CEFUROXIME injection powder for solution

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

CEFUROXIME (UNII: O1R9FJ93ED) (CEFUROXIME - UNII:O1R9FJ93ED)

Предлага се от:

APP Pharmaceuticals, LLC

INN (Международно Name):

CEFUROXIME

Композиция:

CEFUROXIME 750 mg

Вид предписание :

PRESCRIPTION DRUG

Статус Оторизация:

Abbreviated New Drug Application

Данни за продукта

CEFUROXIME- CEFUROXIME INJECTION, POWDER, FOR SOLUTION
APP PHARMACEUTICALS, LLC
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CEFUROXIME FOR INJECTION, USP
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of Cefuroxime for
Injection, USP and other antibacterial drugs, Cefuroxime for
Injection, USP should be used only to treat
or prevent infections that are proven or strongly suspected to be
caused by bacteria.
DESCRIPTION
Cefuroxime for Injection, USP is a sterile semisynthetic,
broad-spectrum, cephalosporin antibiotic for
parenteral administration. It is the sodium salt of
(6R,7R)-3-carbamoyloxymethyl-7-[Z-2-methoxyimino-
2-(fur-2-yl) acetamido] ceph-3-em-4-carboxylate, and it has the
following chemical structure:
The empirical formula is C
H N NaO S, representing a molecular weight of 446.4.
Cefuroxime for Injection, USP contains approximately 54.2 mg (2.4 mEq)
of sodium per gram of
cefuroxime activity.
Cefuroxime for Injection, USP in sterile crystalline form is supplied
in vials and is equivalent to 750 mg
or 1.5 g of cefuroxime as cefuroxime sodium. Solutions of Cefuroxime
for Injection, USP range in
color from light yellow to amber, depending on the concentration and
diluent used. The pH of freshly
constituted solutions usually ranges from 6 to 8.5.
CLINICAL PHARMACOLOGY
After intramuscular (IM) injection of a 750 mg dose of cefuroxime to
normal volunteers, the mean peak
serum concentration was 27 mcg/mL. The peak occurred at approximately
45 minutes (range, 15 to 60
minutes). Following IV doses of 750 mg and 1.5 g, serum concentrations
were approximately 50 and
100 mcg/mL, respectively, at 15 minutes. Therapeutic serum
concentrations of approximately 2 mcg/mL
or more were maintained for 5.3 hours and 8 hours or more,
respectively. There was no evidence of
accumulation of cefuroxime in the serum following IV administration of
1.5 g doses every 8 hours to
normal volunteers. The serum half-life after either IM or IV
injections is approximately 80 minutes.
Approximately 89% of a dose of cefuroxime is excreted