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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:
10/01/2001
Trade Name:
Betapace
Generic Name or Proper Name (*):
sotalol
Indications Studied:
Arrhythmia
Label Changes Summary:
Analysis of 2 trials provided information on PK and PD in children 3 days 12 years; safety and efficacy have not been established Information on dose, pharmacokinetics and AE's Pharmacokinetics: BSA most important covariate and more relevant than age Smaller children (BSA < 0.33 m2) showed tendency for larger change in QTc and increased frequency of prolongation of the QTc interval as well as greater beta-blocking effects Individualized dosing on a mg/m2 basis Information on preparation of a suspension
Product Labeling:
Labeling
BPCA(B):
B
Sponsor:
Berlex
Pediatric Exclusivity Granted Date:
01/06/2000
NNPS:
FALSE'
Therapeutic Category:
Antiarrhythmic
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