Isosorbide dinitrate Pregnancy and Breastfeeding Warnings
Isosorbide dinitrate Pregnancy Warnings
Isosorbide dinitrate has been assigned to pregnancy category C by the FDA. Animal studies have revealed evidence of embryotoxicity at oral dosages 35 and 150 times the maximum recommended human daily dosage. There are no controlled data in human pregnancy. Isosorbide should only be given during pregnancy when there are no alternatives and benefit outweighs risk.
There are no reports on the use of isosorbide dinitrate during human pregnancy. There are, however, reports of malformations associated with some vasodilators such as nitroglycerin and amyl nitrate during the first trimester of human pregnancy. Data from the Michigan Medicaid Birth Defects Study has failed to reveal an association between the use of isosorbide and congenital abnormalities (written communication, Franz Rosa, MD, Food and Drug Administration, 1994). This was a retrospective study of 229,101 completed pregnancies between 1985 and 1992, of which 13 were exposed to isosorbide at some time during the first trimester, and 27 were exposed to the drug at any time during pregnancy. There were no observations of birth defects. Based on the small number of exposures, these data are inconclusive.
Isosorbide dinitrate Breastfeeding Warnings
There are no data on the excretion of isosorbide dinitrate into human milk. The manufacturer recommends caution when administering isosorbide dinitrate to nursing women.
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