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Results described here may not be representative of entire patient population; individual results may vary
Long-term Safety of Topical Calcineurin Inhibitors Has Not Been Established.
Continuous long-term use of ELIDEL Cream in any age group should be avoided. Application should be limited to areas of involvement with atopic dermatitis.
* ELIDEL (pimecrolimus) Cream 1% is indicated as second-line therapy for the short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis in
non-immunocompromised people ages 2 and older who have failed to respond adequately to other topical prescription treatments, or when those treatments are not advisable. ELIDEL is not indicated for use in children under 2 years of age.
The most common adverse events seen in clinical studies included application-site burning, headache, pharyngitis, nasopharyngitis, cough, influenza, pyrexia, and viral infection.
In clinical studies, skin papilloma or warts were observed in 1% of ELIDEL patients.
Patients should minimize or avoid exposure to natural or artificial sunlight, even when ELIDEL is not on the skin. ELIDEL should not be used with occlusive dressings.
In 2 identical, independent, 6-week, randomized, double-blind, multicenter studies comparing the efficacy and safety of ELIDEL to placebo cream in pediatric patients (N=403), followed by a 20-week open-label extension. At double-blind study endpoint, 35% of patients treated with ELIDEL were "clear or almost clear" of the signs of atopic dermatitis, vs 18% of placebo cream patients.5
* ELIDEL is indicated for short-term and intermittent long-term treatment of atopic dermatitis.
Patients should be re-evaluated if symptoms persist beyond 6 weeks.
Reference:
- Eichenfield LF, Lucky AW, Boguniewicz M, et al. Safety and efficacy of pimecrolimus (ASM 981) cream 1% in the treatment of mild and moderate atopic dermatitis in children and adolescents. J Am Acad
Dermatol. 2002;46:495-504.
Please see complete Prescribing Information.
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