Topiramate

TOPIRAMATE- topiramate tablet, film coated
American Health Packaging

1 INDICATIONS AND USAGE

1.1 Monotherapy Epilepsy

Topiramate tablets and topiramate capsules are indicated as initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older.

1.2 Adjunctive Therapy Epilepsy

Topiramate tablets and topiramate capsules 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.

1.3 Migraine

Topiramate tablets and topiramate capsules are indicated for the preventive treatment of migraine in patients 12 years of age and older.

2 DOSAGE AND ADMINISTRATION

2.1 Dosing in Monotherapy Epilepsy

Adults and Pediatric Patients 10 Years of Age and Older The recommended dose for topiramate 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):

Table 1 Monotherapy Titration Schedule for Adults and Pediatric Patients 10 years and older

	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

Pediatric Patients 2 to 9 Years of Age Dosing in patients 2 to 9 years of age is based on weight. During the titration period, the initial dose of topiramate 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 mg/day to 50 mg/day each subsequent week as tolerated. Titration to the minimum maintenance dose should be attempted over 5 weeks to 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 mg/day to 50 mg/day weekly increments. The total daily dose should not exceed the maximum maintenance dose for each range of body weight (Table 2).

Table 2 Monotherapy Target Total Daily Maintenance Dosing for Patients 2 to 9 Years of Age

* Administered in two equally divided doses
Weight (kg)	Total Daily Dose (mg/day) * Minimum Maintenance Dose	Total Daily Dose (mg/day) * Maximum Maintenance Dose
Up to 11	150	250
12 to 22	200	300
23 to 31	200	350
32 to 38	250	350
Greater than 38	250	400

2.2 Dosing in Adjunctive Therapy Epilepsy

Adults (17 Years of Age and Older)
The recommended total daily dose of topiramate as adjunctive therapy in adults with partial-onset seizures or Lennox-Gastaut Syndrome is 200 mg/day 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 should be initiated at 25 mg/day to 50 mg/day followed by titration to an effective dose in increments of 25 mg/day 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 as adjunctive therapy for pediatric patients 2 years to 16 years of age with partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome is approximately 5 mg/kg/day to 9 mg/kg/day in two divided doses. Titration should begin at 25 mg/day (or less, based on a range of 1 mg/kg/day 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 mg/kg/day 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.

2.3 Dosing for the Preventive Treatment of Migraine

The recommended total daily dose of Topiramate 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 for the preventive treatment of migraine is as follows:

Table 3 Preventive Treatment of Migraine Titration Schedule for Patients 12 Years of Age and Older

	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

Dose and titration rate should be guided by clinical outcome. If required, longer intervals between dose adjustments can be used.