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:

Sandoz Inc

INN (International Name):

CEFEPIME HYDROCHLORIDE

Composition:

CEFEPIME 1 g

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Cefepime for injection, USP is indicated in the treatment of the following infections caused by susceptible strains of the designated microorganisms (see also PRECAUTIONS: Pediatric Use and DOSAGE AND ADMINISTRATION ): Pneumonia (moderate to severe) caused by Streptococcus pneumoniae , including cases associated with concurrent bacteremia, Pseudomonas aeruginosa , Klebsiella pneumoniae , or Enterobacter species. Empiric Therapy for Febrile Neutropenic Patients. 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 .) Uncomplicated and Complicated Urinary Tract Infection

Product summary:

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. 1 g* vial (tray of 10) NDC 0781-3222-95 2 g* vial (tray of 10) NDC 0781-3223-95 IN THE DRY STATE STORE AT 20° TO 25°C (68° TO 77°F) [SEE USP CONTROLLED ROOM TEMPERATURE]. PROTECT FROM LIGHT. RETAIN IN CARTON UNTIL TIME OF USE.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CEFEPIME HYDROCHLORIDE- CEFEPIME HYDROCHLORIDE INJECTION, POWDER, FOR
SOLUTION
SANDOZ INC
----------
CEFEPIME FOR INJECTION, USP
FOR INTRAVENOUS OR INTRAMUSCULAR USE
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.
DESCRIPTION
Cefepime for injection, USP is a semi-synthetic, broad spectrum,
cephalosporin antibiotic for parenteral
administration. The chemical name is
1-[[(6R,7R)-7-[2-(2-amino-4-thiazolyl)-glyoxylamido]-2-carboxy-
8-oxo-5-thia-1-azabicyclo
[4.2.0]oct-2-en-3-yl]methyl]-1-methylpyrrolidinium chloride, 7
-(Z)-(O-
methyloxime), monohydrochloride, monohydrate, which corresponds to the
following structural
formula:
Cefepime hydrochloride is a white to pale yellow powder. Cefepime
hydrochloride contains the
equivalent of not less than 825 mcg and not more than 911 mcg of
cefepime (C
H N O S ) per mg,
calculated on an anhydrous basis. It is highly soluble in water.
Cefepime for injection, USP is supplied for intramuscular or
intravenous administration in strengths
equivalent to 1 g, and 2 g of cefepime. (See DOSAGE AND
ADMINISTRATION.) Cefepime for
injection, USP is a sterile, dry mixture of cefepime hydrochloride and
L-arginine. It contains the
equivalent of not less than 90 percent and not more than 115 percent
of the labeled amount of cefepime
(C
H N O S ).
The L-arginine, at an approximate concentration of 707 mg/g of
cefepime, is added to control the pH of
the constituted solution at 4 to 6. Freshly constituted solutions of
cefepime for injection, USP will
range in color from pale yellow to amber.
CLINICAL PHARMACOLOGY
Cefepime is an antibacterial agent belonging to the cephalosporin
class of antibacterials with _in vitro_
antibacterial activity against facultative Gram-positive and
Gram-negative bacteria.
PHARMACOKINETICS
The average plasma concentrations of cefepime observe