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 5 mL contains:
Clarithromycin …………. 125 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.

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.

INDICATION:

Upper & Lower respiratory tract, skin & soft tissue infections. Acute otitis media, Disseminated or localized mycobacterial infections due to Mycobacterium avium or Mycobacterium intracellulare.

PRECAUTIONS:

Impaired hepatic function & moderate to severe renal impairment.

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; 30-40 kg (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)
50 ml and 70 ml Bottle

Shake well before using.