Topiramate Dosage

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Usual Adult Dose for:

Usual Pediatric Dose for:

Additional dosage information:

Usual Adult Dose for Migraine Prophylaxis

Maintenance dose: 50 mg orally 2 times daily, in the morning and in the evening

Titration to 100 mg:
-Week 1: 25 mg orally once daily in the evening
-Week 2: 25 mg orally 2 times a day, in the morning and in the evening
-Week 3: 25 mg orally in the morning and 50 mg orally in the evening
-Week 4: 50 mg orally in the morning and 50 mg orally in the evening

Longer intervals between dose adjustments may be used as needed.

FDA Approved Indication: For adults for the prophylaxis of migraine headache.

Usual Adult Dose for Seizure Prophylaxis

IMMEDIATE RELEASE:

Monotherapy (adults and pediatric patients 10 years and older):
-Recommended dose: 400 mg orally daily in two divided doses
-The dose should be achieved by titration:
Week 1: 25 mg orally in the morning and 25 mg orally in the evening
Week 2: 50 mg orally in the morning and 50 mg orally in the evening
Week 3: 75 mg orally in the morning and 75 mg orally in the evening
Week 4: 100 mg orally in the morning and 100 mg orally in the evening
Week 5: 150 mg orally in the morning and 150 mg orally in the evening
Week 6: 200 mg orally in the morning and 200 mg orally in the evening

Adjunctive Therapy (adults 17 years and older): Partial Onset Seizures, Primary Generalized Tonic-Clonic Seizures, or Lennox-Gastaut Syndrome:
-Recommended dose:
Partial onset seizures or Lennox-Gastaut Syndrome: 200 to 400 mg orally daily in two divided doses
Primary generalized tonic-clonic seizures: 400 mg orally daily in two divided doses
-Therapy should be initiated at 25 to 50 mg orally daily followed by titration to an effective dose in increments of 25 to 50 mg daily every week. Titrating in increments of 25 mg daily every week may delay the time to reach an effective dose.
-Doses above 400 mg daily have not been shown to improve responses in dose-response studies in adults with partial onset seizures. Daily doses above 1600 mg have not been studied.
-In the study of primary generalized tonic-clonic seizures, the initial titration rate was slower than in previous studies. The assigned dose was reached at the end of 8 weeks.

EXTENDED-RELEASE:

Monotherapy (adults and pediatric patients 10 years and older with partial onset or primary generalized tonic-clonic seizures):
-Recommended dose: 400 mg orally once daily
-The dose should be achieved by titration:
Week 1: 50 mg once daily
Week 2: 100 mg once daily
Week 3: 150 mg once daily
Week 4: 200 mg once daily
Week 5: 300 mg once daily
Week 6: 400 mg once daily

Adjunctive Therapy (adults 17 years and older): Partial Onset Seizures, Primary Generalized Tonic-Clonic Seizures, or Lennox-Gastaut Syndrome:
-Recommended dose:
Partial onset seizures or Lennox-Gastaut Syndrome: 200 to 400 mg orally once daily
Primary generalized tonic-clonic seizures: 400 mg orally once daily
-Therapy should be initiated at 25 to 50 mg orally once daily followed by titration to an effective dose in increments of 25 to 50 mg daily every week.
-Daily doses above 1600 mg have not been studied.
-In the study of primary generalized tonic-clonic seizures, the assigned dose was reached at the end of 8 weeks.

Usual Pediatric Dose for Seizure Prophylaxis

IMMEDIATE RELEASE:

Monotherapy:
The dose in children 2 to less than 10 years with partial onset or primary generalized tonic-clonic seizures is based on weight:
Titration schedule:
-Week 1: 25 mg orally daily in the evening
-Week 2 (if week 1 dose is tolerated): 25 mg orally 2 times daily
-Thereafter: Dosage can be increased by 25 to 50 mg orally daily each week as tolerated.
-Titration to the minimum maintenance dose should be attempted over 5 to 7 weeks of the total titration period.
-Based upon tolerability and seizure control, titration to a higher dose (up to the maximum maintenance dose) can be attempted with 25 to 50 mg daily in weekly increments.
-The total daily dose should not exceed the maximum maintenance dose for each range of body weight:
Monotherapy total daily maintenance dosing for patients 2 to less than 10 years:
Up to 11 kg: Minimum dose: 150 mg daily; Maximum dose: 250 mg daily
12 to 22 kg: Minimum dose: 200 mg daily; Maximum dose: 300 mg daily
23 to 31 kg: Minimum dose: 200 mg daily; Maximum dose: 350 mg daily
32 to 38 kg: Minimum dose: 250 mg; Maximum dose: 350 mg
Greater than 38 kg: Minimum dose: 250 mg daily; Maximum dose: 400 mg daily

Adjunctive therapy:
Pediatric patients ages 2 to 16 years with partial onset seizures, primary generalized tonic-clonic seizures, or Lennox-Gastaut Syndrome:
-Recommended dose: 5 to 9 mg/kg/day in two divided doses
-Titration should begin at 25 mg orally daily (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 response. Dose titration should be guided by clinical outcome.

EXTENDED-RELEASE:

Monotherapy:
See adult dosing.

Adjunctive therapy:
Pediatric patients ages 6 to 16 years with partial onset seizures, primary generalized tonic-clonic seizures, or Lennox-Gastaut Syndrome:
-Recommended dose: 5 to 9 mg/kg orally once daily.
-Titration should begin at 25 mg once daily (based on a range of 1 mg/kg/day to 3 mg/kg/day) given 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 to achieve optimal response. Dose titration should be guided by clinical outcome. If required, longer intervals between dose adjustments can be used.

Renal Dose Adjustments

CrCl less than 70 mL/min: One-half the usual starting and maintenance dose is recommended in patients with moderate or severe renal impairment.

Liver Dose Adjustments

In hepatically impaired patients, the clearance of topiramate may be decreased.

Dose Adjustments

Addition or withdrawal of phenytoin and/or carbamazepine during adjunctive therapy with topiramate may require adjustment of the dose of topiramate.

Dialysis

Topiramate is cleared by hemodialysis at a rate 4 to 6 times greater than a normal individual. Prolonged
dialysis may cause topiramate concentration to fall below that required to maintain the antiseizure effect. To avoid rapid drops in topiramate plasma concentration during hemodialysis, a supplemental dose of topiramate may be required. The adjustment should take into account 1) the duration of dialysis period, 2) the clearance rate of the dialysis system being used, and 3) the effective renal clearance of topiramate in the patient being dialyzed.

Other Comments

It is not necessary to monitor topiramate plasma concentrations to optimize therapy.

No evidence of tolerance has been demonstrated in humans. Doses above 400 mg/day have not been shown to improve responses in dose range studies in adults with partial onset seizures.

Topiramate may be given without regard to meals. Because of the bitter taste, tablets should not be broken.

Topiramate 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.

Topiramate extended-release must be swallowed whole. Do not sprinkle on food, chew, or crush.

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