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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:
07/21/2005
Trade Name:
Adderall XR
Generic Name or Proper Name (*):
amphetamines mixed salts
Indications Studied:
ADHD
Label Changes Summary:
Expanded labeling for 13-17 year olds On a mg/kg body weight basis children 6-12 years have a higher clearance than adolescents or adults. Body weight is the primary determinant There was not adequate evidence that doses greater than 20 mg/day conferred additional benefit in a placebo-controlled study conducted in adolescents aged 13-17 with ADHD In a single-dose PK study in adolescents, isolated increases in systolic blood pressure (SBP) were observed in patients receiving 10 mg and 20 mg Adderall XR. Higher single doses were associated with a greater increase in SBP Sustained increases in blood pressure should be treated with dose reduction and/or appropriate medication Information on dose, PK parameters, and AE profile
Product Labeling:
Labeling
BPCA(B) and PREA(P):
B, P
Sponsor:
Shire
Pediatric Exclusivity Granted Date:
10/28/2004
NNPS:
FALSE'
Therapeutic Category:
CNS Stimulant
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