitis, renal involvement,thrombocytopenia, haemolytic or aplastic anaemia. In some cases, dose ofAmiodarone may be reduced. In other cases, Amiodarone therapy mayneed to be stopped.

Use in Pregnancy and LactationIn general, Amiodarone should not be administered during pregnancybecause there have been reports of hypo- or hyperthyroidism in infantsfrom oral Amiodarone use during pregnancy. If Amiodarone use isconsidered essential, however, the patient should be warned of the risk tothe foetus. The safe use of Amiodarone in lactating women has not beenestablished.

Drug InteractionsAmiodarone may interact with β-blockers such as Atenolol, Propranolol,Metoprolol, or certain calcium channel blockers, such as Verapamil orDiltiazem, resulting in an excessively slow heart rate. Amiodaroneincreases the blood levels of Digoxin when the two drugs are giventogether. Flecainide blood concentrations increase by more than 50%with Amiodarone. Procainamide and Quinidine concentrations increaseby 30-50% during the first week of Amiodarone therapy. Amiodaronealso can interact with tricyclic antidepressants (TCA). Amiodaroneinteracts with Warfarin and increases the risk of bleeding. Amiodaroneinhibits the metabolism of Dextromethorphan.

Pharmaceutical PrecautionTablets should be kept at room temperature, less than 30°C.


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Commercial PackPacet 100 Tablet : Box containing 3 x 10’s tablets in blister strips. Eachtablet contains Amiodarone Hydrochloride BP 100 mg.

Pacet 200 Tablet : Box containing 3 x 10’s tablets in blister strips. Eachtablet contains Amiodarone Hydrochloride BP 200 mg.


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Pedeamin®

Syrup

DescriptionAmber glass bottle containing 100 ml syrup. Each 5 ml contains 10 mgDiphenhydramine Hydrochloride BP.

IndicationsPedeamin is indicated for the treatment of following :♦ Seasonal, perennial, vasomotor rhinitis♦ Urticaria, angioneurotic oedema, anaphylaxis♦ Pruiritic conditions♦ Premedication for emesis and motion sickness♦ Miscellaneous include Ménière’s disease and parkinsonism

Dosage and AdministrationAdult→ Most allergic conditions are controlled in adult with 25-50 mg three

times a day with a further 50 mg at night.

Children →1 to 5 years of age : 5 mg i.e., 2.5 ml of elixir 4 times a day

→ More than 6 years of age : 10 mg i.e. 5 ml of elixir 4 times a day

Contraindication♦ Any patients in whom drowsiness is undesirable e.g. drivers, machine

operators.

♦ Concomitant consumption of alcohol or central nervous system (CNS)depressants will potentiate drowsiness.

♦ Patients with known hypersensitivity to Diphenhydramine or anycomponents of the product.

♦ Care should be taken in administration during pregnancy.

Use in Pregnancy and LactationDiphenhydramine cross the placenta. There has been a suggestion thatDiphenhydramine ingestion during pregnancy is associated with a higherincidence of cleft palate. As for all drugs care should be taken whenprescribing Diphenhydramine during pregnancy and lactation.


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Side EffectsSide-effect includes sedation, dizziness, tinnitus, fatigue, ataxia, blurredvision, diplopia, euphoria, and epigastric discomfort.

Drug InteractionsDiphenhydramine administration significantly reduces the absorption ofthe antituberculous agent para-aminosalicyclic acid (PAS) from thegastrointestinal tract.

CNS depressants may potentiate the sedative action ofDiphenhydramine. Anticholinergic drugs may potentiateDiphenhydramine’s anticholinergic side effects.

Commercial PackPedeamin Syrup : Amber glass bottle containing 100 ml syrup. Each 5 mlcontains 10 mg Diphenhydramine Hydrochloride BP.


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Pregvit®

Capsule

DescriptionPregvit is a special preparation of Iron, Folic Acid, Vitamin B complex,and Vitamin C. Iron is presented in timed release form to escape gastricirritation. Each extended release capsule contains : ♦ Ferrous Sulphate BP 150 mg

♦ Folic Acid USP 0.5 mg

♦ Thiamine Mononitrate (vitamin B1) USP 2 mg

♦ Riboflavin (vitamin B2) USP 2 mg

♦ Nicotinamide (vitamin B3) USP 10 mg

♦ Pyridoxine Hydrochloride (vitamin B6) USP 1 mg

♦ Ascorbic Acid (vitamin C) USP 50 mg

Indications and UsesPregvit is indicated for the treatment and prophylaxis of Iron, Folic Acid,Vitamin B complex and Vitamin C deficiency, or to meet extra need ofthese vitamins and minerals especially in pregnancy or when planning forpregnancy.

Dosage and AdministrationRecommended adult dose is one capsule daily. In more severe deficiencystates, 2 capsules a day may be required or as directed by the physician.

ContraindicationThis product is contraindicated in patients with a known hypersensitivityto any of the ingredients. Iron therapy is contraindicated inhaemachromatosis and haemosiderosis, and in patients receiving repeatedblood transfusion or with anaemia not not due to by iron deficiency.

Should be given cautiously to patients taking Levodopa as one of theingredients of Pregvit (Pyridoxine) reduces the effect of Levodopa.

Side EffectsGenerally well tolerated. However, a few gastrointestinal disorders andallergic reactions may be occurred.


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Use in Pregnancy and LactationIt is recommended during pregnancy and lactation.

Drug InteractionsCare should be taken when given to patients with Iron storage or Ironabsorption disease. Iron form chelates with antacids and Tetracycline andabsorption of all these may be impaired if taken concurrently.

OverdosageOverdosage of Iron is dangerous, particularly in children and requiresimmediate attention. Gastric lavage should be carried out in the earlystages, vomiting may also be induced.

Pharmaceutical PrecautionStore in a dry place below 25ºC. Protect from light and Keep out of reachof children.

Commercial PackPregvit Capsule : Each box contains 5 blister strips of 10 capsules each.Each extended release capsule contains Ferrous Sulphate BP 150 mg,Folic Acid USP 0.5 mg, Thiamine Mononitrate (vitamin B1) USP 2 mg,Riboflavin (vitamin B2) USP 2 mg, Nicotinamide (vitamin B3) USP 10mg, Pyridoxine Hydrochloride (vitamin B6) USP 1 mg, Ascorbic Acid(vitamin C) USP 50 mg.


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Premil®Tablet

DescriptionThe active ingredient of Premil is Repaglinide. Repaglinide belongs to anew class of oral antidiabetic drug called meglitinide which stimulatesinsulin release from β-cells of pancreas.

IndicationsPremil is indicated as an adjunct to diet and exercise to lower the bloodglucose level in patients with type 2 diabetes mellitus (NIDDM) whosehyperglycaemia cannot be controlled satisfactorily by diet and exercisealone. It is also indicated for use in combination with Metformin to lowerblood glucose in patients whose hyperglycaemia cannot be controlled byexercise, diet, and either Repaglinide or Metformin alone.

Mechanism of ActionRepaglinide binds to specific receptors in the ß-cell membrane leading tothe closure of ATP-dependent K+ channels and the depolarization of ß-cell membrane. This in turn, leads to Ca++ influx, increased intracellularCa++ and the stimulation of insulin secretion.

Therapeutic AdvantagePremil is taken in relation to meal i.e. one meal one dose, no meal no dose.Many oral blood glucose-lowering drugs release insulin throughout theday, irrespective of taking meal or not. This may lead to hypoglycaemia ifa meal is missed or delayed. But Premil is different because it is takenbefore meals. Premil begins to work very quickly to increase insulin levelwhile the food is digested and glucose enters the blood stream. Premilhelps body release insulin to handle the blood glucose from that meal.Premil leaves the blood stream quickly, so that body doesn’t keep releasinginsulin. Thus it helps to release insulin when it is needed. Moreover, itgives the flexibility to plan medication around meals instead of planningmeals around medication.

Dosage and AdministrationPremil has to be taken just before or up to 30 minutes before the meal.Premil can be taken two, three or four times a day, depending on how


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many meals are taken. If a meal is missed, Premil should also be avoided.If an extra meal is taken, an extra dose of Premil should be taken withthat meal. If a dose of Premil is missed, it should not be taken betweenmeals. Rather the usual dose should be taken before the next meal.

The dose ranges from 0.5 to 4 mg before each meal. The starting dose ofRepaglinide in patients with HbA1c <8% is 0.5 mg before each meal. In

patients with HbA1c >8% the starting dose is 1 or 2 mg before each meal.

The dose may be increased gradually up to 4 mg before each meal.

Side EffectsHypoglycaemia is possible with all blood glucose-lowering drugs. If thereare symptoms of low blood glucose (for example, headache, dizziness,tiredness, nervousness or shakiness, rapid heartbeat, or nausea), bloodglucose should be tested right away. If it is low (less than 70 mg/dl on ahome glucose meter), a simple carbohydrate food (for example, orangejuice, quick-dissolving sugar, candies, or glucose tablets) should be taken.If the symptoms do not go away, doctor should be informed.

Some of the other common symptoms reported by patients takingRepaglinide include cold and flu-like symptoms, diarrhoea, joint ache, andback pain.

There is some evidence that oral diabetes drugs may increase the risk ofheart problems. But experts are not sure what the real risk is, if any, fromtaking oral diabetes medicine.

Drug InteractionsThe dose of Premil may need to be adjusted, if taken with othermedications. The possible interactions of Repaglinide with other drugsare : i) Inhibitors of the cytochrome P450 enzyme system (azoleantifungals and macrolides) may lead to lower Repaglinide clearance andlonger half life. ii) Inducers of the cytochrome P450 enzyme system(Rifampin, Phenobarbital, Carbamazepine, Troglitazone, etc.) mayaccelerate Repaglinide metabolism and shorten its effect. iii) Cimetidinehas no significant effect on Repaglinide absorption or clearance. iv)Repaglinide has no significant effect on Digoxin, Theophyllin, orWarfarin. v) Highly protein-bound drugs (e.g., NSAIDs) may increase theplasma level of unbound Repaglinide and potentiate its glucose-loweringeffect. Thus, co-administration of these drugs with Repaglinide may


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increase the risk of hypoglycaemia. vi) The risk of hypoglycaemia mayalso be increased when hypoglycaemic agents are co-administered withcertain drugs such as salicylates, sulfonamides, Chloramphenicol,coumarins, Probenecid, monoamine oxidase (MAO) inhibitors, and betaadrenergic blockers.

ContraindicationPremil is contraindicated in patients with diabetic ketoacidosis, with orwithout coma, in patients with type I diabetes and in patients with knownhypersensitivity to any of the components of the product.

PrecautionsPremil should also be used with caution in renal and hepatic insufficiency.In pregnancy, safety of Repaglinide has not been established. Hence,Premil should be used during pregnancy only if it is clearly needed. It isnot known whether Repaglinide is excreted in human milk. Because manydrugs are excreted in human milk and because of potential for seriousadverse reactions in nursing infants from Repaglinide, a decision shouldbe made whether to discontinue nursing or the drug, taking into accountthe importance of the drug to the mother.

Accidental OverdosageIn clinical trials patients receiving up to 80 mg of Repaglinide developedfew adverse effects other than lowering of blood glucose. Hypoglycaemiadid not occur when meals were given with these high doses.Hypoglycaemic symptoms without loss of consciousness or neurologicfindings should be treated aggressively with oral glucose. Patients shouldbe closely monitored for a minimum of 24 to 48 hours, sincehypoglycaemia may recur after apparent clinical recovery. There is noevidence that Repaglinide is dialysable using haemodialysis. Severehypoglycaemic reactions with coma, seizure or other neurologicalimpairment occur infrequently but constitute medical emergenciesrequiring immediate hospitalization. If hypoglycaemic coma is diagnosedor suspected, the patient should be given a rapid intravenous injection ofconcentrated (50%) glucose solution. This should be followed by acontinuous infusion of more dilute (10%) glucose solution at a rate thatwill maintain the blood glucose at a level above 100 mg/dl.


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Pharmaceutical PrecautionPremil should be stored at room temperature away from moisture. Likeall other medications, Premil should be kept out of the reach of children.

Commercial PackPremil 0.5 Tablet : Box containing 30 tablets in 3 x 10’s blister strips. Eachtablet contains Repaglinide USP 0.5 mg.

Premil 1 Tablet : Box containing 30 tablets in 3 x 10’s blister strips. Eachtablet contains Repaglinide USP 1 mg.

Premil 2 Tablet : Box containing 30 tablets in 3 x 10’s blister strips. Eachtablet contains Repaglinide USP 2 mg.


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Pretin®

Tablet

DescriptionPretin is a potent, rapidly effective and long-acting non-sedative,histamine H1 receptor antagonist, with anti-allergic properties. Each

tablet contains 10 mg of Loratadine INN.

IndicationsPretin is indicated for- ♦ Seasonal allergic rhinitis ♦ Perennial allergic rhinitis

♦ Sneezing, rhinorrhoea and itching

♦ Ocular itching and burning

♦ Chronic urticaria and other allergic dermatologic disorders

Dosage and AdministrationAdult and children above 12 years of age : 10 mg (1 Pretin tablet) once-a-day

Children → 6 - 12 year : 10 mg (1 Pretin tablet) once-a-day→ 2 - 5 year : 5 mg (½ Pretin tablet) once-a-day

Safety and efficacy of Loratadine in children below 2 years of age havenot yet been established.

ContraindicationLoratadine is contraindicated in patients who have hypersensitivity oridiosyncrasy to any of its component.

Side EffectsPotentially life threatening effects : No effects of this kind have beenencountered.

Acute overdose : No cases of acute overdose have been reported.


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Severe or irreversible side effects : No effects of this kind have beenreported.

Symptomatic side effects : Clinical trials suggest a very low rate of adverseeffects, comparable to placebo, in particular for CNS effects (includingsedation) and anticholinergic activity.

The lack of sedation by Loratadine was further confirmed by specialpsychomotor studies such as the driving performance test.

PrecautionsNeonates : The drug is not normally used in neonates

Lactating mothers : Like other H1 receptor antagonists, Loratadine is also

excreted in breast milk, so lactating mothers are advised not to take thedrug.

Children : There are no special precautions required for young childrenover 2 years. But the safety and efficacy of Loratadine in children below2 years of age have not yet been established.

Pregnant women : Although Loratadine was not found to be teratogenic inanimals, safe use of Loratadine during pregnancy has not been established.There have been no case reports of any adverse foetal consequences. Thedrug should be used only if the potential benefit justifies the potential riskto the foetus.

Drug InteractionsThere are no reports of potentially hazardous interactions with otherdrugs to date. Psychomotor performance studies show that unlike otherH1 receptor antagonists, Loratadine does not potentiate the effect of

alcohol when administered concomitantly with it.

Commercial PackPretin Tablet : Box containing 10 blister strips of 10 tablets. Each tabletcontains Loratadine INN 10 mg.


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Primace®

Capsule

DescriptionPrimace (Ramipril) is an angiotensin-converting enzyme (ACE) inhibitor,which after hydrolysis to ramiprilat, blocks the conversion of angiotensinI to the vasoconstrictor substance, angiotensin II. So, inhibition of ACEby Ramipril results in decreased plasma angiotensin II, which leads todecreased vasopressor activity and decreased aldosterone secretion. ThusRamipril exerts its antihypertensive activity. It is also effective in themanagement of heart failure and reduction of the risk of stroke,myocardial infarction and death from cardiovascular events. It is longacting and well tolerated, so, can be used in long term therapy.

IndicationsPrimace is indicated in the following cases-- Mild to severe hypertension - Heart failure.- To reduce the risk of stroke, myocardial infarction and death from

cardiovascular events in patients with a history of cardiovasculardisease.

Dosage and AdministrationHypertension: For the management of hypertension initial dose ofPrimace is 1.25 mg daily, can be increased with an interval of 1-2 weeks;usual dosage range is 2.5-5 mg daily up to a maximum of 10 mg daily.

Heart failure: In this case initial dose of Primace is 1.25 mg once dailyunder supervision; dosage can be increased at intervals of 1-2 weeks;maximum of 10 mg daily can be taken and if necessary in 2 divided doses.

For prophylaxis and after myocardial infarction (3-10 days afterinfarction): Initial dose of Primace is 2.5 mg twice daily; can be increasedto 5 mg twice daily after 2 days; 2.5 mg to 5 mg twice daily formaintenance.

Dosage in renal impairment: For the patient with hypertension and renalimpairment the recommended initial dose is 1.25 mg Primace once daily.


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Subsequent dosage should be titrated according to individual toleranceand blood pressure response, up to a maximum of 5 mg daily. For thepatients with heart failure and renal impairment, the recommended doseis 1.25 mg once daily. The dose may be increased to 1.25 mg twice dailyand up to a maximum dose of 2.5 mg twice daily depending upon clinicalresponse and tolerability.

ContraindicationRamipril is contraindicated in patients who are hypersensitive to anycomponent of this product and in patients with a history of angioedemarelated to previous treatment with ACE inhibitor.

PrecautionsRamipril should be used with caution in patients with impaired renalfunction, hyperkalaemia, hypotension, and impaired hepatic function.

Side EffectsRamipril is generally well tolerated. Dizziness, headache, fatigue andasthenia are commonly reported side effects. Other side effects occurringless frequently include symptomatic hypotension, cough, nausea,vomiting, diarrhoea, rash, urticaria, oliguria, anxiety, amnesia etc.Angioneurotic oedema, anaphylactic reactions and hyperkalaemia havealso been reported rarely.

Use in Pregnancy and LactationInsufficient data is available for the use of Ramipril in pregnant andlactating mothers. Therefore, the use of Ramipril in pregnancy andlactation is not advisable.

Use in ChildrenNo information is yet available in the use of Ramipril in children.

Drug InteractionsConcomitant administration with diuretics may lead to serioushypotension, and in addition dangerous hyperkalaemia with potassiumsparing diuretics. Concomitant therapy with Lithium may increase theserum Lithium concentration. NSAIDs may reduce the antihypertensiveeffect of Ramipril and cause deterioration of renal function.


