Proven Efficacy Profile
TOPAMAX®:Proven to help stop migraines before they start, so patients can get fewer of them.5,6
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Adapted from Silberstein, et al. Arch Neurol, 2004.
*Results taken from a 26-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group clinical trial of 469 patients. Based on ITT (intent-to-treat) study population. In clinical studies, the 50 mg QD dose was not statistically different from placebo in the reduction of migraine frequency and the 100 mg BID dose was not statistically different from the 50 mg BID dose. The recommended target maintenance dose is 50 mg BID.
TOPAMAX is proven to help stop migraines before they start, so patients can get fewer of them. In a 26-week controlled clinical study of 469 patients, TOPAMAX 100 mg significantly reduced migraine frequency from baseline compared to placebo throughout the 6-month trial. Significant reductions were seen initially, with continuous improvement and sustained efficacy observed over time.
The 50 mg once-daily dose was not statistically different from placebo and the 100 mg twice-daily dose was not statistically different from the 50 mg twice-daily dose. The recommended target maintenance dose of TOPAMAX is 50 mg twice daily. In a post-hoc analysis of two 26-week controlled clinical studies, TOPAMAX was proven effective in patients who previously tried and discontinued use of preventive medicines including tricyclic antidepressants, beta-blockers, and other neuromodulators.
Migraine is a highly individualized condition and your patient's experience may vary.
Dispensing errors have been reported between TOPAMAX® (topiramate) Tablets and TOPROL-XL® (metoprolol succinate) extended-release Tablets.
Please be sure to check your tablets to ensure you are taking the right medicine.
*TOPROL-XL is a registered trademark of the AstraZeneca group of companies.
TOPAMAX Tablets and TOPAMAX Sprinkle Capsules are indicated for adults for the prophylaxis of migraine headache. The usefulness of TOPAMAX in the acute treatment of migraine headache has not been studied.
TOPAMAX is contraindicated in patients with a history of hypersensitivity to any component of this product.
IMPORTANT SAFETY INFORMATION
TOPAMAX has been associated with serious adverse events, including:
- Hyperchloremic, non-anion gap metabolic acidosis - lowering of bicarbonate levels in the blood. Measurement of baseline and periodic serum bicarbonate is recommended.
- Acute myopia and secondary angle-closure glaucoma - patients should be cautioned to seek medical attention if they experience blurred vision or ocular pain.
- Oligohidrosis and hyperthermia - decreased sweating and increased body temperature, especially in hot weather. The majority of reports have been in children.
- Cognitive/psychiatric side effects including cognitive dysfunction, psychiatric/behavioral disturbances, including suicidal thoughts or behavior, and somnolence and fatigue.
Most common adverse events associated with TOPAMAX 100 mg vs placebo were: paresthesia, 51% vs 6%; anorexia,* 15% vs 6%; fatigue, 15% vs 11%; nausea, 13% vs 8%; diarrhea, 11% vs 4%; weight decrease, 9% vs 1%; taste alteration, 8% vs 1%.
The possibility of decreased contraceptive efficacy and increased breakthrough bleeding should be considered in patients taking combination oral contraceptive products with TOPAMAX.
Patients should be instructed to maintain an adequate fluid intake in order to minimize the risk of renal stone formation.
*Anorexia is defined as loss of appetite
Please see full U.S. Prescribing Information
