Drug Detail:Topiramate er (eqv-qudexy xr) (Topiramate [ toe-pyre-a-mate ])
Drug Class: Carbonic anhydrase inhibitor anticonvulsants
Usual Adult Dose for Epilepsy
MONOTHERAPY:
Immediate-Release: 400 mg orally daily in 2 divided doses
- The dose should be achieved by titration according to the following schedule:
Week 2: 50 mg orally in the AM and 50 mg orally in the PM
Week 3: 75 mg orally in the AM and 75 mg orally in the PM
Week 4: 100 mg orally in the AM and 100 mg orally in the PM
Week 5: 150 mg orally in the AM and 150 mg orally in the PM
Week 6: 200 mg orally in the AM and 200 mg orally in the PM
Extended-Release: 400 mg orally once a day
- The dose should be achieved by titration according to the following schedule:
Week 2: 100 mg orally once a day
Week 3: 150 mg orally once a day
Week 4: 200 mg orally once a day
Week 5: 300 mg orally once a day
Week 6: 400 mg orally once a day
ADJUNCTIVE THERAPY:
Immediate-Release:
- Partial onset seizures: 200 to 400 mg orally daily in 2 divided doses
- Primary generalized tonic-clonic seizures: 400 mg orally daily in 2 divided doses
Extended-Release:
- Partial onset seizures: 200 to 400 mg orally once a day
- Primary generalized tonic-clonic seizures: 400 mg orally once a day
Comments:
- Dose titration rate should be guided by clinical outcome, if needed, longer intervals between dose increases may be used.
- Doses above 400 mg daily have not been shown to improve responses in dose-response studies in adults with partial onset seizures.
- Daily topiramate doses above 1600 mg have not been studied.
- Co-administration with phenytoin and/or carbamazepine may require dose adjustments.
Uses:
- Initial monotherapy or adjunctive therapy for patients with partial onset or primary generalized tonic-clonic seizures.
Usual Adult Dose for Migraine Prophylaxis
IMMEDIATE RELEASE: 100 mg orally daily in 2 divided doses
The dose should be achieved by titration: If required, longer intervals between dose adjustments can be used
Week 1: No dose in the AM and 25 mg orally in the PM
Week 2: 25 mg orally in the AM and 25 mg orally in the PM
Week 3: 25 mg orally in the AM and 50 mg orally in the PM
Week 4: 50 mg orally in the AM and 50 mg orally in the PM
EXTENDED-RELEASE: 100 mg orally once a day
The dose should be achieved by titration: If required, longer intervals between dose adjustments can be used
Week 1: 25 mg orally once a day
Week 2: 50 mg orally once a day
Week 3: 75 mg orally once a day
Week 4: 100 mg orally once a day
Comments:
- Dose titration rate should be guided by clinical outcome, if needed, longer intervals between dose adjustments may be used.
Use: For the prophylaxis of migraine headache
Usual Adult Dose for Lennox-Gastaut Syndrome
Immediate-Release: 200 to 400 mg orally daily in 2 divided doses
- Initiate with 25 to 50 mg orally once a day; increase in increments of 25 to 50 mg per week to an effective dose.
Extended-Release: 200 to 400 mg orally once a day
- Initiate therapy at 25 to 50 mg orally once a day followed by titration in increments of 25 to 50 mg per week to an effective dose.
Comments:
- Doses above 400 mg daily have not been shown to improve responses in dose-response studies in adults with partial onset seizures.
- Daily topiramate doses above 1600 mg have not been studied.
- Co-administration with phenytoin and/or carbamazepine may require dose adjustments.
Use: Adjunctive therapy for patients with seizures associated with Lennox-Gastaut syndrome (LGS).
