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Buspar pediatric use precautions

February 1st, 2010 Leave a comment Go to comments

The safety and effectiveness of Buspar were evaluated in two placebo-controlled 6-week trials involving a total of 559 pediatric patients (ranging from 6 to 17 years of age) with GAD. Doses studied were 7.5 mg to 30 mg b.i.d. (15-60 mg/day). There were no significant differences between Buspar and placebo with regard to the symptoms of GAD following doses recommended for the treatment of GAD in adults. Pharmacokinetic studies have shown that, for identical doses, plasma exposure to Buspar and its active metabolite, 1-PP, are equal to or higher in pediatric patients than adults. No unexpected safety findings were associated with Buspar in these trials. There are no long-term safety or efficacy data in this population.

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