Safety and Tolerability Profile
Adverse events occured more frequently during titration than during maintenance.8
Dose and titration rate can be adjusted based on patient response and tolerability.
More than 4 million patients worldwide have been treated with topiramate.*8
*Since 1995, regardless of indication.
Proven Safety Profile
- Extensively studied
- Proven safety profile
Proven Tolerability Profile
- Most adverse events were mild to moderate
- Most adverse events occurred less frequently after titration
- No significant drug-drug interactions with sumatriptan, propranolol, or dihydroergotamine
TOPAMAX and Combination Oral Contraceptives*
- No significant effect on progestin or ethinyl estradiol (EE) levels for TOPAMAX doses of 50 mg/day to 200 mg/day
- TOPAMAX doses of 200 mg/day to 800 mg/day were associated with a decrease in EE levels
- The possibility of decreased contraceptive efficacy and increased breakthrough bleeding should be considered in patients taking combination oral contraceptive products with TOPAMAX
*Based on pharmacokinetic data with an oral contraceptive product containing 1 mg norethindrone 35 mcg ethinyl estradiol.
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
