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Label Changes for:

Zestoretic (lisinopril/hydrochlorothiazide) Tablets

August 2015

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)

Increased risk for angiodema.

Including

  • Lotensin HCT (benazepril hydrochloride/hydrochlorothiazide) Tablets
  • Prestalia (perindopril arginine/amlodipine besylate) Tablets
  • Prinivil (lisinopril) Tablets
  • Vaseretic (enalapril maleate/hydrochlorothiazide) Tablets
  • Vasotec (enalapril maleate) Tablets
  • Zestoretic (lisinopril/hydrochlorothiazide) Tablets
  • Zestril (lisinopril) Tablets

August 2015

WARNINGS and PRECAUTIONS

Angioedema and Anaphylactoid Reactions
  • ‚ĶPatients receiving coadministration of ACE inhibitor and mTOR (mammalian target of rapamycin) inhibitor (e.g., temsirolimus, sirolimus, everolimus) therapy may be at increased risk for angioedema

ADVERSE REACTIONS

Drug Interactions

Mammalian Target of Rapamycin (mTOR) Inhibitors

  • Patients taking concomitant mTOR inhibitor (e.g., temsirolimus, sirolimus, everolimus) therapy may be at increased risk for angioedema
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