PIPERACILLIN SODIUM AND TAZOBACTAM SODIUM injection, powder, 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:

Xellia Pharmaceuticals USA LLC

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/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 are supplied as follows: Storage Conditions 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. Sterile, Nonpyrogenic, Preservative-free. The container closure is not made with natural rubber latex.

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

PIPERACILLIN SODIUM AND TAZOBACTAM SODIUM- PIPERACILLIN SODIUM AND
TAZOBACTAM SODIUM INJECTION, POWDER, FOR SOLUTION
XELLIA PHARMACEUTICALS 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)
8/2021
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:
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 Rena