CEFEPIME injection, powder, for solution

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

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

Mevcut itibaren:

WG Critical Care, LLC

Uygulama yolu:

INTRAVENOUS

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

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

Ürün özeti:

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. NDC 44567-130-10 1 gram* vial (carton of 10 vials) NDC 44567-131-10 2 grams* vial (carton of 10 vials) *Based on cefepime activity. Storage and Handling Cefepime for Injection, USP in the dry state should be stored at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. Protect from light. Retain in carton until time of use. Discard unused portion.

Yetkilendirme durumu:

Abbreviated New Drug Application

Ürün özellikleri

CEFEPIME- CEFEPIME INJECTION, POWDER, FOR SOLUTION
WG CRITICAL CARE, LLC
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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:
•
•
•
•
•
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
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
Complicated Intra-abdominal Infections§ (used in combination with
metronidazole)
2 g IV
Every 12
hours
7 to 10
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)
Pediatric Patients (2 months to 16 years)
Recommended dosage in pediatric with CrCL greater than 60 mL/min.
(2.2)
•
•
DOSAGE FORMS AND STRENGTHS
Cefepime for Injection, USP is a sterile powder of cef