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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 olderEfficacy is based on 2 clinical trials in children and adolescents 6 -17 years Kapvay has not been studied in children with ADHD < 6 yearsKapvay can cause dose related decreases in blood pressure and heart rateCommon 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 formulationInformation on adverse events, and clinical trialsNew 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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