Label Changes for:

Zosyn (piperacillin and tazobactam for injection, USP)Zosyn (piperacillin and tazobactam injection) in Galaxy Containers (PL 2040 Plastic)

September 2013

Changes have been made to the WARNINGS, PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)

 

September 2013

5 WARNINGS AND PRECAUTIONS

5.2 Serious Skin Reactions
  • Serious skin reactions, such as Stevens-Johnson syndrome and toxic epidermal  necrolysis, have been reported in patients receiving ZOSYN. If patients develop a skin rash they should be monitored closely and ZOSYN discontinued if lesions progress.

6 ADVERSE REACTIONS

6.2 Post-Marketing Experience
  • Skin and Appendages— added ..... Stevens-Johnson syndrome, toxic epidermal necrolysis
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