Ortho-McNeil: TOPAMAX® (topiramate)

TOPAMAX^® for Epilepsy
TOPAMAX^® (topiramate) is approved as initial monotherapy in patients 10 years of age and older with partial-onset or primary generalized tonic-clonic seizures. Effectiveness was demonstrated in a controlled trial in patients with epilepsy who had no more than two seizures in the three months prior to enrollment. 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. TOPAMAX^® Tablets and Sprinkle Capsules is approved as add-on therapy for patients 2 years of age and older with primary generalized tonic-clonic seizures, partial-onset seizures, or seizures associated with Lennox-Gastaut syndrome. For more information please visit www.topamax-epilepsy.com.

IMPORTANT SAFETY INFORMATION ABOUT TOPAMAX^® Epilepsy Serious risks associated with TOPAMAX^® include lowered bicarbonate levels in the blood resulting in an increase in the acidity of the blood (metabolic acidosis). Symptoms could include hyperventilation (rapid, deep breathing), tiredness, loss of appetite, irregular heartbeat or changes in the level of alertness. Call your doctor immediately if you get these symptoms. Your doctor may want to do simple blood tests. Chronic, untreated metabolic acidosis may increase the risk for kidney stones or bone disease. Other serious risks include decreased sweating, increased body temperature, kidney stones, sleepiness, dizziness, confusion, difficulty concentrating, and increased eye pressure (glaucoma). Call your doctor immediately if you have any decrease in vision or eye pain. These problems can lead to blindness if not treated right away. More common side effects are tingling in arms and legs, loss of appetite, tiredness, nausea, diarrhea, taste change and weight loss. As monotherapy, the most common side effects of TOPAMAX^® (in the 400 mg/day group and at a rate higher than the 50 mg/day group) in adults were tingling in arms and legs, weight decrease, sleepiness, loss of appetite, dizziness, and difficulty with memory; and in children, weight decrease, upper respiratory tract infection, tingling in arms and legs, loss of appetite, diarrhea, and mood problems. In combination with other antiepileptic drugs (AEDs), the most common side effects of TOPAMAX^® in adults (200 to 400 mg/day) were sleepiness, dizziness, nervousness, loss of muscle coordination, fatigue, speech disorders and related problems, psychomotor slowing, abnormal vision, difficulty with memory, tingling in arms and legs, and double vision; and in children (5 to 9 mg/kg/day), fatigue, sleepiness, loss of appetite, nervousness, difficulty with concentration/attention, difficulty with memory, aggressive reaction, and weight decrease. Tell your doctor about other medications you take. Please see full US Prescribing Information.

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