PIPERACILLIN AND TAZOBACTAM- piperacillin sodium,tazobactam sodium injection, powder, for solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Fresenius Kabi USA, LLC

INN (International Name):

PIPERACILLIN SODIUM

Composition:

PIPERACILLIN ANHYDROUS 3 g in 15 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 isol

Product summary:

Piperacillin and Tazobactam for Injection is supplied in the following sizes: Store Piperacillin and Tazobactam for Injection dry powder at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature] prior to reconstitution. This container closure is not made with natural rubber latex.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

PIPERACILLIN AND TAZOBACTAM- PIPERACILLIN SODIUM,TAZOBACTAM SODIUM
INJECTION,
POWDER, FOR SOLUTION
FRESENIUS KABI USA, LLC
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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 INJECTION.
PIPERACILLIN AND TAZOBACTAM FOR INJECTION: SINGLE-DOSE VIALS
INITIAL U.S. APPROVAL: 1993
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 INFECTIONS THAT ARE PROVEN OR STRONGLY SUSPECTED TO
BE CAUSED BY BACTERIA.
INDICATIONS AND USAGE
Piperacillin and Tazobactam for Injection is a combination
penicillin-class antibacterial and β-lactamase inhibitor indicated
for treatment of:
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)
DOSAGE AND ADMINISTRATION
The usual daily dose of Piperacillin and Tazobactam for Injection for
adults is 3.375 g every six hours totaling 13.5 g
(12.0 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 18.0 g (16.0 g piperacillin/2.0 g
tazobactam). ( 2.2)
Dosage in patients with renal impairment (≤40 mL/min of CRCL) and
dialysis patients should be reduced, based on the
degree of actual renal function impairment. ( 2.3)
For children with appendicitis and/or peritonitis the recommended
Piperacillin and Tazobactam for Injection dosage is
100 mg piperacillin/12.5 mg tazobactam per kilogram of body weight,
every 8 hours in pediatric patients 9 months of
age and older. For pediatric patients 2 to 9 months of age, the
recommended dosage