Usual Pediatric Dose for Epilepsy
MONOTHERAPY: 2 to less than 10 years old:
IMMEDIATE-RELEASE:
- Week 1: 25 mg orally once a day in the evening; If tolerated, increase to 25 mg orally twice a day for Week 2; Thereafter, increase by 25 to 50 mg/day each week as tolerated
- Titration to the minimum maintenance dose should be attempted over 5 to 7 weeks; based upon tolerability and clinical response, titration to a higher dose (up to the maximum maintenance dose) can be attempted weekly in increments of 25 to 50 mg/day
- Weight: Up to 11 kg: Minimum: 150 mg/day; Maximum: 250 mg/day
- Weight: 12 to 22 kg: Minimum: 200 mg/day; Maximum: 300 mg/day
- Weight: 23 to 31 kg: Minimum: 200 mg/day; Maximum: 350 mg/day
- Weight: 32 to 38 kg: Minimum: 250 mg/day; Maximum: 350 mg/day
- Weight: Greater than 38 kg: Minimum: 250 mg/day; Maximum: 400 mg/day
- Week 1: 25 mg orally once a day in the evening; If tolerated, increase to 50 mg orally once a day for Week 2; Thereafter, increase by 25 to 50 mg/day each week as tolerated
- Titration to the minimum maintenance dose should be attempted over 5 to 7 weeks; based upon tolerability and clinical response, titration to a higher dose (up to the maximum maintenance dose) can be attempted weekly in increments of 25 to 50 mg/day. (administered once a day):
- Maintenance Dose: Same minimum and maximum doses as immediate-release except administration is once a day
MONOTHERAPY: 10 years or older:
IMMEDIATE-RELEASE: 400 mg orally daily in 2 divided doses
- The dose should be achieved by titration according to the following schedule:
Week 2: 50 mg orally in the AM and 50 mg orally in the PM
Week 3: 75 mg orally in the AM and 75 mg orally in the PM
Week 4: 100 mg orally in the AM and 100 mg orally in the PM
Week 5: 150 mg orally in the AM and 150 mg orally in the PM
Week 6: 200 mg orally in the AM and 200 mg orally in the PM
EXTENDED-RELEASE: 400 mg orally once a day
- The dose should be achieved by titration according to the following schedule:
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
ADJUNCTIVE THERAPY: 2 to 16 years old:
IMMEDIATE-RELEASE: 5 to 9 mg/kg in 2 divided doses
The dose should be achieved by titration:
- Initiate with 25 mg orally once a day (or less, based on range of 1 to 3 mg/kg/day); increase in increments of 1 to 3 mg/kg/day (in divided doses twice a day) every 1 or 2 weeks to an effective dose.
EXTENDED-RELEASE: 5 to 9 mg/kg/day
The dose should be achieved by titration:
- Initiate with 25 mg orally once a day (based on range of 1 to 3 mg/kg/day); increase in increments of 1 to 3 mg/kg/day every 1 or 2 weeks to an effective dose.
ADJUNCTIVE THERAPY: 17 years or older: See Adult Dosing
Comments:
- Dose titration rate should be guided by clinical outcome, if needed, longer intervals between dose increases may be used.
- Qudexy XR: Extended-release capsules may be swallowed whole or opened and sprinkled on a spoonful of soft food. These extended-release capsules are appropriate for pediatric patients 2 years or older.
- Trokendi XR: Extended-release capsules must be swallowed whole and intact and therefore are not appropriate for children less than 6 years of age.
- Dose titration should be guided by clinical outcome.
- Co-administration with phenytoin and/or carbamazepine may require dose adjustments.
Uses:
- Initial monotherapy in patients 2 years or older with partial onset or primary generalized tonic-clonic seizures, and as adjunctive therapy for patients with partial onset or primary generalized tonic-clonic seizures or seizures associated with Lennox-Gastaut syndrome.
