MAXIPIME- 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:

Hospira, Inc.

INN (International Adı):

CEFEPIME HYDROCHLORIDE

Kompozisyon:

CEFEPIME 1 g

Uygulama yolu:

INTRAVENOUS

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

MAXIPIME 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. MAXIPIME 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) ]. MAXIPIME 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 infection is severe, or caused by Escherichia c

Ürün özeti:

How Supplied MAXIPIME for injection is supplied as follows: MAXIPIME for Injection in the dry state, is a white to pale yellow powder. Constituted solution of MAXIPIME can range in color from pale yellow to amber. Storage and Handling MAXIPIME for injection in the dry state should be stored at 20 to 25° C (68 to 77° F) [see USP controlled room temperature.] and protected from light.

Yetkilendirme durumu:

New Drug Application

Ürün özellikleri

MAXIPIME- CEFEPIME 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
MAXIPIME SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR MAXIPIME.
MAXIPIME (CEFEPIME HYDROCHLORIDE) FOR INJECTION, FOR INTRAVENOUS OR
INTRAMUSCULAR USE
INITIAL U.S. APPROVAL: 1996
INDICATIONS AND USAGE
MAXIPIME 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 MAXIPIME and other antibacterial
drugs, MAXIPIME 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)
**Intramuscular route of administration is indicated only for mild to
moderate, uncomplicated or complicated UTIs due to
E. coli. (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
1-2 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
Infe ctions
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)
•
•
DOSAGE FORMS AND STRENGTHS
MAXIPIME for injection is a sterile powder of cefepime in vials for
reconstitution, available in the following strengths:
•
•
CON