Nitrostat Pregnancy Warnings
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 C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.
AU: Contraindicated
UK and US: Use is recommended only if clearly needed and the benefit outweighs the risk.
AU TGA pregnancy category: B2
US FDA pregnancy category: C
US FDA pregnancy category: Not assigned (sublingual tablets; sublingual spray)
Risk Summary (sublingual tablets): Insufficient data exist to determine a drug associated risk of major birth defects or miscarriage.
See references
Nitrostat Breastfeeding Warnings
AU: Contraindicated
UK: A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.
US: Benefit should outweigh risk.
Excreted into human milk: Unknown
Excreted into animal milk: Data not available
Topical use for anal fissures by nursing mothers appears to have no adverse effects on their breastfed infants. This drug has been used topically on the nipples for Raynaud phenomenon of the nipples, but only after discontinuation of breastfeeding.
See references
