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Topiramate Dosage

Applies to the following strength(s): 25 mg ; 50 mg ; 100 mg ; 200 mg ; 15 mg ; 150 mg

The information at Drugs.com is not a substitute for medical advice. ALWAYS consult your doctor or pharmacist.

Usual Adult Dose for:

Usual Pediatric Dose for:

Additional dosage information:

Usual Adult Dose for Seizures

IMMEDIATE RELEASE:
MONOTHERAPY (For initial monotherapy in patients 10 years of age and older with partial onset or primary generalized tonic-clonic seizures):
Recommended dose: 400 mg orally per day in 2 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

IMMEDIATE RELEASE:
ADJUNCTIVE THERAPY: (For adjunctive therapy for adults and pediatric patients ages 2 to 16 years with partial onset seizures or primary generalized tonic-clonic seizures, and in patients 2 years of age and older with seizures associated with Lennox-Gastaut Syndrome):
Recommended dose:
-Partial onset seizures or Lennox-Gastaut Syndrome: 200 to 400 mg orally per day in 2 divided doses
-Primary generalized tonic-clonic seizures: 400 mg orally per day in 2 divided doses
-Therapy should be initiated at 25 to 50 mg orally per day followed by titration to an effective dose in increments of 25 to 50 mg per day every week. Titrating in increments of 25 mg per day every week may delay the time to reach an effective dose.
-Doses above 400 mg per day 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: (For adults and pediatric patients 10 years and older with partial onset seizures or primary generalized tonic-clonic seizures):
Recommended dose: 400 mg orally once a day
The dose should be achieved by titration:
Week 1: 50 mg once a day
Week 2: 100 mg once a day
Week 3: 150 mg once a day
Week 4: 200 mg once a day
Week 5: 300 mg once a day
Week 6: 400 mg once a day

EXTENDED-RELEASE:
ADJUNCTIVE THERAPY: (For adults 17 years and older with 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 a day
-Primary generalized tonic-clonic seizures: 400 mg orally once a day
-Therapy should be initiated at 25 to 50 mg orally once a day followed by titration to an effective dose in increments of 25 to 50 mg 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 Adult Dose for Lennox-Gastaut Syndrome

IMMEDIATE RELEASE:
MONOTHERAPY (For initial monotherapy in patients 10 years of age and older with partial onset or primary generalized tonic-clonic seizures):
Recommended dose: 400 mg orally per day in 2 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

IMMEDIATE RELEASE:
ADJUNCTIVE THERAPY: (For adjunctive therapy for adults and pediatric patients ages 2 to 16 years with partial onset seizures or primary generalized tonic-clonic seizures, and in patients 2 years of age and older with seizures associated with Lennox-Gastaut Syndrome):
Recommended dose:
-Partial onset seizures or Lennox-Gastaut Syndrome: 200 to 400 mg orally per day in 2 divided doses
-Primary generalized tonic-clonic seizures: 400 mg orally per day in 2 divided doses
-Therapy should be initiated at 25 to 50 mg orally per day followed by titration to an effective dose in increments of 25 to 50 mg per day every week. Titrating in increments of 25 mg per day every week may delay the time to reach an effective dose.
-Doses above 400 mg per day 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: (For adults and pediatric patients 10 years and older with partial onset seizures or primary generalized tonic-clonic seizures):
Recommended dose: 400 mg orally once a day
The dose should be achieved by titration:
Week 1: 50 mg once a day
Week 2: 100 mg once a day
Week 3: 150 mg once a day
Week 4: 200 mg once a day
Week 5: 300 mg once a day
Week 6: 400 mg once a day

EXTENDED-RELEASE:
ADJUNCTIVE THERAPY: (For adults 17 years and older with 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 a day
-Primary generalized tonic-clonic seizures: 400 mg orally once a day
-Therapy should be initiated at 25 to 50 mg orally once a day followed by titration to an effective dose in increments of 25 to 50 mg 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 Seizures

IMMEDIATE RELEASE:
MONOTHERAPY (For patients 2 years of age and older with partial onset or primary generalized tonic-clonic seizures):
-The dose in children 2 to less than 10 years is based on weight:
Titration schedule:
-Week 1: 25 mg orally per day in the evening
-Week 2 (if week 1 dose is tolerated): 25 mg orally 2 times a day
-Thereafter: Dosage can be increased by 25 to 50 mg orally per day 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 per day 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 per day; Maximum dose: 250 mg per day
12 to 22 kg: Minimum dose: 200 mg per day; Maximum dose: 300 mg per day
23 to 31 kg: Minimum dose: 200 mg per day; Maximum dose: 350 mg per day
32 to 38 kg: Minimum dose: 250 mg; Maximum dose: 350 mg
Greater than 38 kg: Minimum dose: 250 mg per day; Maximum dose: 400 mg per day

IMMEDIATE RELEASE:
ADJUNCTIVE THERAPY (For 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 orally once a day
-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 mg/kg/day 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.

