We know you’re concerned about seizures

We also know seizures aren’t your only concern.

For Healthcare Professionals

This portion of the Web site for TOPAMAX contains clinical information and data that are intended for U.S. healthcare professionals only.

Attention TOPAMAX Patients and Medical Professionals

Dispensing errors have been reported between TOPAMAX ® (topiramate) tablets and TOPROL-XL ® (metroprolol succinate) extended-release tablets.

Please visit www.RxforSafety.com for complete information, and be sure to check your tablets to ensure you are taking the right medicine.

Click here if you would like to be contacted by an Ortho-McNeil Neurologics Sales Representative.

TOPAMAX Overview

TOPAMAX has been available in the United States since 1997, when it was approved for use as adjunctive therapy in epilepsy. It has also been available in parts of Europe since 1995, regardless of condition.

Studies show that TOPAMAX offers significant benefit in patients with primary generalized tonic-clonic seizures and partial-onset seizures previously resistant to antiepileptic drug therapy.

Click here for Broad-Spectrum Coverage of Seizure Types.

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: hyperchloremic, non-anion gap metabolic acidosis (lowering of serum bicarbonate levels) - measurement of baseline and periodic serum bicarbonate levels is recommended; 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; 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.

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 (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 (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.

Please see full U.S. Prescribing Information.

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

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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: Jul 26 2007 at 13:45:29 EDT