Efficacy established in 2 controlled clinical trials in children 6-17 years Safety and efficacy in pediatric patients< 6 years have not been established In clinical trials, there were dose and exposure-related risks for adverse events (AEs) including hypotension, bradycardia, and sedative events. Somnolence and sedation were reported in 38% on guanfacine vs. 12% on placebo in children and adolescents with ADHD, especially during initial use Information on dosing, clinical trials, and AEs New dosage form
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