CEFEPIME injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Baxter Healthcare Corporation

INN (International Name):

CEFEPIME HYDROCHLORIDE

Composition:

CEFEPIME 1 g in 50 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

Cefepime Injection is supplied as a frozen, iso-osmotic, sterile, nonpyrogenic solution in 50 mL and 100 mL single-dose Galaxy Containers (PL 2040 Plastic) as follows:  2G3578   NDC 0338-1301-41  1 g* in 50 mL   Supplied 24/box   2G3579   NDC 0338-1301-48   2 g* in 100 mL   Supplied 12/box  Store at or below –20°C (-4°F). Handle frozen product containers with care. Product containers may be fragile in the frozen state. Thaw frozen container at room temperature 25°C (77°F) or under refrigeration 5°C (41°F). Do not force thaw by immersion in water baths or by microwave irradiation. The thawed solution remains stable for 7 days under refrigeration 5°C (41°F) or 24 hours at room temperature 25°C (77°F). Do not refreeze. [See Dosage and Administration (2.4)].

Authorization status:

New Drug Application

Summary of Product characteristics

CEFEPIME- CEFEPIME INJECTION, SOLUTION
BAXTER HEALTHCARE CORPORATION
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CEFEPIME INJECTION SAFELY
AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR CEFEPIME
INJECTION.
CEFEPIME INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1996
INDICATIONS AND USAGE
Cefepime Injection is a cephalosporin antibacterial indicated in the
treatment of the following infections
caused by susceptible isolates 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); and
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 Injection
and other antibacterial drugs, Cefepime 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
RECOMMENDED DOSAGE IN ADULTS WITH CREATININE CLEARANCE (CRCL)
GREATER THAN 60 ML/MIN (2.1)
SITE AND TYPE OF INFECTION (ADULTS)
DOSE
(IV)
FREQUENCY
DURATION
(DAYS)
*
†
Moderate to Severe Pneumonia
1-2 g
Every
8-12 hours
10
Empiric therapy for febrile neutropenic patients
2 g
Every
8 hours
7
Mild to Moderate Uncomplicated or Complicated
Urinary Tract Infections
0.5-1 g
Every
12 hours
7-10
Severe Uncomplicated or Complicated Urinary
Tract Infections
2 g
Every
12 hours
10
Moderate to Severe Uncomplicated Skin and
Skin Structure Infections
2 g
Every
12 hours
10
Complicated Intra-abdominal Infections (used in
combination with metronidazole)
2 g
Every
8-12 hours
7-10
•
•
•
•
•
•
DOSAGE FORMS AND STRENGTHS
•
CONTRAINDICATIONS
•
For _Pseudomonas aeruginosa_, use 2 g IV every 8 hours (2.1)
Or until resolution of neutropenia (2.1)
*
†
*
Pediatric Patients (2 months to 16 years) – Recommended d