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New Pediatric Labeling Information Database - Detail
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Pediatrics
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
PREA(P):
P
Sponsor:
Rhodes Pharmaceuticals L.P.
NNPS:
FALSE
Therapeutic Category:
CNS Stimulant
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