국가: 미국
언어: 영어
출처: NLM (National Library of Medicine)
CEFEPIME HYDROCHLORIDE (UNII: I8X1O0607P) (CEFEPIME - UNII:807PW4VQE3)
Apotex Corporation
CEFEPIME HYDROCHLORIDE
CEFEPIME 500 mg
PRESCRIPTION DRUG
Abbreviated New Drug Application
CEFEPIME- CEFEPIME INJECTION, POWDER, FOR SOLUTION APOTEX CORPORATION ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE CEFEPIME FOR INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR CEFEPIME FOR INJECTION. CEFEPIME FOR INJECTION, FOR INTRAVENOUS OR INTRAMUSCULAR USE INITIAL U.S. APPROVAL: 1996 INDICATIONS AND USAGE Cefepime for Injection is a cephalosporin antibacterial indicated for the treatment of the following infections caused by susceptible strains of the designated microorganisms: • • • • • To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cefepime for Injection and other antibacterial drugs, Cefepime for Injection should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. (1.6) DOSAGE AND ADMINISTRATION For _Pseudomonas aeruginosa_, use 2 g IV every 8 hours. (2.1) *Or until resolution of neutropenia. (2.1) **Intramuscular route of administration is indicated only for mild to moderate, uncomplicated or complicated UTIs due to E. coli. (2.1) RECOMMENDED DOSAGE IN ADULTS WITH CREATININE CLEARANCE (CRCL) GREATER THAN 60 ML/MIN (2.1) SITE AND TYPE OF INFECTION DO SE FREQUENCY DURATION (DAYS) Moderate to Severe Pneumonia 1to2 g IV Every 8to12 hours 10 Empiric Therapy for Febrile Neutropenic Patients 2 g IV Every 8 hours 7 Mild to Moderate Uncomplicated or Complicated Urinary Tract Infections 0.5to1 g IV/IM Every 12 hours 7to10 Severe Uncomplicated or Complicated Urinary Tract Infe ctions 2 g IV Every 12 hours 10 Moderate to Severe Uncomplicated Skin and Skin Structure Infections 2 g IV Every 12 hours 10 Complicated Intra-abdominal Infections (used in combination with metronidazole) 2 g IV Every 12 hours 7to10 Pediatric Patients (2 months to 16 years) Recommended dosage in pediatric with CrCL greater than 60 mL/min. (2.2) • • DOSAGE FORMS AND STRENGTHS Cefepime for injection, USP is a sterile powder of cefepime in vials for reconsti 전체 문서 읽기