Piperacillin And Tazobactam And Sodium Chloride Side Effects

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Hypersensitivity Adverse Reactions [see Warnings and Precautions (5.1) ] Severe Cutaneous Adverse Reactions [see Warnings and Precautions (5.2) ] Hemophagocytic Lymphohistiocytosis [see Warnings and Precautions (5.3) ] Rhabdomyolysis [see Warnings and Precautions (5.4) ] Hematologic Adverse Reactions [see Warnings and Precautions (5.5) ] Central Nervous System Adverse Reactions [see Warnings and Precautions (5.6) ] Nephrotoxicity in Critically Ill Patients [see Warnings and Precautions (5.7) ] High Sodium Load and Electrolyte Effects [see Warnings and Precautions (5.8) ] Clostridioides difficile -Associated Diarrhea [see Warnings and Precautions (5.9) ] The most common adverse reactions (incidence >5%) are diarrhea, constipation, nausea, headache, and insomnia.

( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact B.

Braun Medical Inc.

at 1-833-425-1464 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The safety of Piperacillin and Tazobactam for Injection and Sodium Chloride Injection has been established from adequate and well-controlled studies of piperacillin and tazobactam.

Below is a display of the adverse reactions of piperacillin and tazobactam in these adequate and well controlled studies.

Clinical Trials in Adult Patients During the initial clinical investigations, 2621 patients worldwide were treated with piperacillin and tazobactam in phase 3 trials.

In the key North American monotherapy clinical trials (n=830 patients), 90% of the adverse events reported were mild to moderate in severity and transient in nature.

However, in 3.2% of the patients treated worldwide, piperacillin and tazobactam was discontinued because of adverse events primarily involving the skin (1.3%), including rash and pruritus;