TOPAMAX- topiramate tablet, coated
TOPAMAX- topiramate capsule, coated pellets
Janssen Pharmaceuticals, Inc.
TOPAMAX® is indicated as initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older.
TOPAMAX® is 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.
TOPAMAX® is indicated for the preventive treatment of migraine in patients 12 years of age and older.
Adults and Pediatric Patients 10 Years of Age and Older
The recommended dose for TOPAMAX® 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|
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 TOPAMAX® 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|
|12 – 22||200||300|
|23 – 31||200||350|
|32 – 38||250||350|
|Greater than 38||250||400|
Adults (17 Years of Age and Older)
The recommended total daily dose of TOPAMAX® 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. TOPAMAX® 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 TOPAMAX® 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 TOPAMAX® 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 TOPAMAX® 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|
Dose and titration rate should be guided by clinical outcome. If required, longer intervals between dose adjustments can be used.
TOPAMAX® can be taken without regard to meals.
Because of the bitter taste, tablets should not be broken.
TOPAMAX® Sprinkle Capsules
TOPAMAX® Sprinkle Capsules may be swallowed whole or may be administered by carefully opening the capsule and sprinkling the entire contents on a small amount (teaspoon) of soft food. This drug/food mixture should be swallowed immediately and not chewed. It should not be stored for future use.
In patients with renal impairment (creatinine clearance less than 70 mL/min/1.73 m2), one-half of the usual adult dose of TOPAMAX® is recommended [see Use in Specific Populations (8.5, 8.6), Clinical Pharmacology (12.3)].
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