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Label Changes for:

Zestril (lisinopril) Tablets

September 2015

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

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

September 2015

WARNINGS AND PRECAUTIONS

Angioedema and Anaphylactoid Reactions
  • …Patients 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

DRUG INTERACTIONS

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

 

December 2014

*The following was added:

DRUG INTERACTIONS

  • Dual blockade…RAS…  The VA NEPHRON trial enrolled 1448 patients with type 2 diabetes, elevated urinaryalbumin-to-creatinine ratio, and decreased estimated glomerular filtration rate (GFR 30 to 89.9 ml/min), randomized them to lisinopril or placebo on a background of losartan therapy and followed them for a median of 2.2 years. Patients receiving the combination of losartan and lisinopril did not obtain any additional benefit compared to monotherapy for the combined endpoint of decline in GFR, end state renal disease, or death, but experienced an increased incidence of hyperkalemia and acute kidney injury compared with the monotherapy group…

 

June 2014

Content, Editorial and organizational changes were made throughout the label to comply with structured product labeling (SPL) formatIncluding content to the following safety sections

WARNINGS AND PRECAUTIONS
--Fetal Toxicity
Pregnancy Category D
Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations.

ADVERSE REACTIONS...

DRUG INTERACTIONS...

 

November 2013

CONTRAINDICATIONS

  • Do not co-administer aliskiren with ZESTRIL in patients with diabetes

ADVERSE REACTIONS

Nervous System/Psychiatric
  • hallucinations

 

 

May 2009

 

ADVERSE REACTIONS

Nervous System/Psychiatric

  • …and mood alterations (including depressive symptoms)

 

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