CEFEPIME hydrochloride injection powder for solution

Држава: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

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

Доступно од:

Hospira, Inc.

INN (Међународно име):

CEFEPIME HYDROCHLORIDE

Састав:

CEFEPIME 1 g

Тип рецептора:

PRESCRIPTION DRUG

Статус ауторизације:

Abbreviated New Drug Application

Карактеристике производа

CEFEPIME- CEFEPIME HYDROCHLORIDE INJECTION, POWDER, FOR SOLUTION
HOSPIRA, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CEFEPIME FOR INJECTION, USP SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR CEFEPIME FOR
INJECTION, USP.
CEFEPIME FOR INJECTION, USP FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1996
INDICATIONS AND USAGE
Cefepime for Injection, USP is a cephalosporin antibacterial indicated
for the treatment of the following infections caused
by susceptible strains of the designated microorganisms:
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To reduce the development of drug-resistant bacteria and maintain the
effectiveness of Cefepime for Injection, USP and
other antibacterial drugs, Cefepime for Injection, USP should be used
only to treat 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)
RECOMMENDED DOSAGE IN ADULTS WITH CREATININE CLEARANCE (CRCL)
GREATER THAN 60 ML/MIN (2.1)
SITE AND TYPE OF INFECTION
DO SE
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
Eve ry
8 hours
7*
Mild to Moderate Uncomplicated or Complicated Urinary
Tract Infections
0.5 to 1 g IV
Eve ry
12 hours
7 to 10
Severe Uncomplicated or Complicated Urinary Tract
Infe ctions
2 g IV
Eve ry
12 hours
10
Moderate to Severe Uncomplicated Skin and Skin
Structure Infections
2 g IV
Eve ry
12 hours
10
Complicated Intra-abdominal Infections (used in
combination with metronidazole)
2 g IV
Eve ry
12 hours
7 to 10
Pediatric Patients (2 months to 16 years)
Recommended dosage in pediatric with CrCL greater than 60 mL/min.
(2.2)
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DOSAGE FORMS AND STRENGTHS
Cefepime for Injection, USP is a sterile powder of cefepime in vials
for reconstitution, available in the following strengths:
•
CONTRAINDICATIONS
Patients with known immediate hype