Negara: Amerika Serikat
Bahasa: Inggris
Sumber: NLM (National Library of Medicine)
CLARITHROMYCIN (UNII: H1250JIK0A) (CLARITHROMYCIN - UNII:H1250JIK0A)
Sandoz Inc
CLARITHROMYCIN
CLARITHROMYCIN 125 mg in 5 mL
ORAL
PRESCRIPTION DRUG
Clarithromycin is 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 is 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 is indicated [see Indications and Usage (1.9) ] for the treatment of mild to moderate infections caused by susceptible isolates due to: Clarithromycin is indicated for the treatment of mild to moderate infections caused by susceptible isolates due to Streptococcus pyogenes as an alternative in individuals who cannot use first line therapy. Clarithromycin is indicated for the treatment of mild to moderate infections caused by susceptible isolates due to Staphylococcus aureus , or Streptococcus pyogenes . Cl
Clarithromycin for oral suspension, USP is supplied in the following strengths and sizes: Total Volume After Constitution Clarithromycin Concentration After Constitution Clarithromycin Contents Per Bottle NDC 50 mL 125 mg/5 mL 1250 mg 0781-6022-52 100 mL 125 mg/5 mL 2500 mg 0781-6022-46 50 mL 250 mg/5 mL 2500 mg 0781-6023-52 100 mL 250 mg/5 mL 5000 mg 0781-6023-46 Store clarithromycin for oral suspension below 25°C (77°F) in a well-closed container [see USP Controlled Room Temperature]. Do not refrigerate clarithromycin suspension.
Abbreviated New Drug Application
CLARITHROMYCIN- CLARITHROMYCIN FOR SUSPENSION SANDOZ INC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE CLARITHROMYCIN FOR ORAL SUSPENSION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR CLARITHROMYCIN FOR ORAL SUSPENSION. CLARITHROMYCIN FOR ORAL SUSPENSION, FOR ORAL USE INITIAL U.S. APPROVAL: 1991 RECENT MAJOR CHANGES Contraindications (4) 05/2023 Drug Interactions (7) 05/2023 INDICATIONS AND USAGE Clarithromycin is a macrolide antimicrobial indicated for mild to moderate infections caused by designated, susceptible bacteria in the following: • • • • • • • Limitations of Use: 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 • • • DOSAGE FORMS AND STRENGTHS • CONTRAINDICATIONS • • • • • • • WARNINGS AND PRECAUTIONS • • • 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) Pediatric Patients: Clarithromycin 15 mg/kg/day divided every 12 hours for 10 days (2.4) Mycobacterial Infections: Clarithromycin 500 mg every 12 hours; Clarithromycin 7.5 mg/kg up to 500 mg every 12 hours in pediatric patients (2.5) Reduce dose in moderate renal impairment with concomitant atazanavir or ritonavir-containing regimens and in severe renal impairment (2.6) Granules for Oral Suspension: 125 mg/5 mL and 250 mg/5 mL (3) Hypersensitivity to clarithromycin or any macrolide drug (4.1) Cisapride and pimozide (4.2) History of cholestatic jaundice/hepatic dysfunction with use of clarithromycin (4. Baca dokumen lengkapnya