Država: Sjedinjene Američke Države
Jezik: engleski
Izvor: NLM (National Library of Medicine)
PIPERACILLIN SODIUM (UNII: M98T69Q7HP) (PIPERACILLIN ANHYDROUS - UNII:9I628532GX), TAZOBACTAM SODIUM (UNII: UXA545ABTT) (TAZOBACTAM - UNII:SE10G96M8W)
Mitim S.r.l.
PIPERACILLIN SODIUM
PIPERACILLIN ANHYDROUS 2 g in 10 mL
INTRAVENOUS
PRESCRIPTION DRUG
Piperacillin and tazobactam for injection, USP is a combination product consisting of a penicillin-class antibacterial, piperacillin, and a β-lactamase inhibitor, tazobactam, indicated for the treatment of patients with moderate to severe infections caused by susceptible isolates of the designated bacteria in the conditions listed below. Appendicitis (complicated by rupture or abscess) and peritonitis caused by β-lactamase producing isolates of Escherichia coli or the following members of the Bacteroides fragilis group: B. fragilis , B. ovatus , B. thetaiotaomicron , or B. vulgatus . The individual members of this group were studied in fewer than 10 cases. Uncomplicated and complicated skin and skin structure infections, including cellulitis, cutaneous abscesses and ischemic/diabetic foot infections caused by β-lactamase producing isolates of Staphylococcus aureus . Postpartum endometritis or pelvic inflammatory disease caused by β-lactamase producing isolates of Escherichia coli . Community-acquired pneumo
Piperacillin and tazobactam for injection, USP are supplied as single-dose vials in the following sizes: Each piperacillin and tazobactam for injection, USP 2.25 g vial provides piperacillin sodium equivalent to 2 grams of piperacillin and tazobactam sodium equivalent to 0.25 g of tazobactam. Each vial contains 4.87 mEq (112 mg) of sodium. Supplied 10 per box - NDC 64679-034-01 Each piperacillin and tazobactam for injection, USP 3.375 g vial provides piperacillin sodium equivalent to 3 grams of piperacillin and tazobactam sodium equivalent to 0.375 g of tazobactam. Each vial contains 7.30 mEq (168 mg) of sodium. Supplied 10 per box - NDC 64679-056-01 Each piperacillin and tazobactam for injection, USP 4.5 g vial provides piperacillin sodium equivalent to 4 grams of piperacillin and tazobactam sodium equivalent to 0.5 g of tazobactam. Each vial contains 9.74 mEq (224 mg) of sodium. Supplied 10 per box - NDC 64679-012-01 Piperacillin and tazobactam for injection vials should be stored at controlled room temperature (20°C to 25°C [68°F to 77°F]) prior to reconstitution.
Abbreviated New Drug Application
PIPERACILLIN AND TAZOBACTAM- PIPERACILLIN SODIUM AND TAZOBACTAM SODIUM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION MITIM S.R.L. ---------- 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 Warnings and Precautions, Severe Cutaneous Adverse Reactions (5.2) 06/2016 INDICATIONS AND USAGE Piperacillin and tazobactam for injection, USP is a combination penicillin-class antibacterial and β-lactamase inhibitor indicated for treatment of: Intra-abdominal infections (1.1) Skin and skin structure infections (1.2) Female pelvic infections (1.3) Community-acquired pneumonia (1.4) Nosocomial pneumonia (1.5) Usage (1.6) 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 The usual daily dose 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) (2.1) 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). (2.2) Dosage in patients with renal impairment (≤40 mL/min of CRCL) and dialysis patients should be reduced, based on the degree of actual renal function impairment. (2.3) For children with appendicitis and/or peritonitis the recommended piperacillin and tazobactam for injection dosage is 100 mg piperacillin/12.5 mg tazobactam per kilogram of body weight, every 8 h Pročitajte cijeli dokument