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

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

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

Disponível em:

Wockhardt USA LLC.

Via de administração:

INTRAVENOUS

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

Piperacillin and tazobactam for injection, USP is indicated in adults and pediatric patients (2 months of age and older) for the treatment of appendicitis (complicated by rupture or abscess) and peritonitis caused by beta-lactamase producing isolates of Escherichia coli or the following members of the Bacteroides fragilis group: B. fragilis , B. ovatus , B. thetaiotaomicron , or B. vulgatus . Piperacillin and tazobactam for injection, USP is indicated in adults and pediatric patients (2 months of age and older) for the treatment of nosocomial pneumonia (moderate to severe) caused by beta-lactamase producing isolates of Staphylococcus aureus and by piperacillin/tazobactam-susceptible Acinetobacter baumannii , Haemophilus influenzae , Klebsiella pneumoniae , and Pseudomonas aeruginosa (Nosocomial pneumonia caused by P. aeruginosa

Resumo do produto:

Piperacillin and tazobactam for injection, USP are supplied as pharmacy bulk vials in the following sizes: Each piperacillin and tazobactam for injection, USP 40.5 g pharmacy bulk vial provides piperacillin sodium equivalent to 36 grams of piperacillin and tazobactam sodium equivalent to 4.5 grams of tazobactam. Each pharmacy bulk vial contains 87.65 mEq (2016 mg) of sodium. Supplied 1 per box - NDC 64679-679-01 Piperacillin and tazobactam for injection vials should be stored at controlled room temperature (20°C to 25°C [68°F to 77°F]) prior to reconstitution.

Status de autorização:

Abbreviated New Drug Application

Características técnicas

PIPERACILLIN AND TAZOBACTAM - PIPERACILLIN SODIUM AND TAZOBACTAM
SODIUM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
WOCKHARDT 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, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1993
RECENT MAJOR CHANGES
Dosage and Administration ( 2) 7/2021
INDICATIONS AND USAGE
Piperacillin and tazobactam for injection, USP is a combination of
piperacillin, a penicillin-class antibacterial
and tazobactam, a beta-lactamase inhibitor, indicated for the
treatment of:
Intra-abdominal infections in adult and pediatric patients 2 months of
age and older ( 1.1)
Nosocomial pneumonia in adult and pediatric patients 2 months of age
and older ( 1.2)
Skin and skin structure infections in adults ( 1.3)
Female pelvic infections in adults ( 1.4)
Community-acquired pneumonia in adults ( 1.5)
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
If a dose of piperacillin and tazobactam for injection is required
that does not equal 2.25 g, 3.375 g, or
4.5 g, is not recommended for use and an alternative formulation of
piperacillin and tazobactam for
injection should be considered. ( 2.1)
_Adult Patients With Indications Other Than Nosocomial Pneumonia:_ The
usual daily dosage 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). ( 2.2)
_Adult Patients with Nosocomial Pneumonia: _ Initial presumptive
treatment of patients with nosocomial
pneumonia should start with piperacill