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Zosyn Injection

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Zosyn Injection

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ZOSYN®
(piperacillin and tazobactam) for Injection, USP

Pharmacy Bulk Package
Not for Direct Infusion

RECONSTITUTED STOCK SOLUTION MUST BE TRANSFERRED AND FURTHER DILUTED FOR I.V. INFUSION

To reduce the development of drug-resistant bacteria and maintain the effectiveness of ZOSYN® (piperacillin and tazobactam) injection and other antibacterial drugs, ZOSYN (piperacillin and tazobactam) should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

DRUG DESCRIPTION

Package

The PHARMACY BULK VIAL is a container of sterile preparation which contains many single doses for parenteral use. The contents are intended for use in a pharmacy admixture program and are restricted to the preparation of admixtures for intravenous infusion.

Product

ZOSYN (piperacillin and tazobactam for injection, USP) is an injectable antibacterial combination product consisting of the semisynthetic antibiotic piperacillin sodium and the β-lactamase inhibitor tazobactam sodium for intravenous administration.

Piperacillin sodium is derived from D(-)-α-aminobenzyl-penicillin. The chemical name of piperacillin sodium is sodium (2S,5R,6R)-6-[(R)-2-(4-ethyl-2,3-dioxo-l-piperazine-carboxamido)-2-phenylacetamido]-3,3-dimethyl-7-oxo-4-thia-l-azabicyclo[3.2.0]heptane- 2-carboxylate. The chemical formula is C23H26N5NaO7S and the molecular weight is 539.5. The chemical structure of piperacillin sodium is:

Piperacillin sodium Structural Formula Illustration

Tazobactam sodium, a derivative of the penicillin nucleus, is a penicillanic acid sulfone. Its chemical name is sodium (2S,3S,5R)-3-methyl-7-oxo-3-(1H-l,2,3-triazol-l-ylmethyl)-4-thia- 1-azabicyclo[3.2.0]heptane-2-carboxylate-4,4-dioxide. The chemical formula is C10H11N4NaO5S and the molecular weight is 322.3. The chemical structure of tazobactam sodium is:

Tazobactam sodium Structural Formula Illustration

ZOSYN, piperacillin/tazobactam parenteral combination, is a white to off-white sterile, cryodesiccated powder consisting of piperacillin and tazobactam as their sodium salts packaged in glass vials. The formulation also contains 9 mg of edetate disodium dihydrate (EDTA) and sodium citrate.

Each ZOSYN 40.5 g pharmacy bulk vial contains piperacillin sodium equivalent to 36 grams of piperacillin and tazobactam sodium equivalent to 4.5 g of tazobactam sufficient for delivery of multiple doses.

ZOSYN is a monosodium salt of piperacillin and a monosodium salt of tazobactam containing a total of 2.79 mEq (64 mg) of Na+ per gram of piperacillin in the combination product.

Last reviewed on RxList: 6/22/2012
This monograph has been modified to include the generic and brand name in many instances.

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.


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