국가: 미국
언어: 영어
출처: NLM (National Library of Medicine)
CLARITHROMYCIN (UNII: H1250JIK0A) (CLARITHROMYCIN - UNII:H1250JIK0A)
Preferred Pharmaceuticals Inc.
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. 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. Clarithromycin tablets are indicated for the treatment of mild to moderate infections caused by susceptible isolates due to: Clarithromycin tablets are 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 tablets are indicated for the treatment of mild to moderate infections caused by susceptible isolates due to Staphylococcus aureus , or Streptococcus pyogenes . Clarithromycin tablets are indicated in pediatric patients for t
Clarithromycin Tablets USP, 500 mg are light yellow colored, oval shaped, biconvex film-coated tablets, with ‘D’ debossed on one side and ‘63’ on the other side. Bottles of 14 NDC 68788-6936-1 Bottles of 20 NDC 68788-6936-2 Bottles of 28 NDC 68788-6936-8 Bottles of 30 NDC 68788-6936-3 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
Abbreviated New Drug Application
CLARITHROMYCIN- CLARITHROMYCIN TABLET, FILM COATED PREFERRED PHARMACEUTICALS INC. ---------- 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, QT Prolongation (5.2) 11/2018 Warnings and Precautions, Serious Adverse Reactions Due to Concomitant Use with Other Drugs (5.4) 11/2018 Warnings and Precautions, Embryo-fetal Toxicity (5.7) 12/2018 INDICATIONS AND USAGE Clarithromycin tablets are a macrolide antimicrobial indicated for mild to moderate infections caused by designated, susceptible bacteria in the following: • • • • • • • • To reduce the development of drug-resistant bacteria and maintain the effectiveness of clarithromycin tablets 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. (1.10) DOSAGE AND ADMINISTRATION • • • • • DOSAGE FORMS AND STRENGTHS · Tablets: 250 mg and 500 mg (3) 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) _Helicobacter pylori _Infection and Duodenal Ulcer Disease in Adults (1.8) Adults: Clarithromycin tablets 250 mg or 500 mg every 12 hours for 7 to 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 to 14 days. See full prescribing information (FPI) for additional information. (2.3) Pediat 전체 문서 읽기