Onabet Use In Pregnancy & Lactation

Pregnancy: Pregnancy Category C.
There are no adequate and well-controlled studies conducted with Sertaconazole nitrate cream in pregnant women. Sertaconazole nitrate cream should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Reproduction studies have not been performed with Sertaconazole nitrate cream. Sertaconazole nitrate did not produce any evidence of maternal toxicity, embryotoxicity or teratogenicity in rats and rabbits at an oral dose of 160 mg/kg/day (40 times (rats) and 80 times (rabbits) the maximum recommended human dose based on a body surface area comparison). A reduction in live birth indices and an increase in the number of still-born pups were seen at doses of 80 and 160 mg/kg/day sertaconazole nitrate in an oral peri- and post-natal development study in rats.
Nursing Mothers: It is not known if sertaconazole is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when prescribing Sertaconazole nitrate cream, 2%, to a nursing woman.