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U.S. Department of Health and Human Services

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  Opens a new window
 
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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