Usual Pediatric Dose for Lennox-Gastaut Syndrome
MONOTHERAPY: 2 to less than 10 years old:
IMMEDIATE-RELEASE:
- Week 1: 25 mg orally once a day in the evening; If tolerated, increase to 25 mg orally twice a day for Week 2; Thereafter, increase by 25 to 50 mg/day each week as tolerated
- Titration to the minimum maintenance dose should be attempted over 5 to 7 weeks; based upon tolerability and clinical response, titration to a higher dose (up to the maximum maintenance dose) can be attempted weekly in increments of 25 to 50 mg/day
- Weight: Up to 11 kg: Minimum: 150 mg/day; Maximum: 250 mg/day
- Weight: 12 to 22 kg: Minimum: 200 mg/day; Maximum: 300 mg/day
- Weight: 23 to 31 kg: Minimum: 200 mg/day; Maximum: 350 mg/day
- Weight: 32 to 38 kg: Minimum: 250 mg/day; Maximum: 350 mg/day
- Weight: Greater than 38 kg: Minimum: 250 mg/day; Maximum: 400 mg/day
- Week 1: 25 mg orally once a day in the evening; If tolerated, increase to 50 mg orally once a day for Week 2; Thereafter, increase by 25 to 50 mg/day each week as tolerated
- Titration to the minimum maintenance dose should be attempted over 5 to 7 weeks; based upon tolerability and clinical response, titration to a higher dose (up to the maximum maintenance dose) can be attempted weekly in increments of 25 to 50 mg/day. (administered once a day):
- Maintenance Dose: Same minimum and maximum doses as immediate-release except administration is once a day
MONOTHERAPY: 10 years or older:
IMMEDIATE-RELEASE: 400 mg orally daily in 2 divided doses
- The dose should be achieved by titration according to the following schedule:
Week 2: 50 mg orally in the AM and 50 mg orally in the PM
Week 3: 75 mg orally in the AM and 75 mg orally in the PM
Week 4: 100 mg orally in the AM and 100 mg orally in the PM
Week 5: 150 mg orally in the AM and 150 mg orally in the PM
Week 6: 200 mg orally in the AM and 200 mg orally in the PM
EXTENDED-RELEASE: 400 mg orally once a day
- The dose should be achieved by titration according to the following schedule:
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
ADJUNCTIVE THERAPY: 2 to 16 years old:
IMMEDIATE-RELEASE: 5 to 9 mg/kg in 2 divided doses
The dose should be achieved by titration:
- Initiate with 25 mg orally once a day (or less, based on range of 1 to 3 mg/kg/day); increase in increments of 1 to 3 mg/kg/day (in divided doses twice a day) every 1 or 2 weeks to an effective dose.
EXTENDED-RELEASE: 5 to 9 mg/kg/day
The dose should be achieved by titration:
- Initiate with 25 mg orally once a day (based on range of 1 to 3 mg/kg/day); increase in increments of 1 to 3 mg/kg/day every 1 or 2 weeks to an effective dose.
ADJUNCTIVE THERAPY: 17 years or older: See Adult Dosing
Comments:
- Dose titration rate should be guided by clinical outcome, if needed, longer intervals between dose increases may be used.
- Qudexy XR: Extended-release capsules may be swallowed whole or opened and sprinkled on a spoonful of soft food. These extended-release capsules are appropriate for pediatric patients 2 years or older.
- Trokendi XR: Extended-release capsules must be swallowed whole and intact and therefore are not appropriate for children less than 6 years of age.
- Dose titration should be guided by clinical outcome.
- Co-administration with phenytoin and/or carbamazepine may require dose adjustments.
Uses:
- Initial monotherapy in patients 2 years or older with partial onset or primary generalized tonic-clonic seizures, and as adjunctive therapy for patients with partial onset or primary generalized tonic-clonic seizures or seizures associated with Lennox-Gastaut syndrome.
Usual Pediatric Dose for Migraine Prophylaxis
12 years or older:
IMMEDIATE RELEASE: 100 mg orally daily in 2 divided doses
The dose should be achieved by titration: if needed, longer intervals between dose increases may be used
- Week 1: No dose in the AM and 25 mg orally in the PM
- Week 2: 25 mg orally in the AM and 25 mg orally in the PM
- Week 3: 25 mg orally in the AM and 50 mg orally in the PM
- Week 4: 50 mg orally in the AM and 50 mg orally in the PM
EXTENDED-RELEASE: 100 mg orally once a day
The dose should be achieved by titration: if needed, longer intervals between dose increases may be used
- Week 1: 25 mg orally once a day
- Week 2: 50 mg orally once a day
- Week 3: 75 mg orally once a day
- Week 4: 100 mg orally once a day
Comments:
- Dose titration rate should be guided by clinical outcome, if needed, longer intervals between dose increases may be used.
Use: For pediatric patients 12 years or older for the prevention of migraine headache.
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
Topiramate plasma level monitoring is not required to optimize therapy.
