Emimycin® - clarithromycin = Composition: iiiiiiii Emimycin 250 mg Film Coated Tablets: Each FC tablet contains - clarithromycin USP 250 mg - Emimycin 500 mg Film Coated Tablets: Each FC tablet contains

clarithromycin USP 500 mg

Properties: clarithromycin is a semi-synthetic derivative of erythromycin A. It exerts its antibacterial action by binding to the 50s ribosomal sutrunit of susceptible bacteria and suppresses protein synthesis. It is highly potent against a wide variety of aerobic and anaerobic gram-positive and gram-negative organisms. The minimum inhibitory concentrations (MICs) of clarithromycin are generally two-fold lower than the MICs of erythromycin. The 14-hydroxy metabolite of clarithromycin also has antimicrobial activity. The MICs of this metabolite are equal or two-fold higher than the MICs of the parent compound, except for H. influenzae where the 14-hydroxy metabolite is two-fold more active than the parent compound. clarithromycin is usually active against the following organisms in vitro: Gram-positive Bacteria: Stapllylococcus aureus (methicillin susceptible); Streptococcus pyogenes (Group A beta-hemolytic str.eptococci); alpha-hemolytic Streptococci (viridans group); Streptococcus (Diplococcus) pneumoniae; Streptococcus agalactiae; Listeria monocytogenes. Gram-negative Bacteria: Haemophilus influenzae; Haemophilus parainfluenzae; Moraxella (Branhamella) catarrhalis; Neisseria gonorrhoeae; Legionella pneumophila; Bordetella pertussis;Helicobacter pylori; Campylobacter jejuni. Mycoplasma: Mycoplasma pneumoniae; Ureaplasma urealyticum. Other Organisms: Chlamydia trachomatis; Mycobacterium avium; Mycobacterium leprae. Anaerobes: Macrolide-susceptible Bacteroides fragilis; Clostridium perfringens; Peptococcus species; Peptostreptococcus species; Propionibacterium acnes. Clarithromycin has bactericidal activity against several bacterial strains. The organisms include: Haemophilus influenzae, Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus agalactiae, Moraxella (Branhamella) catarrhalis, Neisseria gonorrhoeae, H. pylori and Campylobacter spp.

Indications: Emimycin is indicated for treatment of infections caused by susceptible organisms. Indications include:

-Lower respiratory tract infections for example, acute and chronic bronchitis, and pneumonia. - Upper respiratory tract infections for example, sinusitis and pharyngitis. - Initial therapy in community acquired respiratory infections and has been shown to be active in vitro against common and atypical respiratory pathogens. - Skin and soft tissue infections of mild to moderate severity. - Eradication of H. pylori in patients with duodenal ulcers in presence of acid suppression effected by omeprazole or lansoprazole

Dosage and Administration: Emimycin may be given without regard to meals. As food does not affect the extent of bioavailability. Patients with respiratory tract/skin and soft tissue infections: Adults: The usual dose is 250 mg twice daily for 7 days although this may be increased to 500mg twice daily for up to 14 days in severe infections. Children older than 12 years: As for adults. Eradication of H. pylori in patients with duodenal ulcers (Adults): Triple Therapy (7 -14 days): Emimycin 500mg twice daily and lansoprazole 30mg twice daily should be given with amoxycillin 1000mg twice daily for 7-14 days. Triple Therapy (7 days): Emimycin 500mg twice daily and lansoprazole 30mg twice daily should be given with metronidazole 400mg twice daily for 7 days. Triple Therapy (7 days): Emimycin 500mg twice daily and omeprazole 40mg daily should be given with amoxycillin 1 OOOmg twice daily or metronidazole 400mg twice daily for 7 days. Triple Therapy (10 days): Emimycin 500mg twice daily should be given with amoxycillin 1 OOOmg twice daily and omeprazole 20mg daily for 10 days. Dual Therapy (14 days): The usual dose of Emimycin is 500 mg three times daily for 14 days. Emimycin should be administered with oral omeprazole 40 mg once daily. The pivotal study was conducted with omeprazole 40 mg once daily for 28 days. Supportive studies have been conducted with omeprazole 40 mg once daily for 14 days. Elderly: As for adu~s. Dosage in Renal lmpainnent: Dosage adjustments are not usually required except in patients with severe renal impairment (creatinine clearance < 30 ml/min). If adjustment is necessary, the total daily dosage should be reduced by half, e.g. 250 mg once daily or 250 mg twice daily in more severe infections.

Contraindication&: -clarithromycin is contra-indicated in patients with known hypersensitivity to macrolide antibiotic drugs. -clarithromycin and ergot derivatives should not be co-administered. -Elevated levels have been reported in patients receiving clarithromycin concomitantly with any of the following drugs: cisapride, pimozide and terfenadine. This may result in QT prolongation and cardiac arrhythmias including ventricular tachycardia, ventricular fibrillation and Torsade de Pointes. Similar effects have been observed with concomitant administration of astemizole and other macrolides.

