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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:
10/23/2009
Trade Name:
Focalin XR
Generic Name or Proper Name (*):
dexmethylphenidate
Indications Studied:
ADHD
Label Changes Summary:
Revised maximum daily dosing due to dose-response studies. Doses above 30 mg/day in pediatrics and 40 mg/day in adults have not been studied and are not recommended Dosing should be individualized to patient needs and response. There was no clear benefit of the higher doses compared to the lower doses. Adverse events and discontinuations were dose-related. New dosing regimen; new dosage strength (30 mg capsule)
Product Labeling:
Labeling
PREA(P):
P
Sponsor:
Novartis
NNPS:
FALSE'
Therapeutic Category:
CNS Stimulant
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