Piperacillin and Tazobactam

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. • Nosocomial pneumonia in adult and pediatric patients 2 months of age and older. • Skin and skin structure infections in adults. • Female pelvic infections in adults. • Community-acquired pneumonia in adults. 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.

ZOSYN is an antibacterial drug.

• If a dose of ZOSYN is required that does not equal 2.25 g, 3.375 g, or 4.5 g, ZOSYN injection in GALAXY Containers is not recommended for use and an alternative formulation of ZOSYN should be considered. • 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 g piperacillin and 1.5 g tazobactam). • 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 g (16 g piperacillin and 2 g tazobactam). • Adult Patients with Renal Impairment: Dosage in patients with renal impairment (creatinine clearance less than or equal to 40 mL/min) and dialysis patients should be reduced, based on the degree of renal impairment.

ZOSYN is contraindicated in patients with a history of allergic reactions to any of the penicillins, cephalosporins, or beta-lactamase inhibitors. Patients with a history of allergic reactions to any of the penicillins, cephalosporins, or beta-lactamase inhibitors.

• Serious hypersensitivity reactions (anaphylactic/anaphylactoid) reactions have been reported in patients receiving ZOSYN. Discontinue ZOSYN if a reaction occurs. • 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. • Hemophagocytic lymphohistiocytosis (HLH) has been reported with the use of ZOSYN. If HLH is suspected, discontinue ZOSYN immediately. • Rhabdomyolysis: If signs or symptoms of rhabdomyolysis are observed, discontinue ZOSYN and initiate appropriate therapy. • Hematological effects (including bleeding, leukopenia and neutropenia) have occurred. Monitor hematologic tests during prolonged therapy.

The following clinically significant adverse reactions are described elsewhere in the labeling: • Hypersensitivity Adverse Reactions • Severe Cutaneous Adverse Reactions • Hemophagocytic Lymphohistiocytosis • Rhabdomyolysis • Hematologic Adverse Reactions • Central Nervous System Adverse Reactions • Nephrotoxicity in Critically Ill Patients • Clostridioides difficile- Associated Diarrhea The most common adverse reactions (incidence >5%) are diarrhea, constipation, nausea, headache, and insomnia.

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

Supplied 12/box—NDC 0338-9638-12 ZOSYN Injection in GALAXY Containers should be stored at or below -20°C (-4°F).