Alclometasone Dipropionate

Alclometasone dipropionate cream and ointment are low to medium potency corticosteroids indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Alclometasone dipropionate cream and ointment may be used in pediatric patients 1 year of age or older, although the safety and efficacy of drug use for longer than 3 weeks have not been established (see PRECAUTIONS: Pediatric Use ).

Since the safety and efficacy of alclometasone dipropionate cream and ointment have not been established in pediatric patients below 1 year of age, their use in this age-group is not recommended.

Alclometasone dipropionate cream and ointment are contraindicated in those patients with a history of hypersensitivity to any of the components in these preparations.

Pregnancy Teratogenic Effects 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. There are no adequate and well-controlled studies in pregnant women. Alclometasone dipropionate cream or ointment should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

The following local adverse reactions have been reported with alclometasone dipropionate cream in approximately 2% of patients: itching and burning, erythema, dryness, irritation, and papular rashes. The following local adverse reactions have been reported with alclometasone dipropionate ointment in approximately 1% of patients: itching, burning, and erythema. The following additional local adverse reactions have been reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings.

These reactions are listed in approximate decreasing order of occurrence: folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, skin atrophy, striae, and miliaria.