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)
PD-Rx Pharmaceuticals, Inc.
CLARITHROMYCIN
CLARITHROMYCIN 500 mg
ORAL
PRESCRIPTION DRUG
Clarithromycin extended-release 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 extended-release tablets (in adults) 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 extended-release 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) - Haemophilus parainfluenzae (in adults) - Moraxella catarrhalis (in adult
Clarithromycin Extended-release Tablets USP are supplied as yellow, film coated, oval shaped, unscored tablets debossed with and “777” on one side. Bottles of 14 (NDC 43063-520-14). Store Clarithromycin Extended-release Tablets USP at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
Abbreviated New Drug Application
CLARITHROMYCIN- CLARITHROMYCIN TABLET, FILM COATED, EXTENDED RELEASE PD-RX PHARMACEUTICALS, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE CLARITHROMYCIN EXTENDED-RELEASE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR CLARITHROMYCIN EXTENDED-RELEASE TABLETS. CLARITHROMYCIN EXTENDED-RELEASE TABLETS, FOR ORAL USE INITIAL U.S. APPROVAL: 1991 RECENT MAJOR CHANGES Contraindications, Lomitapide, Lovastatin, and Simvastatin ( 4.5) 9/2019 Warnings and Precautions, QT Prolongation ( 5.2) 11/2018 Warnings and Precautions, Serious Adverse Reactions Due to 9/2019 Concomitant Use with Other Drugs ( 5.4) Warnings and Precautions, Embryo-Fetal Toxicity ( 5.7) 12/2018 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) Limitations of Use Clarithromycin extended-release tablets are indicated only for acute bacterial exacerbation of chronic bronchitis, acute maxillary sinusitis, and community-acquired pneumonia in adults. ( 1.9) To reduce the development of drug-resistant bacteria and maintain the effectiveness of clarithromycin and other antibacterial drugs, clarithromycin 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 extended-release tablets 1 gram every 24 hours for 7 to 14 days ( 2.2) Reduce dose in moderate renal impairment with concomitant atazanavir or ritonavir-containing regimens and in severe renal impairment ( 2.6) DOSAGE FORMS AND STRENGTHS Extended-release Tablets: 500 mg ( 3) CONTRAINDICATIONS Hypersensitivity to clarithromycin or any macrolide drug ( 4.1) Cisapride and pimozide ( 4.2) History of cholestatic jaundice/hepatic dysfunction with use of cla 完全なドキュメントを読む