CEFEPIME HYDROCHLORIDE injection, powder, for solution

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

有効成分:

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

から入手可能:

Xellia Pharmaceuticals USA LLC

投与経路:

INTRAMUSCULAR

処方タイプ:

PRESCRIPTION DRUG

適応症:

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

製品概要:

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 solutions of Cefepime for Injection, USP can range in color from pale yellow to amber. Storage and Handling Cefepime for Injection, USP in the dry state should be stored at 20° to 25°C (68° to 77°F); excursion permitted between 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature.] Protect from light. Retain in carton until time of use. Discard unused portion. Sterile, Nonpyrogenic, Preservative-free. The container closure is not made with natural rubber latex.

認証ステータス:

Abbreviated New Drug Application

製品の特徴

CEFEPIME HYDROCHLORIDE- CEFEPIME HYDROCHLORIDE INJECTION, POWDER, FOR
SOLUTION
XELLIA PHARMACEUTICALS USA LLC
----------
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:
Pneumonia. (1.1)
Empiric therapy for febrile neutropenic patients. (1.2)
Uncomplicated and complicated urinary tract infections (including
pyelonephritis). (1.3)
Uncomplicated skin and skin structure infections. (1.4)
Complicated intra-abdominal infections (used in combination with
metronidazole) in adults. (1.5)
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 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
1-2 g IV
Every 8-12 hours
10
Empiric Therapy for Febrile Neutropenic
Patients
2 g IV
Every 8 hours
7
Mild to Moderate Uncomplicated or
Complicated Urinary Tract Infections
0.5-1 g IV/IM
Every 12 hours
7-10
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
7-10
Pediatric Patients (2 months to 16 years)
Recommended dosage in pediatric with CrCL greater than 60 mL/min.
(2.2)
The usual recommend