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Isosorbide mononitrate Pregnancy and Breastfeeding Warnings

Isosorbide mononitrate is also known as: Imdur, Ismo, Monoket

Isosorbide mononitrate Pregnancy Warnings

Use is recommended only if clearly needed and the benefit outweighs the risk. AU TGA pregnancy category: B2 US FDA pregnancy category: B

Animal studies have failed to reveal evidence of teratogenicity. There are no controlled data in human pregnancy. AU TGA pregnancy category B2: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals are inadequate or may be lacking, but available data show no evidence of an increased occurrence of fetal damage. US FDA pregnancy category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.

Isosorbide mononitrate Breastfeeding Warnings

Use is not recommended. (AU) Caution is recommended and this drug should be used only if the benefits outweigh the risks. (UK, US) Excreted into human milk: Unknown Excreted into animal milk: Data not available Comment: The effects in the nursing infant are unknown.

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