Country: Amerika Syarikat
Bahasa: Inggeris
Sumber: NLM (National Library of Medicine)
CEFEPIME HYDROCHLORIDE (UNII: I8X1O0607P) (CEFEPIME - UNII:807PW4VQE3)
Meitheal Pharmaceuticals Inc.
INTRAVENOUS
PRESCRIPTION DRUG
Cefepime for Injection is indicated in the treatment of pneumonia (moderate to severe) caused by susceptible strains of Streptococcus pneumoniae , including cases associated with concurrent bacteremia, Pseudomonas aeruginosa , Klebsiella pneumoniae , or Enterobacter species. Cefepime for Injection as monotherapy is indicated for empiric treatment of febrile neutropenic patients. In patients at high risk for severe infection (including patients with a history of recent bone marrow transplantation, with hypotension at presentation, with an underlying hematologic malignancy, or with severe or prolonged neutropenia), antimicrobial monotherapy may not be appropriate. Insufficient data exist to support the efficacy of cefepime monotherapy in such patients [see Clinical Studies (14.1)] . Cefepime for Injection is indicated in the treatment of uncomplicated and complicated urinary tract infections (including pyelonephritis) caused by susceptible isolates of Escherichia coli or Klebsiella pneumoniae , when the infec
How Supplied Cefepime for Injection, USP is supplied as follows: *Based on cefepime activity. Cefepime for Injection, USP in the dry state, is a white to pale yellow powder. Constituted solutions of Cefepime for Injection, USP can range in color from pale yellow to amber. Storage and Handling In the dry state store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F). [See USP Controlled Room Temperature.] Protect from light. Retain in carton until time of use. Discard unused portion. Sterile, Nonpyrogenic, Preservative-free. The container closure is not made with natural rubber latex.
Abbreviated New Drug Application
CEFEPIME- CEFEPIME HYDROCHLORIDE INJECTION, POWDER, FOR SOLUTION MEITHEAL PHARMACEUTICALS INC. ---------- 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: Pneumonia. (1.1) Empiric therapy for febrile neutropenic patients. (1.2) Uncomplicated and complicated urinary tract infections (including pyelonephritis). (1.3) Uncomplicated skin and skin structure infections. (1.4) Complicated intra-abdominal infections (used in combination with metronidazole) in adults. (1.5) 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 DOSE FREQUENCY DURATION (DAYS) Moderate to Severe Pneumonia 1 to 2 g IV Every 8 to 12 hours 10 Empiric Therapy for Febrile Neutropenic Patients 2 g IV Every 8 hours 7* Mild to Moderate Uncomplicated or Complicated Urinary Tract Infections 0.5 to 1 g IV/IM** Every 12 hours 7 to 10 Severe Uncomplicated or Complicated Urinary Tract Infections 2 g IV Every 12 hours 10 Moderate to Severe Uncomplicated Skin and Skin Structure Infections 2 g IV Every 12 hours 10 Compl Baca dokumen lengkap