FORTAZ Powder for solution for injection Ref.[49688] Active ingredients: Ceftazidime

Source: FDA, National Drug Code (US)  Revision Year: 2017 

Product description

Ceftazidime is a semisynthetic, broad-spectrum, beta-lactam antibacterial drug 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 molecular formula is C22H22N6O7S2•5H2O, representing a molecular weight of 636.65.

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 single-dose vials equivalent to 500 mg, 1 g, 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.

How Supplied

FORTAZ in the dry state should be stored between 15° and 30°C (59° and 86°F) and protected from light. FORTAZ is a dry, white to off-white powder supplied in vials as follows:

  • NDC 52565-105-10 500-mg* Single-Dose Vial (Carton of 10)
  • NDC 52565-106-10 1-g* Single-Dose Vial (Carton of 10)
  • NDC 52565-107-10 2-g* Single-Dose Vial (Carton of 10)

* Equivalent to anhydrous ceftazidime.

Manufactured by: Astral SteriTech Pvt. Ltd., India

Distributed by: Teligent Pharma, Inc., Buena, NJ 08310

Drugs

Drug Countries
FORTAZ Brazil, United States

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