Land: USA
Språk: engelsk
Kilde: NLM (National Library of Medicine)
CLARITHROMYCIN (UNII: H1250JIK0A) (CLARITHROMYCIN - UNII:H1250JIK0A)
American Health Packaging
CLARITHROMYCIN
CLARITHROMYCIN 500 mg
ORAL
PRESCRIPTION DRUG
Clarithromycin tablets are indicated in adults for the treatment of mild to moderate infections caused by susceptible isolates due to Haemophilus influenzae , Haemophilus parainfluenzae , Moraxella catarrhalis , or Streptococcus pneumoniae [see Indications and Usage ( 1.9)] . Clarithromycin tablets are indicated for the treatment of mild to moderate infections caused by susceptible isolates due to Haemophilus influenzae , Moraxella catarrhalis , or Streptococcus pneumoniae [see Indications and Usage ( 1.9)] . Clarithromycin tablets are indicated [see Indications and Usage ( 1.9)] for the treatment of mild to moderate infections caused by susceptible isolates due to: - Haemophilus influenzae (in adults) - Mycoplasma pneumoniae, Streptococcus pneumoniae, Chlamydophila pneumoniae Clarithromycin tablets are indicated for the treatment of mild to moderate infections caused by susceptible isolates due to Streptococcus pyogenes as an alternative in in
Clarithromycin tablets, USP 500 mg are white, oval-shaped, film-coated tablets, debossed GG C9 on one side and plain on the reverse side, and are supplied as follows: Unit dose packages of 30 (5 x 6) NDC 68084-651-25 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light. FOR YOUR PROTECTION: Do not use if blister is torn or broken.
Abbreviated New Drug Application
CLARITHROMYCIN- CLARITHROMYCIN TABLET AMERICAN HEALTH PACKAGING ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE CLARITHROMYCIN TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR CLARITHROMYCIN TABLETS. CLARITHROMYCIN TABLETS, FOR ORAL USE INITIAL U.S. APPROVAL: 1991 RECENT MAJOR CHANGES Warnings and Precautions, Acute Hypersensitivity Reactions ( 5.1) 06/2017 Warnings and Precautions, All-Cause Mortality in Patients With Coronary Artery Disease Years After Clarithromycin Exposure ( 5.5) 06/2017 INDICATIONS AND USAGE Clarithromycin is a macrolide antimicrobial indicated for mild to moderate infections caused by designated, susceptible bacteria in the following: Acute Bacterial Exacerbation of Chronic Bronchitis in Adults ( 1.1) Acute Maxillary Sinusitis ( 1.2) Community-Acquired Pneumonia ( 1.3) Pharyngitis/Tonsillitis ( 1.4) Uncomplicated Skin and Skin Structure Infections ( 1.5) Acute Otitis Media in Pediatric Patients ( 1.6) Treatment and Prophylaxis of Disseminated Mycobacterial Infections ( 1.7) _Helicobacter pylori_ Infection and Duodenal Ulcer Disease in Adults ( 1.8) Limitations of Use 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. ( 1.9) DOSAGE AND ADMINISTRATION Adults: clarithromycin tablets 250 mg or 500 mg every 12 hours for 7–14 days ( 2.2) _H. pylori_ eradication (in combination with lansoprazole/amoxicillin, omeprazole/amoxicillin, or omeprazole): clarithromycin tablets 500 mg every 8 or 12 hours for 10–14 days. See full prescribing information (FPI) for additional information. ( 2.3) Pediatric Patients: clarithromycin 15 mg/kg/day divided every 12 hours for 10 days ( 2.4) Mycobacterial Infections: clarithromycin tablets 500 mg every 12 hours; clarithromycin tablets 7.5 mg/kg up to 500 mg ev Les hele dokumentet