drug alert (august-2011)

8/2/2019 Drug Alert (August-2011)

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CONTENTS

1

Editorial - 1

Case Report - 2

New Approach - 3

Update - 4

New Approvals - 5

Cross Word - 7

DRUG ALERTADR Monit or ing Centre

Department of Pharmacology, JIPMER, Puducherry-605006, India

Co-ordinator: Dr. C. Adithan

Sub Co-ordinator: Dr. Steven A Dkhar

Editors: Dr. Melvin George, Dr. Sandhiya S, Dr. Surendiran A

Website: www.j ipmer.edu

E-mail: [email protected]

Volume V, Issue 3 August - 2011

Benflu orex - A French story to rememb er ...

Edi to r ia l

Benfluorex, a fenflura mine d erived p rodu ct has been

in wid e use s ince 1975 in several European and Asian

countries. In France, the dr ug w as initially promoted as a

hypolipidemic drug until 1987 when its therapeutic

indication was expand ed to includ e it as an aid to dieting

in patients with hypertriglyceridemia or overweight

patients and diabetes. The drug was mark eted und er the

brand name of Mediator by the ph arm aceutical comp any

Servier. In 2007, a reassessm ent of the benefit-risk balan ce

wa s don e by the AFSSAPS (Agence Francaise de Secur ite

Sanitaire des Produ its de Sante), the French dru g regu lating

agency, as there w ere case reports of cardiac valvular

regurgi ta t ion and severe pu lmonary hypertension.

Following this a d ecision wa s taken to restrict its use only

to patients with diabetes wh o are overweight.

Meanwhile a cohort stud y was u ndertaken u sing the

French database am ong 10,48,173 d iabetic patient s du ring

the per iod betw een 2007 and 2008. A total of 43044(4.1%)

were exposed to benfluorex. The relative risk [RR] of

hospitalization for an y cardiac valvular regurgitation wa s

higher in the benfluorex grou p, crud e RR = 2.9[95% CI, 2.2

-3.7] and ad justed RR = 3.1[95% CI, 2.4-4.0]. Adjusted RR

for mitral regur gitation and a ortic regur gitation were 2.5

and 4.4 respectively. There was also an increased need for

valve replacement su rgery in these p atients. In fact it has

come to light, that in the last 33 years since this dr ug has

been in the m arket there h ave been atleast 500 reported

cases of valvu lar regur gitation and several more cases of

related hospitalizations.

The results of this study and other similar reports

plus its marginal benefit in d iabetes patients led to the

drug being withdrawn by the AFSSAPS and EMA

(European Medical Agency) in France and EU cou ntries

respectively towards the end of 2009. However a lot of

eyebrows w ere raised as the French regulatory bodys

response w as rather p rotracted in the light of emerging

eviden ce as early as 2007. Earlier case reports of similar

kind w hich w ere noticed in Spain led to the dru g being

with dra wn in 2005 from the Span ish mar ket. The French

regulatory body drew a lot of flak for its sluggish response

and a revamp ing of the w hole pharm acovigilance process

has been m uch sough t after in the French parliament ever

since.

However wh at is interesting to learn is that 11 cases

of valvular regu rgitation w ere solely detected by th eBrest University in Paris in the year 2009 due to the

active surveillance coordinated by a chest physician,

Irene Franchon. She went on to expose the drug by

writing a book for the pub lic highlighting th e problems

associated w ith benfluorex and slamming the French

regulatory agency for their lacklustre response to the

situa tion. Althoug h her actions have stirred a hornets

nest in the French med ia and public, it appa rently has

generated a p rocess of tightening the loose ends of the

French pharmacovigilance system to prevent such

mishaps from occurring aga in. One hopes that th e recent

improvements in our nations p harma covigilanceprogramme w ould serve to bring out similar dan gerous

trends an d remove such unsa fe dru gs from the Indian

market before a disaster of this mag nitud e strikes our

country.

References

1. Weill A et al. Pharmacoepidemiol Drug Saf.2010;

19: 1256-62

2. Tribouilloy C. Eur J Echocardiogr.2010; 11: 614-21

3. Moulin P et al. Diabetes Metab. 2010; 36: 76-77.

Dr. Melv in George, Dr. Radhik a A ,

Dr. Steven A Dkhar,

Department of Pharmacology,

JIPMER, Pondicherry.


