CEFUROXIME SODIUM injection powder for solution

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

CEFUROXIME SODIUM (UNII: R8A7M9MY61) (CEFUROXIME - UNII:O1R9FJ93ED)

Доступна с:

Samson Medical Technologies, L.L.C.

ИНН (Международная Имя):

CEFUROXIME SODIUM

состав:

CEFUROXIME SODIUM 75 g

Тип рецепта:

PRESCRIPTION DRUG

Статус Авторизация:

Abbreviated New Drug Application

Характеристики продукта

CEFUROXIME SODIUM- CEFUROXIME SODIUM INJECTION, POWDER, FOR SOLUTION
SAMSON MEDICAL TECHNOLOGIES, L.L.C.
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CEFUROXIME FOR INJECTION, USP
PHARMACY BULK PACKAGE -
NOT FOR DIRECT INFUSION
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of cefuroxime and
other antibacterial drugs, Cefuroxime for Injection should be used
only to treat or prevent infections
that are proven or strongly suspected to be caused by bacteria.
DESCRIPTION
Cefuroxime is a 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 contains approximately 54.2 mg (2.4 mEq) of
sodium per gram of cefuroxime
activity.
Cefuroxime for Injection in sterile crystalline form is supplied in
Pharmacy Bulk Packages equivalent to
75 g or 225 g of cefuroxime as cefuroxime sodium. Solutions of
cefuroxime 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.
A Pharmacy Bulk Package is a container of a sterile preparation for
intravenous use that contains many
single doses. The contents are intended for use in a pharmacy
admixture service and are restricted to the
preparation of admixtures for intravenous infusion. BEFORE
ADMINISTRATION, THIS
PHARMACY BULK PACKAGE REQUIRES RECONSTITUTION TO A CONCENTRATION
OF 95 MG/ML OR 100 MG/ML AND TRANSFER INTO STERILE SYRINGES.
CLINICAL PHARMACOLOGY
Following intravenous 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 f