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Renal Insufficiency The effect of renal insufficiency on the pharmacokinetics of topically administered pimecrolimus has not been evaluated. Given the very low systemic exposure of pimecrolimus via the topical route, no change in dosing is required. Hepatic Insufficiency Text Continues Below
The effect of hepatic insufficiency on the pharmacokinetics of topically administered pimecrolimus has not been evaluated. Given the very low systemic exposure of pimecrolimus via the topical route, no change in dosing is required. CLINICAL STUDIES Three randomized, double-blind, vehicle-controlled, multi-center, Phase 3 studies were conducted in 1335 pediatric patients ages 3 months -17 years old to evaluate Elidel ® (pimecrolimus) Cream 1% for the treatment of mild to moderate atopic dermatitis. Two of the three trials support the use of Elidel Cream in patients 2 years and older with mild to moderate atopic dermatitis (see Pediatric Use). Three other trials provided additional data regarding the safety of Elidel Cream in the treatment of atopic dermatitis. Two of these other trials were vehicle-controlled with optional sequential use of a medium potency topical corticosteroid in pediatric patients and one trial was an active comparator trial in adult patients with atopic dermatitis (see Pediatric Use and ADVERSE REACTIONS). Two identical 6-week, randomized, vehicle-controlled, multi-center, Phase 3 trials were conducted to evaluate Elidel Cream for the treatment of mild to moderate atopic dermatitis. A total of 403 pediatric patients 2-17 years old were included in the studies. The male/female ratio was approximately 50% and 29% of the patients were African American. At study entry, 59% of patients had moderate disease and the mean body surface area (BSA) affected was 26%. About 75% of patients had atopic dermatitis affecting the face and/or neck region. In these studies, patients applied either Elidel Cream or vehicle cream twice daily to 5% to 96% of their BSA for up to 6 weeks. At endpoint, based on the physician’s global evaluation of clinical response, 35% of patients treated with Elidel Cream were clear or almost clear of signs of atopic dermatitis compared to only 18% of vehicle-treated patients. More Elidel patients (57%) had mild or no pruritus at 6 weeks compared to vehicle patients (34%). The improvement in pruritus occurred in conjunction with the improvement of the patients’ atopic dermatitis. Page: << Prev | 1 | 2 | 3 | 4 | Next >>
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