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2

L-Asparginase in du ced cortical venou s th rombosis

L-Asparginase is used for remission induction in acute

lymph oblastic leu kemia (ALL). 16 yr old boy d iagnos ed

as ALL received L-Aspa rginase 6000 IU/ m 2 on alternatedays d uring the repeat indu ction ph ase. He presented w ith

headache, vomiting an d seizures. Contrast enhan ced CT

Bra in was taken which revea led cor t i ca l venous

thrombosis (CVT). He was started on heparin and his

symptoms improved.

L-Asparaginase is a bacteria-derived enzyme that

provides specific therapy for lymphoid malignancies su ch

as acut e lymph oblastic leukem ia (ALL) by catalyzing the

hyd rolysis of l-asparag ine to l-aspartic acid an d dep leting

the circulating pools of this amino acid. Although the

capacity to syn thesize l-asparagine is constitutive in most

normal tissu es, malignancies of lymph oid origin lack theenzym e tha t catalyzes the transformation of l-aspartic acid

to l-asparagine (asparagine synthetase) and therefore

depend on exogenous sou rces of l-asparagine. Despite this

app arent specificity for lymp hoblasts, however, therap y

with l-aspara ginase is often limited by significan t toxicity

such as coagulation abnorm alities an d h ypersensitivity

reactions.

of sinovenous thrombosis in the brain. About 2% of

c h i l d r e n t r e a t e d w i t h L - a s p a r a g i n a s e d e v e l o p

hemorrhagic or nonh emorrhagic infarcts consequ ent tocortical sinusven ous throm bosis (CSVT).

Treatment of CVT resulting from L-aspa raginase-

indu ced an t i thrombin d ef ic iency includ es general

sup portive measures, anticonvu lsants for seizures, and

an t icoagula t ion . Fur ther L-asparag inase i s

contraindicated. However, the key to management is

early diagnosis by imaging as delayed institution of

an t icoagula t ion may be fu t i l e . For the rapeu t ic

anticoagulation, low m olecular w eight h eparin is given

initially and th is may be continued or it may be substitu ted

by oral anticoagulant s for 36 month s.

We conclude that, diagnosis of CSVT in leukemic

patients being treated with L-asparaginase requires a high

ind ex of clinical susp icion in the presen ce of seizu res, a

focal neurological def ic i t , and features of ra ised

intracranial tension. Early diagnosis demands a low

thresh old for imaging, and MRI shou ld be preferred over

CT. Identification of relevant findings such as venous

Venous throm bosis may cause as man y as 30% of the

acute central nervous system events in acute leuk emias.

The estimated risk of thrombosis during th e treatment of

ALL in ch i ld ren i s abou t 5%. L i fe - th rea ten ing

complications may resu lt when th e central nervous system

is involved. L-asparaginase may impair the h emostatic

system by redu cing the syn thesis of coagulation factors

(includ ing fibrinogen, factor II, IX, and X) and inhibitors

of coagulation (such as antithrombin, protein C, and

protein S) as a consequence of asparagine depletion.

D e s p i t e a r e d u c t i o n o f b o t h p r o c o a g u l a n t a n d

anticoagulant activity, the h emostatic balance app ears tobe shifted tow ard s a hyp ercoagu lable state. Asparaginase-

indu ced deficiency of antithrombin III, the most important

end ogenou s anticoagulan t, significantly increases the risk

infarcts, the emp ty delta sign, and absent flow in the d ural

sinuses on CT and MR venography enables proper

diagnosis and man agement.

References

1. Sbire G et a l.Brain.2005;128:47789.

2. Caru so V et al.Blood.2006;108:221622.

3. Vzque z E et al.Radiograph ics.2002;22:141128.

4. Hu nau lt-Berger M et al.Haematologica.2008;93:

148894

5. Connor SE et al.Clin Rad iol.2002;57:44961.

Dr. Biswajit Dubashi,

Department of Medical Oncology,


Case Repor t


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3

Revolution in man agement of chron ic hep atitis C: to wh at extent?

