Antifungal
PREGNANCY RECOMMENDATION: No Human Data—Probably Compatible
BREASTFEEDING RECOMMENDATION: No Human Data—Probably Compatible
PREGNANCY SUMMARY
No reports describing the use of oxiconazole in human pregnancy have been located. The drug is used topically and the systemic bioavailability is minimal. The animal reproduction data suggest that the risk to the embryo or fetus is low. Moreover, there is no evidence suggesting that similar topical imidazole derivative antifungal agents cause embryo–fetal harm, and there is no reason to believe that oxiconazole would be different.
FETAL RISK SUMMARY
Oxiconazole is available for topical use as a cream or lotion. It is in the same antifungal class of imidazole derivatives as butoconazole, clotrimazole, econazole, ketoconazole, miconazole, sertaconazole, sulconazole, and tioconazole. Oxiconazole is indicated for the treatment of tinea pedis, tinea cruris, and tinea corporis due to Trichophyton rubrum, T. mentagrophytes, or Epidermophyton floccosum. The cream also is indicated for the treatment of tinea (pityriasis) versicolor due to Malassezia furfur. Neither the cream nor the lotion should be applied intravaginally. Systemic absorption from the skin is low, with <0.3% of the applied dose recovered in the urine of healthy adults (1). Information regarding the metabolism, plasma protein binding, and elimination half-life has not been located.
Reproduction studies with orally administered oxiconazole have been conducted in pregnant mice, rats, and rabbits. No evidence of fetal harm was observed in these species at doses that were 27, 40, and 57 times, respectively, the human dose based on BSA (1).
Studies evaluating the carcinogenic potential of oxiconazole have not been conducted by the manufacturer. No evidence of mutagenicity was found in multiple assays. In female and male rats, oral doses that were 1 and 4 times, respectively, the human dose based on BSA did not impair fertility. At higher doses, there was a decrease in fertility parameters in both females and males, decreased number of sperm in vaginal smears, extended estrous cycle, and a decrease in mating frequency (1).
It is not known if oxiconazole crosses the human placenta. The molecular weight (about 492) is low enough for passage, but the minimal systemic bioavailability suggests that exposure of the embryo or fetus is clinically insignificant.
BREASTFEEDING SUMMARY
No reports describing the use of oxiconazole during human lactation have been located. The molecular weight (about 492) is low enough for excretion into breast milk, but the minimal systemic bioavailability suggests that exposure of the nursing infant would be clinically insignificant.
Reference
1.Product information. Oxistat. PharmaDerm, 2008.