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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:  06/29/2005
 
Trade Name:  Topamax Tablets and Sprinkle Capsules
 
Generic Name or Proper Name (*):  topiramate
 
Indications Studied:  Initial monotherapy for partial onset or primary generalized tonic-clonic seizures in children 10 years of age and older
 
Label Changes Summary:  * Effectiveness established in studies of patients down to 6 years of age * Use in patients who were converted to monotherapy from a previous regimen of other anticonvulsant drugs have not been established in controlled trials * Provides information regarding treatment-emergent decrease in serum bicarbonate and adverse events * Some patients in the study discontinued therapy due to adverse events; however, adverse events associated with discontinuing therapy included difficulty with concentration/attention * Studies waived in children 0-2 years of age; deferred in children 2-10 years of age * New indication
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Johnson & Johnson
 
NNPS:  FALSE
 
Therapeutic Category:  Anticonvulsant
 
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