• 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

The multiple mechanisms of action of TOPAMAX may contribute to antiseizure efficacy.

References

1. Rogawski MA, Loscher W. The neurobiology of antiepileptic drugs. Nat Rev Neurosci. 2004;5:553-564.

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: Jul 26 2007 at 13:45:29 EDT