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

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

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

متاح من:

Wockhardt USA LLC.

INN (الاسم الدولي):

PIPERACILLIN SODIUM

تركيب:

PIPERACILLIN ANHYDROUS 2 g in 10 mL

طريقة التعاطي:

INTRAVENOUS

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

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

ملخص المنتج:

Piperacillin and tazobactam for injection, USP are supplied as single-dose vials in the following sizes: Each piperacillin and tazobactam for injection, USP 2.25 g vial provides piperacillin sodium equivalent to 2 grams of piperacillin and tazobactam sodium equivalent to 0.25 g of tazobactam. Each vial contains 4.87 mEq (112 mg) of sodium. Supplied 10 per box - NDC 64679-034-01 Each piperacillin and tazobactam for injection, USP 3.375 g vial provides piperacillin sodium equivalent to 3 grams of piperacillin and tazobactam sodium equivalent to 0.375 g of tazobactam. Each vial contains 7.30 mEq (168 mg) of sodium. Supplied 10 per box - NDC 64679-056-01 Each piperacillin and tazobactam for injection, USP 4.5 g vial provides piperacillin sodium equivalent to 4 grams of piperacillin and tazobactam sodium equivalent to 0.5 g of tazobactam. Each vial contains 9.74 mEq (224 mg) of sodium. Supplied 10 per box - NDC 64679-012-01 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.

الوضع إذن:

Abbreviated New Drug Application

خصائص المنتج

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
_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 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). ( 2.3)
_Adult Patients with Renal Impairment_ : Dosage in patients with renal
impairment (creatinine cle