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OverdosageLimited data on human overdosage are available. The most likely clinicalmanifestations would be symptoms attributable to hypotension. Becausethe hypotensive effect of Ramipril is achieved through vasodilation andeffective hypovolemia, it is reasonable to treat Ramipril overdose byinfusion of normal saline solution.

Commercial PackPrimace 1.25 Capsule : Box contains 3 blister strips of 10 capsules. Eachcapsule contains 1.25 mg of Ramipril BP.

Primace 2.50 Capsule : Box contains 3 blister strips of 10 capsules. Eachcapsule contains 2.50 mg of Ramipril BP.

Primace 5 Capsule : Each box contains 3 blister strips of 10 capsules.Each capsule contains 5 mg of Ramipril BP.


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Proceptin®-20Capsule

DescriptionProceptin capsule contains 20 mg of Omeprazole BP as enteric coatedgranules.

IndicationsProceptin offers significant therapeutic gains in the treatment of acidrelated diseases. Healing rates are high in duodenal ulcer, gastric ulcer anderosive reflux oesophagitis; acid production is controlled effectively inZollinger-Ellison Syndrome, and symptom relief is prompt and sustainedin all indications.

Less clear-cut indications where benefit might be expected but where dataare limited include : ♦ Prevention of stress ulceration, ♦ Prevention ofacid aspiration syndrome and ♦ Treatment of upper gastrointestinalbleeding.

Note : In comparative studies, Omeprazole has been found to producefaster symptom relief and higher healing rates in a greater percentage ofpatients than either Cimetidine or ranitidine, confirming the ‘therapeuticgains’ achievable with Proceptin over existing therapies.

Dosage and AdministrationDuodenal ulcer : 20 mg once daily for 4 weeks. In severe cases, 40 mgonce daily for 4 weeks.

Gastric ulcer : 20 mg once daily for 8 weeks. In severe cases, 40 mg oncedaily for 8 weeks.

Erosive Reflux Oesophagitis : 20 mg once daily for 4 weeks. For thosenot fully healed, to be continued for 4 more weeks.

Refractory Reflux Oesophagitis : 40 mg once daily for 8 weeks.

Zollinger-Ellison Syndrome : 60 mg once daily, adjusted individually andcontinued as long as necessary.


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Most patients will be effectively controlled with 20-120 mg daily. Dosageabove 80 mg should be divided and given twice daily. Long-termmaintenance treatment with Proceptin is not recommended. Impairedrenal or hepatic function : Adjustment is not required. Patients withsevere liver disease should not require more than 20 mg Omeprazoledaily.

ContraindicationOmeprazole capsule is contraindicated in patients with knownhypersensitivity to any component of the formulation.

Use in Pregnancy and LactationThere are no adequate or well controlled studies in this group of patients.Omeprazole should not be given during pregnancy and lactation unless itsuse is considered essential.

Paediatric UseSafety and effectiveness in children have not been established.

Adverse EffectsSide effects reported with Omeprazole in clinical studies have includednausea, diarrhoea, constipation, flatulence, abdominal colic, paraesthesia,dizziness and headache but are rare. Skin rashes, leucopenia and transientelevation of plasma activation of hepatic amino-transferases have beenobserved occasionally in few patients and there has been no consistentrelationship with treatment.

ToxicologyIn two 24-months carcinogenicity studies in rats, Omeprazole at dailydoses of 1.7, 3.4, 13.8, 44.0 and 140.8 mg/kg/day (approximately 4 to 352times the human dose, based on a patient weight of 50 kg and a humandose of 20 mg) produced gastric entero-chromaffin like (ECL) cellcarcinoids in a dose related manner in both male and female rats. Notreatment related mucosal changes have been observed in patients treatedcontinuously for periods up to 4 years.

PrecautionsSymptomatic responses to therapy with Omeprazole does not precludethe presence of gastric malignancy.


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WarningIn long-term (2 years) studies in rats, Omeprazole produced a dose relatedincrease in gastric carcinoid tumours. While available endoscopicevaluations and histologic examinations of biopsy specimens fromhuman stomachs have not detected a risk from short-term exposure toOmeprazole, further human data on the effects of sustainedhypochlorhydria and hypergastrinemia are needed to rule out thepossibility of an increased risk for the development of tumours inhumans receiving long-term therapy with Omeprazole.

Drug InteractionsOmeprazole can delay the elimination of Diazepam, Phenytoin andWarfarin. Monitoring of patients receiving Warfarin or Phenytoin isrecommended and a reduction of Warfarin or Phenytoin dose may benecessary when Omeprazole is added to treatment. Omeprazole does notinterfere with Theophylline or Propranolol metabolism.

Information for PatientsProceptin should be taken before meals. Patients should be cautioned thatthe capsules should not be opened, chewed or crushed and should beswallowed whole.

Commercial PackProceptin-20 Capsule : Box contains 3 blister strips of 10 capsules, eachcapsule contains 20 mg of Omeprazole BP as enteric coated granules.


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Prosan®

Tablet

DescriptionProsan (Losartan Potassium) is an angiotensin-II receptor (type AT1)

antagonist. Angiotensin-II is a potent vasoconstrictor, the primaryvasoactive hormone of the renin-angiotensin system and an importantcomponent in the pathophysiology of hypertension. Losartan and itsprincipal active metabolite block the vasoconstrictor and aldosteronesecreting effects of angiotensin-II by selectively blocking the binding ofangiotensin-II to the AT1 receptor found in many tissues.

IndicationsIt is indicated for the treatment of hypertension. It may be used alone orin combination with other antihypertensive agents.

Dosage and AdministrationThe usual starting dose is 50 mg once daily, with 25 mg used in patientswith possible depletion of intravascular volume (e.g., patients treated withdiuretics) and patients with a history of hepatic impairment. It can beadministered once or twice daily with total daily doses ranging from 25mg to 100 mg.

ContraindicationLosartan Potassium is contraindicated in patients who are hypersensitiveto the active ingredient or any component of the drug.

Adverse ReactionsIn clinical trials, dizziness was the only side effect reported that occurredwith an incidence greater than placebo in 1% patients treated withLosartan. Rarely, rash was reported, although the incidence in controlledclinical trials was less than placebo. Angioedema, involving swelling of theface, lips and/or tongue, has been reported rarely in patients treated withLosartan. The incidence of cough is similar to placebo and significantlylower than that observed with ACE inhibitors.


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Use in Special PopulationChildren : There are no data on the safety or efficacy of Losartan inchildren.

Pregnant women : Prosan must be discontinued as soon as possible whenpregnancy is detected. It should not be prescribed during lactation, asthere is no information in human on the passage of Losartan into breastmilk.

Elderly : In elderly patients up to 75 years of age, no dosage adjustment isnecessary.

Drug InteractionsNo drug interactions of clinical significance have been identified.Compounds that have been studied in clinical pharmacokinetic trialsinclude Hydrochlorothiazide, Digoxin, Warfarin, Cimetidine,Ketoconazole, and Phenobarbital.

OverdosageLimited data are available regarding overdosage in human. The most likelymanifestation of overdosage would be hypotension and tachycardia.Supportive treatment should include repletion of the intravascular fluids.

Pharmaceutical PrecautionStore in a dry place, at temperature between 15oC and 30oC. Keep awayfrom light.

Commercial PackProsan 25 Tablet : Box containing 50 tablets in 5 x 10’s blister strips. Eachtablet contains Losartan Potassium INN 25 mg.

Prosan 50 Tablet : Box containing 50 tablets in 5 x 10’s blister strips. Eachtablet contains Losartan Potassium INN 50 mg.


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Prosfin®

Tablet

DescriptionProsfin is a preparation of Finasteride, a competitive inhibitor of the 5α-reductase enzyme which is used in the treatment of benign prostatichyperplasia. It is selective for 5α-reductase type-2 enzyme and has noaffinity for androgen receptors.

IndicationsProsfin is indicated for the treatment and control of benign prostatichyperplasia (BPH)- ♦ to cause regression of the enlarged prostate

♦ to improve urinary flow

♦ to improve the symptoms associated with BPH.

Mode of ActionThe development of the prostate gland and subsequent BPH isdependent upon conversion of testosterone to dihydrotestosterone(DHT) within the prostate. Prosfin belongs to a new class of specificinhibitors of 5α-reductase, an intracellular enzyme, which metabolizestestosterone into the more potent androgen, DHT. Finasteride has noaffinity for the androgen receptor.

Dosage and AdministrationThe recommended dosage is one 5 mg tablet daily.

Although early improvement may be seen, treatment for at least sixmonths may be necessary to assess whether a beneficial response hasbeen achieved. Thereafter, treatment should be continued.

Use in renal insufficiency : Dosage adjustments are not necessary inpatients with renal insufficiency since pharmacokinetic studies did notindicate any change in the disposition of Finasteride.

Use in hepatic insufficiency : There are no data available in patients withhepatic insufficiency.

Use in the elderly : No dosage adjustment is required in elderly patients.


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Precautions General : Since the beneficial response to Finasteride may not bemanifested immediately, patients with large residual urine volume and/orseverely diminished urinary flow should be carefully monitored forobstructive uropathy.

Prostate cancer : Digital rectal examination, as well as, other evaluations forprostate cancer, should be performed on patients with BPH prior toinitiating therapy with Finasteride and periodically thereafter. Finasteridecauses a decrease in serum concentration of markers of prostatic cancersuch as prostate specific antigen (PSA); therefore, reduction of serumlevels of these markers in patients with BPH treated with Finasteride doesnot rule out concomitant prostate cancer. No clinical benefit has yet beendemonstrated in patients with prostate cancer treated with Finasteride.

ContraindicationHypersensitivity to any component of this medication. Finasteride use isalso contraindicated in women and paediatric patient.

WarningCrushed or broken Finasteride tablets should not be handled by womenwho are or may become pregnant; in addition, since it is present in semen,male patients should wear a condom or otherwise avoid exposure offemale sexual partner who have the potential to become pregnant.

Pharmaceutical PrecautionStore at room temperature below 30°C. Protect from light.

Drug InteractionsNo clinically important drug interactions have been identified. Finasteridedoes not appear to significantly affect the cytochrome P450 linked drugmetabolizing enzyme system. Compounds which have been tested in maninclude Propranolol, Digoxin, Glibenclamide, Warfarin, Theophylline,and antipyrine.

Side EffectsFinasteride is well tolerated. In clinical studies, the following adverseexperiences have been reported as possibly drug related in 1% of patients


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treated for 12 months with 5 mg Finasteride daily : impotence (3.7%),decreased libido (3.3%), and decreased volume of ejaculate (2.8%).

OverdosageNo specific treatment of overdosage with Finasteride is recommended.Patients have received single doses of Finasteride up to 400 mg andmultiple doses of Finasteride up to 80 mg/day for up to three monthswithout any adverse effects.

Commercial PackProsfin Tablet : Box containing 3 blister strips of 10 tablets, each tabletcontains Finasteride USP 5 mg.


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Protolan®

Capsule

DescriptionProtolan (Lansoprazole) is a proton pump inhibitor. It is an irreversibleinhibitor of the parietal cell H+-K+ ATPase, which leads to profoundinhibition of gastric acid secretion.

Indications♦ Duodenal ulcer

♦ Gastric ulcer

♦ Oesophagitis/Ulceration

♦ Zollinger-Ellison syndrome

♦ Resistant ulcers and oesophagitis

♦ Eradication of Helicobacter pylori in the treatment of peptic ulcer (incombination with antibiotics)

Dosage and Administration → Benign gastric ulcer : 30 mg daily in the morning for 8 weeks

→ Duodenal ulcer : 30 mg daily in the morning for 4 weeks; maintenance15 mg daily

→ NSAID-associated duodenal or gastric ulcer : 15-30 mg daily for 4weeks, followed by a further 4 weeks if not fully healed

→ Zollinger-Ellison syndrome (and other hypersecretory conditions) :Initially 60 mg once daily adjusted according to response; daily doses of120 mg or more is given in two divided doses

→ Gastro-oesophageal reflux disease : 30 mg daily in the morning for 4 weeks, followed by a further 4 weeks if not fully healed; maintenance 15-30 mg daily

→ Acid-related dyspepsia : 15-30 mg daily in the morning for 2-4 weeks.


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ContraindicationThe use of Protolan is contraindicated in patients with a history ofhypersensitivity to any of the ingredients of Protolan capsule.

Side EffectsPotentially life-threatening effects : None has been recorded.

Acute overdosage : None has been reported.

Severe or irreversible adverse effects : The possible induction of carcinoidtumors by profound acid suppression, and a rise in serum gastrin mayoccur. There is a rise in serum gastrin levels in the first 3 months oftreatment, which are then maintained though at a lower level than thosefound in pernicious anaemia. Long- term treatment with a proton pumpinhibitor in patients with Helicobacter pylori infection may accelerate thedevelopment of atrophic gastritis.

Symptomatic adverse effect : Dose dependent diarrhoea occurs with anincidence of about 4% at 30 mg per day, rising to 8% at 60 mg per day.Headache occurs in 2-3% of treated patients.

Use in Special PopulationNeonates : There is no relevant human data. The drug is not recommendedfor use in neonates.

Children : The youngest person to have received Lansoprazole in clinicaltrials was 13 years old.

Pregnant women : There is no relevant human data.

The elderly : No problems have been encountered in clinical use and therehas been no increase in adverse drug reaction in the elderly.

Drug InteractionsLansoprazole appears to be a selective inhibitor of the cytochrome P450monooxygenase system; there may be an effect on hepatic clearance, butthere have been no reports to date of clinically relevant interactions.There is some uncertainty over the effect of Lansoprazole on the oralcombined contraceptive pill.


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Commercial Pack Protolan-15 Capsule : Box containing 30 capsules in 3 x 10’s blister strips.Each capsule contains Lansoprazole USP 15 mg as enteric coatedgranules.

Protolan-30 Capsule : Box containing 30 capsules in 3 x 10’s blister strips.Each capsule contains Lansoprazole USP 30 mg as enteric coatedgranules.


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Recox®

Tablet

DescriptionRofecoxib is a selective cyclooxygenase-2 (COX-2) inhibitor, non-steroidal anti-inflammatory drug (NSAID). By selectively inhibiting thecyclooxygenase-2 (COX-2) enzyme, it shows analgesic, antipyretic, andanti-inflammatory action.

Indications♦ For the treatment of acute mild or moderate pain including bone pain,

dental pain, and orthopaedic surgical pain♦ For the treatment of primary dysmenorrhoea

♦ For the relief of the signs and symptoms of osteoarthritis

♦ For the relief of the signs and symptoms of rheumatoid arthritis

Dosage and AdministrationRecox is administered orally. The lowest dose of Recox should be soughtfor each patient.

For the relief of acute pain and treatment of primary dysmenorrhoea :The recommended initial dose of Rofecoxib is 50 mg once daily.Subsequent doses should be 25 to 50 mg once daily. The maximumrecommended daily dose is 50 mg.

Osteoarthritis : The recommended starting dose of Rofecoxib is 12.5 mgonce daily. Some patients may receive additional benefit by increasing thedose to 25 mg once daily. The maximum recommended daily dose is 25mg.

Rheumatoid arthritis :The recommended dose of Rofecoxib is 50 mgonce daily. The maximum recommended daily dose is 50 mg twice daily.

ContraindicationRecox is contraindicated in patients with known hypersensitivity to Rofecoxib.Recox should not be given to patients who have experienced asthma, urticaria,or allergic-type reactions after taking Aspirin or other NSAIDs.


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Side EffectsCommon side effects of Rofecoxib, with an incidence greater thanplacebo include : dizziness, sinusitis, back pain, fatigue, and bronchitis.Infrequent side effects are headache, maculopapular rash, dermatitis, andanorexia.

Use in Special PopulationGeriatric : Dose adjustment in the elderly is not generally necessary.However, therapy should be initiated at the lowest recommended dose.

Paediatric : The safety and efficacy of Rofecoxib is not established inpaediatric patients.

Hepatic Insufficiency : No dosage adjustment is required in patients withmild to moderate hepatic insufficiency. The safety and efficacy ofRofecoxib in patients with severe hepatic impairment have not beenstudied.

Pregnancy : In third trimester of pregnancy, Rofecoxib should be avoidedbecause it may cause premature closure of the ductus arteriosus.

PrecautionsRecox can be administered with or without food.

Drug InteractionsACE Inhibitors : Reports suggest that non-steroidal anti-inflammatorydrugs (NSAIDs) may diminish the antihypertensive effect of angiotensin-converting enzyme (ACE) inhibitors.

Aspirin : Concomitant administration of low-dose Aspirin with Rofecoxibmay result in an increased rate of gastrointestinal ulceration or othercomplications, compared to use of Rofecoxib alone.

Frusemide : Clinical studies have shown that NSAIDs can reduce thenatriuretic effect of Frusemide and thiazides in some patients.

Lithium : NSAIDs have produced an elevation of plasma Lithium levelsand a reduction in renal Lithium clearance. Thus, when Rofecoxib and


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Lithium are administered concurrently, subjects should be observedcarefully for signs of Lithium toxicity.

Rifampicin : Co-administration of Rofecoxib with Rifampicin 600 mg dailymay produce a 50% decrease in Rofecoxib plasma concentrations.

Warfarin : Anticoagulant activity should be monitored, particularly in thefirst few days after initiating or changing Rofecoxib therapy in patientsreceiving Warfarin or similar agents. Bleeding events and increases inprothrombin time, have been reported, predominantly in the elderlypatients.

OverdosageAdministration of up to 1000 mg of Rofecoxib per day did not result inserious toxicity. In the event of overdose, it is reasonable to employ theusual supportive measures, e.g., remove unabsorbed material from thegastrointestinal tract, employ clinical monitoring, and institute supportivetherapy, if required.


Commercial PackRecox 12.5 Tablet : Box containing 50 tablets in 5 x 10’s blister strips.Each tablet contains Rofecoxib INN 12.5 mg.

Recox 25 Tablet : Box containing 50 tablets in 5 x 10’s blister strips. Eachtablet contains Rofecoxib INN 25 mg.

