Piperacillin - Warnings and Precautions

5 WARNINGS AND PRECAUTIONS Serious hypersensitivity reactions (anaphylactic/anaphylactoid) reactions have been reported in patients receiving piperacillin and tazobactam for injection.

Discontinue piperacillin and tazobactam for injection if a reaction occurs.

Piperacillin and tazobactam for injection 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 piperacillin and tazobactam for injection for progressive rashes.

Hemophagocytic lymphohistiocytosis (HLH) has been reported with the use of piperacillin and tazobactam for injection.

If HLH is suspected, discontinue piperacillin and tazobactam for injection immediately.

Rhabdomyolysis: If signs or symptoms of rhabdomyolysis are observed, discontinue Piperacillin and tazobactam for injection and initiate appropriate therapy.

Hematological effects (including bleeding, leukopenia and neutropenia) have occurred.

Monitor hematologic tests during prolonged therapy.

As with other penicillins, piperacillin and tazobactam for injection 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.

Nephrotoxicity in critically ill patients has been observed; the use of piperacillin and tazobactam for injection 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 piperacillin and tazobactam for injection Clostridioides difficile- associated diarrhea: evaluate patients if diarrhea occurs.

5.1 Hypersensitivity Adverse Reactions Serious and occasionally fatal hypersensitivity (anaphylactic/anaphylactoid) reactions (including shock) have been reported in patients receiving therapy with piperacillin and tazobactam for injection.

These reactions are more likely to occur in individuals with a history of penicillin, cephalosporin, or carbapenem hypersensitivity or a history of sensitivity to multiple allergens.

Before initiating therapy with piperacillin and tazobactam for injection, careful inquiry should be made concerning previous hypersensitivity reactions.

If an allergic reaction occurs, piperacillin and tazobactam for injection should be discontinued and appropriate therapy instituted.

5.2 Severe Cutaneous Adverse Reactions Piperacillin and tazobactam for injection 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.

If patients develop a skin rash they should be monitored closely and piperacillin and tazobactam for injection discontinued if lesions progress.

5.3 Hemophagocytic Lymphohistiocytosis Cases of hemophagocytic lymphohistiocytosis (HLH) have been reported in pediatric and adult patients treated with piperacillin and tazobactam for injection.

Signs and symptoms of HLH may include fever, rash, lymphadenopathy, hepatosplenomegaly and cytopenia.

If HLH is suspected, discontinue piperacillin and tazobactam for injection immediately and institute appropriate management.

5.4 Rhabdomyolysis Rhabdomyolysis has been reported with the use of Piperacillin and tazobactam for injection [see Adverse Reactions ] .