"There is a risk for dosing errors with the dual antibacterial ceftolozane/tazobactam (Zerbaxa, Cubist Pharmaceuticals) due to confusion about the drug strength displayed on the vial and carton labeling, the US Food and Drug Administration "...
(ceftazidime) for Injection
To reduce the development of drug-resistant bacteria and maintain the effectiveness of FORTAZ and other antibacterial drugs, FORTAZ should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
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-1methylethoxy)imino]acetyl]amino]-2-carboxy-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-en-3yl]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 in sterile crystalline form is supplied in vials equivalent to 500 mg, 1 g, 2 g, or 6 g of anhydrous ceftazidime and in TwistVial™ vials equivalent to 1 or 2 g of anhydrous ceftazidime. Solutions of FORTAZ 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 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 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.
What are the possible side effects of ceftazidime injection (Fortaz, Tazicef)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have a serious side effect such as:
- diarrhea that is watery or bloody;
- swelling, pain, or irritation where the injection was given;
- cold feeling, discoloration, or skin changes in your fingers;
- seizure (black-out or convulsions);
- white patches or sores inside your mouth or on your lip;
- jaundice (yellowing of the eyes or...
Last reviewed on RxList: 11/7/2014
This monograph has been modified to include the generic and brand name in many instances.
Additional Fortaz Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find out what women really need.