Recox 50 Tablet : Box containing 50 tablets in 5 x 10’s blister strips. Eachtablet contains Rofecoxib INN 50 mg.


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Recur®

Tablet

DescriptionRecur is a preparation of Finasteride, a competitive inhibitor of steroidType II 5α-reductase, an intracellular enzyme that converts the androgentestosterone into 5α-dihydrotestosterone (DHT).

Mode of ActionFinasteride is a competitive and specific inhibitor of Type II 5α-reductase, an intracellular enzyme that converts the androgen testosteroneinto DHT. Finasteride has no affinity for the androgen receptor and hasno androgenic or antiandrogenic effects. Inhibition of Type II 5α-reductase blocks the conversion of testosterone to DHT, resulting insignificant decreases in serum and tissue DHT concentrations. In menwith male pattern hair loss, the balding scalp contains miniaturized hairfollicles and increased amounts of DHT compared with hairy scalp.Administration of Finasteride decreases scalp and serum DHTconcentrations in these men.

IndicationsRecur is indicated for the treatment of male pattern hair loss (androgenicalopecia) in MEN ONLY.

Dosage and AdministrationThe recommended dosage is 1 mg once a day. Recur may be administeredwith or without meals. In general, daily use for three months or more isnecessary before benefit is observed. Continued use is recommended tosustain benefit. Withdrawal of treatment leads to reversal of effect within12 months.

ContraindicationHypersensitivity to any component of this medication. Finasteride use isalso contraindicated in women and paediatric patient.

PrecautionsCaution should be used in the administration of Recur in patients withliver function abnormalities, as Finasteride is metabolized extensively in


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the liver. Women who are or may potentially be pregnant should nothandle crushed or broken tablets of Recur.

Drug InteractionsNo drug interactions of clinical importance have been identified.

Side EffectsFinasteride is well tolerated. In clinical studies, the following adversereactions were reported as possibly drug related in >1% of patientstreated for 12 months with Finasteride 1 mg daily : decreased libido(1.8%), erectile dysfunction (1.3%), ejaculation disorder (1.2%) anddecreased volume of ejaculate (0.8%).

OverdosageIn clinical studies, single dose of Finasteride up to 400 mg and multipledoses of Finasteride up to 80 mg/day for three months did not result inadverse reactions. Until further experience is obtained, no specifictreatment for an overdose with Finasteride can be recommended.

Pharmaceutical PrecautionStore at room temperature, 15o to 30oC. Protect from moisture.

Commercial PackRecur Tablet : Box containing 3 blister strips of 10 tablets, each tabletcontains Finasteride USP 1 mg.


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Reflon®

Tablet

DescriptionReflon film coated tablet contains Glucosamine Hydrochloride USP.Glucosamine is a naturally occurring compound for the body'sproduction of point lubricants and shock-absorbers necessary tomaintain healthy cartilage and joint function. Glucosamine Hydrochlorideis a prodrug for glucosamine that is well absorbed after oraladministration and diffuses into several tissues, including bones andarticular cartilages. The active ingredient in the treatment of osteoarthritisis glucosamine.

Data supports Glucosamine as the first anti-osteoarthritic drug that treatsboth sign and symptoms of osteoarthritis and modifies diseaseprogression. It is as effective as NSAIDs with significantly bettertolerability and clinical compliance.

Indications♦ Indicated for the treatment of osteoarthritis of knee, hip, spine, and

other locations.

♦ As dietary supplement

Dosage and AdministrationOne (500 mg) tablet three times daily or as directed by the physicians. Asingle dose of 1500 mg daily may also be effective. Obese individuals mayneed higher doses, based on body weight.

ContraindicationThere are no known contraindication for Glucosamine. But provenhypersensitivity to Glucosamine is a contraindication.

PrecautionsDiabetics are advised to monitor blood glucose levels regularly whiletaking Glucosamine. No special studies were performed in patientswith renal and/or hepatic insufficiency. The toxicological andpharmacokinetic profile of the product does not indicate limitations for


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these patients. However administration of Glucosamine to these patientswith severe hepatic or renal insufficiency should be under appropriatemedical supervision.

Side EffectsSafety studies with Glucosamine show no demonstrable toxicity. Rarelyoccurring side effects like mild and reversible intestinal flatulence arealmost like placebo.

Use in Pregnancy and LactationWomen who are pregnant or who could become pregnant should notsupplement with glucosamine. Glucosamine has not been studied enoughto determine their effects on a developing fetus. And no studies haveevaluated the use of Glucosamine during pregnancy or lactation. Itshould be taken with caution and medical advice during pregnancy andlactation.

Drug InteractionsThere have been no reports of significant drug interactions ofGlucosamine with antibiotics/antidepressants/antihypertensives/nitrates/antiarrythmics/anxiolytic/hypoglycaemic agents/anti-secretives.

Commercial PackReflon Tablet : Each box contains 10 blister strips or 10 tablets. Each filmcoated tablet contains Glucosamine Hydrochloride USP equivalent to 500mg Glucosamine.


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Relentus®

Tablet

Description Tizanidine Hydrochloride is a centrally acting skeletal muscle relaxant.Each tablet contains Tizanidine Hydrochloride INN equivalent to 2 mgTizanidine.

IndicationsIt is used in the symptomatic treatment of painful muscle spasmassociated with musculoskeletal conditions and as an adjunct in themanagement of spasticity associated with multiple sclerosis or spinal corddisorders.

Dosage and AdministrationThe usual initial daily dose is 2 mg as a single dose. The daily dose may beincreased thereafter according to response in steps of 2 mg at intervals ofat least 3 to 4 days, usually up to 24 mg daily given in 3 to 4 divided doses.The maximum recommended dose is 36 mg daily.

ContraindicationTizanidine Hydrochloride is contraindicated to the patients who haveknown hypersensitivity to this drug and in case of severe hepaticimpairment.

PrecautionsPatients with impaired kidney or liver function; when patients drive avehicle or operate machinery.

Side EffectsTizanidine Hydrochloride may cause drowsiness, fatigue, dizziness, drymouth, nausea, gastrointestinal disturbances, hypotension. Bradycardia,insomnia, hallucinations and altered liver enzymes, and rarely acutehepatitis have also been reported.

Drug InteractionsAlcohol or other CNS depressants may enhance the CNS effects ofTizanidine. There may be an additive hypotensive effect when Tizanidineis used in patients receiving antihypertensive therapy.


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Use in ChildrenExperience in children is limited and the use of Tizanidine in this patientgroup is not recommended.

Use in ElderlyRenal clearance in the elderly may in some cases be significantlydecreased. Caution is therefore indicated when using in elderly patients.

Use in Pregnancy and LactationTizanidine has no teratogenic effects in rats and rabbits. As there havebeen no controlled studies in pregnant women, however, it should not beused during pregnancy unless the benefit clearly outweighs the risk.Although only small amounts of Tizanidine are excreted in animal milk,lactating women should not take Tizanidine.

Commercial PackRelentus Tablet : Box containing 3 blister strips of 10 tablets, each tabletcontains Tizanidine Hydrochloride INN equivalent to 2 mg Tizanidine.


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Resitone®

Tablet

DescriptionResitone is a combination of a potassium sparing diuretic, Spironolactoneand a loop diuretic, Frusemide. This combination produces synergistic oradditive diuretic effects. Frusemide component inhibits the

Na+/K+/2Cl- co-transporter in the ascending limb of Loop of Henleand blocks the reabsorption of sodium, potassium and chloride ionsthereby increasing the quantity of sodium and the volume of waterexcreted in the urine. Spironolactone component inhibits thereabsorption of sodium and excretion of potassium at the distal tubule byblocking the action of aldosterone. So the excretion of sodium isincreased and the excess loss of potassium, induced by Frusemide isdecreased.

IndicationsResitone is indicated for the treatment of

- Oedema- Congestive heart failure- Liver cirrhosis with ascites- Essential hypertension- Hyperaldosteronism

Dosage and Administration1 to 4 tablets daily (50 to 200 mg of Spironolactone and 20 to 80 mg ofFrusemide) according to the patient’s response.

ContraindicationResitone is contraindicated in patients with a history of hypersensitivityto Spironolactone or Frusemide. It is also contraindicated in acute renalinsufficiency, anuria, and Hyperkalemia.

Side EffectsFatigue, blood disorders, skin rashes, diarrhoea, constipation, nausea,vomiting, abdominal pain, hyperglycaemia, hypotension, gynaecomastia,irregular menstrual cycle, disturbances in the levels of electrolyte in theblood, and impotence may occur.


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Precautions It is recommended that individuals taking this medicine have their fluidand electrolyte balance monitored regularly. Resitone should be used withcaution in diabetes, enlarged prostate, hypotension and hypovolaemia.

Use in Pregnancy and LactationResitone should be used with caution during pregnancy and only ifexpected benefit to mother is greater than the possible risk to the foetus.It is recommended that mothers should avoid using this medicine whilebreast feeding.

Drug InteractionsWhen taken together with ACE inhibitors or potassium salts there is anincreased risk of hyperkalaemia. Spironolactone increases the levels ofcardiac glycosides such as Digoxin in the blood and this may result indigitalis toxicity. Corticosteroids may cause hypokalaemia if they are usedwith Spironolactone. When taken together with drugs that decrease bloodpressure there is an increased risk of significant lowering of bloodpressure and may cause fainting, especially when given with the first doseof ACE inhibitors (e.g. Captopril). The blood pressure lowering anddiuretic effects of Frusemide may be reduced or abolished when usedtogether with Indomethacin and possibly other non-steroidal anti-inflammatory drugs (NSAIDs).

Pharmaceutical PrecautionStore between 15ο C to 25ο C. Keep in a cool dry place. Keep out of thereach of children

Commercial Pack Resitone Tablet : Box containing 30 tablets in 3 x 10’s blister strips. Eachtablet contains Spironolactone BP 50 mg and Frusemide BP 20 mg.


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Reumafen®

Tablet/Suspension

DescriptionReumafen (Ibuprofen) is chemically (±)-2-(p-isobutylphenyl) propionicacid. It is a non-steroidal anti-inflammatory agent with analgesic andantipyretic properties.

After oral administration, Ibuprofen is rapidly and almost completelyabsorbed. Peak serum levels are achieved between 1 and 2 hours afterdosing. Ibuprofen is excreted in the urine and excretion is completedwithin 24 hour.

IndicationsReumafen is indicated for the treatment of- ♦ rheumatoid arthritis, ankylosing spondylitis, osteoarthritis and other

non-rheumatoid arthropathies

♦ non-articular rheumatic conditions such as frozen shoulder, bursitis,tendinitis, tenosynovitis and low back pain

♦ soft tissue injuries such as sprain, strain and post-operative pain

♦ dysmenorrhoea

♦ dental pain

♦ cold and fever

Dosage and AdministrationFor children 20 mg per kg body weight daily in divided doses. In children weighing lessthan 30 kg the total daily dosage should not exceed 500 mg. Ifgastrointestinal disturbances occur Reumafen should be given with foodor milk. 1-2 years : ½ tea spoonful (2.5 ml) 3-4 times daily; 3-7 years : 1tea spoonful (5 ml) 3-4 times daily; 8-12 years : 2 tea spoonful (10 ml) 3-4 times daily.

For adult For arthritic pain : The dosage range is from 0.9 to 2.4 g per day. The usualdose is 400 mg, 3-4 times per day, preferably after food.


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The dose may be raised to a maximum of 2.4 g daily depending on theseverity of symptom at the time of initiating drug therapy or as patientsfail to respond. After a satisfactory response has been achieved the doseshould be reviewed and adjusted as required and tapered gradually.

For mild to moderate pain : 400 mg 6 hourly or as demanded by thecondition.

For dysmenorrhoea : 400 mg every 4 hours or as demanded by the condition.

Contraindication Reumafen should not be given to patients with hypersensitivity tolbuprofen and to individuals who show nasal polyps, angioedema,bronchospastic reactivity to Aspirin or other non-steroidal anti-inflammatory drug.

PrecautionsReumafen should be given with caution to patients with bleedingdisorders, cardiovascular diseases, peptic ulceration or a history of suchulceration and in those who are receiving coumarin anticoagulants and inpatients with renal or hepatic impairment.

Use in Pregnancy and LactationReumafen is not recommended during pregnancy or for use in nursingmothers.

Side EffectsUsually Reumafen has a low incidence of side effects. The most frequentside effects are gastrointestinal disturbances. Peptic ulceration andgastrointestinal bleeding have occasionally been reported. Other sideeffects include headache, dizziness, nervousness, skin rash, pruritus,drowsiness, insomnia, blurred vision and other ocular reactions,hypersensitivity reaction, abnormal liver function test, impairment ofrenal function, agranulocytosis and thrombocytopenia.

OverdosageGastric lavage, correction of blood electrolyte (if necessary). There is nospecific antidote for Ibuprofen.


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Pharmaceutical PrecautionKeep in a cool and dry place. Keep out of the reach of children.

Commercial PackReumafen-200 Tablet : Box containing 100 sugar coated tablets in 10 x10's blister strips, each tablet contains Ibuprofen BP 200 mg.

Reumafen-400 Tablet : Box containing 100 sugar coated tablets in 10 x10's blister strips, each tablet contains Ibuprofen BP 400 mg.

Reumafen Suspension : 100 ml suspension in amber glass bottle. Each 5ml contains Ibuprofen BP 100 mg.


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Rolacin®

Tablet

DescriptionRolacin (Clarithromycin) is a semisynthetic antibiotic of macrolide group,available as 250 mg and 500 mg film coated tablet. It binds to the 50Sribosomal subunit of susceptible bacteria and suppresses its proteinsynthesis. Rolacin is highly effective against a wide range of aerobic andanaerobic Gram-positive and Gram-negative bacteria. The activeingredient of Rolacin is Clarithromycin USP.

IndicationsRolacin (Clarithromycin) is indicated for the treatment of mild tomoderate infections caused by susceptible strains of the microorganismslisted below-♦ Upper respiratory tract infections : pharyngitis and tonsillitis due to

Streptococcus pyogenes, Acute maxillary sinusitis due to Streptococcuspneumoniae

♦ Lower respiratory tract infections : pneumonia due to Mycoplasmapneumoniae or Streptococcus pneumoniae, Acute exacerbation of chronicbronchitis

♦ Uncomplicated skin and skin structure infections due to Staphylococcusaureus or Streptococcus pyogenes

♦ Acute otitis media

♦ As an adjunct in the treatment of duodenal ulcers for the eradicationof H. pylori.

Dosage and AdministrationAdult : Recommended dosage in adults is 250 mg every 12 hours for 7days. In severe cases, dosage may be increased up to 500 mg every 12hours for up to 14 days.

In patients with renal impairment with creatinine clearance <30 ml/ min,the dosage should be reduced by half.


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Eradication of H. pylori : Rolacin-500 (Clarithromycin) 1 Tablet twice dailyProceptin-20 (Omeprazole) 1 Capsule twice daily

Filmet-400 (Metronidazole) 1 Tablet twice daily

(For 7-day treatment regimen)

Dosage schedule of Children :-Body weight under 8 kg : 7.5 mg/kg twice daily

8-11 kg (1 to 2 years) : 62.5 mg twice daily

12-19 kg (3 to 6 years) : 125 mg twice daily

20-29 kg (7 to 9 years) : 187.5 mg twice daily

Children older than 10 years : 250 mg twice daily

The usual duration of treatment is 7 to 14 days depending on thepathogen involved and the severity of infection.

ContraindicationIt is contraindicated in patients with known hypersensitivity toClarithromycin or any other macrolide antibiotics.

Side EffectsRolacin is generally well tolerated. Commonly reported side effectsinclude nausea, vomiting, diarrhoea, abdominal pain, stomatitis andglossitis. Other side effects include allergic reactions and headache.

PrecautionsClarithromycin is principally excreted by the liver and kidney. Cautionshould be exercised in administering this antibiotic to patients withimpaired hepatic and renal functions. Prolonged or repeated use ofClarithromycin may result in an overgrowth of non-susceptible bacteriaor fungi. If superinfection occurs, Clarithromycin should be discontinuedand appropriate therapy instituted. Concomitant administration withTheophylline has been associated with increased serum Theophyllinelevel. Effects of Digoxin and Warfarin may be potentiated withconcomitant administration of Clarithromycin.

Drug InteractionsClarithromycin should not be prescribed with Terfenadine and Cisapride.


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Commercial PackRolacin Tablet : Box containing 20 tablets in 2 x 10’s blister strips. Eachfilm coated tablet contains Clarithromycin USP 250 mg.

Rolacin-500 Tablet : Box containing 10 tablets in 1 x 10’s blister strip.Each film coated tablet contains Clarithromycin USP 500 mg.


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Rostil®Tablet

DescriptionRostil is a musculotropic antispasmodic agent available as film coatedtablet, each containing 135 mg of Mebeverine Hydrochloride BP. It actsdirectly on smooth muscle of gastrointestinal tract and is used to treatbowel spasm.

Indications Rostil is indicated :

♦ for the symptomatic relief of irritable bowel syndrome♦ other conditions include;

- Chronic irritable colon- Spastic constipation- Mucous colitis- Colicky abdominal pain and cramps- Persistent non-specific diarrhoea

Dosage and Administration Adults (including elderly) : One tablet three times a day, preferably 20minutes before meals. After a period of several weeks when the desiredeffect has been obtained, the dosage may be gradually reduced.

Side Effects There are no known life-threatening toxic effects of Rostil. There are fewreported cases of overdose with Mebeverine.

Contraindication None known.

Use in Special PopulationNeonates : Not recommended for neonates.

Children : The preparation is only recommended for children over 10years.


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Pregnant woman : No teratogenicity has been shown in animalexperiments and there are no known teratogenic effects in human.

Drug Interactions None known.

OverdosageOn theoretical grounds it may be predicted that CNS excitability willoccur in cases of overdosage. No specific antidote is known; gastriclavage and symptomatic treatment is recommended.

Commercial Pack Rostil Tablet : Box containing 5 blister strips of 10 tablets, each tabletcontains Mebeverine Hydrochloride BP 135 mg.


