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U.S. Department of Health and Human Services

Safety

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Zestoretic (lisinopril and hydrochlorothiazide) and Zestril (lisinopril) tablets

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

 

August 2012

Summary View

 

PRECAUTIONS

Drug Interactions
  • Dual Blockade of the Renin-Angiotensin System (RAS) Dual blockade of the RAS with angiotensin receptor blockers, ACE inhibitors, or aliskiren is associated with increased risks of hypotension, hyperkalemia, and changes in renal function (including acute renal failure) compared to monotherapy. Closely monitor blood pressure, renal function and electrolytes in patients on Zestril and other agents that affect the RAS.
  • Do not co-administer aliskiren with Zestril in patients with diabetes. Avoid use of aliskiren with Zestril in patients with renal impairment (GFR <60 ml/min). 

 

May 2012

Summary View

6 ADVERSE REACTIONS 

  • added ... psoriasis

 

March 2012

Summary View

BOXED WARNING

WARNING: FETAL TOXICITY

  • When pregnancy is detected, discontinue Zestoretic as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus.

WARNINGS

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. Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death. When pregnancy is detected, discontinue Zestoretic as soon as possible. These adverse outcomes are usually associated with use of these drugs in the second and third trimester of pregnancy…

PRECAUTIONS

Information for patients:

Pregnancy:

  • Female patients of childbearing age should be told about the consequences of exposure to Zestoretic during pregnancy. Discuss treatment options with women planning to become pregnant.
Pediatric Use

Neonates with a history of in utero exposure to Zestoretic:

  • If oliguria or hypotension occurs, direct attention toward support of blood pressure and renal perfusion. Exchange transfusions or dialysis may be required as a means of reversing hypotension and/or substituting for disordered renal function…
     

November 2009 

Summary View

 

ADVERSE REACTIONS

Endocrine
  • inappropriate antidiuretic hormone secretion
Special Senses
  • olfactory disturbance

 

 

 

May 2012