The global prevalence of hep atitis C is around 2% and

it accounts for 350,000 dea ths every year. Stud ies in Ind ia

among blood d onors have noted th e prevalence of HCV

(hepa titis C virus) infection to be be low 2%. Hep atitis C is

also the major indication for liver tran splant . The stand ard

of care for chronic hep atitis C has be en th e combination

of interferon-/ peginterferon-with ribavirin. However,

despite a long term regimen for about a year, this

combination cannot achieve cure in about half of the

patient s. In addition to tha t, it is also associated w ith man y

intolerable side-effects rang ing from fatigue and flu like-

symptoms to an aemia and severe depression. Neither of

the tw o directly targets HCV. While interferon- boosts

pat ients immu ne system ; ribavirin is a genera l inhibitor

of viral rep lication.

In May 2011, FDA approved two new oral drugs

(protease inhibitors) for chronic hepatitis C; namely

boceprevir and telaprevir. Both the dru gs are app roved

for genotype 1 chronic hepatitis C infection with

compen sated liver disease, in treatm ent nave as well as

previously treated p atients. These dru gs are directly acting

antivirals inhibiting non-structural (NS) protease NS3/

4A. This se r ine p ro tease c leaves HCV encoded

polyproteins into m ature forms of NS4A, NS4B, NS5A an d

NS5B; so it is essential for viral replication. These d ru gs

are approved for use in patients aged 18 years and abov e;

only in combination w ith peginterferon- and ribavirin(PR). In phase III trials, both t hese d rugs had a significantly

higher rates of sustained virological response (SVR)

compared to standard treatm ent. SVR is defined as absence

of serum HCV RNA by PCR assay 24 weeks after

completion of therapy. Although being a surrogate end

point of virological cur e; SVR is show n to be associated

with su bstantially reduced all cause mortality in H CV

patients. In a ph ase III trial among previously unt reated

patients, boceprevir group achieved SVR in 63-66%

compared to 38% in PR48 (peginte rferon-with ribavirin

for 48 weeks) group . While in pat ients w ith previously

failed th erapy SVR rates were 59-66% in boceprevir groupand 23% in PR48 group . With respect to telaprevir; ph ase

III stud ies in treatm ent n ave patients showed SVR rates

of 74-79% compared to 46% in PR48 grou p. In p articu lar,

SVR rates were substan tially improved in patients ha ving

nega tive pred ictive factors for a respon se to PR therap y,

such as bridging fibrosis/ cirrhosis, older age, diabetes,

HCV RNA levels > 800,000 IU/ ml or m ore. The p hase III

trial in previously treated patients show ed SVR in 65% of

telaprevir group compared to 17% in PR48 grou p. The

greatest improvem ents in SVR rates (upto six times) were

seen in prior null respond ers to PR. Among th e two, only

telaprevir has been stud ied in previous nu ll-respond ers

and achieved better SVR. In ad dition to h igher SVR rates,

both the d rugs show ed considerably lower relapse rates

also.

Based on period ic HCV RNA levels, response gu ided

therapy (RGT) is recommend ed for both boceprevir and

telaprevir. Triple therapy with telaprevir + PR is given

for 12 weeks, followed by dual therapy with PR for

ad ditional 12 or 36 weeks. Favou rable HCV RNA levels

could be obtained in more than half of treatment n ave

patients, requiring total therapy for 24 weeks only. In

case of boceprevir, therapy is initiated with PR for 4 weeks

as a lead in phase, followed by triple therapy with

boceprevir + PR for 24 to 32 weeks, with or without

ad ditional 12 weeks of PR.

The common adverse effects seen with boceprevir are

fatigue, anemia, nau sea, headache and dysgeu sia. It causes

anemia in up to half of the p atients, causing ad ditional

drop in Hemoglobin to that caused by interferon-/

r ibavir in . Neutropenia and thrombocytopenia are

relatively rare but occur m ore frequen tly compa red to

interferon- / ribavirin. The ad verse effects seen w ith

telaprevir are rash, pruritus, anemia, nau sea, hemorrhoids,

diar rhea, anor ectal discomfort, vomiting. Rash occurs in

over 50% patients, w hich may become severe in minority

of patients and requ ire treatment discontinuation. Anemia

with telaprevir is comparatively less frequent than

boceprevir, but still more frequent than interferon-/

ribavirin. Both telaprevir and boceprevir are inhibitors

of CYP3A4 and P-gp. As both th ese drugs are appr oved to

be used only in combination with interferon- andribavirin, the contr aindications to interferon-/ ribavirin

(eg. pregn an cy) also apply to these dru gs.

