Información de la droga para Zosyn (Piperacillin and Tazobactam Injection) in Galaxy Containers (PL 2040 Plastic) (Wyeth Piperacillin Division of Wyeth Holdings Corporation): 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 ß-lactamase inhibitor tazobactam sodium for intravenous administration.

    Piperacillin sodium is derived from D(-)-a-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:

    Component*FunctionDosage Formulations
    2.25 g/50 mL3.375 g/50 mL4.5 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 ß-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, 8.38 mEq (192 mg) per 50 mL in the 3.375 g dose, and 11.17 mEq (256 mg) per 100 mL in the 4.5 g dose.

  • Drug Information Provided by National Library of Medicine (NLM).