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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:
04/14/2004
Trade Name:
Detrol LA
Generic Name or Proper Name (*):
tolterodine
Indications Studied:
Urinary frequency and urge incontinence due to neurogenic conditions
Label Changes Summary:
Efficacy in pediatric population has not been demonstrated The dose-plasma concentration relationship is linear in patients from 11 to 15 years Parent/ metabolite ratios differed according to CYP2D6 metabolizer status 710 pediatric patients ages 5 -10 years with urinary frequency and urge incontinence were studied in 2 randomized placebo controlled trials. Urinary tract infections were higher in patients treated with Detrol LA (6.6%) compared to placebo (4.5%) Aggressive, abnormal and hyperactive behavior and attention disorders occurred in 2.9% of children treated with Detrol LA compared to 0.9% treated with placebo
Product Labeling:
Labeling
BPCA(B):
B
Sponsor:
Pfizer
Pediatric Exclusivity Granted Date:
01/05/2004
NNPS:
FALSE'
Therapeutic Category:
Urology
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