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Generic Enalapril (10mg + 25)
ENALAPRIL
(Vasotec)
Enalapril is an angiotensin-converting enzyme (ACE) inhibitor that is administered orally in the treatment of hypertension. Enalapril is usually given orally in doses of 2.5-40 mg/d; the drug may also be given intravenously in a dose of 5 mg/d.
Teratogenic Risk
Magnitude of teratogenic risk to child born after exposure during gestation:
First-trimester use: Undetermined
Use later in pregnancy: Moderate
Quality and quantity of data on which risk estimate is based:
First-trimester use: Poor
Use later in pregnancy: Fair to good
A small risk cannot be excluded, but a high risk of congenital anomalies in the children of women treated with enalapril during pregnancy is unlikely.
There is a substantial risk of oligohydramnios and fetal distress or death in hypertensive women treated with enalapril in the latter part of pregnancy. The effect may be related to the pharmacological action of this drug on the fetus.
The risk associated with maternal use of enalapril during the second or third trimester of pregnancy increases with the duration of treatment.
One malformed infant was observed among 12 in one series of infants born to women treated with enalapril or another ACE inhibitor during the first trimester of pregnancy. This child, whose mother had been treated with enalapril, had an occipital encephalocele.
Two cases have been reported in which hypocalvaria, an unusual underdevelopment of the skull bones, and other skeletal anomalies occurred in the infants of women treated with enalapril throughout pregnancy. Five infants with similar unusual skull defects have been observed after maternal treatment throughout pregnancy with other ACE inhibitors.
Oligohydramnios, fetal growth retardation and neonatal renal failure, hypotension, pulmonary hypoplasia, joint contractures, and death have been repeatedly observed after maternal treatment with enalapril or related drugs during pregnancy. One infant among 15 born to women treated with enalapril or other ACE inhibitors during the second or third trimester of pregnancy in one series had oligohydramnios and neonatal hypotension and anuria. It is important to note that these effects do not appear to reflect abnormal embryogenesis but rather a pharmacologic response of the fetus to enalapril during the second half of gestation.
Multi-cystic, dysplastic kidneys were found in an infant born at 37 weeks after a pregnancy complicated by long-standing oligohydramnios and maternal enalapril treatment throughout pregnancy. No causal inference is possible on the basis of this single case report, but renal tubular dysplasia has been observed among other infants who died in the neonatal period with anuria after maternal treatment during pregnancy with enalapril or other ACE inhibitors.
The frequency of malformations was no greater than expected but fetal growth retardation was increased among the offspring of rats treated with 4-1500 times the usual human dose of enalapril during pregnancy. Incomplete skull ossification was also reported in two of these studies. Increased frequencies of fetal death but not of malformations were observed among the offspring of rabbits treated during pregnancy with 4- 40 times the human dose of enalapril.
Fetal death occurred only when the drug was administered during the last portion of pregnancy. Fetal hypotension has been demonstrated when pregnant sheep were given 2.5 times the human dose of enalapril.
Risk Related to Breast-feeding
Enalapril and its active metabolite, enalaprilat, are excreted in the breast milk in low concentrations. The amount of enalapril and enalaprilat that the nursing infant would be expected to receive is approximately 0-3% of the lowest pediatric dose of enalapril, based on data from six lactating women. Enalaprilat was not detected in the breast milk of three lactating women in another study.
CARDIO & BLOOD
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