Trandolapril Pregnancy and Breast Feeding Warnings
Trandolapril is also known as: Mavik
Overview
Do not take Trandolapril after the third month of pregnancy. It may cause injury or death to the fetus. If you become pregnant, contact your doctor right away. Trandolapril is found in breast milk. Do not breast-feed while taking Trandolapril .
Trandolapril Pregnancy Warnings
Trandolapril 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. 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, trandolapril should be discontinued as soon as possible. Trandolapril is considered contraindicated during pregnancy.
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, trandolapril should be discontinued as soon as possible.
Trandolapril Lactation Warnings
There are no data on the excretion of trandolapril into human milk. Radiolabeled trandolapril or its metabolites are secreted in rat milk. The manufacturer recommends that trandolapril should not be administered to nursing mothers.
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