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Sensipin®

Tablet

Description Sensipin tablet contains Clozapine BP 25 mg, which is an atypicalneuroleptic and a dibenzodiazepine.

Indications Sensipin is indicated for- Refractory psychoses, psychotic patients withsevere extrapyramidal symptoms with other treatments, and psychoticpatients with severe tardive dyskinesia with other treatments.

Dosage and Administration To minimize the incidence of adverse effects, Sensipin should beintroduced gradually, beginning with low doses and increasing accordingto response.

Initial Treatment : It is recommended that treatment with Sensipin shouldbegin with one-half of a 25 mg tablet (12.5 mg) once or twice daily andthen be continued with daily dosage increments of 25-50 mg/day, if well-tolerated, to achieve a target dose of 300-450 mg/day by the end of twoweeks. Subsequent dosage increments should be made not more thanonce or twice weekly, in increments not to exceed 100 mg. Most patientsare expected to respond to 200-450 mg daily, a larger proportion may begiven at night.

Maintenance dose : Once a therapeutic response has been obtained, agradual reduction of dosage to a maintenance dose of 150 to 300 mgdaily may be made. Daily maintenance doses of 200 mg or less may begiven as a single dose in the evening. Where possible, Sensipin should bewithdrawn gradually over a 1-2 week period.

Discontinuation of treatment : In the event of planned termination ofSensipin therapy, gradual reduction in dose is recommended over a 1-2week period. However, if a patient’s medical condition requires abruptdiscontinuation (e.g. Leucopenia), the patient should be carefullyobserved for the recurrence of psychotic symptoms.


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Contraindication Sensipin is contraindicated in patients with myeloproliferative disorders,uncontrolled epilepsy, or with a history of Clozapine inducedagranulocytosis or severe granulocytopenia. As with more typicalantipsychotic drugs, Sensipin is contraindicated in severe central nervoussystem (CNS) depression or comatose states from any causes. Sensipinshould not be used simultaneously with other agents having a well-knownpotential to cause agranulocytosis or otherwise suppress bone marrowfunction. The mechanism of Clozapine induced agranulocytosis isunknown; nonetheless, it is possible that causative factors may interactsynergistically to increase the risk and/or severity of bone marrowsuppression.

Side Effects Potentially life-threatening effects : Clozapine can cause reversible neutropeniawhich may progress to a potentially fatal agranulocytosis; the greatest riskis from the second to the sixth month of treatment. All patientsundergoing treatment should have weekly differential white cell counts.Agranulocytosis is reversible on drug withdrawal but potentially fatal ifunheeded or undetected. Acute overdosage : No case of this kind has beenreported. Severe or irreversible adverse effects : Toxic delirium can occur inabout 3% of patients. Symptomatic adverse effects : Sedation and syncopefrom hypotension may occur especially at the start of treatment. The drughas been reported to cause influenza like syndrome. Extrapyramidaldisorders including tardive dyskinesia appear to be rare or absent withSensipin. Sensipin has little effect on prolactin secretion; endocrine andsexual dysfunction are uncommon.

Overdosage Human experience : The most commonly reported signs and symptomsassociated with Clozapine overdoses are altered states of consciousness,including drowsiness, delirium and coma; tachycardia; hypotension;respiratory depression or failure; hypersalivation. Aspiration pneumoniaand cardiac arrhythmias have also been reported. Seizures have occurredin a minority of reported cases. Fatal overdoses have been reported withClozapine, generally at doses above 2500 mg.

Management of overdosage : Establish and maintain airways; ensure adequate


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oxygenation and ventilation. Activated charcoal, which may be used withsorbitol, may be as or more effective than emesis or lavage and should beconsidered in treating overdosage. Cardiac and vital signs monitoring isrecommended along with general symptomatic and supportive measures.There are no specific antidotes for Clozapine. Forced diuresis, dialysis,haemoperfusion and exchange transfusion are unlikely to be of benefit.In managing overdosage, the physician should consider the possibility ofmultiple drug involvement.

Precautions General : Because of the significant risk of agranulocytosis and seizure, theextended treatment failing to show an acceptable level of clinical responseshould ordinarily be avoided. In addition, the need for continuingtreatment in patients exhibiting beneficial clinical responses should beperiodically re-evaluated.

Fever : During Clozapine therapy, patients may experience transienttemperature elevations above 100.4ºF with the peak incidence within thefirst 3 weeks of treatment. On occasion, there may be an associatedincrease or decrease in WBC count. Patients with fever should be carefullyevaluated to rule out the possibility of an underlying infectious process orthe development of agranulocytosis. In presence of high fever, thepossibility of Neuroleptic Malignant Syndrome (NMS) must beconsidered.

Anticholinergic toxicity : Clozapine has very potent anticholinergic effectsand great care should be exercised in using this drug in presence ofprostatic enlargement or narrow angle glaucoma. In addition, Clozapineuse has been associated with varying degrees of impairment of intestinalperistalsis, ranging from constipation to intestinal obstruction, faecalimpaction and paralytic ileus.

Interference with cognitive and motor performance : Because of initial sedation,Clozapine may impair mental and/or physical abilities, especially duringthe first few days of therapy. The recommendations for gradual doseescalation should be carefully adhered to, and patients be cautioned aboutactivities requiring alertness.


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Use in patients with concomitant illness : Clinical experience with Clozapine inpatients with concomitant systemic diseases is limited. Nevertheless,caution is advisable in using Clozapine in patients with hepatic, renal orcardiac disease.

Use in patients undergoing general anaesthesia : Caution is advised in patientsbeing administered general anaesthesia because of the CNS effects ofClozapine. Checking with the anaesthesiologist is required regardingcontinuation of Clozapine therapy in a patient scheduled for surgery.

Drug Interactions The risk of using Clozapine in combination with other drugs has notbeen systematically evaluated. The mechanism of Clozapine inducedagranulocytosis is unknown; nonetheless, the possibility that causativefactors may interact synergistically to increase the risk and/or severity ofbone marrow suppression warrants consideration. Therefore, Clozapineshould not be used with other agents having a well-known potential tosuppress bone marrow function. Given the primary CNS effects ofClozapine, caution is advised in using it concomitantly with other CNSactive drugs or alcohol. Orthostatic hypotension in patients takingClozapine can, in rare cases, be accompanied by profound collapse andrespiratory and/or cardiac arrest. Although it has not been establishedthat there is an interaction between Clozapine and benzodiazepines orother psychotropics, caution is advised when Clozapine is initiated inpatients taking a benzodiazepine or any other psychotropic drug.

Commercial Pack Sensipin Tablet : Box containing 3 blister strips of 10 tablets, each tabletcontains Clozapine BP 25 mg.


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Serelose®

Solution

DeascriptionSerelose is a brand of Lactulose, a hyperosmolar laxative- an effectivetreatment approach for constipation. It is a non-absorbable disaccharidewhich draws water into the bowel; causes distention through fluidaccumulation, thus promotes soft stool and accelerates bowel motion.

What is Constipation?Constipation is a common problem with a variety of possible causes. Thisterm may be used to describe several different symptoms. The normalfrequency of stool passage is from three times a day to once in every threedays. Going more than three days without a bowel movement is thereforeconsidered abnormal. Some people feel miserable if they do not defaecateon a daily basis. Others may go a week or longer without any ill effects.Hard stool, straining to pass, or a sense of incomplete evacuation mayalso be termed constipation. Constipation may worsen with time becauseof the disease process. If a person feels uncomfortable as a result ofbowel problems then treatment is justified to relieve or minimize thesesymptoms.

Indications♦ Constipation♦ Hepatic encephalopathy

Dosage and AdministrationAdults (including elderly) : 3 tea spoonful or 15 ml twice daily

Children 5 to 10 years : 2 tea spoonful or 10 ml twice daily

Children under 5 years : 1 tea spoonful or 5 ml twice daily

Babies under 1 year : ½ tea spoonful or 2.5 ml twice daily (paediatric dose should be given after breakfast)

Each dose of Serelose may, if necessary, be taken with water or fruitjuices, usually once a day, preferably in the morning. If a dose is forgotten


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it should be taken as soon as one remembers up to 8 hours beforebedtime. If later, wait for next scheduled dose (don’t double this dose).Don’t take at bedtime. Usual time lapse before drug works is 30 minutesto 3 hours.

OverdosageSymptoms of overdosage include fluid depletion, weakness, vomiting,fainting etc. Overdosage is unlikely to threaten life. If one takes muchlarger amount than prescribed, consultation with physician is essential.

Side EffectsLife threatening : None expected; Common : Increased thirst, cramps, nausea,diarrhoea, flatulence; Infrequent : Irregular heart beat, muscle cramps; Rare: Dizziness, confusion, fatigue, weakness.

SafetySerelose is safe in the long term and has been used effectively even in frailelderly patients.

PrecautionsIt should be avoided if one is allergic to any hyperosmotic laxative, havesymptoms of appendicitis, inflammatory bowel diseases or intestinalblockage, have missed a bowel movement for only 1 or 2 days. Adversereactions over age 60 year may be more frequent and severe than inyounger persons. In pregnancy no proven problems were detected. Avoidthe drug if possible. Consultation with physician is required. It has no sideeffect during breast feeding. Lactulose oral solution could be used ininfants and children only under medical supervision. It should not beused to ‘flush out’ the system or as a ‘tonic'.

Commercial pack Serelose Solution : Each amber glass bottle contains 100 ml Serelosesolution. Each 5 ml contains Lactulose solution BP equivalent to 3.35 gLactulose.


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Sibulin®

Capsule

DescriptionSibulin is an orally administered agent for the treatment of obesity. Eachcapsule contains 5 mg of Sibutramine Hydrochloride Monohydrate INN.

IndicationsSibulin is indicated for the management of obesity including weight lossand maintenance of weight loss and should be used in conjunction witha reduced calorie diet. Sibulin is recommended for obese patients with aninitial body mass index 30 kg/m2 or 27 kg/m2 in the presence of otherrisk factors (e.g. hypertension, diabetes, dyslipidaemia). [Metricconversion are as follows : 2.2 pounds = 1 kg and inches x 2.54 = meter.]

Dosage and AdministrationThe recommended starting dose of Sibulin is 10 mg administered oncedaily with or without food. If there is inadequate weight loss the dose maybe titrated after four weeks to a total of 15 mg once daily. The 5 mg doseshould be reserved for patients who do not tolerate the 10 mg dose.

ContraindicationSibulin is contraindicated in patients receiving monoamine oxidaseinhibitors (MAOIs) antidepressants, with hypersensitivity to Sibutramineor any of the ingredients of Sibulin, who have anorexia nervosa, and inthose taking other centrally acting appetite suppressant drugs.

Side EffectsIn placebo-controlled obesity studies the most common events were drymouth, anorexia, insomnia and constipation.

Use in Special PopulationPaediatric : The safety and effectiveness of Sibulin in paediatric patientsunder 16 years old has not been established.

Renal Insufficiency : Sibulin should not be used in patients with severe renalimpairment.


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Hepatic Insufficiency : Dosage adjustment in patients with mild to moderatehepatic impairment is not required. Sibulin should not be used in patientswith severe hepatic dysfunction.

Use in Pregnancy and LactationThe use of Sibulin during pregnancy is not recommended. Women ofchild-bearing potential should employ adequate contraception whiletaking Sibulin. It is not known whether Sibutramine or its metabolites areexcreted in human milk. Sibulin is not recommended for use in nursingmothers.

Drug InteractionsBecause Sibulin inhibits serotonin reuptake it should not be administeredwith other serotonergic agents such as Fluoxetine, Fluvoxamine,Paroxetine, Sertraline and Venlafaxine. Because Sibulin inhibits serotoninreuptake, Sibulin should not be used concomitantly with monoamineoxidase inhibitors MAOIs e.g. Phenelzine and Selegiline. At least 2 weeksshould elapse between discontinuation of a MAOI and initiation oftreatment with Sibulin. Similarly at least 2 weeks should elapse betweendiscontinuation of Sibulin and initiation of treatment with MAOI. Therare but serious constellation of symptoms termed serotonin syndromehas also been reported with the concomitant use of two serotoninreuptake inhibitors.

WarningSibulin substantially increases blood pressure in some patients. Regularmonitoring of blood pressure is required when prescribing Sibulin.Sibulin should not be used in patients with a history of coronary arterydisease, congestive heart failure, arrhythmias or stroke.

Because Sibulin can cause mydriasis, it should be used with caution inpatients with narrow angle glaucoma.

Organic causes of obesity (e.g. hypothyroidism) should be excludedbefore prescribing Sibulin.

OverdosageThere is no specific antidote to Sibulin. Treatment should consist ofgeneral measures employed in the management of overdosage, an airwayshould be established, cardiac and vital sign monitoring is recommended;


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general symptomatic and supportive measures should be instituted.Cautious use of β-blockers may be indicated to control elevated bloodpressure or tachycardia.


Commercial PackSibulin Capsule : Box containing 60 capsules in 6 x 10’s blister strips. Eachcapsule contains Sibutramine Hydrochloride Monohydrate INN 5 mg.


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Spanil®Tablet

DescriptionSpanil is an antispasmodic containing in each tablet 10 mg of HyoscineButylbromide BP. Hyoscine Butylbromide is a competitive antagonist ofacetylcholine at postganglionic parasympathetic nerve endings. It relaxessmooth muscles of the hollow organs of the abdominal and pelviccavities.

IndicationsIt is indicated for the following conditions :

♦ Spasm of the gastrointestinal tract♦ Spasm of the genito-urinary tract♦ Spasmodic dysmenorrhoea

Dosage and Administration Adult : 1-2 tablets 3-4 times dailyChildren (6-12 years) : 1 tablet 3 times daily

ContraindicationSpanil should not be given to patients suffering from glaucoma.

PrecautionsShould be used with caution during 1st trimester of pregnancy.

Side Effects Dryness of mouth and tachycardia have been reported infrequentlyduring treatment with Hyoscine Butylbromide.

Commercial PackSpanil Tablet : Box containing 10 blister strips of 10 film coated tablets,each tablet contains 10 mg of Hyoscine Butylbromide BP.


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Sparlin®

Tablet

DescriptionSparlin (Sparfloxacin) is a synthetic, broad-spectrum antibacterial agentfrom the fluoroquinolone family. It has been reported to be more activein vitro than other fluoroquinolones against some Gram-positiveorganisms (such as Streptococcus pneumoniae and Staphylococcus aureus),Mycobacteria and Chlamydia spp. Each Sparlin tablet containsSparfloxacin INN 200 mg.

IndicationsSparlin is indicated for the treatment of the following infections due tosusceptible microorganisms:

♦ Upper and lower respiratory tract infections including sinusitis, acuteexacerbation of chronic bronchitis, community and hospital acquiredpneumonia.

♦ Urinary tract infections including gonococcal and non-gonococcalurethritis, chancroid and other sexually transmitted diseases.

♦ Skin and soft tissue infections.

♦ Prophylactic use in different urological and ophthalmic operations.

Dosage and AdministrationThe recommended daily adult dose is two tablets (400 mg) on first day asa loading dose, followed by one tablet (200 mg) daily as a maintenancedose. Duration of maintenance treatment is 5 to 10 days. It can be takenwith or without food.

Use in Children, Pregnancy and LactationIt is not recommended for children below 12 years of age. Sparfloxacinshould be administered in pregnant women and lactating mother only ifthe potential maternal benefits justify the risks to the foetus/neonate.


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ContraindicationHypersensitivity to fluoroquinolones including Sparfloxacin. It is alsocontraindicated in patients with known QTc prolongation or in thosewith pre-arrhythmic conditions (e.g., hypokalaemia, significantbradycardia, congestive heart failure, atrial fibrillation or other cardiacdisease).

PrecautionsRenal disease, gastric ulcers, concomitant use of NSAIDs. In renal failureof third degree severity (creatinine clearance <30 ml/min) dosagemodification is recommended- 400 mg on 1st day, 200 mg on 2nd and 3rdday followed by 200 mg every 48 hours. Because fluoroquinolones havebeen associated with tendon rupture, Sparfloxacin should be discontinuedat the first sign of tendon pain. Exposure to UV radiation duringtreatment should be avoided.

Side EffectsSide effects are mild, transient and seldom. These are allergic reactions;photosensitization; gastrointestinal disorders including nausea, vomiting,diarrhoea; headache and sleep disturbance at the start of treatment.

Drug Interactions On concomitant use with Quinidine, Sotalol, Erythromycin, Astemizole,Terfenadine, vinca alkaloids there is increased risk of arrhythmia. Salts,oxides and hydroxides of Magnesium, Aluminium and Calcium decreaseabsorption of Sparfloxacin.

Commercial PackSparlin Tablet : Box containing 1 blister strip of 10 tablets, each tabletcontains Sparfloxacin INN 200 mg.


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Spulyt®

Tablet/Syrup

DescriptionSpulyt (Bromhexine Hydrochloride) is a highly effective expectorant.

IndicationsSpulyt is indicated in the treatment of respiratory disorders associatedwith productive cough. These include; tracheobronchitis, bronchitis withemphysema, bronchiectasis, bronchitis with bronchospasm, chronicinflammatory pulmonary conditions and pneumoconiosis.

Dosage and Administration Spulyt tablet Adults and Children over 10 years : 8-16 mg 3 times daily.

Spulyt syrupAdults: The recommended daily dose is 2 to 4 tea spoonfuls 3 times.Initially 4 tea spoonfuls 3 times daily and then as required.

Children: Suggested dosage for children under 2 years is ¼ tea spoonful3 times daily, for 2-5 years is ½ tea spoonful 3 times daily and for childrenaged 5-10 years 1 tea spoonful 3 times daily.

Side EffectsGastrointestinal side effects may occur occasionally with BromhexineHydrochloride, and a transient rise in serum aminotransferase values hasbeen reported. Other reported adverse effects include headache,dizziness, sweating and skin rash.

PrecautionsSince Bromhexine Hydrochloride may disrupt the gastric mucosa soBromhexine Hydrochloride should be used with care in patients with ahistory of peptic ulceration. Care is also advisable in asthmatic patients.

