CEFUROXIME injection powder for solution

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

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

Prieinama:

APP Pharmaceuticals, LLC

INN (Tarptautinis Pavadinimas):

CEFUROXIME

Sudėtis:

CEFUROXIME 7.5 g in 80 mL

Recepto tipas:

PRESCRIPTION DRUG

Autorizacija statusas:

Abbreviated New Drug Application

Prekės savybės

CEFUROXIME- CEFUROXIME INJECTION, POWDER, FOR SOLUTION
APP PHARMACEUTICALS, LLC
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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 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 Pharmacy Bulk Package
equivalent to 7.5 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.
A pharmacy bulk package is a container of a sterile powder for
parenteral 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. FURTHER DILUTION
IS REQUIRED BEFORE
USE.
CLINICAL PHARMACOLOGY
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.
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