TOPIRAMATE- topiramate tablet
PD-Rx Pharmaceuticals, Inc.
Topiramate tablets are indicated as adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, and seizures associated with Lennox-Gastaut syndrome in patients 2 years of age and older.
The recommended dose for topiramate tablets monotherapy in adults and pediatric patients 10 years of age and older is 400 mg/day in two divided doses. The dose should be achieved by titration according to the following schedule (Table 1):
|Morning Dose||Evening Dose|
|Week 1||25 mg||25 mg|
|Week 2||50 mg||50 mg|
|Week 3||75 mg||75 mg|
|Week 4||100 mg||100 mg|
|Week 5||150 mg||150 mg|
|Week 6||200 mg||200 mg|
Dosing in patients 2 to 9 years of age is based on weight. During the titration period, the initial dose of topiramate tablet is 25 mg/day nightly for the first week. Based upon tolerability, the dosage can be increased to 50 mg/day (25 mg twice daily) in the second week. Dosage can be increased by 25-50 mg/day each subsequent week as tolerated. Titration to the minimum maintenance dose should be attempted over 5-7 weeks of the total titration period. Based upon tolerability and clinical response, additional titration to a higher dose (up to the maximum maintenance dose) can be attempted at 25-50 mg/day weekly increments. The total daily dose should not exceed the maximum maintenance dose for each range of body weight (Table 2).
|Weight (kg)||Total Daily Dose (mg/day)* Minimum Maintenance Dose||Total Daily Dose (mg/day)* Maximum Maintenance Dose|
|Up to 11||150||250|
|Greater than 38||250||400|
|*Administered in two equally divided doses|
The recommended total daily dose of topiramate tablets as adjunctive therapy in adults with partial onset seizures or Lennox-Gastaut Syndrome is 200 to 400 mg/day in two divided doses, and 400 mg/day in two divided doses as adjunctive treatment in adults with primary generalized tonic-clonic seizures. Topiramate tablets should be initiated at 25 to 50 mg/day, followed by titration to an effective dose in increments of 25 to 50 mg/day every week. Titrating in increments of 25 mg/day every week may delay the time to reach an effective dose. Doses above 400 mg/day have not been shown to improve responses in adults with partial-onset seizures.
Pediatric Patients 2 to 16 Years of Age
The recommended total daily dose of topiramate tablets as adjunctive therapy for pediatric patients 2 to 16 years of age with partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome is approximately 5 to 9 mg/kg/day in two divided doses. Titration should begin at 25 mg/day (or less, based on a range of 1 to 3 mg/kg/day) nightly for the first week. The dosage should then be increased at 1- or 2-week intervals by increments of 1 to 3 mg/kg/day (administered in two divided doses), to achieve optimal clinical response. Dose titration should be guided by clinical outcome. The total daily dose should not exceed 400 mg/day.
The recommended total daily dose of topiramate tablets as treatment for patients 12 years of age and older for the preventive treatment of migraine is 100 mg/day administered in two divided doses (Table 3). The recommended titration rate for topiramate tablets for the preventive treatment of migraine is as follows:
|Morning Dose||Evening Dose|
|Week 1||None||25 mg|
|Week 2||25 mg||25 mg|
|Week 3||25 mg||50 mg|
|Week 4||50 mg||50 mg|
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