Klacid 250 mg Film-coated Tablets

Active: Clarithromycin 250.00 mg/tablet

For a full list of excipients, see section 6.1.

Film-coated tablet

Yellow, ovaloid, impressed with the Abbott logo on one side.

Clarithromycin is indicated for the treatment of infections due to susceptible organisms. Such infections include:

1. Lower respiratory tract infections (e.g. bronchitis, pneumonia).

2. Upper respiratory tract infections (e.g. pharyngitis, sinusitis).

3. Skin and soft tissue infections (e.g. folliculitis, cellulitis, erysipalis).

4. Disseminated or localised mycobacterial infections due to Mycobacterium avium or Mycobacterium intracellulare. Localised 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.

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 TID 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: Use of clarithromycin tablets is not recommended for 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 starting dose is 500mg twice daily. If no clinical or bacteriologic response is observed in 3 to 4 weeks, the dose may be increased to 1000mg twice daily. Treatment of disseminated MAC infections in AIDS patients should be continued, as long as clinical microbiological benefit is demonstrated. Clarithromycin should be used in conjunction with other antimycobacte