The p rotease inhibitors h ave certainly revolutionized

the treatm ent of chronic hepatitis C, by imp roving the

outcome as well as decreasing the du ration of therapy.

Yet certain hurdles are not yet overcome. These newer

dru gs are not studied in genotypes other than genotype 1,

HIV co-infection, H BV co-infection and decomp ensat ed

cirrhosis. As these drugs only supplement rather than

replacing the older d rugs, patients will be su bjected to

same ad verse effects, an d possibly a few m ore.

References

1. Shepard CW et al. Lancet Infect Dis. 2005;5:558-67.

2. Perz JF et al. J Hep atol. 2006;45:529-38.

3. Mukhop ad hyaya A. J Biosci. 2008;33:465-73.

4. Poord ad F et al. N Engl J Med. 2011;364:1195-206.

5. Poynard T et al. Lancet. 1998;352:142632.

6. McHutchison JG et al. N Engl J Med . 1998;339:148592.

7. Jacobson IM et al. Hepatology. 2010;52:427A.

8. Zeuzem S et al. N Engl J Med. 2011;364:2417-28.

Dr. Anil Rajani, Dr. Steven A Dkhar

Department of Pharmacology


New Approach


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4

Tardive dyskinesia: an up date

First described by Faurbye in 1964, tard ive dyskinesia

(TD) is one of th e most serious ad verse effects of long-

term an tipsychotic treatm ent. TD consists of involun tary

movemen ts that have both faster and slower components(choreo-athetoid movements), with a tendency to

involve the lips, tongu e, facial mu scles, and r espirator y

muscles. A variant form, tardive dystonia, consists of

sustained postu res of larger muscles in the n eck and trunk.

Clinical features:

Tardive d yskinesia affects aroun d 20-30% of patients

taking long-term an tipsychotics, with an approximate risk

of 3-5% per year of treatm ent. Factors associated w ith th e

developmen t of TD includ e extremes of age, organic brain

d isorders , i r regu la r t rea tment , h igh-po tency

ant ipsychotic treatment, acute extrapyra mida l side-effects

(EPS), and u se of an ticholinergic dr ug s. An Indian stu dy

found male gender , early age of onset of mental illness,

an d p oor functioning to be s ignificant risk factors. TD is

potentially irreversible, and the rate of reversibility

declines w ith age. Though rarely fatal on its ow n, TD is

disfigu ring, and m ay be associated w ith a poorer outcome

of schizophr enia and increased long-term mortality. It m ay

also contribute to the stigma faced by mentally ill patients

receiving d rug therapy.

Atypical antipsychotics and the risk of TD:

The most widely accepted p athop hysiological mod el

for TD is dopamine (D 2) receptor supersensitivityfollowing prolonged blockade, though other theories

have been proposed Theoretically, the newer or atypical

antipsychotics which are less potent D2

blockers and

cause less acute EPS should carry a lowe r risk of TD.

However, long-term stud ies in real-world settings, such

as the Clinical Antipsychotic Trials of Intervention

Effectiveness (CATIE) found tha t th ese differences were

small and did not contribute significantly to cost-

effectiveness. A stud y from Europe found that at ypical

an tipsychotics may ha ve a significan tly lower risk of TD

in the long term, after 5 or more years of treatmen t.

Prevention of TD:As there is no cure for TD, prevention is vital.

Antipsychotics should be prescribed only for valid

indications, such as schizophrenia and man ia, by trained

medical personnel. The need for long-term treatment

should be periodically assessed. If older d rugs are used ,

lower d oses are pr eferred. Regular checks for TD, using a

structured instrum ent such as the Abnormal Involuntary

Movement Scale (AIMS), are recommended every 6

months . Efforts should be m ade to ensu re that patientstake their medication regularly, and anticholinergics

should be prescribed only when necessary. Medical

conditions that may increase the risk of TD, such as diabetes

mellitus and iron deficiency, shou ld be corrected.

Treating TD:

No sing le effective treatm ent exists. Dose redu ction

and dru g d iscontinua tion are often tried, but there is little

eviden ce for this pra ctice. Cha nging from a typ ical to an

atypical drug, su ch as risperidone, olanzapine, qu etiapine

or aripipra zole, may be ben eficial. Clozap ine is useful in

both TD and tardive dystonia, bu t is reserved for resistant

cases because of its ad verse e ffect profile. Tetrabena zine,

wh ich d epletes central dop amine, has sh own efficacy in a

controlled trial. Benzodiazepines have a modest but

significant effect. Other treatment approaches, such as

cholinesterase inhibitors and d eep brain stimu lation, are

still experimental. Finally, supp lementation w ith v itamin

E (400-1600 IU/ day ) may p revent or slow th e progression

of TD.

