CEFEPIME HYDROCHLORIDE AND DEXTROSE- cefepime hydrochloride injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

B. Braun Medical Inc.

INN (International Name):

CEFEPIME HYDROCHLORIDE

Composition:

CEFEPIME 1 g in 50 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Cefepime for Injection and Dextrose Injection is indicated for the treatment of pneumonia (moderate to severe) caused by Streptococcus pneumoniae (including cases associated with concurrent bacteremia), Pseudomonas aeruginosa , Klebsiella pneumoniae , or Enterobacter species. Cefepime for Injection and Dextrose 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 and Dextrose Injection is indicated for uncomplicated and complicated urinary tract infections (including pyelonephritis) caused by Escherichia coli or Klebsiella pneumoniae when the

Product summary:

Cefepime for Injection USP and Dextrose Injection USP in the DUPLEX® Container is a flexible dual chamber container supplied in two strengths, 1 and 2 g cefepime. The diluent chamber contains approximately 50 mL of 5% Dextrose Injection. Cefepime for Injection USP and Dextrose Injection USP is supplied sterile and nonpyrogenic in the DUPLEX Container packaged 24 single-dose units per case. Store the unactivated unit at 20–25°C (68–77°F). Excursions permitted to 15–30°C (59–86°F). [See USP Controlled Room Temperature.] Do not freeze. Not made with natural rubber latex, PVC or Di(2-ethylhexyl)phthalate (DEHP). As with other cephalosporins, reconstituted Cefepime for Injection USP and Dextrose Injection USP tends to darken depending on storage conditions, within the stated recommendations. However, product potency is not adversely affected. Use only if prepared solution is clear and free from particulate matter.

Authorization status:

New Drug Application

Summary of Product characteristics

CEFEPIME HYDROCHLORIDE AND DEXTROSE- CEFEPIME
HYDROCHLORIDE INJECTION, SOLUTION
B. BRAUN MEDICAL INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CEFEPIME FOR INJECTION
AND DEXTROSE INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
CEFEPIME FOR INJECTION AND DEXTROSE INJECTION.
CEFEPIME FOR INJECTION AND DEXTROSE INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1996
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of Cefepime for
Injection USP and Dextrose Injection USP and other antibacterial
drugs, Cefepime for Injection USP and
Dextrose Injection USP should be used only to treat or prevent
infections that are proven or strongly
suspected to be caused by bacteria. (1)
INDICATIONS AND USAGE
Cefepime for Injection and Dextrose Injection is a cephalosporin
antibacterial indicated in 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 (1.3)
Uncomplicated skin and skin structure infections (1.4)
Complicated intra-abdominal infections (used in combination with
metronidazole) (1.5)
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of Cefepime for
Injection and Dextrose Injection and other antibacterial drugs,
Cefepime for Injection and Dextrose
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 intravenous use only administered over approximately 30 minutes.
(2)
Use this formulation of cefepime only in adult and pediatric patients
who require the entire 1 or 2 gram
dose and not any fraction thereof. (2.1, 2.2)
RECOMMENDED DOSING SCHEDULE IN ADULT PATIENTS WITH CRCL GREATER THAN
60 ML/MIN (2.1)
SITE AND TYPE OF INFECTION
DOSE
FREQUENCY
DURATION
(DAYS)
*
†
Moderate to se