البلد: الولايات المتحدة
اللغة: الإنجليزية
المصدر: NLM (National Library of Medicine)
CLARITHROMYCIN (UNII: H1250JIK0A) (CLARITHROMYCIN - UNII:H1250JIK0A)
Aidarex Pharmaceuticals LLC
CLARITHROMYCIN
CLARITHROMYCIN 250 mg
ORAL
PRESCRIPTION DRUG
To reduce the development of drug-resistant bacteria and maintain the effectiveness of clarithromycin tablet and other antibacterial drugs, clarithromycin tablet should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Clarithromycin tablet is indicated for the treatment of mild to moderate infections caused by susceptible strains of the designated microorganisms 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
Clarithromycin tablet, USP 250 mg are supplied as white oval film-coated tablets debossed with W954 on one side and other side plain. Bottles of 20 Tablets (NDC 33261-0631-20) Clarithromycin tablet, USP 500 mg are supplied as white oval film-coated tablets debossed with W949 on one side and other side plain. Bottles of 10 Tablets (NDC 33261-0618-10) Bottles of 14 Tablets (NDC 33261-0618-14) Bottles of 20 Tablets (NDC 33261-0618-20) Store at 20° - 25°C (68° - 77°F) [See USP Controlled Room Temperature]
Abbreviated New Drug Application
CLARITHROMYCIN- CLARITHROMYCIN TABLET, FILM COATED AIDAREX PHARMACEUTICALS LLC ---------- CLARITHROMYCIN TABLETS, USP Rx only To reduce the development of drug-resistant bacteria and maintain the effectiveness of clarithromycin tablet and other antibacterial drugs, clarithromycin tablet 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. Clarithromycin tablet are available as immediate-release tablets. Each white oval film-coated immediate-release clarithromycin tablet contains 250 mg or 500 mg of clarithromycin and the following inactive ingredients: 250 mg tablets: microcrystalline cellulose, lactose monohydrate, hydroxypropyl cellulose, sodium starch glycolate, colloidal silicon dioxide, talc, magnesium stearate, hypromellose, titanium dioxide, and polyethylene glycol. 500 mg tablets: microcrystalline cellulose, lactose monohydrate, hydroxypropyl cellulose, sodium starch glycolate, colloidal silicon dioxide, talc, magnesium stearate, hypromellose, titanium dioxide, and polyethylene glycol. CLINICAL PHARMACOLOGY PHARMACOKINETICS Clarithromycin is rapidly absorbed from the gastrointestinal tract after oral administration. The absolute 38 69 13 bioavailability of 250 mg clarithromycin tablet 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 an اقرأ الوثيقة كاملة