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

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

Piperacillin Sodium (UNII: M98T69Q7HP) (Piperacillin Anhydrous - UNII:9I628532GX), Tazobactam Sodium (UNII: UXA545ABTT) (Tazobactam - UNII:SE10G96M8W)

제공처:

Sagent Pharmaceuticals

INN (국제 이름):

Piperacillin Sodium

구성:

Piperacillin Anhydrous 2 g in 10 mL

관리 경로:

INTRAVENOUS

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

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 uncomplica

제품 요약:

Piperacillin and Tazobactam for Injection, USP is supplied in single-dose vials as follows: Storage Conditions Prior to Reconstitution: Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Sterile, Nonpyrogenic, Preservative-free. The container closure is not made with natural rubber latex.

승인 상태:

Abbreviated New Drug Application

제품 특성 요약

PIPERACILLIN, TAZOBACTAM- PIPERACILLIN SODIUM, TAZOBACTAM SODIUM
INJECTION, POWDER,
LYOPHILIZED, FOR SOLUTION
SAGENT PHARMACEUTICALS
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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
Indications and Usage (1)
5/2020
Dosage and Administration (2)
5/2020
Warnings and Precautions, Central Nervous System
Adverse Reactions (5.4)
5/2020
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 grams every six hours
totaling 13.5 grams (12 grams piperacillin/1.5 grams
tazobactam). (2.1)
_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 grams every six hours plus an
aminoglycoside, totaling 18 grams (16 grams piperacil