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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:
02/23/2007
Trade Name:
Coreg
Generic Name or Proper Name (*):
carvedilol
Indications Studied:
Heart failure
Label Changes Summary:
Effectiveness has not been established in patients < 18 years In a double-blind trial of 161 children, 2 months to 17 years with chronic heart failure receiving standard background treatment, randomized to placebo or carvedilol, carvedilol demonstrated reduction of heart rate 4-6 beats per minute There was no significant effect of treatment on clinical outcomes after 8 months of follow-up AEs occurring in e 10% of patients treated with carvedilol included chest pain (17%), dizziness (13%), and dyspnea (11%)
Product Labeling:
Labeling
BPCA(B) and PREA(P):
B, P
Sponsor:
GlaxoSmithKline
Pediatric Exclusivity Granted Date:
11/08/2006
NNPS:
FALSE'
Therapeutic Category:
Antihypertensive
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