DOSAGE FORM
Film-coated tablets.
Main physicochemical properties: film-coated tablets, yellow in color, with a biconvex surface, with a score on one side of the tablet and embossing "KMP" on the other side. A white core is visible on the cross section.
COMPOSITION
active ingredient: clarithromycin;
1 tablet contains clarithromycin, calculated as 100% substance – 250 mg or 500 mg;
excipients: microcrystalline cellulose; sodium starch glycolate (type A); sodium lauryl sulfate; hypromellose; calcium stearate; coating mixture "Opadry II Yellow" (contains: triacetin; hypromellose; lactose, monohydrate; titanium dioxide (E 171); polyethylene glycol; iron oxide yellow (E 172)).
PHARMACOTHERAPEUTIC GROUP
Antimicrobials for systemic use. Macrolides. ATX code J01F A09.
INDICATIONS FOR USE
• Treatment of infections caused by microorganisms susceptible to clarithromycin:
• Upper respiratory tract infections, i.e. nasopharynx (tonsillitis, pharyngitis), and sinus infections.
• Lower respiratory tract infections (bronchitis, acute lobar pneumonia and primary atypical pneumonia) (see sections “Pharmacological properties.
• Pharmacodynamics” and “Special Instructions for Use” regarding susceptibility testing).
• Skin and soft tissue infections (impetigo, folliculitis, erysipeloid, furunculosis, infected wounds) (see sections “Pharmacological properties. Pharmacodynamics” and “Special instructions for use” for susceptibility testing).
• Acute and chronic odontogenic infections.
• Disseminated or localized mycobacterial infections caused by Mycobacterium avium or Mycobacterium intracellulare. Localized infections caused by Mycobacterium chelonae, Mycobacterium fortuitum or Mycobacterium kansasii.
• Eradication of H. pylori in patients with duodenal ulcer when suppressing hydrochloric acid secretion (clarithromycin activity against H. pylori at neutral pH is higher than at acidic pH).