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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:  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  Opens a new window
Sponsor:  Berlex
Pediatric Exclusivity Granted Date:  01/06/2000
Therapeutic Category:  Antiarrhythmic