Ceftizoxime description

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Ceftizoxime
CEFIZOX® FDA Package Insert
Description
Clinical Pharmacology
Microbiology
Indications and Usage
Contraindications
Warnings and Precautions
Adverse Reactions
Dosage and Administration
How Supplied

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]

Description

Cefizox® (ceftizoxime injection) in the Galaxy® plastic container (PL 2040) contains ceftizoxime as ceftizoxime sodium. It is a sterile, semisynthetic, broad spectrum, cephalosporin antibiotic for intravenous administration. Chemically, it is the sodium (6R, 7R)­7­[2-(2­imino­4­ thiazolin-4-yl) glyoxylamido]­8­oxo­5­thia­1­azabicyclo[4.2.0.]oct­2­ene­2­carboxylate 7²-(Z)-(O-methyloxime). The molecular formula is C13H12N5NaO5S2 and the molecular weight is 405.38. The structural formula of ceftizoxime sodium is as follows:

efizox (ceftizoxime injection) in the Galaxy® plastic container is a frozen iso-osmotic, sterile, nonpyrogenic premixed 50 mL solution containing 1 g or 2 g of ceftizoxime as ceftizoxime sodium. Dextrose, USP has been added to these dosages to adjust osmolality (approximately 1.9 g and 950 mg to the 1 g and 2 g dosages as dextrose hydrous, respectively). Thawed solutions range from very pale yellow to yellow. The pH of thawed solutions range from 5.5 to 8.0. After thawing to room temperature, the solution is intended for intravenous use only. The Galaxy® container is fabricated from a specially designed multilayer plastic (PL 2040). Solutions are in contact with the polyethylene layer of this container and can leach out certain chemical components of the plastic in very small amounts within the expiration dating period. The suitability of the plastic has been confirmed in tests in animals according to the USP biological tests for plastic containers, as well as by tissue culture toxicity studies.[1]

References

  1. "CEFIZOX (CEFTIZOXIME SODIUM) SOLUTION [ASTELLAS PHARMA US, INC.]".

Adapted from the FDA Package Insert.