Antifungal
PREGNANCY RECOMMENDATION: No Human Data—Probably Compatible
BREASTFEEDING RECOMMENDATION: No Human Data—Probably Compatible
PREGNANCY SUMMARY
No reports describing the use of sertaconazole in human pregnancy have been located. The lack of animal developmental toxicity and the failure to detect the drug in the plasma after multiple applications to diseased skin suggest that risk to the human embryo–fetus is negligible. If indicated, the topical antifungal appears to be compatible with pregnancy.
FETAL RISK SUMMARY
Sertaconazole is available as a topical cream. It is in the same antifungal class of imidazole derivatives as butoconazole, clotrimazole, econazole, ketoconazole, miconazole, oxiconazole, sulconazole, and tioconazole. Sertaconazole is indicated for the treatment of interdigital tinea pedis caused by Trichophyton rubrum, T. mentagrophytes, and Epidermophyton floccosum in immunocompetent patients. Systemic absorption of sertaconazole from diseased skin after multiple applications is negligible as plasma concentrations were below the level of detection (2.5 ng/mL) (1).
Reproduction studies have been conducted with sertaconazole in rats and rabbits. No evidence of maternal toxicity, embryo toxicity, or teratogenesis was observed in pregnant rats and rabbits given oral doses 40 and 80 times, respectively, the maximum recommended human dose based on BSA (MRHD). In a peri-postnatal study in rats, doses 20–40 times the MRHD caused a decrease in live birth indices and an increase in the number of stillborn pups. The antifungal agent had no effect on fertility in male and female rats at doses 16 times the MRHD. Although long-term studies for carcinogenicity have not been conducted, tests for mutagenicity or clastogenicity were negative (1).
It is not known if sertaconazole crosses the human placenta. Since systemic absorption after topical application was not detected in one study, it appears that exposure of the embryo and/or fetus does not occur.
BREASTFEEDING SUMMARY
No reports describing the use sertaconazole during human lactation have been located. The drug does not produce detectable plasma concentrations after multiple applications to diseased skin. Therefore, the risk to a nursing infant can be considered negligible, and the antifungal agent is probably compatible with breastfeeding.
Reference
1.Product information. Ertaczo. OrthoNeutrogena Division of Ortho-McNeil Pharmaceuticals, 2006.