Country: United States
Language: English
Source: NLM (National Library of Medicine)
PIPERACILLIN SODIUM (UNII: M98T69Q7HP) (PIPERACILLIN ANHYDROUS - UNII:9I628532GX), TAZOBACTAM SODIUM (UNII: UXA545ABTT) (TAZOBACTAM - UNII:SE10G96M8W)
Hospira, Inc
PIPERACILLIN SODIUM
PIPERACILLIN ANHYDROUS 12 g in 60 mL
INTRAVENOUS
PRESCRIPTION DRUG
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
Piperacillin and tazobactam for injection, USP is supplied as a powder in the pharmacy bulk bottle as follows: Piperacillin and tazobactam for injection, USP 13.5 g pharmacy bulk bottle containing piperacillin sodium equivalent to 12 grams of piperacillin, tazobactam sodium equivalent to 1.5 grams tazobactam and 28.2 mEq (648 mg) of sodium. Supplied as 1 pharmacy bulk package bottle per box – NDC 0409-2999-14 Piperacillin and tazobactam for injection, USP pharmacy bulk bottles should be stored at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature] prior to reconstitution.
Abbreviated New Drug Application
PIPERACILLIN AND TAZOBACTAM- PIPERACILLIN AND TAZOBACTAM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION HOSPIRA, INC ---------- 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, PHARMACY BULK BOTTLESPHARMACY BULK PACKAGE – NOT FOR DIRECT INFUSION 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: • • • • • 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 • • • • 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 • • • DOSAGE FORMS AND STRENGTHS 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 Read the complete document