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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:
11/20/2014
Trade Name:
Kapvay Extended Release Tablets
Generic Name or Proper Name (*):
clonidine
Indications Studied:
Attention Deficit Hyperactivity Disorder (ADHD)
Label Changes Summary:
*One additional study was conducted. *A 40-week, dose optimization, randomized withdrawal study of 135 pediatric patients 6 to 17 years. *Blood pressure (BP): Mean increases in both systolic and diastolic BP (SBP/DBP) Hg were seen in drug treated patients. *Heart rate (HR): Mean decreases in HR were noted in drug treated patients
Product Labeling:
Labeling
PREA(P):
P
Sponsor:
Concordia Pharmaceuticals, Inc.
Therapeutic Category:
Non-stimulant ADHD treatment
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