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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:  06/14/2019
 
Trade Name:  Aptensio XR
 
Generic Name or Proper Name (*):  methylphenidate hydrochloride
 
Indications Studied:  Attention Deficit Hyperactivity Disorder (ADHD)
 
Label Changes Summary:  *Safety and effectiveness in pediatric patients under 6 years have not been established. *Safety and efficacy were evaluated in a multicenter, placebo-controlled, double-blind, parallel group study in 119 children 4 to <6 years with ADHD followed by a 12-month open-label extension in 44 of these children. *In these studies, patients experienced high rates of adverse reactions, most notably weight loss. Comparing weights prior to initiation of Aptensio XR (in the safety and efficacy study) to weights after 12 months of treatment (in the open-label extension), 20 of 39 patients with data (50%) had lost enough weight to decrease 10 or more percentiles on a Centers for Disease Control growth chart for weight. In addition, systemic drug exposures in patients 4 to <6 years of age were higher than those observed in older children and adolescents at the same dose (2 to 3 fold higher Cmax and AUC). *Therefore, the benefits do not outweigh the risks in pediatric patients 4 to <6 years. *Postmarketing study.
 
PREA(P):  P
 
Sponsor:  Rhodes Pharmaceuticals L.P.
 
NNPS:  FALSE
 
Therapeutic Category:  CNS Stimulant
 
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