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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:  09/28/2010
 
Trade Name:  Kapvay Extended Release Tablets
 
Generic Name or Proper Name (*):  clonidine
 
Indications Studied:  Treatment of attention deficit hyperactivity disorder (ADHD) as monotherapy and as adjunctive therapy to stimulant medications
 
Label Changes Summary:  * New indication in children 6 years and older* Efficacy is based on 2 clinical trials in children and adolescents 6 -17 years * Kapvay has not been studied in children with ADHD < 6 years* Kapvay can cause dose related decreases in blood pressure and heart rate* Common adverse events reported in clinical trials included somnolence, fatigue, upper respiratory tract infection irritability, throat pain, insomnia, nightmares, emotional disorder. In fixed dose pediatric monotherapy study, 31% of patients treated with 0.4 mg/day and 38% treated with 0.2 mg/day vs 7% of placebo treated patients reported somnolence. * Kapvay is an extended-release tablet formulation of clonidine; therefore, it is not to be used interchangeably with the immediate-release formulation* Information on adverse events, and clinical trials*New indication
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Shionogi
 
NNPS:  FALSE
 
Therapeutic Category:  Non-stimulant ADHD treatment
 
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