Adults and adolescents 12 years of age and older for the prophylaxis of migraine headache. The usefulness of TOPAMAX® in the acute treatment of migraine headache has not been studied.
Initial monotherapy in patients 2 years of age and older with partial onset or primary generalized tonic-clonic seizures. Safety and effectiveness in patients who were converted to monotherapy from a previous regimen of other anticonvulsant drugs have not been established in controlled trials.
Adjunctive therapy for adults and pediatric patients ages 2 to 16 years with partial onset seizures or primary generalized tonic-clonic seizures, and in patients 2 years of age and older with seizures associated with Lennox-Gastaut syndrome.
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March 4, 2011 - FDA Drug Safety Communication: TOPAMAX® (topiramate) use during pregnancy can cause fetal harm, including an increased risk for cleft lip and/or cleft palate. For information from the company click here. The FDA announcement can be found at www.fda.gov.