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Benazepril Pregnancy and Breastfeeding Warnings

Benazepril is also known as: Lotensin

Benazepril 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. The use of drugs that act directly on the renin-angiotensin system during the second and third trimesters of pregnancy have 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 renal function; oligohydramnios in this setting has been associated with decreased fetal limb contractures, craniofacial deformation, and hypoplastic lung development. Exposure to ACE inhibitors during the first trimester of pregnancy has been associated with prematurity, intrauterine growth retardation, patent ductus arteriosus, other structural cardiac malformations, and neurological malformations. Mothers whose embryos and fetuses are exposed to an ACE inhibitor should be informed of the risks. When pregnancy is detected or expected, benazepril should be discontinued as soon as possible.

Benazepril has been assigned to pregnancy category D by the FDA. Animal and human data have revealed evidence of embryolethality and teratogenicity associated with angiotensin converting enzyme (ACE) inhibitors. 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, benazepril should be discontinued as soon as possible. Benazepril is considered contraindicated during pregnancy.

Benazepril Breastfeeding Warnings

A breast-fed baby may receive 0.04% and 0.10% of the weight-adjusted maternal benazepril dose as benazepril and benazeprilat, respectively. Use of benazepril during breast-feeding should be used cautiously, taking into account the need of benazepril therapy to the nursing mother.

Benazepril is excreted in small amounts into human milk. There are no reports of adverse effects in the nursing infant. 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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