ContraindicationContraindicated to those who are hypersensitive to BromhexineHydrochloride.


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Pharmaceutical PrecautionStore below 25οC. Protect from light. Keep the container tightly closed.

Commercial PackSpulyt Tablet : Each box contains 10 blister strips of 10 tablets. Eachtablet contains Bromhexine Hydrochloride BP 8 mg.

Spulyt Syrup : Bottle containing 100 ml syrup. Each 5 ml containsBromhexine Hydrochloride BP 4 mg.


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Tamona®

Tablet

DescriptionTamona (Tamoxifen) is a non-steroidal, triphenylene-based drug whichdisplays a complex spectrum of oestrogen antagonist and oestrogenagonist-like pharmacological effects in different tissues. In breast cancerpatients, at the tumour level, Tamoxifen acts primarily as anantioestrogen, preventing oestrogen binding to the oestrogen receptor.Additionally Tamoxifen has been reported to lead to maintenance ofbone mineral density in postmenopausal women of the order of 10-20%.Additionally Tamoxifen has been reported to lead to maintenance ofbone mineral density in postmenopausal women.

PharmacologyAfter oral administration, Tamona (Tamoxifen) is absorbed rapidly withmaximum serum concentrations attained within 4-7 hours. Steady stateconcentrations (about 300 mg/ml) are achieved after four weekstreatment with 40 mg daily. The drug is highly protein bound to serumalbumin (99%). Metabolism is by hydroxylation, demethylation andconjugation, giving rise to several metabolites which have a similarpharmacological profile to the parent compound and thus contribute tothe therapeutic effect. Excretion occurs primarily via the faeces and anelimination half-life of approximately seven days has been calculated forthe drug itself, whereas that for N-desmethyltamoxifen, the principalcirculating metabolite, is 14 days.

IndicationsTamona is indicated for the treatment of breast cancer.

Dosage and AdministrationAdults (including elderly): The dosage range is 20 to 40 mg daily, giveneither in divided doses twice daily or as a single dose once daily.

ContraindicationTamona must not be administered during pregnancy. Tamona should notbe given to patients who have experienced hypersensitivity to the productor any of its ingredients.


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Side EffectsSide effects can be classified as either due to the pharmacological actionof the drug, e.g. hot flushes, vaginal bleeding, vaginal discharge, pruritusvulvae and tumour flare or as more general side effects, e.g.gastrointestinal intolerance, headache, light-headedness and occasionallyfluid retention and alopecia. When such side effects are severe, it may bepossible to control them by a simple reduction of dosage (within therecommended dose range) without loss of control of the disease.

Skin rashes including isolated reports of erythema multiforme, Stevens-Johnson syndrome and bullous pemphigoid and rare hypersensitivityreactions, including angioedema have been reported. A small number ofpatients with bony metastases have developed hypercalcaemia oninitiation of therapy.

Falls in platelet count, usually only to 80,000-90,000 per/mm3 butoccasionally lower, have been reported in patients taking Tamona forbreast cancer.

A number of cases of visual disturbances including infrequent reports ofcorneal changes and retinopathy have been described in patients receivingTamoxifen therapy. An increased incidence of cataracts has beenreported in association with the administration of the drug. Uterinefibroids and endometrial changes including hyperplasia and polyps havebeen reported. Cystic ovarian swellings have occasionally been observedin premenopausal women receiving Tamoxifen.

Leucopenia has been observed following the administration ofTamoxifen, sometimes in association with anaemia and/orthrombocytopenia. Neutropenia has been reported on rare occasions; thiscan sometimes be severe. There is evidence of an increased incidence ofthromboembolic events including deep vein thrombosis and pulmonaryembolism during Tamoxifen therapy.

Tamoxifen has been associated with changes in liver enzyme levels and onrare occasions with a spectrum of more severe liver abnormalities,including fatty liver, cholestasis and hepatitis.


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Rarely, elevation of serum triglyceride levels, in some cases withpancreatitis, may be associated with the use of Tamoxifen.

OverdosageOn theoretical grounds, overdosage would be expected to causeenhancement of the pharmacological effects mentioned above.Observations in animals show that extreme overdosage (100-200 timesrecommended daily dose) may produce oestrogenic effects. There is nospecific antidote to overdosage and treatment must be symptomatic.

PrecautionsMenstruation is suppressed in a proportion of premenopausal womenreceiving Tamoxifen for the treatment of breast cancer. An increasedincidence of endometrial cancer has seen reported in association withTamoxifen treatment. The underlying mechanism is unknown, but maybe related to the oestrogen-like effect of Tamona. Any patients receivingor having previously received Tamona, who report abnormalgynecological symptoms, especially vaginal bleeding, should be promptlyinvestigated.

A number of second primary tumors, occurring at sites other than theendometrium and the opposite breast, have been reported in clinical trials,following the treatment of breast cancer patients with Tamoxifen. Nocausal link has been established and the clinical significance of theseobservations remains unclear.

Drug InteractionsWhen Tamoxifen is used in combination with coumarin typeanticoagulants, a significant increase in anticoagulant effect may occur.Where such co-administration is initiated, careful monitoring of thepatient is recommended. When Tamoxifen is used in combination withcytotoxic agents, there is an increased risk of thromboembolic events.

Use in Pregnancy and LactationTamoxifen must not be administered during pregnancy. There have beena small number of reports of spontaneous abortions, birth defects andfoetal deaths after women have taken Tamoxifen, although no causalrelationship has been established. Reproductive toxicology studies in rats,rabbits and monkeys have shown no teratogenic potential.


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Women should be advised not to become pregnant whilst taking Tamonaand should use barrier or other nonhormonal contraceptive methods ifsexually active. Premenopausal patients must be carefully examinedbefore treatment to exclude pregnancy. Women should be informed ofthe potential risks to the foetus, if they want to become pregnant whilsttaking Tamona or within two months of cessation of therapy.

It is not known if Tamoxifen is excreted in human milk and therefore thedrug is not recommended during lactation. The decision to discontinueTamona should take into account in case of the importance of the drugto the lactating mother.

Commercial Pack Tamona 10 Tablet : Box containing 30 tablets in 3 x 10’s Alu-Alu formpacks. Each tablet contains Tamoxifen Citrate BP equivalent to 10 mg ofTamoxifen.

Tamona 20 Tablet : Box containing 30 tablets in 3 x 10’s Alu. Alu. formpacks. Each tablet contains Tamoxifen Citrate BP equivalent to 20 mg ofTamoxifen.


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Taverin®

Tablet

DescriptionEach tablet contains Drotaverine Hydrochloride INN 40 mg. Taverin isa potent synthetic antispasmodic which is readily absorbed from theintestine. Like papaverine, it acts directly on the smooth muscle fibers,exceeding however, the antispasmodic effect of the standardpreparations. Taverin is characterized by a rapid onset of actions which isvery advantageous in cases of acute painful spastic conditions. In additionto its spasmolytic and vasodilatory actions, Taverin elicits a selectiveblockade of cardiac β-receptors.

IndicationsTaverin is indicated in the following indications :i) Spastic conditions of the gastrointestinal tract: irritable bowelsyndrome, tensmus in dysentery; biliary colics and spastic conditions ofthe biliary tract such as cholecystolithiasis, cholecystitis, cholangitis; ii)Renal colics and spastic conditions of the urogenital tract: nephrolithiasis,ureterolithiasis, pyelitis, cystitis; iii) Spastic conditions of the uterus:dysmenorrhoea, imminent abortion, uterine tetanus.

Owing to its freedom from cardiotoxic and hypotensive effects as well asits specificity of cardiac adrenolytic action. For this reason Taverin is ofoutstanding value in the treatment of coronary insufficiency and anginapectoris.

Dosage and AdministrationThe average dose for adults is daily three-times 1 to 2 tablets. Childrenshould be given smaller doses according to age and body weight. Smallchildren should receive once or twice daily ¼ - ½ tablet, older children ½to 1 tablet daily. In peptic ulcer it is expedient to combine Taverin withatropine or atropine-like compounds.

ContraindicationHypersensivity to Drotaverine or any of the components of Taverin.


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Side EffectsThe common side effects are headache, dizziness, rhinitis, sinusitis,gastrointestinal upset, nausea, pharyngitis, oedema and fatigue.

Use in Pregnancy and LactationAs with most drugs, the use of Drotaverine Hydrochloride should beavoided during pregnancy and lactation unless essential.

Pharmaceutical PrecautionShould be kept away from moisture and heat and out of the reach ofchildren.

Commercial PackTaverin Tablet: Box containing 100 tablets in 10 x 10’s blister strips. Eachtablet contains Drotaverine Hydrochloride INN 40 mg.


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Terbex®

Cream/Tablet

DescriptionTerbex is a preparation of Terbinafine Hydrochloride. Terbinafine is anallylamine with a range of antifungal activity. It is fungicidal againstdermatophytes, moulds and certain dimorphic fungi. Terbinafine is eitherfungicidal or fungistatic against yeasts, depending on the species.Terbinafine interferes with fungal ergosterol biosynthesis by inhibitingsqualene epoxidase in the fungal cell membrane at an early stage. Thisleads to a deficiency in ergosterol and to intracellular accumulation ofsqualene, resulting in fungal cell death. Terbinafine is highly effective infungal infections of the skin, hair and nails caused by Trichophyton spp.,Microsporum spp . and Epidermophyton floccosum . It is also effective againstyeast infections of the skin, principally those caused by the genus candida.Topical terbinafine appears to be effective in pityriasis versicolor due toPityrosporum arbiculare.

IndicationsTerbex cream is indicated for the treatment of the followingdermatological infections : interdigital tenia pedis (Athlete’s foot), teniacruris (jock itch) or tenia corporis (ring worm) due to susceptibleorganisms and planter tenia pedis (mocasin type) due to Trichophyton spp.

Terbex tablet is indicated for the treatment of onychomycosis of the toenail or finger nail due to dermatophytes and also by non-dermatophytefungi.

Dosage, Application and AdministrationTopical application of Terbex cream to affected areas once or twice dailyfor 1-2 weeks may be adequate for fungal infections of the skin butcertain infections may require oral Terbex tablet therapy.

Usual duration of treatment of Terbex cream in Tinea corporis and Tineacruris : 1-2 weeks. In Tinea pedis : 2-4 weeks (One week of treatment willnormally suffice if the cream is applied twice daily.). In Cutaneouscandidiasis : 1-2 weeks and in Pityriasis (tinea) versicolor : 2 weeks.


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To prevent relapses in fungal infection, treatment should be continued fora adequate length of time. To apply Terbex cream clean and dry theaffected areas thoroughly and apply the cream once or twice a day to theaffected skin and surrounding area in a thin layer and rub in lightly. In thecase of intertriginous infections the application may be covered with agauze strip, especially at night.

Oral administration of Terbex tablet is essential for hair or nail infections.The usual oral dose is 1 Terbex tablet (250 mg) daily for 2 to 12 weeksdepending upon the infection. Finger nail onychomycosis : 1 Terbextablet (250 mg) once daily for 6 weeks. Toe nail onychomycosis : 1 Terbextablet (250 mg) once daily for 12 weeks.

Use in ChildrenExperience with topical Terbex in children is limited and its use cannottherefore be recommended.

ContraindicationHypersensitivity to Terbinafine or any of the excipients in thepreparation.

Side Effects In general, the side effects are mild, transient and do not lead todiscontinuation of therapy. The side effects reported includegastrointestinal disturbances (diarrhoea, dyspepsia, and abdominal pain),rashes etc. Rarely, cases of symptomatic hepatobiliary dysfunctionincluding cholestatic hepatitis have been reported. Besides, there havebeen isolated reports of serious skin reactions. If progressive skin rashoccurs, treatment should be discontinued.

Commercial PackTerbex Cream : Tubes containing 5 g cream, each gram containsTerbinafine Hydrochloride INN 10 mg.

Terbex Tablet : Box containing 1 blister strip of 10 tablets, each tabletcontains Terbinafine Hydrochloride INN equivalent to 250 mgTerbinafine.


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Tofen®

Tablet/Syrup

DescriptionTofen is a preparation of Ketotifen, which has antiallergic properties andhas been used similarly, to Sodium Chromoglycate in the prophylactictreatment of asthma. It also has the properties of an antihistamine.

Tofen possesses marked anti-anaphylactic properties and is effective inpreventing asthmatic attack. Tofen exerts sustained inhibitory effect onhistamine reactions, which can be clearly dissociated from its anti-anaphylactic properties. Experimental investigations in asthmatic subjectshave shown that Ketotifen is as effective orally as administered byinhalation as a selective mast cell stabilizer. Antihistamines wereineffective in those tests. The effectiveness of Ketotifen has been studiedin long term clinical trials. Asthma attacks were reduced in number,severity and duration and in some cases, the patients were completelyfreed from attacks. Progressive reduction of corticosteroids and/orbronchodilators was also possible. The prophylactic activity of Tofen maytake several weeks to become fully established. Tofen will not abortestablished attacks of asthma.

Indications♦ Prophylactic treatment of bronchial asthma.♦ Symptomatic treatment of allergic conditions including rhinitis and

conjunctivitis.

Dosage and AdministrationAdults : 1 mg twice daily with food. If necessary the dose may beincreased to 2 mg twice daily in severe cases. Children above 2 (two) years: 1 mg twice daily with food. Patient’s known to be easily sedated shouldbegin treatment with 0.5 to 1 mg at night for the first few days or asdirected by the physician. Use in elderly : Same as adult dose or as advisedby the physician.

ContraindicationA reversible fall in the platelet count has been observed in a few patientsreceiving Ketotifen concomitantly with oral antidiabetic agent and it has


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been suggested that this combination should therefore be avoided.

Use in Pregnancy and LactationAlthough there is no evidence of any teratogenic effect,recommendations for Ketotifen in pregnancy or when breastfeeding cannot be given.

PrecautionsIt is important to continue the previous treatment for a minimum of twoweeks after starting Tofen to avoid the possibility of exacerbation ofasthma. This applies specially to systemic corticosteroids and ACTHbecause of the possible existence of adrenocortical insufficiency insteroid dependent patient. If intercurrent infection occurs, Tofentreatment must be supplemented by specific antimicrobial therapy.During the first day of treatment with Tofen, reactions may be impairedand patients should be warned not to take charge of vehicle or machineryuntil the effect of Tofen treatment on the individual is known. Patientshould be advised to avoid alcoholic drinks. Tofen may potentiate theeffects of sedatives, hypnotic, antihistamines and alcohol.

Overdosage The reported features of overdosage include confusion, drowsiness,nystagmus, headache and disorientation. Bradycardia and respiratorydepression should be watched for. Elimination of the drug with gastriclavage or emessis is recommended. Otherwise general supportivetreatment shall be instituted.

Side EffectsDrowsiness and in isolated cases, dry mouth and slight dizziness mayoccur at the beginning of treatment, but usually disappear spontaneouslyafter a few days.

Pharmaceutical PrecautionTofen tablet should be protected from heat and moisture.

Commercial PackTofen Tablet : Box containing 10 blister strips of 10 tablets, each tabletcontains Ketotifen Fumarate BP equivalent to 1 mg Ketotifen.

Tofen Syrup : 100 ml syrup in amber glass bottle, each 5 ml containsKetotifen Fumarate BP equivalent to 1 mg Ketotifen.


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Triocim®

Capsule/Suspension

DescriptionTriocim (Cefixime) is a broad spectrum cephalosporin antibiotic of thirdgeneration for oral administration. It is a bactericidal antibiotic and isstable to hydrolysis by many β-lactamases. Triocim kills bacteria byinterfering in the synthesis of the bacterial cell wall. 40-50% of an oraldose is absorbed from gastrointestinal tract, whether taken with meals ornot. The plasma half life is usually about 3 to 4 hours and may beprolonged when there is renal impairment. Triocim is mainly excretedunchanged in bile and urine.

Indications ♦ Upper and lower respiratory tract infections

♦ Urinary tract infections

♦ Gonococcal urethritis

♦ Acute otitis media

Dosage and AdministrationAdult dose : 1 or 2 capsule as a single dose or in two divided doses dailyfor 7 to 14 days, according to the severity of infection.

Child dose : 8 mg/kg daily as a single dose or in two divided doses for 7to 14 days according to the severity of infection age of the children.

½ -1 year : 3.75 ml or 75 mg1 - 4 year : 5 ml or 100 mg5 -10 year : 10 ml or 200 mgAbove 10 year : Adult dose

Side EffectsTriocim is generally well tolerated. The majority of adverse reactionsobserved in clinical trials were mild and self limiting in nature. Amongthem diarrhoea, changes in the colour of stool, nausea, abdominal pain,dyspepsia, headache, dizziness, elevation of serum amylase may occur.


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ContraindicationPatients with known hypersensitivity to cephalosporin group of drugs.

PrecautionsTriocim should be prescribed with caution in individuals with a history ofgastrointestinal diseases, particularly colitis. Dosage adjustment is onlynecessary in severe renal failure. In pregnancy no data are available, so itis probably best to avoid using the drug during pregnancy and by thenursing mothers.

Drug InteractionsNo data are available.

Commercial PackTriocim Capsule : Box containing 3 x 4’s capsule in strip. Each capsulecontains Cefixime Trithydrate USP equivalent to Cefixime 200 mg.

Triocim Suspension : Bottle containing dry powder for preparation of 50ml suspension. After reconstitution, each 5 ml contains CefiximeTrithydrate USP equivalent to Cefixime 100 mg.


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Triovix®

Tablet

DescriptionEach Triovix tablet contains Lamivudine INN 150 mg, Zidovudine USP300 mg and Nevirapine INN 200 mg. A fixed dose combination ofLamivudine, Zidovudine and Nevirapine is recommended for HumanImmunodeficiency Virus-1 (HIV-1) infected patients who are able totolerate standard doses of Lamivudine, Zidovudine and Nevirapine for atleast 2 weeks prior to switching over to this fixed dose combination.Patients should have demonstrated adequate tolerability to Nevirapine.

