PIPERACILLIN AND TAZOBACTAM injection, powder, lyophilized, for solution

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

Hospira, Inc

INN (Διεθνής Όνομα):

PIPERACILLIN SODIUM

Σύνθεση:

PIPERACILLIN ANHYDROUS 2 g

Οδός χορήγησης:

INTRAVENOUS

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

Piperacillin and tazobactam for injection 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 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 and tazobactam-susceptible Acinetobacter baumannii, Haemophilus influenzae, Klebsiella pneumoniae, and Pseudomonas aeruginosa (Nosocomial pneumonia caused by P. aeruginosa should be treated in combination with an aminoglycoside) [see Dosage and Administration (2) ]. Piperacillin and tazobactam for injection is indicated in adults for the treatment of uncompli

Περίληψη προϊόντος:

Piperacillin and tazobactam for injection, USP is supplied as ADD-Vantage® vials in the following sizes: Each piperacillin and tazobactam for injection, USP 2.25 g ADD-Vantage® vial provides piperacillin sodium equivalent to 2 grams of piperacillin and tazobactam sodium equivalent to 0.25 g of tazobactam. Each ADD-Vantage® vial contains 4.69 mEq (108 mg) of sodium. Supplied 10 per box – NDC 0409-3374-02 Each piperacillin and tazobactam for injection, USP 3.375 g ADD-Vantage® vial provides piperacillin sodium equivalent to 3 grams of piperacillin and tazobactam sodium equivalent to 0.375 g of tazobactam. Each ADD-Vantage® vial contains 7.04 mEq (162 mg) of sodium. Supplied 10 per box – NDC 0409-3378-13 Each piperacillin and tazobactam for injection, USP 4.5 g ADD-Vantage® vial provides piperacillin sodium equivalent to 4 grams of piperacillin and tazobactam sodium equivalent to 0.5 g of tazobactam. Each ADD-Vantage® vial contains 9.39 mEq (216 mg) of sodium. Supplied 10 per box – NDC 0409-3379-04 Piperacillin and tazobactam for injection, USP ADD-Vantage® vials should be stored at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature] prior to reconstitution.

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

PIPERACILLIN AND TAZOBACTAM- PIPERACILLIN AND TAZOBACTAM INJECTION,
POWDER, LYOPHILIZED, FOR SOLUTION
HOSPIRA, 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,
ADD-VANTAGE VIALS
INITIAL U.S. APPROVAL: 1993
RECENT MAJOR CHANGES
Warnings and Precautions, Hemophagocytic Lymphohistiocytosis (5.3)
4/2022
INDICATIONS AND USAGE
Piperacillin and tazobactam for injection is a combination of
piperacillin, a penicillin-class antibacterial and
tazobactam, a beta-lactamase inhibitor, indicated for the treatment
of:
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•
•
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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
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RECOMMENDED DOSAGE OF PIPERACILLIN AND TAZOBACTAM FOR INJECTION FOR
PEDIATRIC PATIENTS 2
MONTHS OF AGE AND OLDER, WEIGHING UP TO 40 KG AND WITH NORMAL RENAL
FUNCTION
AGE
APPENDICITIS AND /OR PERITONITIS
NOSOCOMIAL PNEUMONIA
2 MONTHS TO 9
MONTHS
90 mg/kg (80 mg piperacillin and 10 mg
tazobactam) every 8 (_eight_) hours
90 mg/kg (80 mg piperacillin and 10 mg
tazobactam) every 6 (_six_) hours
OLDER THAN 9
MONTHS
112.5 mg/kg (100 mg piperacillin and
12.5 mg tazobactam) every 8 (_eight_)
hours
112.5 mg/kg (100 mg piperacillin and
12.5 mg tazobactam) every 6 (_six_) hours
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®
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-acqui