Country: United States
Language: English
Source: NLM (National Library of Medicine)
CLARITHROMYCIN (UNII: H1250JIK0A) (CLARITHROMYCIN - UNII:H1250JIK0A)
Bryant Ranch Prepack
CLARITHROMYCIN
CLARITHROMYCIN 500 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 Tablets, USP are generally effective in the eradication of S. pyogenes from the nasopharynx; however, data establishing the efficacy of Clarithromycin Tablets, USP 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 in
Clarithromycin Tablets, USP: 250 mg, white, biconvex beveled edge round coated tablets debossed on one side and plain on the other side (Identified 54 271). NDC 0054-0036-21: Bottles of 60 Tablets 500 mg, white, biconvex capsule shaped coated tablets debossed on one side and plain on the other side (Identified 54 312). NDC 0054-0037-21: Bottles of 60 Tablets Store at 20° to 25°C (68° to 77°F). Excursions permitted to 15° to 30°C (59° to 86°).[See USP Controlled Room Temperature.] Dispense in a USP tight, light-resistant container.
Abbreviated New Drug Application
CLARITHROMYCIN- CLARITHROMYCIN TABLET, COATED BRYANT RANCH PREPACK ---------- CLARITHROMYCIN TABLETS, USP RX ONLY To reduce the development of drug-resistant bacteria and maintain the effectiveness of clarithromycin and other antibacterial drugs, clarithromycin tablets 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 747.96. 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 Tablets, USP are available as immediate-release tablets. Each tablet for oral administration contains 500 mg of clarithromycin and the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, Opadry II (White), povidone, stearic acid, and talc. Opadry II (White) contains hypromellose, polyethylene glycol, polydextrose, titanium dioxide and triacetin. CLINICAL PHARMACOLOGY 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, clarithromyc Read the complete document