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)
RedPharm Drug, Inc.
CLARITHROMYCIN
CLARITHROMYCIN 500 mg
ORAL
PRESCRIPTION DRUG
1.1 Acute Bacterial Exacerbation of Chronic Bronchitis 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)]. 1.2 Acute Maxillary Sinusitis 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)]. 1.3 Community-Acquired Pneumonia 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 1.4 Pharyngitis/Tonsillitis Clarithromycin tablets are indicated for the treatment of mild to moderate infections
Clarithromycin tablets, USP 250 mg are white, oval-shaped, film-coated tablets, debossed GG C6 on one side and plain on the reverse side, and are supplied as follows: NDC 0781-1961-60 in bottles of 60 tablets 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: NDC 0781-1962-60 in bottles of 60 tablets Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight container as described in the USP. Protect from light.
Abbreviated New Drug Application
CLARITHROMYCIN- CLARITHROMYCIN TABLET REDPHARM DRUG, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION 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, Serious Adverse Reactions with Concomitant Use with Other Drugs (5.4) 10/2015 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 every 12 hours in pediatric patient 完全なドキュメントを読む