Teratogenicity studies in mice using the subcutaneous route resulted in fetotoxicity at the highest dose tested (1 mg/kg) and teratogenicity at all dose levels tested down to mg/kg. These doses are approximately and times, respectively, the human topical dose of clobetasol propionate cream and ointment. Abnormalities seen included cleft palate and skeletal abnormalities. In rabbits, clobetasol propionate was teratogenic at doses of 3 and 10 mcg/kg. These doses are approximately and times, respectively, the human topical dose of clobetasol propionate cream and ointment. Abnormalities seen included cleft palate, cranioschisis, and other skeletal abnormalities.
There are no available data on the presence of fluticasone propionate in human milk, the effects on the breastfed child, or the effects on milk production. Other corticosteroids have been detected in human milk. However, fluticasone propionate concentrations in plasma after inhaled therapeutic doses are low and therefore concentrations in human breast milk are likely to be correspondingly low [see Clinical Pharmacology ()] . The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for FLOVENT DISKUS and any potential adverse effects on the breastfed child from FLOVENT DISKUS or from the underlying maternal condition.
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