Enalapril Pregnancy and Breastfeeding Warnings
Enalapril Pregnancy Warnings
Data have shown an association between major congenital malformations and the use of ACE inhibitors during the first trimester. The use of drugs that act directly on the renin-angiotensin system during the second and third trimesters of pregnancy has been associated with fetal and neonatal injury, including hypotension, neonatal skull hypoplasia, anuria, reversible or irreversible renal failure, and death. Oligohydramnios has also been reported, presumably resulting from decreased fetal limb contractures, craniofacial deformation, and hypoplastic lung development. Prematurity, intrauterine growth retardation, and patent ductus arteriosus have also been reported, although it is not clear whether these occurrences were due to exposure to the drug. Mothers whose embryos and fetuses are exposed to an ACE inhibitor during the first trimester should be informed of the risks. When pregnancy is detected or expected, enalapril should be discontinued as soon as possible. AU TGA pregnancy category D: Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details. US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks. US FDA pregnancy category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
Use during pregnancy is considered contraindicated. (AU, UK) This drug is only recommended for use during pregnancy when there are no alternatives and the benefit outweighs the risk. (US) AU TGA pregnancy category: D US FDA pregnancy category: -Injection solution: D (for use during the second and third trimesters) and C (during the first trimester) -Enalapril oral tablets and oral solution: D Comments: -Adequate methods of contraception should be encouraged. -Drugs that act directly on the renin-angiotensin system can cause fetal and neonatal morbidity and death when administered during pregnancy. -If pregnancy is detected, enalapril should be discontinued as soon as possible.
Enalapril Breastfeeding Warnings
-A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother. (AU, US) -According to the manufacturer, use during lactation is not recommended when the infant is preterm or in the first few weeks after delivery. Use of by mothers of older infants can be considered if the treatment is necessary for the mother and the infant is monitored for any adverse effects. (UK) Excreted into human milk: Yes
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