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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:  04/17/2015
 
Trade Name:  Aptensio XR
 
Generic Name or Proper Name (*):  methylphenidate hydrochloride
 
Indications Studied:  Attention Deficit Hyperactivity Disorder
 
Label Changes Summary:  *Safety and effectiveness of have been established in pediatric patients ages 6 to 17 years in two adequate and well-controlled clinical trials. * Safety and effectiveness in pediatric patients under six years have not been evaluated. *The long-term efficacy of methylphenidate in pediatric patients has not been established. * CNS stimulants have been associated with weight loss and slowing of growth rate in pediatric patients. Closely monitor weight and height in pediatric patients treated with CNS stimulants, including Aptensio XR. Pediatric patients not growing or gaining weight as expected may need to have their treatment interrupted. * Information on dosing, adverse reactions, and clinical trials
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Rhodes Pharmaceuticals L.P.
 
NNPS:  FALSE
 
Therapeutic Category:  CNS Stimulant
 
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