Desloratadine dose selection in children aged 6?months to 2?years: comparison of population pharmacokinetics between children and adults

摘要

What is already known about this subject ? According to recent literature, the pathophysiologies of allergic rhinitis and chronic idiopathic urticaria are thought to be similar in adults and children. In addition, the response to antihistamine treatment is similar in adults and children, suggesting a similar concentration-response relationship. ? However, an appropriate dose selection and the pharmacokinetics of desloratadine in children of ≥6 months?≤2 years old have never been addressed in the literature. What this study adds ? This study demonstrated that desloratadine syrup offers a safe treatment option for allergic conditions in young children. ? A suitable dose for children aged ≥6 months? Aims The aim of this study was to identify the dose of desloratadine in children aged ≥6 months?≤2 years that would yield a single-dose target exposure (AUC) comparable with that in adults taking 5 mg desloratadine as syrup. Methods In a phase 1, single-dose, open-label, pharmacokinetic study in 58 children aged ≥6 months? Results The apparent clearance (CL/ F ) of desloratadine, population estimate (%CV), in children aged ≥6 months? ?1 (35) and corresponding values in children ≥1 year?≤2 years was 35.5 l h ^?1 (51), compared with 137 l h ^?1 (58) for adults. The CL/ F ratios (children to adults) indicated that doses of 1 mg for ≥6 months? Conclusions Doses of 1.0 and 1.25 mg in children aged ≥6 months?≤2 years should result in an exposure to desloratadine similar to that of adults receiving doses of 5 mg.