PIPERACILLIN AND TAZOBACTAM injection, powder, lyophilized, for solution

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

有効成分:

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

から入手可能:

Sandoz GmbH

投与経路:

INTRAVENOUS

処方タイプ:

PRESCRIPTION DRUG

適応症:

Piperacillin and tazobactam for injection is a combination product consisting of a penicillin-class antibacterial, piperacillin, and a β-lactamase inhibitor, tazobactam, indicated for the treatment of patients with moderate to severe infections caused by susceptible isolates of the designated bacteria in the conditions listed below. Appendicitis (complicated by rupture or abscess) and peritonitis caused by β-lactamase producing isolates 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 fewer than 10 cases. Uncomplicated and complicated skin and skin structure infections, including cellulitis, cutaneous abscesses and ischemic/diabetic foot infections caused by β-lactamase producing isolates of Staphylococcus aureus . Postpartum endometritis or pelvic inflammatory disease caused by β-lactamase producing isolates of Escherichia coli . Community-acquired pneumonia (

製品概要:

Piperacillin and tazobactam for injection, USP is supplied as ADD-Vantage® vials in the following sizes: Each piperacillin and tazobactam for injection, USP 2.25 g ADD-Vantage® vial provides piperacillin sodium equivalent to 2 grams of piperacillin and tazobactam sodium equivalent to 0.25 g of tazobactam. Each ADD-Vantage® vial contains 4.69 mEq (108 mg) of sodium. Supplied 10 per box – NDC 43858-160-02 Each piperacillin and tazobactam for injection, USP 3.375 g ADD-Vantage® vial provides piperacillin sodium equivalent to 3 grams of piperacillin and tazobactam sodium equivalent to 0.375 g of tazobactam. Each ADD-Vantage® vial contains 7.04 mEq (162 mg) of sodium. Supplied 10 per box – NDC 43858-147-02 Each piperacillin and tazobactam for injection, USP 4.5 g ADD-Vantage® vial provides piperacillin sodium equivalent to 4 grams of piperacillin and tazobactam sodium equivalent to 0.5 g of tazobactam. Each ADD-Vantage® vial contains 9.39 mEq (216 mg) of sodium. Supplied 10 per box – NDC 43858-148-04 Piperacillin and tazobactam for injection, USP ADD-Vantage® vials should be stored at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature] prior to reconstitution.

認証ステータス:

Abbreviated New Drug Application

製品の特徴

PIPERACILLIN AND TAZOBACTAM- PIPERACILLIN AND TAZOBACTAM INJECTION,
POWDER,
LYOPHILIZED, FOR SOLUTION
SANDOZ GMBH
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PIPERACILLIN AND TAZOBACTAM FOR
INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
PIPERACILLIN AND TAZOBACTAM FOR
INJE C TIO N.
PIPERACILLIN AND TAZOBACTAM FOR INJECTION, FOR INTRAVENOUS USE
ADD-VANTAGE VIALS
INITIAL U.S. APPROVAL: 1993
INDICATIONS AND USAGE
Piperacillin and tazobactam for injection is a combination
penicillin-class antibacterial and β-lactamase inhibitor indicated
for
treatment of:
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DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
Piperacillin and tazobactam for injection: 2.25 g, 3.375 g, and 4.5 g
lyophilized powder for reconstitution in ADD-Vantage
vials (3)
CONTRAINDICATIONS
Patients with a history of allergic reactions to any of the
penicillins, cephalosporins, or β-lactamase inhibitors. (4)
WARNINGS AND PRECAUTIONS
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®
Intra-abdominal infections (1.1)
Skin and skin structure infections (1.2)
Female pelvic infections (1.3)
Community-acquired pneumonia (1.4)
Nosocomial pneumonia (1.5)
Usage (1.6)
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of piperacillin and tazobactam
for injection and other antibacterial drugs, piperacillin and
tazobactam for injection should be used only to treat or
prevent infections that are proven or strongly suspected to be caused
by bacteria. (1.6)
The usual daily dose of piperacillin and tazobactam for injection for
adults is 3.375 g every six hours totaling 13.5 g
(12 g piperacillin/1.5 g tazobactam). (2.1)
Initial presumptive treatment of patients with nosocomial pneumonia
should start with piperacillin and tazobactam for
injection at a dosage of 4.5 g every six hours plus an aminoglycoside,
totaling 18 g (16 g piperacillin/2 g tazobactam).
(2.2)
Dosage in patients with renal impairment (≤40 mL/min of CRCL) and
di