Country: United States
Language: English
Source: NLM (National Library of Medicine)
CEFEPIME HYDROCHLORIDE (UNII: I8X1O0607P) (CEFEPIME - UNII:807PW4VQE3)
Qilu Pharmaceutical Co., Ltd.
CEFEPIME HYDROCHLORIDE
CEFEPIME 1 g
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: Cefepime for Injection, USP in the dry state, is a white to pale yellow powder. Constituted solution of Cefepime for Injection, USP can range in color from pale yellow to amber. Unit of Sale Strength NDC 67184-1002-1 Carton containing 10 Single-dose Vials 500 mg* NDC 67184-1003-1 Carton containing 10 Single-dose Vials 1 gram* NDC 67184-1004-1 Carton containing 10 Single-dose Vials 2 grams* Storage and Handling Cefepime for injection, USP in the dry state should be stored at 20 to 25°C (68 to 77°F) [see USP controlled room temperature] and protected from light.
Abbreviated New Drug Application
CEFEPIME- CEFEPIME HYDROCHLORIDE INJECTION, POWDER, FOR SOLUTION QILU PHARMACEUTICAL CO., LTD. ---------- 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 (CEFEPIME HYDROCHLORIDE) 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 or prevent 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 1-2 g IV Every 8-12 hours 10 Empiric Therapy for Febrile Neutropenic Patients 2 g IV Every 8 hours 7* Mild to Moderate Uncomplicated or Complicated Urinary Tract Infections 0.5-1 g IV/IM** Every 12 hours 7-10 Severe Uncomplicated or Complicated Urinary Tract Infections 2 g IV Every 12 hours 10 Moderate to Severe Uncomplicated Skin and Skin Structure Infe Read the complete document