Antifungal
PREGNANCY RECOMMENDATION: No Human Data—Probably Compatible
BREASTFEEDING RECOMMENDATION: No Human Data—Probably Compatible
PREGNANCY SUMMARY
Although there is no published human pregnancy data, the low systemic bioavailability and the absence of developmental toxicity in four animal species suggest that the use of ciclopirox is low risk for the embryo–fetus.
FETAL RISK SUMMARY
Ciclopirox is a synthetic anti-infective agent used topically for its antifungal properties. Very small amounts (1.3% of the dose with occlusive dressings) are absorbed systemically from the skin (1).
There was no evidence of teratogenic effects or other fetal harm in animals (mice, rats, rabbits, and monkeys) given doses of 10 times or more the topical human dose by various routes of administration (1).
No reports of its use in human pregnancy have been located. The manufacturer has no reports of congenital abnormalities occurring after use of ciclopirox (C.K. Whitmore, personal communication, Hoechst-Roussel Pharmaceuticals, Inc., 1987).
BREASTFEEDING SUMMARY
No reports describing the use of ciclopirox during lactation have been located. The very small amounts (1.3%) absorbed systemically with occlusive dressings probably indicates that infant exposure via the milk is negligible, if it occurs at all.
Reference
1.Product information. Loprox. MEDICIS, The Dermatology Company, 2000.