Prolonged or repeated used of clarithromycin may result in an overgrowth of non-susceptible bacteria or fungi. If super infection occurs, clarithromycin should be discontinued and appropriate therapy instituted. H. Pylori organisms may develop resistance to clarithromycin in a small number of patients.

Use in Pregnancy and Lactation: The safety of clarithromycin during pregnancy and lactation has not been established. As with all medicines, use should be avoided in pregnancy and during breast-feeding.

Side Effects: -clarithromycin is generally well tolerated. Side effects include nausea, dyspepsia, diarrhoea, vomiting, abdominal pain and paraesthesia .. Stomatitis, glossitis, oral monilia and tongue discolouration have been reported. Other side effects include headache, arthralgia, myalgia and allergic reactions ranging from urticaria, mild skin eruptions and angioedema to anaphylaxis and rarely Stevens-Johnson syndrome I toxic epidermal necrolysis. -Reports of alteration of the sense of smell, usually in conjunction with taste perversion have also been received. There have been reports of tooth discolouration in patients treated with clarithromycin. Tooth discolouration is usually reversible with professional dental cleaning. -There have been reports of transient central nervous system side-effects including dizziness, vertigo, anxiety, insomnia, bad dreams, tinnitus, confusion, disorientation, hallucinations, psychosis and depersonalisation. There have been reports of hearing loss with clarithromycin, which is usually reversible on withdrawal of therapy. - Pseudomembranous colitis has been reported rarely with clarithromycin, and may range in severity from mild to life threatening. -There have been rare reports of hypoglycaemia, some of which have occurred in patients on concomitant oral hypoglycaemic agents or insulin. There have been very rare reports of uveitis mainly in patients treated with concomitant rifabutin most of these were reversible. Isolated cases of leukopenia and thrombocytopenia have been reported. :As wi.th other macrolides, hepatic dysfunction {which is usually reversible) ~nclud1ng altered liver function tests, hepatitis and cholestasis with or without jaundice, has been reported. Dysfunction may be severe and very rarely fatal hepatic failure has been reported. -Cases of increased serum creatinine, interstitial nephritis, renal failure, pancreatitis and convulsions have been reported rarely. -As with other macrolides, QT prolongation, ventricular tachycardia and Torsade de Pointes have been rarely reported with clarithromycin.

Drug Interactions: -clarithromycin has been shown not to interact with oral contraceptives. -As with other macrolide antibiotics the use of clarithromycin in patients concurrently taking drugs metabolised by the cytochrome P450 system (eg. warfarin, ergot alkaloids, triazolam, midazolam, disopyramide, lovastatin, rifabutin, phenytoin ,cyclosporin and tacrolimus) may be associated with elevations in serum levels of these other drugs. -Rhabdomyolysis, co-incident with the co- administration of clarithromycin, and HMG-CoA reductase inhibitors, such as lovastatin and simvastatin has been reported. -The administration of clarithromycin to patients who are receiving theophylline has been associated with an increase in serum theophylline levels and potential theophylline toxicity. -The use of clarithromycin in patients receiving warfarin may result in potentiation of the effects of warfarin .. -The effects of digoxin may be potentiated with concomitant administration of Clarithromycin. -clarithromycin may potentiate the effects of carbamazepine due to a reduction in the rate of excretion. -Simultaneous oral administration of clarithromycin tablets and zidovudine to HIV infected adult patients may result in decreased steady-state zidovudine levels. -Although the plasma concentrations of clarithromycin and omeprazole may be increased when they are administered concurrently, no adjustment to the dosage is necessary. At the dosages recommended, there is no clinically significant interaction between clarithromycin and lansoprazole. -Increased plasma concentrations of clarithromycin may also occur when it is co-administered with Maalox or ranitidine.

Overdosage: The ingestion of large amounts of clarithromycin can be expected to produce gastro-intestinal symptoms. Patient who had a history of bipolar disorder ingested 8 grams of clarithromycin, showed altered mental status, paranoid behaviour, hypokalemia and hypoxemia. The symptoms of overdosage should be treated by gastric lavage and supportive measures. As with other macrolides, clarithromycin serum levels are not expected to be affected by haemodialysis or peritoneal dialysis.

Presentation: Emimycin 250 mg Film Coated Tablets in packs of 14 FC tablets as 7's blister x 2 Emimycin 500 mg Film Coated Tablets in packs of 20 FC tablets as 10's blister x 2

Store below 25°C in a dry place. Protect from light.

THIS IS A MEDICAMENT

A Medicament is a product, which affects your health and its consumption contrary to instruction, is dangerous for you. ' '

~f~~oewp~~~~J~~ ~~~t~~fcft~i%iC~~·~~~tmethod of use and the instructions

The doctor and the pharmacist are experts in medicine, its benefits and risks.

Do not, by yourself, intemupt the period of treatment prescribed for you.

Do not repeat the same prescription without consulting your doctor.

Keep medicament• out of the reach of children

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