eMPR Drug Database

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