Clarinex pediatric use precautions
The recommended dose of Clarinex Syrup in the pediatric population is based on cross-study comparison of the plasma concentration of Clarinex in adults and pediatric subjects. The safety of Clarinex Syrup has been established in 246 pediatric subjects aged 6 months to 11 years in three placebo-controlled clinical studies. Since the course of seasonal and perennial allergic rhinitis and chronic idiopathic urticaria and the effects of Clarinex are sufficiently similar in the pediatric and adult populations, it allows extrapolation from the adult efficacy data to pediatric patients. The effectiveness of Clarinex Syrup in these age groups is supported by evidence from adequate and well-controlled studies of Clarinex Tablets in adults. The safety and effectiveness of Clarinex Tablets or Clarinex Syrup have not been demonstrated in pediatric patients less than 6 months of age.
The Clarinex RediTabs Tablet 2.5 mg tablet has not been evaluated in pediatric patients. Bioequivalence of the Clarinex RediTabs Tablet and the previously marketed RediTabs Tablet was established in adults. In conjunction with the dose finding studies in pediatrics described, the pharmacokinetic data for Clarinex RediTabs Tablet supports the use of the 2.5 mg dose strength in pediatric patients 6–11 years of age.
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