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Generic Name
Enalapril maleate
Trade Name
Angiotec
Manufacturer
JPM
Risk Category
D*
  • Positive evidence of human fetal risk exists.
  • Potential benefits may warrant use of the drug in pregnant women despite potential risks (e.g. life threatening situations or serious illness).
The risk category is C in the first trimester.
FDA Pregnancy Risk Categories

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Indication
Indication
  • Angiotensin-1-converting enzyme inhibitor, antihypertensive.
  • Fetal Risk
    Fetal Risk
  • In animals it causes fetal growth retardation and incomplete bone ossification.
  • No adequate human data in first trimester but suggested possible association with cardiovascular defects and polydactyly.
  • Use in 2nd and 3rd trimester is teratogenic and toxic leading to: intrauterine growth retardation, oligohydramnios leading to skull deformities, lung hypoplasia, limb contractures, prematurity, fetal distress, neonatal anuria, renal failure requiring dialysis, neonatal hypotension, renal tubular dysplasia.
  • Breast Feeding
    Breast Feeding
  • Compatible with breast feeding as the amount excreted into milk is not significant.
  • Other Trade Names
     
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