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

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

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

제공처:

Wyeth Piperacillin Division of Wyeth Holdings Corporation, a subsidiary of Pfizer

INN (국제 이름):

TAZOBACTAM SODIUM

구성:

TAZOBACTAM 4.5 g in 180 mL

관리 경로:

INTRAVENOUS

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

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

제품 요약:

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 0206-2416-01 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 10/box—NDC 0206-2404-02 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 10/box—NDC 0206-2405-02 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 10/box—NDC 0206-2408-02 ZOSYN (piperacillin and tazobactam injection) in Galaxy Container (PL 2040 Plastic) is supplied as a frozen, iso-osmotic, sterile, nonpyrogenic solution in single-dose plastic containers as follows: 2.25 g (piperacillin sodium equivalent to 2 g piperacillin/tazobactam sodium equivalent to 0.25 g tazobactam) in 50 mL. Each container has 5.58 mEq (128 mg) of sodium. Supplied 24/box—NDC 0206-2409-02 3.375 g (piperacillin sodium equivalent to 3 g piperacillin/tazobactam sodium equivalent to 0.375 g tazobactam) in 50 mL. Each container has 8.38 mEq (192 mg) of sodium. Supplied 24/box—NDC 0206-2411-02 4.5 g (piperacillin sodium equivalent to 4 g piperacillin/tazobactam sodium equivalent to 0.5 g tazobactam) in 100 mL. Each container has 11.17 mEq (256 mg) of sodium. Supplied 12/box—NDC 0206-2413-02

승인 상태:

New Drug Application

제품 특성 요약

ZOSYN PHARMACY BULK PACKAGE- PIPERACILLIN SODIUM AND TAZOBACTAM SODIUM
INJECTION,
POWDER, LYOPHILIZED, FOR SOLUTION
WYETH PIPERACILLIN DIVISION OF WYETH HOLDINGS CORPORATION, A
SUBSIDIARY OF PFIZER
----------
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
ZOSY