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Enalapril / hydrochlorothiazide Pregnancy and Breastfeeding Warnings

Enalapril / hydrochlorothiazide is also known as: Vaseretic, Vaseretic 10-25, Vaseretic 5-12.5

Enalapril / hydrochlorothiazide Pregnancy Warnings

Drugs that act directly on the renin-angiotensin system can cause fetal and neonatal morbidity and death when administered during pregnancy. A committee of the National Institutes of Health has recommended that these drugs be avoided during pregnancy. Limited data have shown an association between major congenital malformations and the use of ACE inhibitors during the first trimester. In addition, 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-hydrochlorothiazide should be discontinued as soon as possible. A 30-year-old woman G3P2 with hypertension received enalapril and furosemide throughout gestation. At 20 weeks' gestation, oligohydramnios, multicystic fetal kidneys, and a small fetal thorax were detected. At 37 weeks' gestation, when the mother developed proteinuria and dyspnea at rest, uncomplicated labor was induced with prostaglandins. She delivered a live 2.8 kg male who died at 10 minutes of life due to respiratory failure. A limited autopsy revealed low set ears, small epicanthic folds, bilateral talipes, a markedly bell-shaped thorax, severe renal cystic dysplasia, and a normal karyotype. The Collaborative Perinatal Project monitored 50,282 mother-child pairs, of whom 233 were exposed to thiazide or related diuretics during the first trimester. An increased risk of malformations was found for thiazide diuretics. Use of thiazides after the first trimester does not seem to carry this risk. Thiazide diuretics may, however pose metabolic risks to the mother and fetus (hyponatremia, hypokalemia, thrombocytopenia, hyperglycemia), and may have a direct effect on smooth muscle, resulting in inhibition of labor. Case reports of neonatal thrombocytopenia associated with antepartum administration of thiazide diuretics are reported.

Enalapril-hydrochlorothiazide has been assigned to pregnancy category D by the FDA for use during the second and third trimesters and to category C during the first trimester. Animal and human data have revealed evidence of embryolethality and teratogenicity associated with ACE inhibitors. Retrospective reviews have shown an increased risk of malformations associated with thiazide-type diuretics. There are no controlled data in human pregnancy. Congenital malformations have been reported with the use of ACE inhibitors during the first trimester of pregnancy, while fetal and neonatal toxicity, death, and congenital anomalies have been reported with the use of ACE inhibitors during the second and third trimesters of pregnancy. If the patient becomes pregnant, enalapril-hydrochlorothiazide should be discontinued as soon as possible. Enalapril-hydrochlorothiazide is considered contraindicated during pregnancy.

Enalapril / hydrochlorothiazide Breastfeeding Warnings

A case report in which a mother taking hydrochlorothiazide (HCTZ) 50 mg daily resulted in a peak milk concentration of 125 ng per mL between 4 and 12 hours after her daily dose. A simultaneously measured maternal serum HCTZ level was approximately 275 ng per mL. There were no detectable drug levels or electrolyte abnormalities in the baby's blood. The authors calculated that, if a 1-month-old infant takes approximately 600 mL of milk per day, and the average milk HCTZ level is approximately 80 ng per mL, the infant would be exposed to approximately 0.05 mg HCTZ daily. This usually represents an insignificant amount of HCTZ to the infant such that adverse effects in the nursing infant are unlikely.

Enalapril, enalaprilat, and hydrochlorothiazide are excreted into human milk. The manufacturer recommends that due to the potential for serious adverse reactions in nursing infants, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

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