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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:
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
PREA(P):
P
Sponsor:
Johnson & Johnson
NNPS:
FALSE'
Therapeutic Category:
Anticonvulsant
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