国: アメリカ合衆国
言語: 英語
ソース: NLM (National Library of Medicine)
CLARITHROMYCIN (UNII: H1250JIK0A) (CLARITHROMYCIN - UNII:H1250JIK0A)
Teva Pharmaceuticals USA, Inc.
CLARITHROMYCIN
CLARITHROMYCIN 250 mg
ORAL
PRESCRIPTION DRUG
Clarithromycin tablets USP are indicated for the treatment of mild to moderate infections caused by susceptible isolates of the designated bacteria in the conditions as listed below: 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 , Mycoplasma pneum
Clarithromycin tablets USP are available as follows: 250 mg – yellow, film-coated, oval-shaped tablets, debossed with “93” on one side and “7157” on the other side in bottles of 60 (NDC 0093-7528-06). 500 mg – light-yellow, film-coated, oval-shaped tablets, debossed with “93” on one side and “7158” on the other side in bottles of 60 (NDC 0093-7529-06). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).
Abbreviated New Drug Application
CLARITHROMYCIN- CLARITHROMYCIN TABLET, FILM COATED TEVA PHARMACEUTICALS USA, INC. ---------- CLARITHROMYCIN TABLETS USP 7528 7529 RX ONLY To reduce the development of drug-resistant bacteria and maintain the effectiveness of clarithromycin tablets USP and other antibacterial drugs, clarithromycin tablets USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. DESCRIPTION Clarithromycin, USP is a semi-synthetic macrolide antibiotic. Chemically, it is 6-_O_- methylerythromycin. The structural formula is: C H NO M.W. 747.96 Clarithromycin, USP 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. Clarithromycin is available as immediate-release tablets. Each yellow, film-coated, oval-shaped clarithromycin tablet USP for oral administration contains 250 mg of clarithromycin, USP and each light-yellow, film-coated, oval-shaped clarithromycin tablet for oral administration contains 500 mg of clarithromycin, USP. Each tablet of both strengths contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, D&C Yellow #10 aluminum lake, FD&C blue #2 indigo carmine aluminum lake, FD&C red #40 allura red AC aluminum lake, hypromellose, magnesium hydroxide, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, sodium starch glycolate, stearic acid, titanium dioxide, and vanillin. CLINICAL PHARMACOLOGY PHARMACOKINETICS 38 69 13 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 bioavailabi 完全なドキュメントを読む