Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels.
Some corticosteroids have been shown to be teratogenic after dermal application to laboratory animals.Clobetasol propionate has not been tested for teratogenicity when applied topically; however, it is absorbed percutaneously, and when administered subcutaneously, it was a significant teratogen in both the rabbit and the mouse.
Clobetasol propionate has greater teratogenic potential than steroids that are less potent.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 0.03 mg/kg.
These doses are approximately 1.4 and 0.04 times, respectively, the human topical dose of Olux-E Foam based on body surface area comparisons.
Abnormalities seen included cleft palate and skeletal abnormalities.In rabbits, clobetasol propionate was teratogenic at doses of 0.003 and 0.01 mg/kg.
These doses are approximately 0.02 and 0.05 times, respectively, the human topical dose of Olux-E Foam based on body surface area comparisons.
Abnormalities seen included cleft palate, cranioschisis, and other skeletal abnormalities.There are no adequate and well-controlled studies of the teratogenic potential of clobetasol propionate in pregnant women.Olux-E Foam should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Olux-E Foam is indicated for the treatment of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 12 years of age or older (see PRECAUTIONS).Treatment should be limited to 2 consecutive weeks and patients should not use greater than 50 grams per week (see DOSAGE AND ADMINISTRATION).Patients should be instructed to use Olux-E Foam for the minimum amount of time necessary to achieve the desired results (see PRECAUTIONS).Use in pediatric patients under 12 years of age is not recommended because of numerically high rates of hypothalamic-pituitary-adrenal (HPA) axis suppression seen in patients under 12 years of age (see PRECAUTIONS: Pediatric Use).
The propellant in Olux-E Foam is flammable.Avoid fire, flame or smoking during and immediately following application.