IndicationsA fixed dose combination of Lamivudine, Zidovudine and Nevirapine isrecommended for HIV-1 infected patients who are able to toleratemaintenance therapy with Nevirapine 200 mg twice daily. All three drugsare to be administered twice daily and each tablet contains half of thedaily dose for each component. Twice daily formulation in single tabletfor three drugs is convenient for patients to take, ensuring higher rate ofcompliance.

Dosage and Administration For treatment of HIV Infection.

Adult dosage : One tablet twice daily. This fixed dose combination is notrecommended for patients who have not been on initial lower dose ofNevirapine 200 mg once daily for 2 weeks and or have not tolerated thisdose. After successful therapy with low dose Nevirapine for two weeks,patients can be switched over to 200 mg bid dose provided they have notdemonstrated any hypersensitivity reaction (rash, abnormal liver functiontests) during their initial exposure to Nevirapine. Monitoring of patientsfor their liver function tests etc. is desirable prior to initiating therapy withNevirapine and monitoring at frequent intervals once therapy with fixeddose combination is continued.

Dosage adjustment : Lamivudine : For patients with low body weight (<50 kg) where dosageadjustment may be required, it is preferable not to use this fixed dosecombination.


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Zidovudine : Because it is a fixed-dose combination, this should not beprescribed for patients requiring dosage adjustment such as those withreduced renal function (creatinine clearance 50 ml/min) or thoseexperiencing dose-limiting adverse events.

Nevirapine : For patients who experience severe rash or rash withconstitutional complaints during the initial low dose Nevirapine phase of14 days with once daily dose of 200 mg; neither, dose should be increasedto twice daily nor they should receive triple fixed dose combination untilthe rash is resolved. Similarly for patients with abnormal liver functiontests, Nevirapine therapy should be stopped till liver function return tonormal and careful restart is advisable after extended observation. Inevent of recurrence, Nevirapine therapy can not be restarted.

For patients where Nevirapine therapy has to be restarted after aninterruption, daily dose of Nevirapine 200 mg for 14 days should befollowed with twice daily dose in absence of any hypersensitivity reaction.Studies have not been documented to suggest dosage of Nevirapine inpatients with hepatic dysfunction, renal insufficiency or undergoingdialysis.

ContraindicationHistory of hypersensitivity to Lamivudine, Zidovudine, Nevirapine andto any of the excipients available in formulation. Not to be used as initialtherapy because initial therapy requires 200 mg once daily of Nevirapinewhereas fixed dose combination allows for 200 mg twice daily ofNevirapine.

Warning and PrecautionsFor the following conditions, assess risk to patient and take action asneeded, chronic hepatitis B, hepatomegaly with steatosis, lactic acidosis,liver function impairment, severe renal function impairment, peripheralneuropathy.

Side EffectsLamivudine : Pancreatitis, paresthesia, peripheral neuropathy, cough,dizziness, fatigue, gastrointestinal problems, headache, insomnia, anaemia,neutropenia, drug induced skin, rash, hair loss.


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Zidovudine : Headache (which may be severe, has been reported in upto 63% of patients receiving Zidovudine and asthenia has been reportedin 9-69%), malaise and fatigue, fever or chills, nausea (61% cases),diaphoresis, dyspnoea, rash and taste perversion have been reported. Skinrashes and myalgia has been reported in patients receiving Zidovudine.Myopathy and myositis with pathologic changes similar to that producedby HIV infection, have been associated with prolonged use ofZidovudine. The major adverse effect is bone marrow toxicity resulting insevere anaemia and/or neutropenia. Patients with low serum folate orvitamin B12 concentrations may be at increased risk for developing bone

marrow toxicity during Zidovudine therapy. There also are limited datasuggesting that bone marrow of patients with fulminant acquiredimmunodeficiency syndrome (AIDS) may be more sensitive toZidovudine-induced toxicity than that of patients with less advanceddisease (eg, AIDS-related complex [ARC]). Anaemia andgranulocytopenia usually resolve when Zidovudine is discontinued orwhen dosage is decreased. Lactic acidosis (in the absence of hypoxaemia)and severe hapatomegaly with steatosis, including some fatalities, havebeen reported in patients receiving Zidovudine.

Nevirapine : More frequent incidences are skin rash, diarrhoea,gastrointestinal problems, headache, nausea and stomach pain. Incidenceof less frequents are aphthous stomatitis, fever, hepatitis and Stevens-Johnson syndrome.

Pharmaceutical PrecautionStore in a cool dry place. Protect from light. Keep out of reach ofchildren.

Commercial PackTriovix Tablet : Each box contains 1 x 10’s tablets in Blister strip. Eachtablet contains Lamivudine INN 150 mg, Zidovudine USP 300 mg andNevirapine INN 200 mg.


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Tripec®

Syrup

DescriptionTripec is a combination preparation of three active ingredients namelyGuaifenesin, Pseudoephedrine Hydrochloride BP and TriprolidineHydrochloride BP. Guaifenesin reduces the viscosity of tenacious sputumand is used as an expectorant. Pseudoephedrine is a decongestant as wellas a bronchodilator for the upper respiratory tract, which givessymptomatic relief of nasal congestion. Triprolidine is an antihistamine;it is used for the symptomatic relief of hypersensitivity reactionsincluding rhinitis, conjunctivitis and urticaria. Tripec is highly palatableorange flavoured syrup.

IndicationsTripec is indicated for the symptomatic relief of upper respiratory tractdisorders associated with common cold, allergy and other viral infections.It is used for the symptomatic treatment of productive cough. Tripec isalso used to relieve symptoms of upper respiratory tract allergies e.g.sneezing, rhinorrhoea and pruritus of nose, eyes and throat.

Dosage and AdministrationAdult and Children over 12 years : 2 tea spoonful thrice daily

Between ages 6-12 years : 1 tea spoonful thrice daily

Between ages 2-5 years : ½ tea spoonful thrice daily,

or as directed by the physician.

ContraindicationTripec is contraindicated in the cases of known hypersensitivity to any ofits constituents, cardiovascular disease including hypertension, lowerrespiratory symptoms including asthma, monoamine oxidase inhibitor(MAOI) therapy.

Warning and Precautions As with any other antihistamine therapy, Tripec may cause drowsiness. Ifaffected, patients should be advised not to drive or operate machinery.


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Concomitant administration of alcohol or other centrally acting sedativesshould be avoided. Although Pseudoephedrine has no pressor effects innormotensive patients but Tripec should be used with caution to patientssuffering from mild to moderate hypertension. Moreover, caution shouldalso be exercised in the following disease conditions- hypertension andheart disease, diabetes, hyperthyroidism, elevated intra-ocular pressure,prostatic enlargement, severe renal and hepatic impairment. Thispreparation should not be used for persistent or chronic cough, whichoccurs with smoking, asthma or emphysema or where excessivesecretions accompany cough, unless directed by a physician.

Side EffectsCNS depression or excitation, drowsiness (reported most frequently),sleep disturbances, hallucinations (rarely reported), skin rashes with orwithout irritation, tachycardia, dryness of mouth, nose and throat haveoccasionally been reported.

Use in Pregnancy Pseudoephedrine, Triprolidine and Guaifenesin have been in widespreaduse without any report of ill-consequences during pregnancy. Butcautions should be exercised by balancing the potential benefit oftreatment to the mother against any possible hazards to the developingfoetus.

Pharmaceutical Precaution Store below 25oC, protected from light. Do not refrigerate.

Commercial PackTripec Syrup : Amber coloured glass bottle containing 100 ml highlypalatable orange flavoured syrup, each 5 ml of which containsGuaifenesin BP 100 mg, Pseudoephedrine Hydrochloride BP 30 mg andTriprolidine Hydrochloride BP 1.25 mg.


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Tycil®Capsule/Suspension/Paediatric Drops

DescriptionTycil contains Amoxicillin (as trihydrate BP) which is chemically D(-)-µ-amino-p-hydroxybenzylpenicillin. It is a broad-spectrum, bactericidalantibiotic similar to Ampicillin in the spectrum of activity but is betterabsorbed when taken orally and produces a higher blood level.

IndicationsTycil is indicated in the following bacterial infections-♦ Infections of the respiratory tract and ear : Laryngitis, Pharyngitis, Tonsillitis,

Sinusitis, chronic and acute Bronchitis, Pneumonia and Otitis media.

♦ Infections of the Biliary and Gastrointestinal tract : Salmonellosis, includingthe carrier stage, Cholecystitis, Peritonitis.

♦ Infections of the Genito-urinary tract : Nephritis, Pyelitis, Pyelonephritis,Cystitis, Urethritis and Gonorrhoea, Bacteriuria in pregnancy.Gynaecological infections including Puerperal sepsis and Septicabortion.

♦ Skin and soft tissue infections : Boils, Carbuncles, Cellulitis.

♦ Prophylaxis of endocarditis : Tycil may be used for the prevention ofdeveloping bacterial endocarditis, associated with procedures such asdental extraction.

♦ Others : Pre- and post-operative prophylaxis and treatment of infections,Septicaemia, Osteomyelitis.

Dosage and AdministrationAdult dosage (including elderly patients) : ♦ Standard dosage : It is 250 mg three times daily, increasing up to 500 mg

three times daily for more severe infections.

♦ Severe or recurrent infection of the respiratory tract : A dosage of 3 gtwice daily is recommended in appropriate cases. (Maximumrecommended oral dosage is 6 g daily in divided doses).

♦ Uncomplicated acute urinary tract infection : A single dose of 3 g.


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♦ Gonorrhoea : A single dose of 3 g, often with 1 g probenecid in thetreatment of uncomplicated gonorrhoea in areas where the pathogen issensitive to Amoxicillin.

♦ Prophylaxis of endocarditis in susceptible patients : A single dose of 3g about 1 hour before procedures such as dental extraction.

Children dosage: ♦ Children up to 10 years of age may be given the equivalent of 125 to

250 mg three times daily.

♦ Children weighing 20 kg or more should be given doses according tothe recommended dosage for adults.

♦ Children under 20 kg body weight a dose of 20 to 40 mg per kg dailyhas been suggested.

♦ In prophylaxis of endocarditis, children may be given half of the adultdose, i.e., 1.5 g about 1 hour before procedures such as dentalextraction.

ContraindicationTycil is contraindicated in patients with known hypersensitivity topenicillins.

Side EffectsSide effects, as with other penicillins, are rare and usually of mild andtransient in nature. Skin rashes may appear to some patients. This must bereported to the physician and treatment should be discontinued.Gastrointestinal complaints such as diarrhoea have occasionally beenobserved. These usually subside on continuation of therapy. Incidence ofpersistent diarrhoea should be reported to the physician.

PrecautionsIn presence of gastrointestinal diseases such as diarrhoea and vomiting,absorption of oral preparation is doubtful. Like all broad-spectrumantibiotics, superinfection may occur in association with Amoxicillin. Insuch cases treatment with Amoxicillin should be discontinued andappropriate therapy to combat superinfection should be instituted.


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Commercial PackTycil-500 Capsule : Box containing 5 blister strips of 10 capsules, eachcapsule contains Amoxicillin Trihydrate BP equivalent to 500 mgAmoxicillin.

Tycil-250 Capsule : Box containing 10 blister strips of 10 capsules, eachcapsule contains Amoxicillin Trihydrate BP equivalent to 250 mgAmoxicillin.

Tycil Suspension : Dry powder in amber glass bottle for reconstitutioninto 100 ml suspension. After reconstitution, each 5 ml containsAmoxicillin Trihydrate BP equivalent to 125 mg Amoxicillin.

Tycil DS Suspension : Dry powder in amber glass bottle for reconstitutioninto 100 ml suspension. After reconstitution, each 5 ml containsAmoxicillin Trihydrate BP equivalent to 250 mg Amoxicillin.

Tycil Paediatric Drops : Dry powder in amber glass bottle forreconstitution into 15 ml suspension. After reconstitution, each 1.25 mlcontains Amoxicillin Trihydrate BP equivalent to 125 mg Amoxicillin.


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Tynisol®

Drops

DescriptionTynisol is a liquid preparation of multivitamin.

Each 0.6 ml contains:Vitamin A 1.2 mgVitamin D 10 µgVitamin C 50 mgThiamine Hydrochloride 1 mgRiboflavin 0.5 mgPyridoxine Hydrochloride 1 mgNiacinamide 5 mgDexpanthenol 3 mg

IndicationsFor prevention and treatment of vitamin deficiency in children andinfants.

Dosage and AdministrationBelow 1 year : 9-10 drops (0.3 ml), 1 year and above : 23-25 drops (1.0 ml)once daily or as advised by the physicians.

ContraindicationSupplemental vitamins should not be prescribed for patients withhaemochromatosis or Wilson’s disease.

Hypersensitivity to any of the active ingredients is a contraindication.Excessive doses of vitamin A and D can lead to hypervitaminosis. Whenmultivitamin preparations are prescribed allowance must be made forvitamins from other sources.

Side EffectsMultivitamin preparation with ordinary doses of component are usuallynontoxic.


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Pharmaceutical PrecautionKeep in cool and dry place. Protect from light. Keep out of the reach ofchildren.

Commercial PackTynisol Multivitamin Drops : Tynisol drops is available in 15 ml amberglass bottle. Each 0.6 ml Tynisol drops contains multivitamin.


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Ultrafen®

Tablet/Suppository/Gel

DescriptionDiclofenac is a non-steroidal anti-inflammatory agent with markedanalgesic, anti-inflammatory and antipyretic properties.

IndicationsRheumatoid arthritis, osteoarthritis, low back pain and other acutemusculo-skeletal disorders such as frozen shoulder, tendinitis, teno-synovitis, bursitis, sprain, strain and dislocation, ankylosing spondylitis,acute gout, pain in orthopaedics, dental and other minor surgery.

Dosage and AdministrationAdults: → Enteric coated tablet- A total of 75-150 mg daily given in two or threedivided doses.

→ Sustained release tablets- One tablet daily, taken whole with liquid,preferably during meal.

→ Suppositories- 75-150 mg daily in divided doses.

→ Gel- Depending on the painful site to be treated, 2-4 g gel may beapplied 3-4 times daily.

Children: → Enteric coated tablet : 1-3 mg/kg per day in divided doses.

→ Sustained release tablets : Not recommended.

→ Suppositories : 1-3 mg/kg body weight in divided doses.

ContraindicationUltrafen should not be given in patients with previous hypersensitivity toDiclofenac. Ultrafen should not be given to asthmatic patients and inwhom attacks of asthma, urticaria or acute rhinitis are precipitated byAspirin or other NSAIDs.


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PrecautionsUltrafen should not be prescribed to pregnant women unless there iscompelling reason for doing so. Patients with a history of peptic ulcer,haematemesis, melaena, bleeding diathesis or with severe hepatic or renalinsufficiency, should be kept under close surveillance. If abnormal liverfunction tests persist or worsen, clinical signs and symptoms consistentwith liver disease or if other manifestations occur (eosinophilia, rash),Ultrafen should be discontinued. Use of Ultrafen in patients with hepaticporphyria may trigger an attack.

Side Effects Epigastric pain, nausea and diarrhoea, headache and slight dizziness maybe complained by some patients. These are often transient, disappearingwith continuation of medication.

Occasionally skin rash, peripheral oedema and abnormalities of serumtransaminase have been reported.

Very rarely reported side effects include activation of peptic ulcer,haematemesis or melaena, blood dyscrasia (in course of extensive usage).There have been isolated reports of anaphylactoid reactions.

Accidental overdosage and treatmentThere is no known antidote to Ultrafen. Haemodialysis is unlikely todecrease plasma concentration due to high degree of protein binding.

Pharmaceutical PrecautionStore in a cool dry place. Store suppositories below 30°C, keep out ofreach of children.

Commercial PackUltrafen-25 Tablet : Box containing 10 blister strips of 10 enteric coatedtablets, each tablet contains Diclofenac Sodium BP 25 mg.

Ultrafen-50 Tablet : Box containing 10 blister strips of 10 enteric coatedtablets, each tablet contains Diclofenac Sodium BP 50 mg.


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Ultrafen 100 SR tablet : Box containing 10 blister strips of 10 sustainedrelease tablets, each tablet contains Diclofenac Sodium BP 100 mg.

Ultrafen 12.5 Suppository : Box containing 10 suppositories (2 x 5’s), eachsuppository contains Diclofenac Sodium BP 12.5 mg.

Ultrafen 50 Suppository : Box containing 10 suppositories (2 x 5’s), eachsuppository contains Diclofenac Sodium BP 50 mg.

Ultrafen 10 Gel : Tube containing 10 g Gel, each gram containsDiclofenac Diethylamine BP equivalent to Diclofenac Sodium 10 mg.

Ultrafen 25 Gel : Tube containing 25 g Gel, each gram containsDiclofenac Diethylamine BP equivalent to Diclofenac Sodium 10 mg.


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Uricon®

Tablet

DescriptionUricon (Oxybutynin Chloride) is an antispasmodic, anticholinergic agent.Each Uricon tablet contains 5 mg of Oxybutynin Chloride USP,formulated as a once-a-day controlled release tablet for oraladministration. Oxybutynin Chloride relaxes bladder smooth muscle. Inpatients with conditions characterized by involuntary bladdercontractions, Oxybutynin Chloride increases bladder capacity, diminishesthe frequency of uninhibited contractions of the detrusor muscle, anddelays the initial desire to void. Uricon thus decreases urgency and thefrequency of both incontinent episodes and voluntary urination.

IndicationsUricon is a once-daily controlled release tablet indicated for the treatmentof overactive bladder with symptoms of urinary incontinence, urgencyfor urination, frequent urination and nocturnal enuresis.

Dosage and AdministrationUricon may be administered with or without food. The recommendedstarting dose of Uricon is 5 mg once daily. Dosage may be adjusted in 5mg increments to achieve a balance of efficacy and tolerability (up to amaximum of 30 mg/day). In general, dosage adjustment may proceed atapproximately weekly intervals.

ContraindicationOxybutynin is contraindicated in patients with urinary retention, gastricretention, or uncontrolled narrow angle glaucoma and in patients who areat risk for these conditions. Uricon is also contraindicated in patients whohave demonstrated hypersensitivity to the drug itself or othercomponents of the product.

