Use in pregnancy: Teratogenic Effects: Pregnancy Category C: Ketconazole is not detected in plasma after chronic shampooing. Ketconazole has been shown to be teratogenic (syndactylia and oligodactylia) in the rat when given orally in the diet at 80 mg/kg/day (10 times the maximum recommended human oral dose). However, these effects may be related to maternal toxicity, which was seen at this and higher dose levels.
There are no adequate and well-controlled studies in pregnant women. Ketoconazole should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Use in lactation: Ketoconazole is not detected in plasma after chronic shampooing. Nevertheless, caution should be exercised when Nitozol is administered to a nursing woman.