CEFEPIME- cefepime hydrochloride injection, powder, for solution

Երկիր: Ամերիկայի Միացյալ Նահանգներ

Լեզու: անգլերեն

Աղբյուրը: NLM (National Library of Medicine)

Ակտիվ բաղադրիչ:

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

Հասանելի է:

Meitheal Pharmaceuticals Inc.

Կառավարման երթուղին:

INTRAVENOUS

Ռեկվիզորի տեսակը:

PRESCRIPTION DRUG

Թերապեւտիկ ցուցումներ:

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

Ապրանքի ամփոփագիր:

How Supplied Cefepime for injection is supplied as follows: *Based on cefepime activity. 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 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.] Protected 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.

Լիազորման կարգավիճակը:

Abbreviated New Drug Application

Ապրանքի հատկությունները

CEFEPIME- CEFEPIME HYDROCHLORIDE INJECTION, POWDER, FOR SOLUTION
MEITHEAL PHARMACEUTICALS INC.
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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:
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
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 UT Is 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 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
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
Co