Maa: Yhdysvallat
Kieli: englanti
Lähde: NLM (National Library of Medicine)
CLARITHROMYCIN (UNII: H1250JIK0A) (CLARITHROMYCIN - UNII:H1250JIK0A)
Preferred 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: Clarithromycin extended-release tablets are indicated only for acute maxillary sinusitis, acute bacterial exacerbation of chronic bronchitis, and community-acquired pneumonia in adults. The efficacy and safety of clarithromycin extended-release tablets in treating other infections for which
Clarithromycin Extended-release Tablets USP are supplied as yellow, film coated, oval shaped, unscored tablets debossed with and “777” on one side. Bottles of 20 Tablets NDC #68788-6887-2 Bottles of 30 Tablets NDC #68788-6887-3 Bottles of 60 Tablets NDC #68788-6887-6 Bottles of 90 Tablets NDC #68788-6887-9 Bottles of 100 Tablets NDC #68788-6887-1 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 PREFERRED 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 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 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 • • DOSAGE FORMS AND STRENGTHS • CONTRAINDICATIONS • • • • WARNINGS AND PRECAUTIONS • • • • • • • • ADVERSE REACTIONS Most frequent adverse reactions for both adult and pediatric populations in clinical trials: abdominal pain, diarrhea, nausea, Acute Bacterial Exacerbation of Chronic Bronchitis in Adults (1.1) Acute Maxillary Sinusitis (1.2) Community-Acquired Pneumonia (1.3) 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) Extended-release Tablets: 500 mg (3) Hypersensitivity to clarithromycin or any macrolide drug (4.1) Cisapride, pimozide, lovastatin/simvastatin, ergotamine/dihydroergotamine (4.2, 4.5, 4.6) History of cholestatic jaundice/hepatic dysfunction with use of clarithromycin (4.3) Colch Lue koko asiakirja