CEFEPIME- 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 1 g

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 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 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 infection is severe, or caused by

Product summary:

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. Storage and Handling Cefepime for injection, USP in the dry state should be stored between 2° to 25° C (36° to 77° F) and protected from light.

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:
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
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
1 to 2 g IV
Every 8 to 12 hours
10
Empiric Therapy for Febrile Neutropenic
Patie nts
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
7to10
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
Complicated Intra-abdominal Infections (used
in combination with metronidazole)
2 g IV
Every 12 hours
7 to 10
Pediatric Patients (2 months to 16 years)
Recommended dosage in pediatric with CrCL greater than 60 mL/min.
(2.2)
The usual recommended dosage in pediatric pa