This drug should be used during pregnancy only if clearly needed and the benefit outweighs the risk.

AU TGA pregnancy category: B1
US FDA pregnancy category: Not assigned.

Risk summary: Insufficient data available on use of this drug in pregnant women to inform a drug-related risk.

Comments: Systemic absorption through intact human skin is minimal.

Animal studies have failed to reveal evidence of fetal harm when this drug is administered topically. There are no controlled data in human pregnancy.

AU TGA pregnancy category B1: 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 malformations or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have not shown evidence of an increased occurrence of fetal damage.

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.

See references

Caution is recommended.

Excreted into human milk: Unknown
Excreted into animal milk: Unknown

Comments:
-If used to treat a cracked nipple, the area should be washed thoroughly before breastfeeding.
-Ointments should not be applied to the breast prior to breastfeeding; water-miscible cream or gel products should be used if necessary.
-Developmental and health benefits of breastfeeding should be considered as well as the mother's clinical need for this drug.
-Potential side effects in the breastfed child due to the drug or the mother's underlying condition should be considered.

Risk to the nursing infant considered low as less than 1% is absorbed after topical application.

See references