Topicort

Clinical summary

Indications and usage INDICATIONS AND USAGE Topicort ® (desoximetasone ointment USP) 0.05% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Dosage and administration DOSAGE AND ADMINISTRATION Apply a thin film of Topicort ® (desoximetasone ointment USP) 0.05% to the affected skin areas twice daily. Rub in gently. Warnings and cautions WARNINGS Keep out of reach of children. Pregnancy Pregnancy Teratogenic Effects Pregnancy Category C 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 in laboratory animals. Desoximetasone has been shown to be teratogenic and embryotoxic in mice, rats, and rabbits when given by subcutaneous or dermal routes of administration in doses 15 to 150 times the human dose of Topicort ® (desoximetasone ointment USP) 0.05%. There are no adequate and well-controlled studies in pregnant women on teratogenic effects from topically applied corticosteroids. Therefore, Topicort ® (desoximetasone ointment USP) 0.05% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Drugs of this class should not be used extensively on pregnant patients, in large amounts, or for prolonged periods of time.