safe in the pediatric population?
Pediatric Use: The safety of Claritin Syrup at a daily dose of 10 mg has been demonstrated in 188 pediatric patients 6-12 years of age in placebo-controlled 2-week trials. The effectiveness of Claritin for the treatment of seasonal allergic rhinitis and chronic idiopathic urticaria in this pediatric age group is based on an extrapolation of the demonstrated efficacy of Claritin in adults in these conditions and the likelihood that the disease course, pathophysiology, and the drugs effect are substantially similar to that of the adults. The recommended dose for the pediatric population is based on cross-study comparison of the pharmacokinetics of Claritin in adults and pediatric subjects and on the safety profile of loratadine in both adults and pediatric patients at doses equal to or higher than the recommended doses. The safety and effectiveness of Claritin in pediatric patients under 6 years of age have not been established.
