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Cefotaxime (cefotaxime for injection) for Injection USP
and Dextrose Injection
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cefotaxime (cefotaxime for injection) for Injection USP and Dextrose Injection and other antibacterial drugs, Cefotaxime (cefotaxime for injection) for Injection USP and Dextrose Injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
Cefotaxime (cefotaxime for injection) for Injection USP and Dextrose Injection is a sterile, nonpyrogenic, single use, packaged combination of Cefotaxime Sodium and Dextrose Injection (diluent) in the DUPLEX sterile container. The DUPLEX Container is a flexible dual chamber container.
The drug chamber is filled with sterile Cefotaxime (cefotaxime for injection) Sodium USP, a semisynthetic, broad-spectrum, cephalosporin antibiotic for parenteral administration. It is the sodium salt of 7-[2-(2-amino-4-thiazolyl) glyoxylamido]-3-(hydroxymethyl)-8-oxo-5-thia-1-azabicyclo [4.2.0] oct-2-ene-2-carboxylate 72 (Z)-(o-methyloxime), acetate (ester). The CAS Registry Number is 64485-93-4.
Cefotaxime (cefotaxime for injection) Sodium has the following structural formula:
The empirical formula of Cefotaxime (cefotaxime for injection) Sodium is C16H16N5NaO7S2, representing a molecular weight of 477.45.
Cefotaxime (cefotaxime for injection) Sodium contains approximately 50.5 mg (2.2 mEq) of sodium per gram of cefotaxime activity.
The diluent chamber contains Dextrose Injection. The concentration of Hydrous Dextrose in Water for Injection USP has been adjusted to render the reconstituted drug product iso-osmotic. Dextrose Injection is sterile, nonpyrogenic, and contains no bacteriostatic or antimicrobial agents.
Hydrous Dextrose USP has the following structural (molecular) formula:
The molecular weight of Hydrous Dextrose USP is 198.17.
Cefotaxime (cefotaxime for injection) Sodium is supplied as a dry powder form equivalent to either 1 g or 2 g of cefotaxime.
Dextrose hydrous USP has been added to the diluent to adjust osmolality (approximately 1.95 g and 1.2 g to 1 g and 2 g dosages, respectively).
After removing the peelable foil strip, activating the seals, and thoroughly mixing, the reconstituted drug product is intended for single intravenous use. When reconstituted, the approximate osmolality for the reconstituted solution for Cefotaxime (cefotaxime for injection) for Injection USP and Dextrose Injection is 290 mOsmol/kg.
The DUPLEX dual chamber container is made from a specially formulated material. The product (diluent and drug) contact layer is a mixture of thermoplastic rubber and a polypropylene ethylene copolymer that contains no plasticizers. The safety of the container system is supported by USP biological evaluation procedures.
Last reviewed on RxList: 10/3/2007
This monograph has been modified to include the generic and brand name in many instances.
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