Source: Υπουργείο Υγείας (CY) Revision Year: 2021 Publisher: Remedica Ltd, Aharnon Street, Limassol Industrial Estate, 3056 Limassol, Cyprus
Clarithromycin is indicated for the treatment of infections caused by susceptible organisms.
Such infections include:
1. Lower respiratory tract infections (e.g. bronchitis, pneumonia) (see section 4.4 and 5.1 regarding Sensitivity Testing).
2. Upper respiratory tract infections (e.g. sinusitis, pharyngitis).
3. Skin and soft tissue infections (e.g. folliculitis, cellulitis, erysipelas) (see section 4.4 and 5.1 regarding Sensitivity Testing).
4. Disseminated or localized mycobacterial infections due to: Mycobacterium avium or Mycobacterium intracellulare. Localized infections due to Mycobacterium chelonae, Mycobacterium fortuitum or Mycobacterium Kansasii.
5. Clarithromycin is indicated for the prevention of disseminated Mycobacterium avium complex infection in HIV-infected patients with CD4 lymphocyte counts less than or equal to 100/mm³.
6. Clarithromycin in the presence of acid suppression is indicated for the eradication of H. pylori, resulting in decreased recurrence of duodenal ulcer (See ‘Further information’).
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.
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 500 mg t.i.d for 14 days with omeprazole 40 mg daily for 28 days.
Clarithromycin has been used in other treatment regiments for the eradication of H. pylori. These regiments include: clarithromycin plus tinidazole and omeprazole; and clarithromycin plus tetracycline, bismuth subsalicylate and ranitidine.
The usual dosage of clarithromycin in adults is 250 mg tablet twice daily. In more severe infections, the dosage can be increased to 500 mg twice daily. The usual duration of therapy is 6 to 14 days.
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.
As for adults.
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.. 250 mg once daily or 250 mg twice daily in more severe infections. Treatment should not be continued beyond 14 days in these patients.
The recommended dose for adults with mycobacterial infections is 500 mg 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 mycobacterial agents.
Treatment of other non-tuberculous mycobacterial infections should continue at the discretion of the physician.
The recommended dosage for clarithromycin in adults is 500 mg twice daily.
Triple Therapy (7 days): Clarithromycin 500 mg twice daily and a proton pump inhibitor (at the approved daily dose)* should be given with amoxycillin 1000 mg twice daily for 7 days.
Triple Therapy (7 days): Clarithromycin 500 mg twice daily and a proton pump inhibitor (at the approved daily dose)* should be given with metronidazole 400 mg twice daily for 7 days.
Triple Therapy (7-10 days): Clarithromycin 500 mg twice daily should be given with omeprazole 20 mg daily and amoxycillin 1000 mg 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 gastro-intestinal symptoms. One patient who had a history of bipolar disorder ingested 8 grams of clarithromycin and showed altered mental status, paranoid behaviour, hypokalemia and hypoxemia.
Adverse reactions accompanying overdosage should be treated by gastric lavage and supportive measures. As with other macrolides, clarithromycin serum levels are not expected to be appreciably affected by haemodialysis or peritoneal dialysis.
3 years.
Store below 25°C. Protect from light and moisture.
Clarem 250 mg film-coated tablets: PVC-PVDC/Aluminium blisters. Pack sizes of 14 and 100 film-coated tablets.
Clarem 500 mg film-coated tablets: PVC-PVDC/Aluminium blisters. Pack sizes of 14 and 100 film-coated tablets.
Not all pack sizes may be marketed.
No special requirements for disposal.
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