Each film coated tablet contains: Clarithromycin 500 mg.
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.
Pharmacology: Pharmacokinetics: Clarithromycin is rapidly absorbed from the gastrointestinal tract following oral administration, 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 600 and 700 nanograms per mL respectively following a single 250-mg dose by mouth; at steady state the same dose given every 12 hours as tablets produces peak concentrations of clarithromycin of about 1 μg per mL. The same dose given as suspension produces a steady-state plasma concentration of about 2 μg 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.
For the treatment of respiratory-tract infections, mild to moderate skin and soft tissue infections, otitis media, and Helicobacter pylori eradication.
The usual recommended dosage of clarithromycin in adults is one 250 mg tablet twice daily. In severe infections, the dosage can be increased to 500 mg twice daily or as prescribed by the physician.
Children 15 mg/kg/day in 2 divided doses maximum of 500 mg every 12 hour. The usual duration of therapy is 5 to 14 days excluding treatment of community acquired pneumonia and sinusitis which require 6 to 14 days of therapy.
Clarithromycin is contraindicated in patient with known hypersensitivity to macrolide antibiotic drugs.
Caution is required in patients with impaired renal or hepatic function and doses should be reduced in those with severe renal impairment.
It should not be used during pregnancy if possible high doses have been associated with embryotoxicity in animal studies.
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 occurred. Transient elevations of liver enzyme value, cholestatic jaundice and hepatitis have been reported. Headache and rashes from mild skin eruption to, rarely, Steven-Johnson syndrome have occurred. There have also been reports of transient CNS effects such as anxiety, dizziness, insomnia, hallucinations, and confusion. Hearing loss has been reported occasionally and is usually reversible. Other adverse effects include hypoglycaemia and thrombocytopenia. Interstitial nephritis and renal failure have been reported rarely.
Cytochrome P450 Interactions data available to date indicate CLARITHROMYCIN is metabolized primarily by the hepatic cytochrome P450 3A (CYP3A) isozyme. This is an important mechanism determining many drug interactions. The metabolism of other drugs by this system may be inhibited by concomitant administration with CLARITHROMYCIN and may be associated with elevation in serum levels of these other drugs.
The following drugs or drug classes are known or suspected to be metabolized by the same CYP3A isozyme: alprazolam, estemizole, carbamazepine, cilostazol, cisapride, cyclosporine, disopyramide, ergot alkaloids, lovastatin, methylprednisolone, midazolam, omeprazole, oral anticoagulants (e.g. warfarin) pimozide, quinidine, rifabutin, sildenafil, simvastatin, tacrolimus, terfenadine, trizolam and vinblastine. Drugs interacting by similar mechanisms through other isozymes within the cytochrome P450 system include phenytoin, theophylline and valproate.
Store at temperatures not exceeding 30°C.
J01FA09 - clarithromycin ; Belongs to the class of macrolides. Used in the systemic treatment of infections.
Claryn FC tab 500 mg