Source: Health Products Regulatory Authority (IE) Revision Year: 2021 Publisher: Mylan IRE Healthcare Limited, Unit 35/36, Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland
Clarithromycin is indicated for the treatment of infections due to susceptible organisms. Such infections include:
Clarithromycin tablets are indicated in adults and children 12 years and older.
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Further Information: H. pylori is strongly associated with peptic ulcer disease. Ninety to 100% of patients with duodenal ulcers are infected with this agent. Eradication of H. pylori has been shown to markedly reduce the rate of duodenal ulcer recurrence, thereby reducing the need for maintenance anti-secretory therapy.
In a well controlled double-blind study, H. pylori infected patients with duodenal ulcer received clarithromycin 500mg t.i.d for 14 days with omeprazole 40mg daily for 28 days.
Clarithromycin has been used in other treatment regimens for the eradication of H. pylori. These regimens include: clarithryomycin plus tinidazole and omeprazole; and clarithromycin plus tetracycline, bismuth subsalicylate and ranitidine.
Adults: The usual recommended dosage of clarithromycin in adults is one 250mg tablet twice daily. In more severe infections, the dosage can be increased to 500mg twice daily. The usual duration of therapy is 6 to 14 days.
Children under 12 years: The use of clarithromycin tablets has not been studied in children under 12 years. Clinical trials have been conducted using clarithromycin paediatric suspension in children 6 months to 12 years of age. Therefore, children under 12 years of age should use clarithromycin paediatric suspension (granules for oral suspension).
Children over 12 years: As for adults.
In patients with renal impairment with creatinine clearance less than 30 ml/min, the dosage of clarithromycin should be reduced by one-half, i.e.: 250mg once daily or 250mg twice daily in more severe infections. Treatments should not be continued beyond 14 days in these patients.
Dosage in patients with mycobacterial infections: The recommended dose for adults with mycobacterial infections is 500mg b.i.d. Treatment of disseminated Mycobacterium avium complex (MAC) infections in AIDS patients should be continued, as long as clinical microbiological benefit is demonstrated. Clarithromycin should be used in conjunction with other antimycobacterial agents.
Treatment of other non-tuberculous mycobacterial infections should continue at the discretion of the physician.
Dosage for MAC prophylaxis: The recommended dosage of clarithromycin in adults is 500mg twice daily.
Eradication of H. pylori:
Triple Therapy (7 days): Clarithromycin (500mg) twice daily and a proton pump inhibitor (at the approved daily dose)* should be given with amoxycillin 1000mg twice daily for 7 days.
Triple Therapy (7 days): Clarithromycin (500mg) twice daily and a proton pump inhibitor (at the approved daily dose)* should be given with metronidazole 400mg twice daily for 7 days.
Triple Therapy (7-10 days): Clarithromycin (500mg) twice daily should be given with omeprazole 20mg daily and amoxycillin 1000mg twice daily for 7-10 days.
* see individual data sheets/SPCs for the dose recommendations for H. pylori eradication.
Reports indicate that the ingestion of large amounts of clarithromycin can be expected to produce gastrointestinal symptoms. One patient who had a history of bipolar disorder ingested eight grams of clarithromycin and showed altered mental status, paranoid behaviour, hypokalemia, and hypoxaemia.
Adverse reactions accompanying overdosage should be treated by the prompt elimination of unabsorbed drug and supportive measures. As with other macrolides, clarithromycin serum levels are not expected to be appreciably affected by haemodialysis or peritoneal dialysis.
2 years.
Do not store above 25°C. Store in the original package in order to protect from light.
2, 14, 56 tablets in PVC/PVdC Al blister pack. The blisters are packaged in a carton with a pack insert. Not all pack sizes may be marketed.
No special requirements.
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