Pimecrolimus 1% cream is used topically as second-line therapy for short-term treatment and noncontinuous chronic treatment of mild to moderate atopic dermatitis (eczema) in immunocompetent adults and children 2 years of age and older who are unable to tolerate or have not responded to first-line therapies (e.g., corticosteroids) or in whom first-line therapies are inadvisable because of potential risks. Because of the potential for increased risk of malignancies, pimecrolimus 1% cream should be used only as a second-line agent for short-term and intermittent treatment. (See Carcinogenicity under Warnings/Precautions: Warnings, in Cautions.)
Pimecrolimus topical cream is not indicated for use in children younger than 2 years of age. (See Pediatric Use under Warnings/Precautions: Specific Populations, in Cautions.)
Efficacy of pimecrolimus 1% cream in the treatment of atopic dermatitis was established principally in 2 randomized, double-blind, vehicle-controlled, multicenter clinical studies of 6 weeks' duration in children 2-17 years of age. In these clinical studies, topical application of pimecrolimus 1% cream to atopic dermatitis lesions involving approximately 5-96% of the body surface area twice daily for up to 6 weeks produced substantial clinical improvement, decreased the percentage of body surface area affected, and alleviated the signs and symptoms of the disease (e.g., pruritus). Such treatment effects usually were evident within 15 days, with signs and symptoms of the disease such as erythema and infiltration or papulation generally reduced within 8 days of initiating pimecrolimus therapy.