📌 COMPOSITION

• Each 5 ml (teaspoonful) of reconstituted suspension contains: Clarithromycin USP 125 mg, 250 mg.
• Each F/C tablet contains: Clarithromycin USP 250 mg, 500 mg.

📌 DESCRIPTION

Clarimax (Clarithromycin) is a new macrolide antibiotic. It exerts its antibacterial activity by binding to the 50S ribosomal subunit and inhibiting protein synthesis of susceptible bacteria. Clarithromycin is highly potent against a wide variety of aerobic, anaerobic, Gram-positive and Gram-negative organisms. It is active against the following organisms in vitro: Streptococcus (agalactiae, pyogenes, viridans, pneumoniae), Haemophilus (influenzae, parainfluenzae), Neisseria gonorrhoeae, Listeria monocytogenes, Legionella pneumophila, Mycoplasma pneumoniae, Helicobacter pylori, Campylobacter jejuni, Chlamydia trachomatis, Moraxella (Branhamella) catarrhalis, Bordetella pertussis, Staphylococcus aureus, Propionibacterium acnes, Mycobacterium (avium, leprae, kansasii, chelonae, fortuitum, intracellulare). Clarithromycin is rapidly absorbed from the gastrointestinal tract following oral administration. The extent of absorption is relatively unaffected by the presence of food. After absorption, clarithromycin rapidly diffuses into the majority of tissues excluding the CNS, without significant differences in concentration. It is metabolised in the liver. The principal metabolite of clarithromycin is a microbiologically active metabolite, 14-hydroxy-clarithromycin. 80% of clarithromycin is bound to plasma proteins at therapeutic levels. Clarithromycin and its metabolites are excreted in urine and faeces.

📌 INDICATIONS

Clarimax is indicated in the treatment of:

• Infections of the nasopharyngeal tract (tonsillitis, pharyngitis), paranasal sinuses and otitis media.
• Infections of the lower respiratory tract (bronchitis, bacterial pneumonia and atypical pneumonia).
• Skin infections (impetigo, erysipelas, folliculitis, furunculosis and septic wounds).
• Eradication of H. pylori in patients with proven duodenal ulcer.

📌 DOSAGE & ADMINISTRATION

Clarimax may be given without regard to meals as follows:

• Adults and children older than 12 years: The usual dose is 250 mg every 12 hours for 7 days. This may be increased to 500 mg every 12 hours in severe infections for up to 14 days.
• Children younger than 12 years: Using Clarimax suspension as follows:
  • Children over 6 months: The recommended daily dose is 15 mg/kg/day in two divided doses.
  • The dose may be increased according to the severity of illness and the physician's opinion.
• For eradication of H. pylori in adults and the elderly:
  • Dual therapy: Clarimax tablets 500 mg three times daily for 14 days, administered with oral Omeprazole 40 mg once daily.
  • Triple therapy: Clarimax tablets 500 mg twice daily, with Amoxicillin 1000 mg twice daily and Omeprazole 20 mg daily for 10 days.
• In patients with renal impairment (creatinine clearance less than 30 ml/min), the dosage should be reduced by half and treatment should not continue beyond 14 days.

📌 RESTRICTIONS ON USE

Contraindications

• Patients with known hypersensitivity to macrolide antibiotics.
• Patients with severe liver insufficiency.
• Concomitant administration of clarithromycin with any of the following drugs is contraindicated (ergot derivatives, cisapride, pimozide and terfenadine).

Use in Pregnancy and Lactation

Clarithromycin should not be used during pregnancy and lactation unless the benefits are considered to outweigh the risks.

Precautions

• Caution should be exercised when administering clarithromycin to patients with impaired hepatic or renal function, and to elderly patients.
• Prolonged or repeated use of clarithromycin may result in overgrowth of non‑susceptible bacteria or fungi. If superinfection occurs, clarithromycin should be discontinued and appropriate therapy instituted.
• H. pylori may develop resistance to clarithromycin in a small number of patients.

📌 DRUG INTERACTIONS

• Concomitant use of clarithromycin with drugs metabolised by the cytochrome P450 system (e.g. warfarin, ergot alkaloids, triazolam, midazolam, disopyramide, lovastatin, rifabutin, phenytoin, cyclosporin and tacrolimus) may be associated with elevated serum levels of these drugs.
• The use of clarithromycin with warfarin leads to potentiation of the effects of warfarin; prothrombin time should be monitored frequently.
• Concomitant administration of clarithromycin with theophylline leads to increased serum theophylline levels and potential theophylline toxicity.
• Clarithromycin may potentiate the effects of digoxin; monitoring of serum digoxin should be considered.
• Clarithromycin may potentiate the effects of carbamazepine by reducing its excretion.
• Although plasma concentrations of clarithromycin and omeprazole may be increased when administered concurrently, no dosage adjustment is necessary.
• Although plasma concentrations of clarithromycin may be increased when co‑administered with Maalox or ranitidine, no dosage adjustment is necessary.
• Oral administration of clarithromycin tablets with zidovudine to HIV‑infected adults may result in decreased steady‑state zidovudine levels.

📌 ADVERSE EFFECTS

Clarithromycin is generally well tolerated. Side effects include:

• Nausea, dyspepsia, diarrhoea, vomiting, abdominal pain, paraesthesia, stomatitis, glossitis, oral moniliasis and tongue discolouration.
• Other side effects include headache, arthralgia, myalgia and allergic reactions ranging from urticaria, mild skin eruptions and angioedema to anaphylaxis; rarely, Stevens–Johnson syndrome.
• Alteration of the sense of smell, usually accompanied by taste perversion.
• Tooth discolouration, which is usually reversible with professional dental cleaning.
• Transient central nervous system side effects including dizziness, anxiety, insomnia, bad dreams, tinnitus, confusion, disorientation, hallucination, psychosis and depersonalisation. There have been reports of hearing loss with clarithromycin, which is usually reversible upon withdrawal of therapy.
• Rarely: pseudomembranous colitis, hypoglycaemia (some cases in patients receiving hypoglycaemic agents or insulin), leucopenia and thrombocytopenia. Hepatic dysfunction has been reported (usually reversible upon discontinuation).

📌 STORAGE INSTRUCTIONS

• Dry suspension: Store below 30°C in a dry place.
• Reconstituted suspension: Store at room temperature for 14 days.
• Tablets: Store below 30°C in a dry place, protect from light.

📌 PHARMACEUTICAL FORMS

• Clarimax 125 powder for oral suspension: Bottle of 60 ml or 100 ml.
• Clarimax 250 powder for oral suspension: Bottle of 60 ml or 100 ml.
• Clarimax 250 film-coated tablets: Pack of 14 tablets and hospital packs of different sizes.
• Clarimax 500 film-coated tablets: Pack of 14 tablets and hospital packs of different sizes.