"The U.S. Food and Drug Administration is alerting health care providers of concerns about a lack of sterility assurance of all sterile drug products made and distributed by NuVision Pharmacy of Dallas, Texas. The FDA recommends that these product"...
(ceftriaxone sodium and dextrose injection (diluent) in the DUPLEX sterile container)
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Ceftriaxone for Injection and Dextrose Injection and other antibacterial drugs, Ceftriaxone for Injection and Dextrose Injection (ceftriaxone sodium and dextrose injection ) should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
Ceftriaxone for Injection and Dextrose Injection (ceftriaxone sodium and dextrose injection ) is a sterile, nonpyrogenic, single use, packaged combination of Ceftriaxone 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 ceftriaxone sodium, a sterile, semisynthetic, broad-spectrum cephalosporin antibiotic for intravenous administration. Ceftriaxone (ceftriaxone sodium and dextrose injection ) sodium is (6R,7R)-7-[2-(2- Amino-4-thiazolyl)glyoxylamido]-8-oxo-3- [[(1,2,5,6-tetrahydro-2-methyl-5,6-dioxo-as-triazin-3- yl)thio]methyl] -5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylicacid,72-(Z)-(0-methyloxime), disodium salt, sesquaterhydrate.
Ceftriaxone Sodium has the following structural formula:
The chemical formula of ceftriaxone (ceftriaxone sodium and dextrose injection ) sodium is C18H16N8Na207S3•3.5H20, representing a molecular weight of 661.60.
Ceftriaxone (ceftriaxone sodium and dextrose injection ) Sodium is supplied as a dry powder form equivalent to either..1 g or 2 g of ceftriaxone. Ceftriaxone Sodium is a white to yellowish-orange crystalline powder which is readily soluble in water, sparingly soluble in methanol and very slightly soluble in ethanol. The pH of a 1% aqueous solution is approximately 6.7. The color of Ceftriaxone Sodium solutions ranges from light yellow to amber, depending on the length of storage and concentration. Ceftriaxone Sodium contains approximately 83 mg (3.6 mEq) of sodium per gram of ceftriaxone (ceftriaxone sodium and dextrose injection ) 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 USP has been added to adjust osmolality (approximately 1.87 g and 1.11 g to 1 g and 2 g dosages, respectively). 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.
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 Ceftriaxone for Injection and Dextrose Injection (ceftriaxone (ceftriaxone sodium and dextrose injection ) sodium and dextrose injection ) is 290 mOsmol/kg.
The DUPLEX Container is Latex-free, PVC-free, and DEHP-free.
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.
Additional Ceftriaxone Information
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