Pharm acogenetics and TD :

An exc i t ing a rea o f cur ren t resea rch i s the

identification of genetic factors linked with TD, which

may allow high-risk p atients to be identified beforestarting treatment. Various cand idate genes hav e been

proposed , but r esults are equ ivocal in most cases. Stud ies

from India suggest th at polymorphisms in serotonin (5-

HT2) receptor genes, and in the dopamine D

3receptor gene,

may be as sociated with a n increased r isk of TD.

Further work in this area, and on developing non-

dop amine based an tipsychotics, wou ld represent a major

advan ce in man aging and treating th is distressing ad verse

effect.

Further reading:

1. Sachd ev PS. Aust N Z J Psychiatr . 2000; 34:355-369.

2. Margolese HC et al. Can J Psychiatry. 2005;50:541-547.

3. Margolese HC et al. Can J Psychiatry. 2005;50:703-714.

Dr. Ravi Philip Rajkumar

Department of Psychiatry


Linaglip tin A new an d b etter choice of drug in Type 2 Diab etes Mellitus

Type 2 diabetes m ellitu s is one of the leading caus es

of death w orldwide. Gliptins are the new class of drugs

used in type 2 diabetes mellitus and linagliptin is thelatest ad d ition to this grou p. Linagliptin (Trad e nam e-

TRADJENTA) is recomm end ed a s 5 m g once d aily ta blet.

This group of drugs acts by inhibiting the enzyme

dipeptidyl peptidase-4 (DPP4) which is responsible for

the inactivation of incretins su ch as glucagon like peptide

1 (GLP-1) and glucose-d epend ent insulinotrop ic pep tide(GIP). These peptides control the dietary glucose

dependent release of insulin. DPP-4 inhibitors increase

the c i rcu la t ing GLP-1 leve l s to the h igh normal

U p d a t e


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List of newly ap p roved drugs in Ind ia from 01-01-2011 to 30-06-2011

New Approvals

S.No.

1.

2.

3.

4.

Indication

For the treatment of patients with

acu te pa in fu l muscu loske le ta l

conditions

For the treatment of patients with

diabetic polyneuropath y

For treatment of hyper pigmentry

disorders

For the treatment of iron deficiencyin adu lts wh en oral iron preparations

are ineffective or cannot be used.

Date of issue

05.01.11

05.01.11

31.01.11

11.02.11

Name of Drug

S (+) Etodolac 300mg +Thiocolchicoside

8mg Tablet

Metformin H Cl IP 500mg + Alpha Lipoic

Acid USP 200mg Tablet

Hyd roquinone USP 2% w/ w + Tretinoin

USP 0.025% w/ w + Allant oin USP 1%w/

w Gel

Ferr ic Carboxymaltose equivalent toelement al Iron50mg/ ml Injection

5

physiological range. They n ot only improve the insulin

secretion from the pancreas bu t also decrease the glucagon

outp ut from cells of islets of p ancreas.

DPP-4 inhibitors carry the advantage over GLP-1

receptor agonists in a wa y that they can be given orally;

have fewer adverse events and do not cause w eight loss,

wh ile possessing s imilar efficacy as compar ed t o GLP-1

agonists in redu cing plasma glucose levels. These d rugs

also enhance the sur vival of cells and stimulate their

growth , thu s preserving cell mass. Among th e gliptins

sitagliptin, saxagliptin and vildagliptin are already

app roved. The approval of alogliptin is delayed because

of the insu fficient d ata regarding its cardiovascular risks.

Linagliptin is the recent dr ug approved by US-FDA on

May 2011.

Linagliptin is a potent an d long acting dru g am ong

the gliptins and has long lasting effect on glucose

tolerance. Gliptins can be used as monotherapy or in

combination with metformin, thiazolidinediones and

sulfonylureas. The other drugs such as sitagliptin,

saxagliptin and vildagliptin have the limitation of

requiring d ose redu ction in renal d ysfunction. How ever,

linagliptin has insign ificant rena l clearance and hen ce it

can be used safely in patients with ren al dysfun ction and

it does not need dose adjustment in liver dysfunction.

