MAXIPIME cefepime hydrochloride injection powder for solution

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

cefepime hydrochloride (UNII: I8X1O0607P) (cefepime - UNII:807PW4VQE3)

Dostupné s:

Cardinal Health

INN (Mezinárodní Name):

cefepime hydrochloride

Složení:

cefepime 1 g

Druh předpisu:

PRESCRIPTION DRUG

Stav Autorizace:

New Drug Application

Charakteristika produktu

MAXIPIME- CEFEPIME HYDROCHLORIDE INJECTION, POWDER, FOR SOLUTION
CARDINAL HEALTH
----------
MAXIPIME
(CEFEPIME HYDROCHLORIDE, USP) FOR INJECTION
FOR INTRAVENOUS OR INTRAMUSCULAR USE
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
or prevent infections that are
proven or strongly suspected to be caused by bacteria.
DESCRIPTION
MAXIPIME (cefepime hydrochloride, USP) is a semi-synthetic, broad
spectrum, cephalosporin
antibiotic for parenteral administration. The chemical name is
1-[[(6R,7R)-7-[2-(2-amino-4-thiazolyl)-
glyoxylamido]-2-carboxy-8-oxo-5-thia-1-azabicyclo[4.2.0]
oct-2-en-3-yl]methyl]-1-
methylpyrrolidinium chloride, 7 -(Z)-(O-methyloxime),
monohydrochloride, monohydrate, which
corresponds to the following structural formula:
Cefepime hydrochloride is a white to pale yellow powder. Cefepime
hydrochloride contains the
equivalent of not less than 825 mcg and not more than 911 mcg of
cefepime (C
H N O S ) per mg,
calculated on an anhydrous basis. It is highly soluble in water.
MAXIPIME for Injection is supplied for intramuscular or intravenous
administration in strengths
equivalent to 500 mg, 1 g, and 2 g of cefepime. (See DOSAGE AND
ADMINISTRATION.)
MAXIPIME is a sterile, dry mixture of cefepime hydrochloride and
L-arginine. It contains the
equivalent of not less than 90 percent and not more than 115 percent
of the labeled amount of cefepime
(C
H N O S ). The L-arginine, at an approximate concentration of 725 mg/g
of cefepime, is added to
control the pH of the constituted solution at 4.0–6.0. Freshly
constituted solutions of MAXIPIME will
range in color from colorless to amber.
CLINICAL PHARMACOLOGY
Cefepime is an antibacterial agent belonging to the cephalosporin
class of antibacterials with _in vitro_
antibacterial activity against facultative Gram-positive and
Gram-negative bacteria.
PHARMACOKINETICS
The average plasma concentrations of cefepime observed in healthy
adult male volunteers