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U.S. Department of Health and Human Services

New Pediatric Labeling Information Database - Detail

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Pediatric Labeling Date:  09/02/2009
Trade Name:  Intuniv
Generic Name or Proper Name (*):  guanfacine
Indications Studied:  ADHD
Label Changes Summary:  * 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
Product Labeling:  Labeling  Opens a new window
Sponsor:  Shire
Therapeutic Category:  Non-stimulant ADHD treatment