ADVERSE EFFECTS:

Gastrointestinal disturbances are the most frequent adverse effect but are usually mild and less frequent than with erythromycin, Taste disturbances, stomatitis, glossitis and tooth discoloration have jaundice and hepatitis have been reported. Headache and rashes from mild skin eruptin to, rarely, Steven-johnson syndrome have occured. There have also been reports of transient CNS effects such as anxiety, dizziness, insomnia, hallucinations and confusion. Hearing loss has been reported occassionally and is usually reversible. Other adverse effects include hypoglycaemia and thrombocytopenia. Intertitial nephritis and renal failure have been reported rarely.

DESCRIPTION:

Clarithromycin is a macrolide derived from erythromycin with similar actions and uses. It is given in the treatment of respiratory tract infections (including otitis media) and in skin and soft-tissue infections.

FORMULATION:

Each Film-coated tablet contains:
Clarithromycin …………. 250 mg

PHARMACOKINETICS:

Clarithromycin is rapidly absorbed rom the gastrointestinal tract following oral adminstration, and undergoes first-pass metabolism; the bioavailability of the parent drug is about 55%. The extent of absorption is relatively unaffected by the presence of food.
Peak concentrations of clarithromycin and its principal active metabolite 14-hydroxyclarithromycin are reported to be about 0.6 and 0.7mg per ml respectively following a single 250-mg dose by mouthl at steady state the same dose given every 12 hours as tablets produces peak concentrations of clarithromycin of about 1 mg per ml. The same dose given as a suspension produces a steady-state plasma concentration of about 2 mg per ml.

The pharmacokinetics of clarithromycin are non-linear and dose dependent; high doses may produce disproportionate increases in peak concentration of the parent drug, due to saturation of the metabolite pathways.

INDICATION:

For respiratory tract infections, mild to moderate skin and soft tissue infections, otitis media; Helicobacter pylori eradication.

PRECAUTIONS:

Caution is required in patients with impared renal or hepatic function and doses should be reduced in those with severe renal impairment. It should not be used during pregnancy high doses have been associated with embryo toxicity in animal studies.

By mouth, 250 mg every 12 hours for 7 days, increase in severe infections to 500 mg every 12 hours for up to 14 days; child body-weight under 8 kg, 7.5 mg/kg twice daily; 8-11 kg (1-2 years). 62.5 mg twice daily; 12-19 kg (3-6 years), 125 mg twice daily; 20-29 kg (7-9 years). 187.5 mg twice daily; 30-40kg (10-12 years) 250 mg twice daily or as
prescribed by the physician.

CAUTION:

Foods, Drugs, Devices and Cosmetics Acts prohibits dispensing without prescription.

STORAGE CONDITION:

Store at temperatures not exceeding 30 degree Celcius.

AVAILABILITY:

Alu-Alu Blister Pack x 8′s (Box of 24′s)