"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"...
(piperacillin/tazobactam) for Injection, USP
To reduce the development of drug-resistant bacteria and maintain the effectiveness of ZOSYN (piperacillin/tazobactam) injection and other antibacterial drugs, ZOSYN (piperacillin/tazobactam) should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
ZOSYN (piperacillin and tazobactam) for Injection and ZOSYN (piperacillin and tazobactam) Injection are injectable antibacterial combination products consisting of the semisynthetic antibacterial 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-1-piperazinecarboxamido)-2-phenylacetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2carboxylate. The chemical formula is C23H26N5NaO7S and the molecular weight is 539.5. The chemical structure of piperacillin sodium is:
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-1,2,3-triazol-1-ylmethyl)-4-thia-1azabicyclo[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:
ZOSYN (piperacillin and tazobactam) for Injection, 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 edetate disodium dihydrate (EDTA) and sodium citrate.
Each ZOSYN 2.25 g single dose vial contains an amount of drug sufficient for withdrawal of piperacillin sodium equivalent to 2 grams of piperacillin and tazobactam sodium equivalent to 0.25 g of tazobactam. The product also contains 0.5 mg of EDTA per vial.
Each ZOSYN 3.375 g single dose vial contains an amount of drug sufficient for withdrawal of piperacillin sodium equivalent to 3 grams of piperacillin and tazobactam sodium equivalent to 0.375 g of tazobactam. The product also contains 0.75 mg of EDTA per vial.
Each ZOSYN 4.5 g single dose vial contains an amount of drug sufficient for withdrawal of piperacillin sodium equivalent to 4 grams of piperacillin and tazobactam sodium equivalent to 0.5 g of tazobactam. The product also contains 1 mg of EDTA per vial.
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 Injection in the Galaxy Container is a frozen iso-osmotic sterile non-pyrogenic premixed solution. The components and dosage formulations are given in the table below:
Table 5: ZOSYN In GALAXY
Containers Premixed Frozen Solution
|2.25 g/ 50 mL||3.375 g/ 50 mL||4.5 g/100 mL|
|Piperacillin||active ingredient||2 g||3 g||4 g|
|Tazobactam||β-lactamase inhibitor||250 mg||375 mg||500 mg|
|Dextrose Hydrous||osmolality adjusting agent||1 g||350 mg||2 g|
|Sodium Citrate Dihydrate||buffering agent||100 mg||150 mg||200 mg|
|Edetate Disodium Dihydrate||metal chelator||0.5 mg||0.75 mg||1 mg|
|Water for Injection||solvent||q.s. 50 mL||q.s. 50 mL||q.s. 100 mL|
|*Piperacillin and tazobactam are present in the formulation as sodium salts. Dextrose hydrous, sodium citrate dihydrate, and edetate disodium dihydrate amounts are approximate.|
ZOSYN contains a total of 2.79 mEq (64 mg) of sodium (Na+) per gram of piperacillin in the combination product.
What are the precautions when taking piperacillin and tazobactam pharmacy bulk vial (Zosyn Injection)?
Before using piperacillin/tazobactam, tell your doctor or pharmacist if you are allergic to either of the drugs; or to penicillin, cephalosporin, or beta-lactam antibiotics; or to other beta-lactamase inhibitors such as sulbactam; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: bleeding problems, cystic fibrosis, kidney disease, seizures.
This medication contains sodium. Consult your doctor or pharmacist if you are on a salt-restricted diet or if you have a condition that could be worsened by an increase in salt intake (such as congestive heart...
Last reviewed on RxList: 9/19/2013
This monograph has been modified to include the generic and brand name in many instances.
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