Company: Ranbaxy Ireland.
Legal category: Prescription. GMS. Sport permitted.
Active ingredient: Clarithromycin 250mg, 500mg.
Description: Light yellow, oval shaped biconvex film-coated tablet, embossed with C1 on one side (250mg) or embossed with C and 2 on either side of a breakline on one side and notched on both sides (500mg). 500mg tablet can be divided into equal halves.
Presentation: 250mg-14, €9.10; 500mg-14, €15.22.
Indications: Infections caused by susceptible organisms. Lower RTIs: Acute and chronic bronchitis, and pneumonia; upper RTIs: Sinusitis and pharyngitis; skin and soft tissue infections of mild to moderate severity. Clarithromycin is appropriate for initial therapy in community acquired respiratory infections and has been shown to be active in vitro against common and atypical respiratory pathogens (see SPC). Eradication of H. pylori in patients with duodenal ulcers in appropriate combination with antibacterial therapeutic regimens and in the presence of acid suppression effected by omeprazole or lansoprazole.
Pharmacology: Clarithromycin is a semi-synthetic derivative of erythromycin A. It exerts its antibacterial action by binding to the 50s ribosomal sub-unit of susceptible bacteria and suppresses protein synthesis. 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.
Dosage: Adult: RTIs /skin and soft tissue infections: 250mg twice daily for 7 days. May be increased to 500mg twice daily for up to 14 days in severe infections. H. pylori eradication, 500mg twice daily as part of either of the following triple therapies: With lansoprazole 30mg twice daily and amoxycillin 1000mg twice daily for 7-14 days; with lansoprazole 30mg twice daily and metronidazole 400mg twice daily for 7days; with omeprazole 40mg daily and amoxicillin 1000mg twice daily or metronidazole 400mg twice daily for 7 days; with amoxycillin 1000mg twice daily and omeprazole 20mg daily for 10 days. Severe renal impairment: If necessary, reduce total daily dosage by half, e.g. 250mg once daily or 250mg twice daily in more severe infections, maximum treatment duration 14 days. Elderly: As per adults. Children: Respiratory tract/skin and soft tissue infections: Adolescents, as per adults. Not suitable for children under 12 years of age weighing less than 30 kg.
Contraindications: Known hypersensitivity to clarithromycin, to any other macrolides antibiotic drug, or to any of the other ingredients in the tablets. Pregnancy (unless clearly needed).
Special precautions: Caution: Renal/hepatic impairment, hypersensitivity to lincomycin or clindamycin, myasthenia gravis, coronary vessel disease, a history of ventricular arrhythmia, severe cardiac insufficiency, non-compensated hypokalemia and/or hypomagnesemia, bradycardia (<50 bpm). May result in an overgrowth of non-susceptible bacteria or fungi (discontinue if superinfection occurs). H. pylori may develop resistance to clarithromycin. Consider pseudomembranous colitis in patients who develop severe diarrhoea during or after therapy. Lactation (assess benefit/risk).
Drug interactions: Contraindicated: Ergot derivatives, substrates of CYP3A4, terfenadine, cisapride, pimozide. Avoid quinidine or disopyramide, oral midazolam. Caution: CYP3A4 inducers, drugs with potential to prolong QT, HMG-CoA reductase inhibitors (simvastatin, atorvastatin or cerivastatin), IV midazolam and other benzodiazepines metabolised by CYP3A4 (incl. triazolam and alprazolam), cyclosporine, tacrolimus, sirolimus, digoxin, warfarin, carbamazepine, theophylline, zidovudine, rifabutin.
Adverse drug reactions: Oral monilia, headache, smell alteration, GI disorders, elevated blood urea nitrogen.
Full prescribing information and references available from the distributor, Johnson Brothers Healthcare. Telephone: (01) 4081400. Fax (01) 4516696. firstname.lastname@example.org