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(ceftazidime for injection)
For Intravenous or Intramuscular Use
To reduce the development of drug-resistant bacteria and maintain the effectiveness of FORTAZ (ceftazidime) and other antibacterial drugs, FORTAZ (ceftazidime) should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
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Ceftazidime is a semisynthetic, broad-spectrum, beta-lactam antibiotic for parenteral administration. It is the pentahydrate of pyridinium, 1-[[7-[[(2-amino-4-thiazolyl)[(1-carboxy-1-methylethoxy)imino]acetyl]amino]-2-carboxy-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-en-3-yl]methyl]-, hydroxide, inner salt, [6R-[6α,7β(Z)]]. It has the following structure:
The empirical formula is C22H32N6O12S2, representing a molecular weight of 636.6.
FORTAZ is a sterile, dry-powdered mixture of ceftazidime pentahydrate and sodium carbonate. The sodium carbonate at a concentration of 118 mg/g of ceftazidime activity has been admixed to facilitate dissolution. The total sodium content of the mixture is approximately 54 mg (2.3 mEq)/g of ceftazidime activity.
FORTAZ (ceftazidime) in sterile crystalline form is supplied in vials equivalent to 500 mg, 1 g, 2 g, or 6 g of anhydrous ceftazidime and in ADD-Vantage® vials equivalent to 1 or 2 g of anhydrous ceftazidime. Solutions of FORTAZ (ceftazidime) range in color from light yellow to amber, depending on the diluent and volume used. The pH of freshly constituted solutions usually ranges from 5 to 8.
FORTAZ (ceftazidime) is available as a frozen, iso-osmotic, sterile, nonpyrogenic solution with 1 or 2 g of ceftazidime as ceftazidime sodium premixed with approximately 2.2 or 1.6 g, respectively, of Dextrose Hydrous, USP. Dextrose has been added to adjust the osmolality. Sodium hydroxide is used to adjust pH and neutralize ceftazidime pentahydrate free acid to the sodium salt. The pH may have been adjusted with hydrochloric acid. Solutions of premixed FORTAZ (ceftazidime) range in color from light yellow to amber. The solution is intended for intravenous (IV) use after thawing to room temperature. The osmolality of the solution is approximately 300 mOsmol/kg, and the pH of thawed solutions ranges from 5 to 7.5.
The plastic container for the frozen solution 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 period. The suitability of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies.
Last reviewed on RxList: 7/19/2007
This monograph has been modified to include the generic and brand name in many instances.
Additional Fortaz Information
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