Country: United States
Language: English
Source: NLM (National Library of Medicine)
CLARITHROMYCIN (UNII: H1250JIK0A) (CLARITHROMYCIN - UNII:H1250JIK0A)
RedPharm Drug, Inc.
CLARITHROMYCIN
CLARITHROMYCIN 500 mg
ORAL
PRESCRIPTION DRUG
Adults (Clarithromycin Extended-Release Tablets, USP) Clarithromycin extended-release tablets, USP are indicated for the treatment of adults with mild to moderate infection caused by susceptible strains of the designated microorganisms in the conditions listed below: 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, Haemophilus parainfluenzae, Moraxella catarrhalis, Streptococcus pneumoniae, Chlamydophila pneumoniae (TWAR), or Mycoplasma pneumoniae. THE EFFICACY AND SAFETY OF CLARITHROMYCIN EXTENDED-RELEASE TABLETS, USP IN TREATING OTHER INFECTIONS FOR WHICH OTHER FORMULATIONS OF CLARITHROMYCIN ARE APPROVED HAVE NOT BEEN ESTABLISHED. To reduce the development of drug-resistant bacteria and maintain the effectiveness of clarit
Clarithromycin extended-release tablets, USP are supplied as yellow, film coated, oval shaped tablets debossed with [Company Logo] and "777" on one side. Bottles of 60 (NDC 0591-2805-60), bottles of 500 (NDC 0591-2805-05), bottles of 1000 (NDC 0591-2805-10). Store clarithromycin extended-release tablets, USP at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]
Abbreviated New Drug Application
CLARITHROMYCIN- CLARITHROMYCIN TABLET, FILM COATED, EXTENDED RELEASE REDPHARM DRUG, INC. ---------- SPL UNCLASSIFIED SECTION Rx Only To reduce the development of drug-resistant bacteria and maintain the effectiveness of clarithromycin extended-release tablets 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 C38H69NO13, and the molecular weight is 747.96. The structural formula is: [Clarithromycin structural formula] 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 yellow oval film-coated clarithromycin extended-release tablet, for oral administration, contains 500 mg of clarithromycin and the following inactive ingredients: compressible sugar, D&C yellow #10 Lake, glycerol monostearate, polyethylene glycol 3000, polyvinyl alcohol, sodium phosphate monobasic (anhydrous), talc and titanium dioxide. Meets USP requirements for dissolution test 2. 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-t Read the complete document