Rx only
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.
DESCRIPTION
ZOSYN (piperacillin and tazobactam injection) in Galaxy® Containers (PL 2040 Plastic) is a sterile 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-1-piperazine-carboxamido)-2-phenylacetamido]-3,3-dimethyl-7-oxo-4-thia-1-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:
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-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:
ZOSYN in the Galaxy Container (PL 2040 Plastic) is a frozen iso-osmotic sterile non-pyrogenic premixed solution. The components and dosage formulations are given in the table below:
TABLE 1: ZOSYN IN GALAXY CONTAINERS (PL 2040 PLASTIC) PREMIXED FROZEN SOLUTION
|
Component* |
Function |
Dosage Formulations |
|
2.25 g/50 mL |
3.375 g/50 mL |
4.5 g/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. |
|
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 |
The pH has been adjusted between 5.5 to 6.8 with sodium bicarbonate and hydrochloric acid.
The solution is intended for intravenous use only.
The plastic container 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 the USP biological tests for plastic containers, as well as by tissue culture toxicity studies.
The approximate total sodium content for ZOSYN in Galaxy Containers is 5.58 mEq (128 mg) per 50 mL in the 2.25 g dose
