Clarithromycin 500mg Tablets
| Each film-coated tablet contains:
Clarithromycin USP 500mg
|CLARITH is pink, oblong, film coated tablet with break line on one side.|
Pharmacotherapeutic Group: Macrolide Antibiotics
Pharmacodynamic properties: CLARITH reversibly binds to P site of 50S ribosomal subunit of susceptible organisms and inhibit RNA-dependent protein synthesis by stimulating dissociation of peptidyl t-RNA from ribosomes, thereby inhibiting bacterial growth.
Absorption: Highly stable in gastric acid, rapidly absorbed from the GI tract (oral). Bioavailability: 50%
Distribution: Widely distributed into most body tissues except CNS. Protein bound: 40-50%
Metabolism: Hepatic (extensive), converted to 14- hydroxyclarithromycin and other metabolites.
Excretion: Via the bile into the faeces, via the urine (20-30% as unchanged, 10-15% as 14-hydroxyclarithromycin and other metabolites.
Elimination half-life: parent form 3-7 hrs and active metabolite 5-9 hrs
H. pylori infections, acute maxillary sinusitis, pharyngitis, tonsillitis, community acquired pneumonia, chronic bronchitis, SSTI, erythrasma
Adult: 500mg twice daily in severe infections for 7-14 days; Paediatric: 7.5-15 mg/kg/day PO divided q12h for 7-4 days
Pregnancy: Category C
Clarithromycin can pass into breast milk and may harm a nursing baby. Do not breastfeed while using clarithromycin.
Storage: Store in a cool and dry place; Protect from light, heat and moisture; Keep away from the reach of children.
Hypersensitivity. Patients receiving terfenadine, astemizole, pimozide, cisapride and ergot derivatives. Pregnancy; history of acute porphyria.
Renal and hepatic impairment; macrolide cross-resistance; lactation, children.
Serious AEs: Pseudomembranous colitis, anaphylaxis, Stevens-Johnson syndrome. General AEs: GI upset, glossitis, stomatitis, altered taste; headache, dizziness, hallucinations, insomnia, other CNS effects; rash; hepatic dysfunction.
May potentiate oral anticoagulant action. May elevate serum-digoxin concentration. May alter the serum concentration of calcium channel blockers when administrated together. Serious drug interaction: Increases plasma concentrations of terfenadine or astemizole.
Each box is supplied with 10 blisters of 4 tablets in each.