Linagliptin has lower drug interactions with CYP3A4

substrate dru gs compared to other gliptins.

In clinical stud ies for safety a nd efficacy, linagliptin

showed significant red u ction in HbA1C

(-0.4% from base

line), fasting plasma glucose and 2 hour post-prandial

plasma glucose levels. Linagliptin 5 mg once daily was

stud ied as m onotherapy in two p lacebo-controlled trials

o f 18 and 24 weeks dura t ion . I t was found tha t

nasopharyngitis occurred in more than 5% of patients

receiving linagliptin (n=2566) and more comm only than

pa tients w ho received p lacebo (n=1183, 5.8% vs 5.5%). A

stud y comparing th e ad verse effects of linagliptin and

glimepiride as add on therapy to metformin showed

greater occurren ce of arthralgia, back pain and head ache

in the group treated with linagliptin. In another stud y it

was shown that linagliptin had similar effect on prod ucing

hypoglycemia compared to placebo when used as

monotherapy or in combina t ion w i th met formin .However, when it was combined with sulphonylurea and

metformin (n=791), they prod uced a greater incidence of

hyp oglycemia compared to the combination of p lacebo

with sulphonylurea and metformin (n=263,22.9% vs

14.8%). Pancreatitis has also been reported with linagliptin

in clinical trials.

The effect of linagliptin on long term use and on

immu ne system is yet to be explored. It is not effective in

type 1 diabetes mellitus and no adequ ate information is

available regard ing the u se of linagliptin in combination

with insulin. It is not recommen ded for use in diabetic

ketoacidosis as its efficacy is not established in thiscondition.

Linagliptin is yet to be marketed in India. With some

advantages over other oral anti-diabetic agents, linagliptin

is an alternative in the treatment of type 2 d iabetes mellitus.

Further reading:

1. Pratley R. Curr Med Res Opin. 2007;23:91931

2. Blech S et al. Drug Met ab Dispos. 2010;38:667-78.

3. Thomas L et al. J Pharmacol Exp Ther. 2009;328:556-63.

4. Heise T et al. Diabetes Obes Metab. 2009;11:786-94.

Dr. Alphienes St anley, Dr. Shewade DG

Department of Pharmacology,



6/8

6

S.No. Indication Date of issueName of Drug

5.

6.

7.

8.

9.

10.

11.

12.

13.

14.

Pidotimod Tablet 400 mg/ 800 mg & Oral

Solution 400 mg/ 800 mg per 7ml

Iloper idone Tab le ts 1mg/ 2mg/ 4mg/

6mg/ 8mg/ 10mg/ 12mg

Cal f lung sur f ac tan t In t r a t r achea l

Suspension containing Phospholipids...

35mg (containing 26 mg ph osphatidy l-

choline of which 16mg is disaturated

phosphatidylcholine) Proteins....0.65mg

(includ ing 0.26mg of surfactant associated

proteins B) per ml

Eslicarbazepine Acetate Tablets 200mg/

400mg/ 600mg/ 800mg

Aspirin (EC Tablets) 75mg/ 75mg / 150mg

+Rosuvastatin (Granu les) 5mg/ 10mg/

10mg Capsules

Ilapra zole Tablets 5mg/ 10mg

Asenapine Maleate Sublingual Tablets

5mg/ 10mg

Tapentad ol Hy dr ochlorid e Tablets 50mg/

75mg/ 100mg

Diclofenac Coles tyramine 145.6 mg

cor responding to 75mg Dic lo fenac

Sodium Capsules.

1. PROBIO:

Each sachet (1g) contain s:

Tota l Probio t ic.... N ot less tha n 1.25

Billion CFU (Lactobacillus acidop hilus,

Lactobacillus rhamnosus, Bifidobacte-

rium longum , Saccharom yces boulardii)

2. PROBIO & PR EBIO (F)s

Each sachet (1g) contain s:

Prob io (CMP 5)Total Probi otic...Not less

than 1.25 Billion CFU (Lactobacillus

acidophilus, Lactobacillus rhamnosus,

Bifidobacterium longum, Saccharomycesboulardii)

Fructo Oligo Saccharides.. 100mg

For infect ions of the respiratory

system in secondary and primary

immu nodeficiency with alteration

in maturation of T cells in adults

only.

