CEFEPIME- cefepime hydrochloride 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:

Sagent Pharmaceuticals

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 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

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. *Based on cefepime activity. 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.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CEFEPIME- CEFEPIME HYDROCHLORIDE INJECTION, POWDER, FOR SOLUTION
SAGENT PHARMACEUTICALS
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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 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 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
C