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Use in pregnancy: Ketoconazole crosses the placenta. Adequate and well-controlled studies in humans have not been done. Studies in rats, given oral doses of 80 mg/kg/day [10 times the maximum recommended human dose (MRHD)], have shown ketoconazole to be teratogenic, causing syndactyly and oligodactyly. However, these effects may be related to maternal toxicity, which was seen at this dose level.
Use in lactation: It is not known whether ketoconazole cream, applied topically on a regular basis, is absorbed systemically in sufficient amounts to be distributed into breast milk in detectable quantities. However, no systemic absorption was detected following a single application of ketoconazole cream to the chest, back and arms of healthy volunteers. Therefore, topical ketoconazole is unlikely to be distributed into breast milk in significant amounts or to cause adverse effects in the nursing infant.