For the acute treatment of adults

with schizophrenia.

(a). As a prophylaxis therapy for

premature in fan t s


7/8

Pharmacology Cross Word

3. Autocoid, causes hypertrichosis as an adverse

effect(11)

4. Side-effect of inhalational Corticosteroids (9)

5. Used for the treatment of Diabetic gastroparesis

(12)

6. Used for the treatmen t of nausea and v omiting,

associated w ith cancer chemotherap y (10)

7. Causes hand and foot syndrom e (12)

8. Opioid an tagonis t useful for pos toperat ive

paralytic ileus (9) Dr. Mani Prabhu

Department of Pharmacology, JIPMER, Puducherry.

Across

1. Monoclonal an tibody, characteristically causes

septal perforation (11)

9. Cell w all synthesis inh ibitor, indicated on ly for

topical use (10)

10. Inhalat ional drug, used oral ly for sys temic

mastocytosis (14)

11. Shortest acting anti-depressant (10)

Down

2. Used as an adjuvant to Sodium stilbogluconate

in the treatm ent of kala azar (11)

Cross Word

S.N o. In dication Date of issueName of Drug

15.

16.

3. PROBIO & PREBIO (D)

Each sachet (1.3g) contains:

Probio (CMP 5)Total probiotic... no t less

than 1.25 bill ion CFU (Lactobacillus

acidophilus, Lactobacillus rhamnosus,

Bifidobacterium longum, Saccharomycesboulardii)

Fructo Oligo Saccharides..... 1000 mg

Silodosin Capsules2mg/ 4mg/ 8mg

Tiapr ide H yd rochloride Tablets 25mg/

50mg/ 100mg

For the t r ea tment o f s igns and

symptoms of ben ign p ros ta t i c

hyp erplasia (BPH) in ad ults only.

For the treatment of agitation and

aggressiveness in ad ult patients with

cognitive impairment.

23.06.11

23.06.11

1 2 3

4

5 6

8

9

1 0

1 1

7

7

Dr. Saranya Vilvan

Department of Pharmacology, JIPMER, Puducherry.

Reference: www.cdsco.nic.in


8/8

8

Attention

Interested Faculty an d Senior/ Ju nior residents of JIPMER may contribu te articles for forth

coming issues of DRUG ALERT. Your articles may include short drug reviews, adverse drug

reactions, ph armacotherapy and other therapeutical dilemmas related to d rug therapy.

For further details kindly contact the address given below:

Email: m elvingeor ge2003@gm ail.com ; sandhiyaselvara jan @gmail.com

Phon e No: 6361/ 6359

Gu idelines for reporting of Ad verse Dru g Reactions

ADR Monitoring Centre, Department of Pharmacology, JIPMER, Pondicherry invites reports

of all suspected adverse reactions to drugs and other medicinal substances, including herbals,

traditional and complementary medicines, blood products, medical devices and vaccines.

Report even if:

The drug is an established one and the adv erse

dru g reaction is well known

You are not certain the produ ct caused adverse

event

You d ont ha ve all the d etails

Who can report?

Any h ealth care professional (doctors including

in te rns , r es iden ts , den t i s t s , nu r ses and

pharmacists)

Where to report: You can rep ort online at w ww.jipmer.edu or send your reports to:

Dr. C. Adithan , Co-ordin ator

ADR Monitoring Centre

Department of Pharm acology, JIPMER, Pondicherry-605006.

Note:If you are at JIPM ER you can also use the yellow forms provided in wards.

Drug Information Service

C Have queries on therapy of disease? C Want to know th e safety of a drug?

C Need to know about d rug interactions? C Searching for information about new dr ugs?

We are here to help you

Drug Information CentreDepa rtm ent of Pharm acology, JIPMER, Puducherry-605 006.

Mob ile No: 8056986804; Pho ne: 2277369; Ext: 6359.

E-mail: ad rjipm er@gm ail.com

Cross W ord Answ ers

Across

1. Bev aciz um ab

9. Ba cit ra cin

10. Cromolynsod ium

11. Nefazodone

Down

2. A llop ur in ol

3. Bim a top rost

4. Dysp hon ia

5. Er yt hro my cin

6. Dr on abin ol

7. Ca pe cit ab in e

8. Alvim op an

drug alert (august-2011)

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