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

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

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

Предлага се от:

Apotex Corporation

INN (Международно Name):

PIPERACILLIN SODIUM

Композиция:

PIPERACILLIN ANHYDROUS 2 g in 10 mL

Начин на приложение:

INTRAVENOUS

Вид предписание :

PRESCRIPTION DRUG

Терапевтични показания:

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 (

Каталог на резюме:

Piperacillin and Tazobactam for Injection, USP is supplied as single-dose vials in the following sizes: Piperacillin and Tazobactam for Injection, USP vials should be stored at controlled room temperature (20°C to 25°C [68°F to 77°F]) prior to reconstitution.

Статус Оторизация:

Abbreviated New Drug Application

Данни за продукта

PIPERACILLIN AND TAZOBACTAM- PIPERACILLIN AND TAZOBACTAM INJECTION,
POWDER, FOR
SOLUTION
APOTEX CORPORATION
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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:
SINGLE-DOSE 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:
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)
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
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
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 ag