Side EffectsThe incidence of dry mouth may occur which is dose-related. Abdominalpain, dry nasal and sinus mucous membranes, back pain, hypertension,palpitation, vasodilatation, flatulence, gastro-oesophageal reflux,


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insomnia, nervousness, confusion, cough, sinusitis, bronchitis, dry skin,rash, impaired urination (hesitancy), urinary retention, etc. may bereported.

PrecautionsUricon should be used with caution in patients with hepatic or renalimpairment, clinically significant bladder outflow obstruction because ofthe risk of urinary retention, gastrointestinal obstructive disordersbecause of the risk of gastric retention, conditions such as ulcerativecolitis, intestinal atony, and myasthenia gravis, gastro-oesophageal refluxand/or who are concurrently taking drugs (such as bisphosphonates) thatcan cause or exacerbate oesophagitis.

Drug InteractionsThe concomitant use of Oxybutynin with other anticholinergic drugs orwith other agents which produce dry mouth, constipation, drowsiness,and/or other anticholinergic-like effects may increase the frequencyand/or severity of such effects. Anticholinergic agents may potentiallyalter the absorption of some concomitantly administered drugs due toanticholinergic effects on gastrointestinal motility.

Pharmacokinetic studies with patients concomitantly receivingcytochrome P450 enzyme inhibitors, such as antimycotic agents (e.g.Ketoconazole, Itraconazole, and Miconazole) or macrolide antibiotics(e.g. Erythromycin and Clarithromycin), have not been performed. Nospecific drug-drug interaction studies have been performed withOxybutynin.

Use in Pregnancy and LactationThe safety of Oxybutynin administration to women who are or who maybecome pregnant has not been established. Therefore, Oxybutyninshould not be given to pregnant women unless, the probable clinicalbenefits outweigh the possible hazards. It is not known whetherOxybutynin is excreted in human milk. Because many drugs are excretedin human milk, caution should be exercised when Oxybutynin isadministered to a nursing woman.


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Commercial PackUricon Tablet : Box containing 30 tablets in 3 x 10's blister strips. Eachcontrolled release tablet contains Oxybutynin Chloride USP 5 mg.


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Uroflo®

Capsule

DescriptionUroflo (Tamsulosin Hydrochloride) is a sulfonamethylamine derivativeα1A adrenergic blocking agent. The drug is pharmacologically related to

Doxazosin, Prazosin, and Terazosin; however, unlike these drugs,Tamsulosin has higher affinity and selectivity for the α1A adrenergic

receptors, which are mainly located in nonvascular smooth muscle (e.g.prostate), than for α1A adrenergic receptors located in vascular smooth

muscle. Such selectivity of Tamsulosin for α1A receptors may result in a

reduced incidence of adverse cardiovascular effects (e.g. syncope,dizziness, and hypotension).

IndicationsUroflo is used in benign prostatic hyperplasia (BPH). It relaxes smoothmuscle in BPH producing an increase in urinary flow rate and animprovement in obstructive symptoms.

Dosage and AdministrationUroflo 400 µg once daily is recommended for the treatment of signs andsymptoms of BPH. It should be administered approximately one andhalf-hour following the same meal each day.

For those patients who fail to respond to the 400 µg dose after 2 to 4weeks of dosing, the dose of Uroflo can be increased to 800 µg oncedaily.

ContraindicationUroflo capsules are contraindicated in patients known to behypersensitive to Tamsulosin or any component of the product. Urofloshould be avoided in patients with a history of orthostatic hypotensionand syncope.

Side EffectsSide effects of Tamsulosin include drowsiness, asthenia, depression,headache, dry mouth, nausea, vomiting, diarrhoea, constipation, oedema,


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blurred vision, rhinitis, erectile disorders, tachycardia and palpitation.Hypersensitivity reactions including rash, pruritus, angioedema have beenreported in some cases.

PrecautionsUroflo should be avoided in patients with a history of orthostatichypotension and syncope. Caution may be taken in the elderly and inpatients with hepatic and renal impairment.

Use in Pregnancy and LactationUroflo is not indicated for use in women.

Drug InteractionsThe pharmacokinetic and pharmacodynamics interactions betweenTamsulosin (Uroflo) and other alpha-adrenergic blocking agents have notbeen determined. However, interactions may be expected and it shouldnot be used in combination with other alpha-adrenergic blocking agents.The pharmacokinetic interaction between Cimetidine and Tamsulosinwas investigated. Caution should be exercised with concomitantadministration of Warfarin and Tamsulosin.

Pharmaceutical PrecautionStore at controlled room temperature 20°C to 25°C. Keep away fromchildren.

Commercial PackUroflo Capsule : Each box containing 20 capsules in 2 x 10's blister strips.Each modified release capsule contains Tamsulosin Hydrochloride INN400 µg.


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Valcap®

Capsule

DescriptionValcap (Valsartan) is a nonpeptide, orally active, and specific angiotensinII antagonist acting on the AT1 receptor subtype. Valsartan is chemicallydescribed as N-(1-oxopentyl)-N-[[2'-(1H-tetrazol-5-yl)[1,1'-biphenyl]-4-yl]methyl]-L-valine.

IndicationsFor the treatment of hypertension. It may be used alone or incombination with other antihypertensive agents.

Dosage and AdministrationThe recommended dose of Valcap is 80 mg once daily, irrespective ofrace, age, or gender. The antihypertensive effect is substantially presentwithin 2 weeks and maximal effects are seen after 4 weeks. In patientswhose blood pressure is not adequately controlled, the daily dose may beincreased to 160 mg or 320 mg or a diuretic may be added. Addition of adiuretic has a greater effect than dose increases beyond 80 mg.

No dosage adjustment is required for patients with renal impairment orfor patients with hepatic insufficiency of non-biliary origin and withoutcholestasis. Valcap may also be administered with other antihypertensiveagents. The safety and efficacy of Valcap have not been established inchildren.

ContraindicationHypersensivity to Valsartan or any of the components of the product.

Drug InteractionsNo drug interactions of clinical significance have been found.Compounds which have been studied in clinical trials include Cimetidine,Warfarin, Frusemide, Digoxin, Atenolol, Indomethacin,Hydrochlorothiazide, Amlodipine, Glibenclamide.

As Valcap is not metabolized to a significant extent, clinically relevant


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drug-drug interactions in the form of metabolic induction or inhibitionof the cytochrome P450 system are not expected with Valsartan.Although valsartan is highly bound to plasma proteins, in vitrostudies havenot shown any interaction at this level with a range of molecules whichare also highly protein bound, such as Diclofenac, Frusemide, andWarfarin. Concomitant use of potassium sparing diuretics (e.g.Spironolactone, Triamterene, Amilorid) potassium supplements, or saltsubstitutes containing potassium may lead to increase in serumpotassium. If co-medication is considered necessary, caution is advisable.

Side EffectsThe overall incidence of adverse experiences with Valsartan was similarto placebo. The common side effects are headache, dizziness, rhinitis,sinusitis, gastrointestinal upset, nausea, rhinitis, sinusitis, pharyngitis,oedema and fatigue. Dose-related orthostatic effects were seen in lessthan 1% of patients. An increase in the incidence of dizziness wasobserved in patients treated with Valsartan 320 mg compared to 80-160mg.

Use in Pregnancy and LactationDue to the mechanisms of action of angiotenin II antagonists, a risk forthe foetus cannot be excluded. In utero exposure to angiotensinconverting enzyme (ACE) inhibitors given to pregnant women during the2nd and 3rd trimesters has been reported to cause foetal injury, includinghypotension, neonatal skull hypoplasia, anuria, reversible or irreversiblerenal failure, and death. As for any drug that also acts directly on the reninangiotensin-aldosterone system (RAAS). When pregnancy is detected,Valcap should be discontinued as soon as possible.

It is not known whether Valsartan is excreted in human milk. Valsartanwas excreted in the milk of lactating rats. Thus, it is not advisable to useValcap in lactating mothers.

OverdosageAlthough there is no experience of overdose with Valcap, the major signthat might be expected is marked hypotension and tachycardia. If theingestion is recent, vomiting should be induced. Otherwise, the usualtreatment would be intravenous infusion of normal saline solution.


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Valsartan is unlikely to be removed by haemodialysis.

Pediatric UseSafety and effectiveness in pediatric patients have not been established.

Geriatric UseNo overall difference in the efficacy or safety of Valsartan was observedin this patient population, but greater sensitivity of some older individualscannot be ruled out.

Pharmaceutical PrecautionShould be kept away from moisture and heat. Keep out of the reach ofchildren.

Commercial PackValcap Capsule : Box containing 30 capsules in 3 x 10's blister strips. Eachcapsule contains Valsartan INN 80 mg.

Valcap 160 Capsule : Box containing 30 capsules in 2 x 10's blister strips.Each capsule contains Valsartan INN 160 mg.


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V-Cox®

Tablet

DescriptionV-cox (Valdecoxib) is a non-steroidal anti-inflammatory drug (NSAID)that exhibits anti-inflammatory, analgesic and antipyretic properties. Themechanism of action is believed to be due to inhibition of prostaglandinsynthesis primarily through inhibition of the enzyme cyclooxygenase-2(COX-2). At therapeutic plasma concentration in human Valdecoxib doesnot inhibit cyclooxygenase-1 (COX-1).

IndicationsV-cox is indicated :

♦ For relief of the signs and symptoms of osteoarthritis (OA) and adultrheumatoid arthritis (RA).

♦ For the treatment of primary dysmenorrhoea.

Dosage and AdministrationOsteoarthritis and Adult Rheumatoid Arthritis

The recommended dose of V-cox for the relief of the signs andsymptoms of arthritis is 10 mg once daily.

Primary DysmenorrhoeaThe recommended dose of V-cox for treatment of primarydysmenorrhoea is 20 mg twice daily, or as needed.

Paediatric UseSafety and effectiveness of V-cox in paediatric patients below the age of18 years have not been evaluated.

ContraindicationValdecoxib is contraindicated in patients with known hypersensitivity toValdecoxib or any component of the product. It should not be given topatients who have experienced asthma, urticaria, or allergic-type reactionsafter taking Aspirin or non-steroidal anti-inflammatory drugs(NSAIDs). Valdecoxib should not be given to patients who havedemonstrated allergic-type reactions to sulfonamides.


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PrecautionsTreatment with Valdecoxib should be initiated with caution in patientswith mild to moderate hepatic impairment and fluid retention. The use ofValdecoxib in patients with severe hepatic impairment is notrecommended.

No information is available regarding the safe use of Valdecoxib inpatients with advanced kidney disease. Therefore, treatment with V-cox isnot recommended in these patients. If therapy with V-cox must beinitiated, close monitoring of the patient's kidney function is advisable.

Side EffectsGastrointestinal events include abdominal fullness, abdominal pain,diarrhoea, dyspepsia, flatulence and nausea. Valdecoxib may causedizziness and headache. In few cases, it may cause back pain, peripheraloedema, influenza-like syndrome, and hypertension. Myalgia, sinusitis andskin rash may occur. In the seven osteoarthritis and rheumatoid arthritiscontrolled studies, the adverse events occurred in 0.1-1.9% of patientstreated with V-cox 10 -20 mg daily.

Drug InteractionsAspirin : Concomitant administration of Aspirin with Valdecoxib mayresult in an increased risk of gastrointestinal ulceration and complicationscompared to Valdecoxib alone.

Methotrexate : Valdecoxib 10 mg bid did not show a significant effect onthe plasma exposure or renal clearance of Methotrexate.

ACE inhibitors : Reports suggest that NSAIDs may diminish theantihypertensive effect of ACE inhibitors. This interaction should begiven consideration in patients taking Valdecoxib concomitantly withACE inhibitors.

Frusemide : Clinical studies, as well as post-marketing observations, haveshown that NSAIDs can reduce the effect of Frusemide and thiazides insome patients. This response has been attributed to inhibition of renalprostaglandin synthesis.


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Anticonvulsants : Anticonvulsant drug interaction studies withValdecoxib have not been conducted. As with other drugs, routinemonitoring should be performed when therapy with Valdecoxib is eitherinitiated or discontinued in patients on anticonvulsant therapy.

Fluconazole and Ketoconazole : Concomitant single dose administrationof Valdecoxib 20 mg with multiple doses of Ketoconazole andFluconazole produced a significant increase in action of Valdecoxib.

Use in Pregnancy and Lactation There are no studies in pregnant women. However, Valdecoxib crossesthe placenta in rats and rabbits. V-cox should be used during pregnancyonly if the potential benefit justifies the potential risk to the foetus. Theeffects of V-cox on labour and delivery in pregnant women are unknown.V-cox is contraindicated in nursing mother.

OverdosageSymptoms following acute NSAID overdoses are usually limited tolethargy, drowsiness, nausea, vomiting, and epigastric pain, which aregenerally reversible with supportive care. Gastrointestinal bleeding canoccur. Hypertension, acute renal failure, respiratory depression and comamay occur, but are rare. Anaphylactoid reactions have been reported withtherapeutic ingestion of NSAIDs, and may occur following an overdose.

WarningSerious gastrointestinal toxicity such as bleeding, ulceration andperforation of the stomach, small intestine or large intestine can occur atany time with or without warning symptoms in patients treated withNSAIDs. Minor gastrointestinal problems such as dyspepsia are commonand may also occur at any time during NSAID therapy.

General InformationV-cox can be taken with or without food. Any food had no significanteffect on either the peak plasma concentration or extent ofabsorption of Valdecoxib. No significant effect on either the rate orextent of absorption of Valdecoxib has occurred by concomitantadministration of Valdecoxib with antacid (aluminium/magnesiumhydroxide).


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Pharmaceutical PrecautionStore at 25°C. Keep away from children.

Commercial PackV-cox 10 Tablet : Box containing 10 x 10's tablets in blister strips. Eachfilm coated tablet contains Valdecoxib INN 10 mg.

V-cox 20 Tablet : Box containing 5 x 10's tablets in blister strips. Eachfilm coated tablet contains Valdecoxib INN 20 mg.


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Xynofen-100 SRCapsule

Description Xynofen-100 SR (Ketoprofen) is a derivative of propionic acid which iswidely used in the treatment of patients with rheumatic diseases. It is apotent non-steroidal anti-inflammatory analgesic agent and a stronginhibitor of prostaglandin synthetase.

Indications♦ Rheumatic diseases : for anti-inflammatory and analgesic use in

rheumatoid arthritis, osteoarthritis, ankylosing spondylitis.

♦ Periarticular and musculoskeletal indications : for analgesia in bursitis,tendinitis, synovitis, tenosynovitis, lumbago.

♦ Prophylaxis and treatment of migraine headache.

♦ Surgical and traumatic uses : for analgesic action after sports injuries,orthopaedic manipulations, dental extraction, surgery.

♦ Infectious diseases : for analgesic, anti-inflammatory and antipyreticpurposes.

♦ Gynaecological uses : in dysmenorrhoea, following IUCD insertion andfor uterine relaxation and analgesia in the post-partum, non-nursingmother.

Dosage and Administration Xynofen-100 SR is administered orally, in the dose of 100-200 mg oncedaily, usually with food, depending on patient weight and on severity ofsymptoms.

Contraindication ♦ Hypersensitivity to Ketoprofen

♦ Patients with rhinitis, nasal polyps and asthma associated with Aspirinmay show cross sensitivity with other NSAIDs including Ketoprofen

♦ Patients with active ulceration or chronic dyspepsia

♦ Severe renal insufficiency


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Side Effects Minor side effects are variable in severity and frequency, consisting mostlyof gastrointestinal problems such as gastrointestinal discomfort, nausea,diarrhoea and occasionally bleeding and ulceration. Dyspepsia may beminimized by taking this drug with food or milk.

Other minor side effects such as headache, dizziness, mild confusion,vertigo, drowsiness, oedema, mood change and insomnia may occur lesscommonly.

Major side effects involving other organ systems such as haematologicalreactions, hepatic or renal damage, dermatological reactions,bronchospasm and anaphylaxis are exceedingly rare.

In all cases of major side effects Xynofen-100 SR should be withdrawn atonce.

Precautions Inhibition of renal prostaglandin synthesis by NSAIDs may interfere withrenal function especially in the presence of existing renal disease.Ketoprofen should therefore be used with caution in patients with renalimpairment. To minimize gastric intolerance, Xynofen-100 SR capsuleshould always be taken with food.

Use in Pregnancy and Lactation The drug should not be used in pregnancy unless clearly needed. It is notrecommended for nursing mother as it is excreted through breast milk.

Drug Interactions Warfarin, Sulphonamide, Hydantoin : Ketoprofen is highly proteinbound. Theoretically, interaction is possible following concomitant use ofother protein bound drugs, for example anticoagulants, sulphonamides,and hydantoin.

Digoxin, Methotrexate, Cyclosporin : Like other NSAIDs, Ketoprofen,through effects on renal prostaglandin, may cause increased toxicity ofcertain drugs. Serum levels of Digoxin and Methotrexate may be elevated;also there may be increased nephrotoxicity with Cyclosporin when usedconcomitantly with Ketoprofen.


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Aspirin : Concomitant administration of Aspirin and Ketoprofen is notrecommended as it decreases the plasma concentration of Ketoprofen.

Lithium : Ketoprofen decreases the renal clearance of Lithium andincreases the plasma level of Lithium. So, Lithium toxicity may develop.

Diuretics : Ketoprofen may reduce the activity of the diuretics.

ß-blockers : Ketoprofen may reduce the antihypertensive effect of ß-blockers.

Oral hypoglycaemics : Ketoprofen may alter the response to insulin ororal hypoglycaemic agents.

Overdosage In case of acute overdosage, it is recommended that stomach be emptiedby vomiting or lavage. The use of activated charcoal orally may also behelpful.

Commercial Pack Xynofen-100 SR Capsule : Box containing 50 capsules in 5 x 10’s blisterstrips, each capsule contains Ketoprofen BP 100 mg as sustained releasepellets.


