Isosorbide mononitrate Pregnancy and Breastfeeding Warnings
Isosorbide mononitrate Pregnancy Warnings
Isosorbide mononitrate has been assigned to pregnancy category C by the FDA. Animal studies have associated its use with stillbirth, neonatal death, and decreases in live litter size and body weights after animals were administered doses 125 times the maximum recommended human daily dose (on a per kg basis). No such adverse effects were noted at half this dose, or 60 times that recommended for humans. There are no controlled data in human pregnancy. Isosorbide mononitrate is only recommended for use during pregnancy when benefit outweighs risk.
There are no reports on the use of isosorbide mononitrate 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 mononitrate Breastfeeding Warnings
There are no data on the excretion of isosorbide mononitrate into human milk. The manufacturer recommends that caution be used when administering isosorbide mononitrate to nursing women.
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