Amlodipine / benazepril Pregnancy and Breastfeeding Warnings
Amlodipine / benazepril is also known as: Amlobenz, Lotrel
Amlodipine / benazepril Pregnancy Warnings
Drugs that act directly on the renin-angiotensin system can cause fetal and neonatal morbidity and death when administered during pregnancy. Several dozen cases have been reported in the world literature. When pregnancy is detected, amlodipine-benazepril should be discontinued as soon as possible and monitoring of fetal development should be performed on a regular basis. Limited data have shown an association between major congenital malformations and the use of ACE inhibitors during the first trimester of pregnancy. The use of ACE inhibitors 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 renal function; oligohydramnios in this setting has been associated with 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 the ACE inhibitor exposure. 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, amlodipine-benazepril should be discontinued as soon as possible.
Amlodipine-benazepril has been assigned to pregnancy category D by the FDA. Animal and human data have revealed evidence of embryolethality and teratogenicity associated with 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, amlodipine-benazepril should be discontinued as soon as possible. Amlodipine-benazepril is considered contraindicated during pregnancy.
Amlodipine / benazepril Breastfeeding Warnings
Minimal amounts of unchanged benazepril and of benazeprilat are excreted into human milk, so that a newborn child ingesting nothing but breast milk would receive less than 0.1% of the maternal doses of benazepril and benazeprilat. It is not known whether amlodipine is excreted in 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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