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ZOSYN® (piperacillin, tazobactam) Highlights

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use ZOSYN safely and effectively. See full prescribing information for ZOSYN.

ZOSYN® (piperacillin and tazobactam) for injection, for intravenous use
ZOSYN® (piperacillin and tazobactam) 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) 4/2020

INDICATIONS AND USAGE

ZOSYN 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 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. (1.6)

DOSAGE AND ADMINISTRATION

  • Adult Patients With Indications Other Than Nosocomial Pneumonia; The usual daily dosage of ZOSYN for adults is 3.375 g every six hours totaling 13.5 g (12.0 g piperacillin/1.5 g tazobactam). (2.1)
  • Adult Patients with 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). (2.2)
  • Adult Patients with Renal Impairment: Dosage in patients with renal impairment (creatinine clearance ≤40 mL/min) and dialysis patients should be reduced, based on the degree of renal impairment. (2.3)
  • Pediatric Patients by Indication and Age: See Table below (2.4)
Recommended Dosage of Zosyn 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/10 mg tazobactam) every 8 (eight) hours 90 mg/kg (80 mg piperacillin/10 mg tazobactam) every 6 (six) hours
Older than 9 months 112.5 mg/kg (100 mg piperacillin/12.5 mg tazobactam) every 8 (eight) hours 112.5 mg/kg (100 mg piperacillin/12.5 mg tazobactam) every 6 (six) hours
  • Administer ZOSYN by intravenous infusion over 30 minutes to both adult and pediatric patients (2.1, 2.2, 2.3, 2.4).
  • ZOSYN and aminoglycosides should be reconstituted, diluted, and administered separately. Co-administration via Y-site can be done under certain conditions. (2.7)
  • See the full prescribing information for the preparation and administration instructions for ZOSYN single-dose vials, pharmacy bulk vials and GALAXY containers.

DOSAGE FORMS AND STRENGTHS

  • ZOSYN® for Injection: 2.25 g, 3.375 g, and 4.5 g lyophilized powder for reconstitution in single-dose vials and 40.5 g lyophilized powder for reconstitution in pharmacy bulk vials. (3)
  • ZOSYN® Injection: 2.25 g in 50 mL, 3.375 g in 50 mL, and 4.5 g in 100 mL frozen solution in single-dose GALAXY Containers. (3, 16)

CONTRAINDICATIONS

Patients with a history of allergic reactions to any of the penicillins, cephalosporins, or beta-lactamase inhibitors. (4)

WARNINGS AND PRECAUTIONS

  • Serious hypersensitivity reactions (anaphylactic/anaphylactoid) reactions have been reported in patients receiving ZOSYN. Discontinue ZOSYN if a reaction occurs. (5.1)
  • ZOSYN may cause severe cutaneous adverse reactions, such as Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms, and acute generalized exanthematous pustulosis. Discontinue ZOSYN for progressive rashes. (5.2)
  • Hematological effects (including bleeding, leukopenia and neutropenia) have occurred. Monitor hematologic tests during prolonged therapy. (5.3)
  • As with other penicillins, ZOSYN may cause neuromuscular excitability or seizures. Patients receiving higher doses, especially in the presence of renal impairment may be at greater risk. Closely monitor patients with renal impairment or seizure disorders for signs and symptoms of neuromuscular excitability or seizures. (5.4)
  • Nephrotoxicity in critically ill patients has been observed; the use of ZOSYN was found to be an independent risk factor for renal failure and was associated with delayed recovery of renal function as compared to other beta-lactam antibacterial drugs in a randomized, multicenter, controlled trial in critically ill patients. Based on this study, alternative treatment options should be considered in the critically ill population. If alternative treatment options are inadequate or unavailable, monitor renal function during treatment with ZOSYN. (5.5)
  • Clostridioides difficile-associated diarrhea: evaluate patients if diarrhea occurs. (5.7)

ADVERSE REACTIONS

The most common adverse reactions (incidence >5%) are diarrhea, constipation, nausea, headache, and insomnia. (6.1)


To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

  • ZOSYN administration can significantly reduce tobramycin concentrations in hemodialysis patients. Monitor tobramycin concentrations in these patients. (7.1)
  • Probenecid prolongs the half-lives of piperacillin and tazobactam and should not be co-administered with ZOSYN unless the benefit outweighs the risk. (7.2)
  • Co-administration of ZOSYN with vancomycin may increase the incidence of acute kidney injury. Monitor kidney function in patients receiving ZOSYN and vancomycin. (7.3)
  • Monitor coagulation parameters in patients receiving ZOSYN and heparin or oral anticoagulants. (7.4)
  • ZOSYN may prolong the neuromuscular blockade of vecuronium and other non-depolarizing muscle relaxants. Monitor for adverse reactions related to neuromuscular blockade. (7.5)

USE IN SPECIFIC POPULATIONS

Dosage in patients with renal impairment (creatinine clearance ≤40 mL/min) should be reduced based on the degree of renal impairment. (2.3, 8.6)

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 7/2020

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