Safety

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

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

June 2016

Summary View

WARNINGS AND PRECAUTIONS

Severe Skin Reactions section renamed to Severe Cutaneous Adverse Reactions
Electrolyte Effects
  • Change ZOSYN contains a total of 2.79 mEq (64 mg) of Na+ per gram of piperacillin in the combination product to ZOSYN contains a total of 2.84 mEq (65 mg) of Na+ (sodium) per gram of piperacillin in the combination product.

DRUG INTERACTIONS

Vancomycin (new section added)
  • A limited number of retrospective studies have detected an increased incidence of acute kidney injury in patients concomitantly administered piperacillin/tazobactam and vancomycin as compared to vancomycin alone. Monitor kidney function in patients concomitantly administered with piperacillin/tazobactam and vancomycin.
  • No pharmacokinetic interactions have been noted between piperacillin/tazobactam and vancomycin.

USE IN SPECIFIC POPULATIONS

Geriatric Use
  • ZOSYN contains 65 mg (2.84 mEq) of sodium per gram of piperacillin in the combination product. At the usual recommended doses, patients would receive between 780 and 1040 mg/day (34.1 and 45.5 mEq) of sodium.

ADVERSE REACTIONS

  • Table 3: Adverse Reactions from ZOSYN Monotherapy Clinical Trials
System Organ Class
Skin and subcutaneous tissue disorders
  • add Purpura (≥1%)
Respiratory, thoracic and mediastinal disorders (new section)
  • Epistaxis (≥1%)
Table 4: Adverse Reactions from ZOSYN Plus Aminoglycoside Clinical Trials
System Organ Class
Psychiatric disorders (new section)
  • Insomnia (4.5%)
Post-Marketing Experience
Respiratory—eosinophilic pneumonia (addition of new subheading)
Skin and Appendages (addition to subsection):
  • dermatitis exfoliative

PATIENT COUNSELING INFORMATION

Serious Hypersensitivity Reactions (addition)
  • Advise patients, their families, or caregivers that serious hypersensitivity reactions, including serious allergic cutaneous reactions, could occur that require immediate treatment. Ask them about any previous hypersensitivity reactions to ZOSYN, other beta-lactams (including cephalosporins), or other allergens.

 

December 2015

Summary View

WARNINGS AND PRECAUTIONS

Skin Reactions
  • drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP)

ADVERSE REACTIONS

Post-Marketing Experience
  • drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP)

 

September 2013

Summary View

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

 

Page Last Updated: 07/07/2016
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