Dosage adjustments may be required following addition or withdrawal of phenytoin and/or carbamazepine.
Drug Discontinuation:
- Antiepileptic drugs including topiramate should not be abruptly discontinued.
- Antiepileptic drugs should be gradually withdrawn in patients both with or without a history of seizures or epilepsy so as to minimize the potential for seizures or increased seizure frequency.
- In situations where rapid withdrawal is medically required, appropriate monitoring will be necessary.
Precautions
CONTRAINDICATIONS:
Immediate-release: None
Extended-release: Trokendi XR: Use of alcohol within 6 hours before or after administration
Safety and effectiveness have not been established for adjunctive treatment of partial onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome in patients younger than 2 years.
Safety and effectiveness have not been established for the prophylaxis of migraine headache in patients younger than 12 years.
Consult WARNINGS section for additional precautions.
Dialysis
Supplemental dosing may be required to avoid a rapid drop in topiramate plasma concentration; to determine actual dose adjustment needed, consider:
- Duration of dialysis period
- Clearance rate of the dialysis system being used
- Effective renal clearance of topiramate in the patient being dialyzed
Other Comments
Administration advice:
- Take orally; may be taken without regard to meals
- Tablets: Swallow whole; should not be broken because of the bitter taste
- Capsules: May be swallowed whole or may be opened and sprinkled on a small amount (teaspoon) of soft food; mixture should be swallowed immediately and not chewed; do not store for future use
- Qudexy XR: May be swallowed whole or may be opened and sprinkled on a small amount (teaspoon) of soft food; mixture should be swallowed immediately and not chewed; do not store for future use
- Trokendi XR: Swallow whole; avoid alcohol 6 hours before to 6 hours after dosing as the presence of alcohol may alter absorption of topiramate
MISSED dose:
- Immediate-release tablets/capsules: If missed, take a soon as possible unless it is within 6 hours of next dose, if within 6 hours of next scheduled dose, skip the missed dose; do not take a double dose. If more than 1 dose has been missed, patients should be instructed to contact their healthcare provider
- Extended-release: If missed, take a soon as possible, do not double the next dose. If more than 1 dose is missed, patients should be instructed to contact their healthcare provider
General:
- Adequate hydration, especially in patients predisposed to kidney stones, is necessary to minimize the risk of kidney stone formation.
- This drug, like other antiepileptic drugs, may increase the risk of suicidal thoughts and behaviors.
Monitoring:
- Monitor for decreased sweating and increased body temperature, especially during hot weather and in pediatric patients
- Obtain ammonia level in patients developing unexplained lethargy, vomiting, or changes in mental status
- Measure baseline and periodic serum bicarbonate concentrations
- Monitor for emergence of worsening depression, suicidal thoughts or behaviors, and/or any unusual changes in mood or behavior
Patient advice:
- Patients should be instructed to read the US FDA-approved patient labeling (Medication Guide).
- Patients should be instructed to maintain adequate fluid intake to avoid the possibility of kidney stones.
- Patients should be instructed to seek immediate medical advice if they develop acute visual loss or ocular pain; any visual disturbances should be reported to their healthcare provider.
- Patients should be instructed to report decreased sweating, high or persistent fevers, hyperventilation, mental status changes, especially if accompanied by lethargy or vomiting.
- Patients should be instructed to report any unusual changes in mood or behavior, suicidal thoughts, or thoughts about self-harm.
- Patients should discuss with their healthcare provider the appropriate caution to take for driving, or engaging in any activities where loss of consciousness could result in serious danger to themselves or those around them.
- Women should be advised to speak to physician or health care professional if pregnant, intend to become pregnant, or are breastfeeding; women of childbearing potential should use effective contraception.
Frequently asked questions
- Can antidepressants be used for arthritis pain?
- Does this drug cause weight loss?
- What not to take with topiramate?
- Does topiramate cause hair loss?
- How long do you stay on Topamax for migraines?
- How long does it take for Topamax to start working?
- How long does Topamax stay in your system?
- How does Trokendi XR help with weight loss?
- Are Topamax and Trokendi XR the same thing?
- What is it used to treat?
- When is the best time of day to take Trokendi XR?
- How fast does Trokendi XR work for migraines?
