Land: USA
Språk: engelsk
Kilde: NLM (National Library of Medicine)
clarithromycin (UNII: H1250JIK0A) (clarithromycin - UNII:H1250JIK0A)
Allied Pharma Inc
clarithromycin
clarithromycin 250 mg
ORAL
PRESCRIPTION DRUG
Clarithromycin tablets are indicated for the treatment of mild to moderate infections caused by susceptible isolates of the designated bacteria in the conditions as listed below: Adults Pharyngitis/Tonsillitis due to Streptococcus pyogenes (The usual drug of choice in the treatment and prevention of streptococcal infections and the prophylaxis of rheumatic fever is penicillin administered by either the intramuscular or the oral route. Clarithromycin is generally effective in the eradication of S. pyogenes from the nasopharynx; however, data establishing the efficacy of clarithromycin in the subsequent prevention of rheumatic fever are not available at present). Acute maxillary sinusitis due to Haemophilus influenzae , Moraxella catarrhalis, or Streptococcus pneumoniae . Acute bacterial exacerbation of chronic bronchitis due to Haemophilus influenzae , Haemophilus parainfluenzae, Moraxella catarrhalis, or Streptococcus pneumoniae. Community-Acquired Pneumonia due to Haemophilus influenzae , Mycop
Clarithromycin Tablets, USP 500 mg are white to off-white, film- coated, oval-shaped tablets, debossed with "NT" on one side and "061" on the other side of the tablet, bottles of 60 NDC 76267-061-02 Clarithromycin Tablets, USP 250 mg are white to off-white, film- coated, oval-shaped tablets, debossed with "NT" on one side and "060" on the other side of the tablet, bottles of 60 NDC 76267-060-02 Store in a well closed container at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature]. Protect from light. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closures (as required).
Abbreviated New Drug Application
CLARITHROMYCIN - CLARITHROMYCIN TABLET, FILM COATED ALLIED PHARMA INC ---------- CLARITHROMYCIN TABLETS, USP R ONLY TO REDUCE THE DEVELOPMENT OF DRUG-RESISTANT BACTERIA AND MAINTAIN THE EFFECTIVENESS OF CLARITHROMYCIN AND OTHER ANTIBACTERIAL DRUGS, CLARITHROMYCIN SHOULD BE USED ONLY TO TREAT OR PREVENT INFECTIONS THAT ARE PROVEN OR STRONGLY SUSPECTED TO BE CAUSED BY BACTERIA. DESCRIPTION Clarithromycin is a semi-synthetic macrolide antibiotic. Chemically, it is 6-_0_-methylerythromycin. The molecular formula is C H NO , and the molecular weight is 747.95. The structural formula is: Clarithromycin is a white to off-white crystalline powder. It is soluble in acetone, slightly soluble in methanol, ethanol, and acetonitrile, and practically insoluble in water. Each white to off-white, film-coated, oval shaped immediate-release clarithromycin tablets, USP contains 250 mg or 500 mg of clarithromycin and the following inactive ingredients: croscarmellose sodium, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, colloidal silicon dioxide, talc, titanium dioxide, polyvinyl alcohol and polyethylene glycol. CLINICAL PHARMACOLOGY X 38 69 13 PHARMACOKINETICS Clarithromycin is rapidly absorbed from the gastrointestinal tract after oral administration. The absolute bioavailability of 250 mg clarithromycin tablets was approximately 50%. For a single 500 mg dose of clarithromycin, food slightly delays the onset of clarithromycin absorption, increasing the peak time from approximately 2 to 2.5 hours. Food also increases the clarithromycin peak plasma concentration by about 24%, but does not affect the extent of clarithromycin bioavailability. Food does not affect the onset of formation of the antimicrobially active metabolite, 14-OH clarithromycin or its peak plasma concentration but does slightly decrease the extent of metabolite formation, indicated by an 11% decrease in area under the plasma concentration-time curve (AUC). Therefore, clarithromycin tablets may be given without regard to food. In n read_full_document