PIPERACILLIN, TAZOBACTAM injection, powder, lyophilized, for solution

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

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

Disponible des:

X-GEN Pharmaceuticals, Inc.

Vía de administración:

INTRAVENOUS

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

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 (

Resumen del producto:

Piperacillin and tazobactam for injection are supplied as pharmacy bulk bottles in the following size: Each piperacillin and tazobactam for injection13.5 g pharmacy bulk bottle provides piperacillin sodium equivalent to 12 grams of piperacillin and tazobactam sodium equivalent to 1.5 g tazobactam. Each bottle contains 29.16 mEq (672 mg) of sodium. Supplied as singles-NDC 39822-0138-8 Each piperacillin and tazobactam for injection 40.5 g pharmacy bulk bottle provides piperacillin sodium equivalent to 36 grams of piperacillin and tazobactam sodium equivalent to 4.5 g of tazobactam. Each pharmacy bulk bottle contains 87.84 mEq (2016 mg) of sodium. NDC 39822-0139-7 Piperacillin and tazobactam for injection pharmacy bulk bottles should be stored at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature] prior to reconstitution.

Estat d'Autorització:

Abbreviated New Drug Application

Fitxa tècnica

PIPERACILLIN, TAZOBACTAM- PIPERACILLIN, TAZOBACTAM INJECTION, POWDER,
LYOPHILIZED, FOR
SOLUTION
X-GEN PHARMACEUTICALS, INC.
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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, FOR
INTRAVENOUS USE.- 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: (2)
•Intra-abdominal infections (1.1) (2)
•Skin and skin structure infections (1.2) (2)
•Female pelvic infections (1.3) (2)
•Community-acquired pneumonia (1.4) (2)
•Nosocomial pneumonia (1.5) (2)
•Usage (1.6) (2)
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) (2)
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