Animal studies have not been reported with this combination drug. Animal studies of corticosteroids have revealed evidence of teratogenicity; in laboratory animals, relatively low doses of systemically administered corticosteroids were generally teratogenic and more potent corticosteroids have been teratogenic after dermal application. There are no controlled data in human pregnancy.

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.

This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus; it should not be used extensively on pregnant patients, for extended periods of time, or in large amounts.

US FDA pregnancy category: C

See references

Caution is recommended.

Excreted into human milk: Unknown
Excreted into animal milk: Data not available

Comments:
-The infant's skin should not come into direct contact with skin that has been treated.
-Ointments should not be applied to the breast prior to breastfeeding; water miscible cream or gel products should be used if necessary.
-Nystatin topical: Since it is essentially unabsorbed orally, use (including topical application to the nipples) is considered acceptable by most experts; any excess cream should be removed from the nipples prior to breastfeeding.
-Triamcinolone topical: This drug has not been studied during breastfeeding; any topical corticosteroid should be thoroughly removed prior to breastfeeding if applied to the breast or nipple area.

Since only applying the most potent corticosteroids extensively may cause systemic effects in the mother, it is unlikely that short-term use of topical corticosteroids would harm a nursing infant via breast milk; however, to be cautious, the least potent drug should be used on the smallest area of skin possible. Only a lower potency corticosteroid should be applied to the nipple/areola where an infant could directly ingest the drug from the skin.

A corticosteroid with relatively high mineralocorticoid activity (isofluprednone acetate) was applied topically to a mother's nipples; she had used the cream since birth for painful nipples. Prolonged QT interval, cushingoid appearance, severe hypertension, decreased growth, and electrolyte abnormalities occurred in her 2-month-old breastfed infant.

See references