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U.S. Department of Health and Human Services

Safety

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Vaseretic (enalapril maleate/hydrochlorothiazide) Tablets

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – February 2012

 

Summary View

 

BOXED WARNING

WARNING: FETAL TOXICITY
  • When pregnancy is detected, discontinue Vaseretic 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 Vaseretic as soon as possible. These adverse outcomes are usually associated with use of these drugs in the second and third trimester of pregnancy…

 

PRECAUTIONS

Drug Interactions:

Non-Steroidal Anti-Inflammatory Agents including Selective Cyclooxygenase – 2 Inhibitors (COX-2 Inhibitors):

 

  • In patients who are elderly, volume-depleted (including those on diuretic therapy), or with compromised renal function, co-administration of NSAIDs, including selective COX-2 inhibitors, with ACE inhibitors, including enalapril, may result in deterioration of renal function, including possible acute renal failure…Monitor renal function periodically in patients receiving enalapril and NSAID therapy…reports suggest that NSAIDs may diminish the antihypertensive effect of ACE inhibitors.

 

Information for patients:  

Pregnancy:

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

 

Pediatric Use

Neonates with a history of in utero exposure to Vaseretic:

  • 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…