PIPERACILLIN SODIUM AND TAZOBACTAM SODIUM injection, powder, for solution

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

即購入

ダウンロード 製品の特徴 (SPC)
26-08-2022

有効成分:

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

から入手可能:

Xellia Pharmaceuticals USA LLC

投与経路:

INTRAVENOUS

処方タイプ:

PRESCRIPTION DRUG

適応症:

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

製品概要:

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.

認証ステータス:

Abbreviated New Drug Application

製品の特徴

                                PIPERACILLIN SODIUM AND TAZOBACTAM SODIUM- PIPERACILLIN SODIUM AND
TAZOBACTAM SODIUM INJECTION, POWDER, FOR SOLUTION
XELLIA PHARMACEUTICALS USA LLC
----------
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
                                
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