• About Epilepsy and its Treatment
• About TOPAMAX for Epilepsy
• Important Safety Information
• Full U.S. Prescribing Information

We know you’re concerned about seizures

We also know seizures aren’t your only concern.

For Healthcare Professionals

TOPAMAX is Generally Well-Tolerated in Adults and Children as
Initial Monotherapy

The most frequently reported adverse events in adults taking TOPAMAX as initial monotherapy at a dosage of 400 mg/day were paresthesia, weight decrease, somnolence, anorexia, dizziness, and difficulty with memory (not otherwise specified).¹

The majority of cognitive-related events were mild to moderate in severity.¹

TOPAMAX is also generally well tolerated in children. The most commonly reported adverse events observed in the higher-dose arm in clinical trials with TOPAMAX monotherapy are shown below.¹

Most Common Adverse Events in Adults*

Most Common Adverse Events in Children*

*Cumulative incidence of treatment-emergent adverse events where rate was ≥ 10%

The incidence of cognitive-related events in children was generally lower than those observed in adults¹

In the higher-dose group, 7 (12%) childern discontinued treatment due to adverse events.¹

TOPAMAX is Generally Well-Tolerated at 200 mg/day

A double-blind, placebo-controlled study evaluated a low dose of TOPAMAX as add-on therapy at 200 mg/day in adults with treatment resistant partial-onset seizures. The results proved that TOPAMAX 200 mg/day is an appropriate initial target dose. There was a low incidence of adverse events and only 8% of TOPAMAX-treated patients discontinued therapy due to adverse events.²

Most Common Adverse Events^*2

*Adverse events more frequent in TOPAMAX-treated patients with reported incidence >5%. Patients in these add-on trials were receiving 1 to 2 concomitant AEDs in addition to TOPAMAX or placebo.

TOPAMAX Offers Flexible Dosing

TOPAMAX recommended daily dose for adjunctive therapy:

Initiate therapy with a PM dose of 25 mg to 50 mg of TOPAMAX.

In adults: 200 to 400 mg/day in two divided doses for partial-onset seizure; 400 mg/day in 2 divided doses for primary generalized tonic-clonic seizures.

In children (ages 2 to 16 years): approximately 5 to 9 mg/kg/day in 2 divided doses.

Reference:

1. TOPAMAX [Prescribing Information]. Titusville, NJ: Ortho-McNeil Neurologics, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc.; 2005.
2. Guberman A, Neto W, Gassmann-Mayer C, and the EPAJ-119 Study Group. Low-dose topiramate in adults with treatment-resistant partial-onset seizures. Acta Neurol Scand. 2002;106:183-189

About TOPAMAX^®

TOPAMAX^® is indicated 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 2 seizures in the 3 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^® is indicated as adjunctive 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.

Important Safety Information

TOPAMAX^® has been associated with serious adverse events including:

• acute myopia and secondary angle-closure glaucoma-patients should seek medical attention if they experience blurred vision or ocular pain
• oligohidrosis and hyperthermia-occurs most often in hot weather and in children
• hyperchloremic, non-anion gap metabolic acidosis (lowering of serum bicarbonate levels)-measurement of baseline and periodic serum bicarbonate levels is recommended
• cognitive/psychiatric side effects including somnolence, fatigue, cognitive dysfunction, and psychiatric/behavioral disturbances including suicidal thoughts or behavior
• hyperammonemia with or without encephalopathy-associated with the concomitant use of valproic acid; and kidney stones-patients should maintain an adequate fluid intake to minimize the risk of renal stone formation.

Antiepileptic drugs (AEDs); including TOPAMAX^® increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. Patients treated with any AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior.

There are no adequate and well-controlled studies using TOPAMAX^® in pregnant women. Pregnancy registry data suggest that there may be an association between the use of TOPAMAX^® during pregnancy and congenital malformations (e.g., craniofacial defects, such as cleft lip/palate, hypospadias, and anomalies involving various body systems). This has been reported with topiramate monotherapy and topiramate as part of a polytherapy regimen.

Physicians are advised to recommend that pregnant patients taking TOPAMAX^® enroll in the NAAED Pregnancy Registry by calling 1-888-233-2334.

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: paresthesia, weight decrease, somnolence, anorexia,* dizziness, and difficulty with memory; and in children: weight decrease, upper respiratory tract infection, paresthesia, anorexia, diarrhea, and mood problems.

In combination with other antiepileptic drugs (AEDs), the most common side effects of TOPAMAX^® in adults (dosed at 200 to 400 mg/day) were: somnolence, dizziness, nervousness, ataxia, fatigue, speech disorders and related problems, psychomotor slowing, abnormal vision, difficulty with memory, paresthesia, and diplopia; and in children (dosed at 5 to 9 mg/kg/day): fatigue, somnolence, anorexia, nervousness, difficulty with concentration/attention, difficulty with memory, aggressive reaction, and weight decrease.

In women taking combination oral contraceptives with TOPAMAX^®, a significant decrease in estrogen exposure has been shown at TOPAMAX^® doses >200 mg/day. The possibility of decreased contraceptive efficacy and increased breakthrough bleeding should be considered.

*Anorexia is defined as loss of appetite.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Please see full U.S. Prescribing Information.

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This site was last modified on: Apr 29 2008 at 16:11:30 EDT