Fluticasone Propionate

Fluticasone Propionate Cream, 0.05% is a medium potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Fluticasone Propionate Cream, 0.05% may be used with caution in pediatric patients 3 months of age or older. The safety and efficacy of drug use for longer than 4 weeks in this population have not been established. The safety and efficacy of Fluticasone Propionate Cream, 0.05% in pediatric patients below 3 months of age have not been established.

Fluticasone Propionate Cream, 0.05% is contraindicated in those patients with a history of hypersensitivity to any of the components in the preparation.

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. Teratology studies in the mouse demonstrated fluticasone propionate to be teratogenic (cleft palate) when administered subcutaneously in doses of 45 mcg/kg per day and 150 mcg/kg per day.

This dose is approximately 14 and 45 times, respectively, the human topical dose of fluticasone propionate cream, 0.05%. There are no adequate and well-controlled studies in pregnant women. Fluticasone Propionate Cream, 0.05% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

In controlled clinical trials of twice daily administration, the total incidence of adverse reactions associated with the use of Fluticasone Propionate Cream, 0.05% was approximately 4%. These adverse reactions were usually mild, self-limiting; and consisted primarily of pruritus, dryness, numbness of fingers, and burning. These events occurred in 2.9%, 1.2%, 1.0%, and 0.6% of patients, respectively. Two clinical studies compared once to twice-daily administration of Fluticasone Propionate Cream, 0.05% for the treatment of moderate to severe eczema.