We know you’re concerned about seizures

We also know seizures aren’t your only concern.

For Healthcare Professionals

TOPAMAX is Efffective in Partial-Onset and Primary
Generalized Tonic-Clonic Seizures1

Kaplan-Meier Estimates of Cumulative Rates for Time to First Seizure1

Kaplan Meier

Across Seizure Types in Adults and Children

In primary generalized tonic-clonic seizures, TOPAMAX demonstrated a clinically significant response in seizure reduction. Fifty-seven percent of patients treated with TOPAMAX achieved a 50% or higher reduction in seizure rate compared to 9% for placebo-treated patients.2

Primary Generalized Tonic-Clonic Seizures in Adults and Children2,3

Primary Generalized Tonic-Clonic Seizures in Adults

Studies in adults and children with partial-onset seizures demonstrated TOPAMAX was effective in reducing seizure rates compared to placebo.4,5

Partial-Onset Seizures in Adults4

Partial-Onset Seizures in Adults

Partial-Onset Seizures in Children 2 to 16 Years of Age5

Partial-Onset Seizures in Children 2 to 16 Years of Age

Early Onset of Effect—Low Target Dose4

TOPAMAX 200 mg/day is an initial appropriate target dose. The therapeutic effect of TOPAMAX can be seen as early as 2 weeks into therapy. In addition, TOPAMAX dosed at 200 mg/day in patients with refractory partial-onset seizures was effective as adjunctive therapy when added to enzyme-inducing AEDs. This rapid onset of effect and low target dose offer a distinct benefit to patients and professionals alike.4

Onset of Effect During Titration4

Onset of Effect During Titration

Demonstrated Seizure Reduction Across Seizure Types in Adults and Children

In controlled clinical trials, TOPAMAX has been effective in reducing monthly seizure rates by at least 50% in 57% of patients with primary generalized tonic-clonic seizures.2,3

An analysis of a study in adults with partial-onset seizures indicates that patients may notice a beneficial effect on seizures early—as early as 2 weeks.

Primary Generalized Tonic-Clonic Seizures in Adults and Children2,3

Primary Generalized Tonic-Clonic Seizures in Adults and Children

After 16 weeks of TOPAMAX therapy, 44% of adults with partial-onset seizures had their monthly seizure rate reduced by at least 50%.3,6

Partial-Onset Seizures in Adults3,6

A

After 16 weeks of TOPAMAX therapy, 39% of children with partial-onset seizures achieved a ≥ 50% reduction in their monthly seizure rate.3,5

Partial-Onset Seizures in Children 2 to 16 Years of Age3,5

Partial-Onset Seizures in Children 2 to 16 Years of Age

In their monthly rate of drop attack seizures, 28% of patients with Lennox-Gastaut syndrome achieved a 50% or greater reduction in seizure frequency from baseline with TOPAMAX.3,7

Drop Attacks Associated With Lennox-Gastaux Syndrome3,7

Drop Attacks Associated with Lennox-Gastaux Syndrome

References:

  1. Arroyo S, Dodson WE, Privitera MD, et al, for the EPMN-106/INT-28 Investigators. Randomized dose-controlled study of topiramate as first-line therapy in epilepsy. Acta Neurol Scand. 2005;112:214-222.
  2. Biton V, Montouris GD, Ritter F, et al, and the Topiramate YTC Study Group. A randomized, placebo-controlled study of topiramate in primary generalized tonic-clonic seizures. Neurology. 1999;52:1330-1337.
  3. Data on file, Ortho-McNeil Neurologics, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc.
  4. 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.
  5. Elterman RD, Glauser TA, Wyllie E, et al, and the Topirmate YP Study Group. A double-blind, randomized trial of topiramate as adjunctive therapy for partial-onset seizures in children. Neurology. 1999;52:1338-1344.
  6. Faught E, Wilder BJ, Ramsay RE, et al, and the Topiramate YD Study Group. Topiramate placebo-controlled dose-ranging trial in refractory partial epilepsy using 200-, 400-, and 600-mg daily dosages. Neurology. 1996;46:1684-1690.
  7. Sachdeo RC, Glauser TA, Ritter F, et al, and the Topiramate YL Study Group. A double-blind, randomized trial of topiramate in Lennox-Gastaut syndrome. Neurology. 1999;52:1882-1887.

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:

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.

© Ortho-McNeil Neurologics, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. 1999- 2010 . All rights reserved.

Your use of the information on this site is subject to the terms of our Legal Statement. Please see our Privacy Policy.

This site is published by Ortho-McNeil Neurologics, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., which is solely responsible for its contents.

Capitalized product names are trademarks of Ortho-McNeil Neurologics, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc.

This information is intended for use by our customers, patients and healthcare professionals in the United States only. Ortho-McNeil Neurologics, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. recognizes that the Internet is a global communications medium; however, laws, regulatory requirements and medical practices for pharmaceutical products vary from country to country. The prescribing information included here may not be appropriate for use outside the United States.

This site was last modified on: Apr 29 2008 at 16:11:27 EDT