CEFEPIME injection powder for solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CEFEPIME HYDROCHLORIDE (UNII: I8X1O0607P) (CEFEPIME - UNII:807PW4VQE3)

Available from:

Apotex Corporation

INN (International Name):

CEFEPIME HYDROCHLORIDE

Composition:

CEFEPIME 500 mg

Prescription type:

PRESCRIPTION DRUG

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CEFEPIME- CEFEPIME INJECTION, POWDER, FOR SOLUTION
APOTEX CORPORATION
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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:
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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)
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DOSAGE FORMS AND STRENGTHS
Cefepime for injection, USP is a sterile powder of cefepime in vials
for reconsti