ZOSYN- tazobactam sodium and piperacillin sodium injection, powder, lyophilized, for solution
ZOSYN PHARMACY BULK PACKAGE- tazobactam sodium and piperacillin sodium injection, powder, lyophilized, for solution
Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of ZOSYN and other antibacterial drugs, ZOSYN should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
1 INDICATIONS AND USAGE
ZOSYN is a combination product consisting of a penicillin-class antibacterial, piperacillin, and a ?-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.
1.1 Intra-abdominal Infections
Appendicitis (complicated by rupture or abscess) and peritonitis caused by ?-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.
1.2 Skin and Skin Structure Infections
Uncomplicated and complicated skin and skin structure infections, including cellulitis, cutaneous abscesses and ischemic/diabetic foot infections caused by ?-lactamase producing isolates of Staphylococcus aureus.
1.3 Female Pelvic Infections
Postpartum endometritis or pelvic inflammatory disease caused by ?-lactamase producing isolates of Escherichia coli.
1.4 Community-acquired Pneumonia
Community-acquired pneumonia (moderate severity only) caused by ?-lactamase producing isolates of Haemophilus influenzae.
1.5 Nosocomial Pneumonia
Nosocomial pneumonia (moderate to severe) caused by ?-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. aeruginosashould be treated in combination with an aminoglycoside) [see Dosage and Administration (2) ].
1.6 Usage
To reduce the development of drug-resistant bacteria and maintain the effectiveness of ZOSYN and other antibacterial drugs, ZOSYN should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
2 DOSAGE AND ADMINISTRATION
ZOSYN should be administered by intravenous infusion over 30 minutes.
2.1 Adult Patients
The usual total daily dose of ZOSYN for adults is 3.375 g every six hours totaling 13.5 g (12.0 g piperacillin/1.5 g tazobactam). The usual duration of ZOSYN treatment is from 7 to 10 days.
ZOSYN should be administered by intravenous infusion over 30 minutes.
2.2 Nosocomial Pneumonia
Initial presumptive treatment of patients with nosocomial pneumonia should start with ZOSYN at a dosage of 4.5 g every six hours plus an aminoglycoside, totaling 18.0 g (16.0 g piperacillin/2.0 g tazobactam). The recommended duration of ZOSYN treatment for nosocomial pneumonia is 7 to 14 days. Treatment with the aminoglycoside should be continued in patients from whom P. aeruginosa is isolated.
