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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:  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  Opens a new window
 
BPCA(B):  B
 
Sponsor:  Pfizer
 
Pediatric Exclusivity Granted Date:  01/05/2004
 
NNPS:  FALSE
 
Therapeutic Category:  Urology
 
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