ZOSYN PHARMACY BULK PACKAGE- tazobactam sodium and piperacillin sodium injection, powder, lyophilized, for solution

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

TAZOBACTAM SODIUM (UNII: UXA545ABTT) (TAZOBACTAM - UNII:SE10G96M8W), PIPERACILLIN SODIUM (UNII: M98T69Q7HP) (PIPERACILLIN ANHYDROUS - UNII:9I628532GX)

Boleh didapati daripada:

Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc.

INN (Nama Antarabangsa):

TAZOBACTAM SODIUM

Komposisi:

TAZOBACTAM 4.5 g in 180 mL

Laluan pentadbiran:

INTRAVENOUS

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

ZOSYN (piperacillin and tazobactam for injection, USP) is indicated for the treatment of patients with moderate to severe infections caused by piperacillin-resistant, piperacillin/tazobactam-susceptible, β-lactamase producing strains of the designated microorganisms in the specified conditions listed below: Appendicitis (complicated by rupture or abscess) and peritonitis caused by piperacillin-resistant, β-lactamase producing strains of Escherichia coli or the following members of the Bacteroides fragilis group: B. fragilis , B. ovatus , B. thetaiotaomicron, or B. vulgatus . The individual members of this group were studied in less than 10 cases. Uncomplicated and complicated skin and skin structure infections, including cellulitis, cutaneous abscesses, and ischemic/diabetic foot infections caused by piperacillin-resistant, β-lactamase producing strains of Staphylococcus aureus . Postpartum endometritis or pelvic inflammatory disease caused by piperacillin-resistant, β-lactamase producing strains of Escher

Ringkasan produk:

ZOSYN (piperacillin and tazobactam for injection, USP) is supplied as a powder in the pharmacy bulk vial as follows: Each ZOSYN 40.5 g pharmacy bulk vial contains piperacillin sodium equivalent to 36 grams of piperacillin and tazobactam sodium equivalent to 4.5 grams tazobactam, 9 mg of edetate disodium dihydrate (EDTA), and 1800 mg of sodium citrate. Each pharmacy bulk vial contains 100.4 mEq (2,304 mg) of sodium. NDC 0206-5501-01 ZOSYN (piperacillin and tazobactam for injection, USP) pharmacy bulk vials should be stored at controlled room temperature 20°C to 25°C (68°F to 77°F) prior to reconstitution. ZOSYN (piperacillin and tazobactam for injection, USP) is also supplied as follows: 2.25 g single-dose vial containing piperacillin sodium equivalent to 2 g of piperacillin and tazobactam sodium equivalent to 0.25 g of tazobactam. Each vial contains 5.58 mEq (128 mg) of sodium. Supplied as follows: 1 vial – NDC-0206-2501-01 10 vials in a carton - NDC-0206-2501-10 3.375 g single-dose vial containing piperacillin sodium equivalent to 3 g of piperacillin and tazobactam sodium equivalent to 0.375 g of tazobactam. Each vial contains 8.38 mEq (192 mg) of sodium. Supplied as follows: 1 vial – NDC-0206-3501-01 10 vials in a carton - NDC-0206-3501-10 4.5 g single-dose vial containing piperacillin sodium equivalent to 4 g of piperacillin and tazobactam sodium equivalent to 0.5 g of tazobactam. Each vial contains 11.17 mEq (256 mg) of sodium. Supplied as follows: 1 vial – NDC-0206-4501-01 10 vials in a carton - NDC-0206-4501-10

Status kebenaran:

New Drug Application

Ciri produk

ZOSYN PHARMACY BULK PACKAGE- TAZOBACTAM SODIUM AND PIPERACILLIN SODIUM
INJECTION,
POWDER, LYOPHILIZED, FOR SOLUTION
WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.
----------
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.
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
(2_S_,5_R_,6_R_)-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 C
H N NaO S 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
(2_S_,3_S_,5_R_)-3-methyl-7-oxo-3-(1_H_-1,2,3-triazol-1-ylmethyl)-4-thia-
1-
azabicyclo[3.2.0]heptane-2-carboxylate-4,4-dioxide. The chemical
formula is C
H N NaO S and the
molecular weight is 322.3. The chemical structure of tazobactam sodium
is:
®
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23
26
5
7
10
11
4
5
ZOSYN, piperacillin/tazobactam