EXTENDED-RELEASE:
MONOTHERAPY (For pediatric patients 2 to less than 10 years with partial onset or primary generalized tonic-clonic seizures):
-The dose in children 2 to less than 10 years is based on weight:
Titration schedule:
-Week 1: 25 mg orally per day in the evening
-Week 2 (if week 1 dose is tolerated): 25 mg orally 2 times a day
-Thereafter: Dosage can be increased by 25 to 50 mg orally per day 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 per day 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 per day; Maximum dose: 250 mg per day
12 to 22 kg: Minimum dose: 200 mg per day; Maximum dose: 300 mg per day
23 to 31 kg: Minimum dose: 200 mg per day; Maximum dose: 350 mg per day
32 to 38 kg: Minimum dose: 250 mg; Maximum dose: 350 mg
Greater than 38 kg: Minimum dose: 250 mg per day; Maximum dose: 400 mg per day

EXTENDED-RELEASE:
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 orally once a day
-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 mg/kg/day 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.

Usual Pediatric Dose for Lennox-Gastaut Syndrome

IMMEDIATE RELEASE:
MONOTHERAPY (For patients 2 years of age and older with partial onset or primary generalized tonic-clonic seizures):
-The dose in children 2 to less than 10 years is based on weight:
Titration schedule:
-Week 1: 25 mg orally per day in the evening
-Week 2 (if week 1 dose is tolerated): 25 mg orally 2 times a day
-Thereafter: Dosage can be increased by 25 to 50 mg orally per day 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 per day 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 per day; Maximum dose: 250 mg per day
12 to 22 kg: Minimum dose: 200 mg per day; Maximum dose: 300 mg per day
23 to 31 kg: Minimum dose: 200 mg per day; Maximum dose: 350 mg per day
32 to 38 kg: Minimum dose: 250 mg; Maximum dose: 350 mg
Greater than 38 kg: Minimum dose: 250 mg per day; Maximum dose: 400 mg per day

IMMEDIATE RELEASE:
ADJUNCTIVE THERAPY (For 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 orally once a day
-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 mg/kg/day 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.

EXTENDED-RELEASE:
MONOTHERAPY (For pediatric patients 2 to less than 10 years with partial onset or primary generalized tonic-clonic seizures):
-The dose in children 2 to less than 10 years is based on weight:
Titration schedule:
-Week 1: 25 mg orally per day in the evening
-Week 2 (if week 1 dose is tolerated): 25 mg orally 2 times a day
-Thereafter: Dosage can be increased by 25 to 50 mg orally per day 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 per day 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 per day; Maximum dose: 250 mg per day
12 to 22 kg: Minimum dose: 200 mg per day; Maximum dose: 300 mg per day
23 to 31 kg: Minimum dose: 200 mg per day; Maximum dose: 350 mg per day
32 to 38 kg: Minimum dose: 250 mg; Maximum dose: 350 mg
Greater than 38 kg: Minimum dose: 250 mg per day; Maximum dose: 400 mg per day

EXTENDED-RELEASE:
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 orally once a day
-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 mg/kg/day 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: Reduce the usual starting and maintenance dose by 50%

Liver Dose Adjustments

Moderate to severe hepatic impairment: Use with caution

Dose Adjustments

For optimum seizure control therapy should be initiated at a low dose and slowly titrated to an adequate clinical response. Topiramate plasma level monitoring is not required to optimize therapy.

Doses greater than or equal to 50 mg should be administered as 2 divided doses.

During adjunctive therapy, a dosage adjustment for topiramate may be required following addition or withdrawal of phenytoin and/or carbamazepine.

When topiramate replaces another antiepileptic drug, the dose of the other antiepileptic should be reduced gradually at the rate of approximately one-third of the dose every 2 weeks while initiating topiramate therapy. When an enzyme-inducing drug is discontinued, topiramate levels may increase and a decrease in the topiramate dosage may be required.

Topiramate should not be abruptly discontinued. It should be gradually withdrawn to minimize the potential for increased seizure frequency. Patients requiring rapid discontinuation should be monitored carefully.

Precautions

Safety and efficacy have not been in patients younger than 2 years.

Consult WARNINGS section for additional precautions.

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

Administration advice:
-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.

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

Monitoring:
Hepatic: Liver function
Metabolic: Serum bicarbonate levels (particularly if metabolic acidosis is suspected); weight loss
Psychiatric: Mood disturbances, depression
Renal: Renal function

Patient advice: Topiramate may cause drowsiness; avoid driving or operating machinery until you know how this drug affects you.

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