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Yamadin®

Tablet

Description The active ingredient of Yamadin-20 and Yamadin-40 tablet isFamotidine. Famotidine is a novel, highly specific and potent competitiveH2 receptor antagonist. It has a rapid onset and prolonged duration of

action. After oral administration, the onset of the antisecretory effectoccurs within one hour and lasts for at least 12 hours by doses of 40 mg.Famotidine reduces the acid and pepsin content, as well as the volume ofbasal, nocturnal and stimulated gastric secretion. Food or antacid doesnot interfere its absorption.

IndicationsYamadin is indicated in-♦ Short term treatment of active duodenal ulcer and benign gastric ulcer ♦ Maintenance therapy for prevention of relapses of duodenal ulceration ♦ Gastro-oesophageal reflux disease ♦ Zollinger-Ellison Syndrome

Dosage and Administration Duodenal ulcer : 40 mg at night for 4 to 8 weeks; Benign gastric ulcer : 40mg at night for 4 to 8 weeks; Maintenance therapy : 20 mg at night forpreventing the recurrences of duodenal ulceration; Gastro-oesophagealreflux disease : 20 mg twice daily for 6 to 12 weeks; Zollinger-EllisonSyndrome : The recommended starting dose is 20 mg every six hours.

Dosage should then be adjusted to individual response. Doses up to 160mg every six hours have been administered to some patients without thedevelopment of significant adverse effects.

Dosage can be administered irrespective of meals. Antacids may be givenconcomitantly if needed.

Side EffectsYamadin is generally well tolerated and side effects are uncommon.Dizziness, headache, constipation and diarrhoea have been reported


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rarely. Other side effects reported less frequently include dry mouth,nausea and/or vomiting, rash, abdominal discomfort, anorexia andfatigue.

ContraindicationThere are no known contraindication to Yamadin. If any evidence ofhypersensitivity appear, the therapy should be discontinued andconsultation with physician is required.

PrecautionsDosage reduction should be considered or interval between doses shouldbe prolonged if creatinine clearance falls to or below 30 ml/min.

Use in Pregnancy and LactationThere are no adequate, well-controlled studies on Famotidine inpregnancy, but it is known to cross the placenta and should be prescribedonly if clearly needed. It is not known whether Famotidine is secretedinto human milk, nursing mothers should either stop nursing or stoptaking the drug.

Drug InteractionsYamadin does not interact with the cytochrome P450 linked drugmetabolizing enzyme system. So, no interactions have been found in manwith Warfarin, Theophylline, Phenytoin, Diazepam, Propranolol,Aminopyrine or antipyrine.

Pharmaceutical PrecautionStore in a dry place below 250 C.

Commercial Pack Yamadin-20 Tablet : Each round, film coated tablet contains 20 mgFamotidine USP. Box containing 10 blister strips of 10 tablets.

Yamadin-40 Tablet : Each round, film coated tablet contains 40 mgFamotidine USP. Box containing 10 blister strips of 10 tablets.


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Zedex®DSSyrup

DescriptionZedex DS (Zinc Sulphate) is a source of Zinc which is an essential traceelement and involved in a number of body enzyme systems. Zinc salts areused as supplements to correct Zinc deficiencies. The consequences ofZinc deficiency are malformations of the brain, eyes, bones, heart andother organs. Zinc is essential for the formation and function of theimmune system. Systems influenced by Zinc include the reproductive,neurologic, immune, dermatologic and gastrointestinal systems.

Indications ♦ Zinc deficiency states♦ Growth retardation, respiratory tract infection, alopecia, dermatitis,

diarrhoea, immunologic dysfunction, psychological disturbances,gonadal atrophy, impaired spermatogenesis, congenital malformations,acrodermatitis enteropathica.

Dosage and Administration→→ Children under 10 kg : 22.5 mg (2¼ tea spoonful) daily in

divided doses.→→ Children within 10 to 30 kg : 22.5 mg (2¼ tea spoonful) 1 to 3

times daily after food.→→ Adults and children over 30 kg : 45 mg (4½ tea spoonful) 1 to 3

times daily after food or as directed by the physician.

Side Effects♦ Zinc salts may cause abdominal pain and dyspepsia.♦ Prolonged use may lead to copper deficiency and anaemia.♦ It can be converted to the corrosive Zinc Chloride, and it is this

corrosive action that accounts for the acute toxicity of the soluble Zincsalts.

Drug InteractionsZinc may inhibit the absorption of concurrently administeredTetracyclines, therefore, an interval of at least 3 hours should be allowedwhile taking these products.


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ContraindicationIt is contraindicated in patients with hypersensitivity to Zinc.

Special Warning and PrecautionsAccumulation of Zinc may occur in case of renal failure.

OverdosageZinc sulphate is corrosive in overdosage. Symptoms are corrosion andinflammation of the mucous membrane of the mouth and stomach;ulceration of the stomach followed by perforation may occur. Gastriclavage and emesis should be avoided. Demulcent such as milk should begiven. Chelating agents such as sodium edetate may be useful.

Pharmaceutical PrecautionStore in a cool and dry place, keep away from light.

Commercial PackZedex DS Syrup : 100 ml syrup in amber glass bottle. Each 5 ml containsZinc Sulphate Monohydrate USP equivalent to 10 mg of elemental Zinc.


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Zocil®Tablet

DescriptionCilostazol (Zocil) is a quinolinone derivative. The mechanism of action isto specifically inhibit cellular phosphodiesterase III (PDE III) andsuppress cAMP degradation with a resultant increase in cAMP in plateletsand blood vessels, leading to inhibition of platelet aggregation andvasodilation.

Indications Zocil is indicated for the reduction of symptoms of intermittentclaudication, as indicated by an increased walking distance.

Dosage and AdministrationThe recommended dosage of Zocil is 100 mg bid, taken at least half anhour before or two hours after breakfast and dinner. A dose of 50 mg bidshould be considered during coadministration of Ketoconazole,Itraconazole, Erythromycin, and Diltiazem.

Side EffectsThe most common side effects are headache, diarrhoea, vomiting, legcramps, rash etc. The less frequent side effects are anorexia and oedema.

ContraindicationZocil is contraindicated in patients with congestive heart failure of anyseverity. Zocil is also contraindicated in patients with known or suspectedhypersensitivity to any of its components.

PrecautionsZocil should be used with caution in patients with any degree of heartfailure. There is no information with respect to the efficacy or safety ofthe concurrent use of Cilostazol and Clopidogrel.

Use in Pregnancy and LactationThere are no adequate and well-controlled studies in pregnant women.Transfer of Cilostazol into milk has been reported in experimental


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animals. Because of the potential risk to nursing infants, a decision shouldbe made to discontinue nursing or to discontinue Zocil.

Paediatric UseThe safety and effectiveness of Zocil in paediatric patients have not beenestablished.

Drug InteractionsPharmacokinetic studies have demonstrated that Omeprazole andErythromycin significantly increased the systemic exposure of Cilostazoland/or its major metabolites. Population pharmacokinetic studies showedhigher concentrations of Cilostazol among patients concurrently treatedwith Diltiazem.

Overdosage Information on acute overdosage with Zocil in humans is limited. Thesigns and symptoms of an acute overdose are severe headache, diarrhoea,hypotension, tachycardia, and possibly cardiac arrhythmias. The patientshould be carefully observed and given supportive treatment.

Pharmaceutical PrecautionKeep in a cool (25oC) and dry place. Keep out of the reach of children.

Commercial PackZocil 50 Tablet : Box containing 30 tablets in 3 x 10’s blister strips. Eachtablet contains Cilostazol INN 50 mg.

Zocil 100 Tablet : Box containing 20 tablets in 2 x 10’s blister strips. Eachtablet contains Cilostazol INN 100 mg.


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Zukast®

Tablet

DescriptionZukast (Zafirlukast) is a synthetic, selective peptide leukotriene receptorantagonist (LTRA) that acts as a prophylactic agent against inflammationin asthma.Cysteinyl leukotriene production and receptor occupation have beencorrelated with the pathophysiology of asthma, including airway oedema,smooth muscle constriction, and altered cellular activity associated withthe inflammatory process, which contribute to the signs and symptoms ofasthma.

IndicationsZukast is indicated for the treatment of asthma.

Dosage and AdministrationZukast should be taken continuously. Children under 7 years of age : There isno clinical experience of the use of Zukast in children under 7 years ofage until safety information is available. Children over 7 years through 11 yearsof age : The recommended dose of Zukast in this age group is 10 mg twicedaily. Adult and children aged 12 years and over : The dosage is one 20 mgtablet twice daily. This dosage should not be exceeded. Higher doses maybe associated with elevations of one or more liver enzymes consistentwith hepatotoxicity. As food may reduce the bioavailability of Zafirlukast,Zukast should not be taken with meals. Elderly : The clearance ofZafirlukast is significantly reduced in elderly patients (over 65 years old),and Cmax and AUC are approximately double than those of youngeradults. However, accumulation of Zafirlukast is not greater than that seenin multiple-dose trials conducted in adult subjects with asthma and theconsequences of the altered kinetic in the elderly are unknown. Clinicalexperience with Zukast in the elderly (over 65 years) is limited and cautionis recommended until further information is available.

No dosage adjustment is necessary in patients with mild renalimpairment.


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ContraindicationZukast should not be given to patients who have previously experiencedhypersensitivity to the product or any of its ingredients. Zukast iscontraindicated in patients with a history of moderate or severe renalimpairment. Zukast is contraindicated in patients with hepaticimpairment or cirrhosis; it has not been studied in patients with hepatitisor in long term studies of patients with cirrhosis. Zukast iscontraindicated in children under 7 years of age until safety informationis available.

Warning and PrecautionsZukast should be taken regularly to achieve benefit, even duringsymptom-free periods. Zukast therapy should normally be continuedduring acute exacerbations of asthma. Zukast does not allow a reductionin existing steroid treatment. As with inhaled steroids and cromones(disodium cromoglycate, nedocromil sodium), Zukast is not indicated foruse in the reversal of bronchospasm in acute asthma attacks. Zukast hasnot been evaluated in the treatment of labile (brittle) or unstable asthma.

Cases of Churg-Strauss Syndrome have been reported in association withZukast usage. A causal relationship has neither been confirmed norrefuted. If a patient develops a Churg-Strauss Syndrome type illness,Zukast should be stopped, a re-challenge test should not be performedand treatment should not be restarted.

Elevations in serum transaminases can occur during treatment withZukast. These are usually asymptomatic and transient but couldrepresent early evidence of hepatotoxicity.

If clinical symptoms or signs suggestive of liver dysfunction occur (e.g.nausea, vomiting, right upper quadrant pain, fatigue, lethargy, flu-likesymptoms, enlarged liver, pruritus and jaundice), the serumtransaminases, in particular serum ALT, should be measured and thepatient managed accordingly. A decision to discontinue Zukast should beindividualized to the patient’s condition, weighing the risk of hepaticdysfunction against the clinical benefit of Zukast to the patient.


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Drug InteractionsZukast may be administered with other therapies routinely used in themanagement of asthma and allergy. Inhaled steroids, inhaled and oralbronchodilator therapy, antibiotics and antihistamines are examples ofagents which have been co-administered with Zukast without adverseinteraction.

Zukast may be administered with oral contraceptives without adverseinteraction. Co-administration with Warfarin results in an increase inmaximum prothrombin time by approximately 35%. It is thereforerecommended that if Zukast is co-administered with Warfarin,prothrombin time should be closely monitored. The interaction isprobably due to an inhibition by Zafirlukast of the cytochrome P450 2C9enzyme system. In clinical trials co-administration with Theophyllineresulted in decreased plasma levels of Zafirlukast, by approximately 30%,but with no effect on plasma Theophylline levels. However, during post-marketing surveillance, there have been rare cases of patientsexperiencing increased Theophylline levels when co-administered withZafirlukast.

Co-administration with Terfenadine resulted in a 54% decrease in AUCfor Zafirlukast, but with no effect on plasma terfenadine levels. Co-administration with Acetylsalicylic acid (650 mg four times a day) mayresult in increased plasma levels of Zafirlukast, by approximately 45%.

Co-administration with Erythromycin will result in decreased plasmalevels of Zafirlukast, by approximately 40%. The clearance of Zafirlukastin smokers may be increased by approximately 20%.

Use in Pregnancy and LactationThe safety of Zukast in human pregnancy has not been established. Inanimal studies, Zafirlukast did not have any apparent effect on fertilityand did not appear to have any teratogenic or selective toxic effect on thefoetus. The potential risks should be weighed against the benefits ofcontinuing therapy during pregnancy and Zukast should be used duringpregnancy only if clearly needed. Zafirlukast is excreted in human breastmilk. Zukast should not be administered to nursing mothers.


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Side EffectsEffect on ability to drive or operate machinery : There is no evidence thatZukast affects the ability to drive and use machinery. Administration ofZukast in clinical trials against placebo has been associated with headache(9.9% vs. 9.0%) or gastrointestinal disturbance (nausea 2.6% vs. 2.2%,vomiting 1.2% vs. 1.0%, diarrhoea 2.3% vs. 1.8%, abdominal pain 1.6%vs. 1.2%). These symptoms are usually mild and do not necessitatewithdrawal from therapy. During post-marketing experience, bruising,bleeding disorders, including menorrhagia (rare), thrombocytopaenia andagranulocytosis (very rare) have also been reported.

Hypersensitivity reactions, including urticaria and angioedema have beenreported. Rashes, including blistering, have also been reported. Theabove events have usually resolved during continued treatment orfollowing cessation of therapy.

Infrequently, elevated serum transaminase levels have been observed inclinical trials against placebo with Zafirlukast (increased AST 1.0% vs.0.9%, increased AST 0.6% vs. 0.6%); at recommended doses theincidence was equivalent to placebo. Rarely the transaminase profile hasbeen consistent with drug-induced hepatitis, which resolved followingcessation of Zukast therapy. During post-marketing experience therehave been rare reports of hepatitis, with or without elevated bilirubinlevels. These cases were usually reversible.

In placebo-controlled clinical trials, an increased incidence of infectionhas been observed in elderly patients given Zafirlukast (7.8% vs. 1.4%).Infections were usually mild, predominantly affecting the respiratorytract.

OverdosageNo information exists with regard to the effects of overdosage of Zukastin humans. Management should be supportive. Removal of excessmedication by gastric lavage may be helpful.

Pharmacological PropertiesThe cysteinyl leukotrienes (LTC4, LTD4 and LTE4) are potentinflammatory eicosanoids released from various cells including mast cells


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and eosinophils. These important pro-asthmatic mediators bind tocysteinyl leukotriene receptors found in the human airway.

Leukotriene production and receptor occupation has been implicated inthe pathophysiology of asthma. Effects include smooth musclecontraction, airway oedema and altered cell activity associated with theinflammatory process, including eosinophil influx to the lung.

Zukast is a competitive, highly selective and potent oral peptideleukotriene antagonist of LTC4, LTD4 and LTE4 components of slowreacting substance of anaphylaxis. In vitro studies have shown that Zukastantagonizes the contractile activity of all three peptide leukotrienes(leukotriene C4, D4 and E4) in human conducting airway smooth muscleto the same extent. Animal studies have shown Zafirlukast to be effectivein preventing peptide leukotriene-induced increases in vascularpermeability, which give rise to oedema in the airways, and to inhibitpeptide leukotriene-induced influx of eosinophils into airways. Thespecificity of Zukast has been shown by its action on leukotrienereceptors and not prostaglandin, thromboxane, histamin, and cholinergicreceptors.

Peak plasma concentrations of Zafirlukast are achieved approximately 3hours after oral administration of Zukast. Administration of Zukast withfood increased the variability in the bioavailability of Zafirlukast andreduced bioavailability in most (75%) subjects. The net reduction wasapproximately 40%. Following twice-daily administration of Zukast (30to 80 mg bid), accumulation of Zafirlukast in plasma was low (notdetectable - 2.9 times first dose values; mean 1.45; median 1.27). Theterminal half-life of Zafirlukast is approximately 10 hours. Steady-stateplasma concentrations of Zafirlukast were proportional to the dose andpredictable from single-dose pharmacokinetic data. Zafirlukast isapproximately 99% protein bound to human plasma proteins,predominantly albumin, over the concentration range 0.25 to 4.0 µg/ml.

Zafirlukast is extensively metabolized. Following a radiolabelled dose theurinary excretion accounts for approximately 10% dose and faecalexcretion for 89%. Zafirlukast is not detected in urine.

Elderly subjects and subjects with stable alcoholic cirrhosis demonstratedan approximately two-fold increase in C max and AUC compared to


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normal subjects given the same doses of Zukast. There are no significantdifferences in the pharmacokinetics of Zafirlukast in patients with mildrenal impairment and in normal subjects.

Pharmaceutical PrecautionStore below 30oC. Protect from light and moisture.

Commercial PackZukast Tablet : Box containing 10 tablets in 1 x 10’s alu-alu form pack,each tablet contains Zafirlukast INN 20 mg.


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Zymet®

Tablet

DescriptionZymet is a preparation of mammalian pancreas containing enzymeprotease, lipase and amylase activity. Each gram of pancreatin contains1400 FIP units of protease activity, 20000 FIP units of lipase activity and24000 FIP units of amylase activity.

UseTo compensate for reduced intestinal enzyme activity in pancreaticdeficiency states.

IndicationsChildren : In children with reduced or absence of pancreatic exocrinesecretion, and Cystic fibrosis.

Adults : In the conditions with deficient pancreatic exocrine functionsuch as♦ Following pancreatectomy♦ Following total gastrectomy♦ Chronic pancreatitis.

Dosage and Administration 1-3 tablets daily with meal or as per direction of the physician.

Side Effects Zymet may cause buccal and perianal soreness, particularly in infants.Hypersensitivity reactions have been reported; these may be sneezing,lacrimation or skin rashes.

PrecautionsZymet should be used with caution in patients known to be allergic toanimal protein.

Pharmaceutical PrecautionKeep in a cool, dry place. Keep out of the reach of children.

Commercial PackZymet Tablet : Box containing 100 tablets in 10 x 10’s blister strips, eachsugar and enteric coated tablet contains Pancreatin BP 325 mg.

therapeutic index final

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