Trokendi XR Dosage
Generic name: topiramate 25mg
Dosage form: capsule, extended release
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Dosing in Monotherapy Epilepsy
Adults and Pediatric Patients 10 Years and Older with Partial Onset or Primary Generalized Tonic-Clonic Seizures
The recommended dose for topiramate monotherapy in adults and in pediatric patients 10 years of age and older is 400 mg orally once daily. Titrate TROKENDI XR® according to the following schedule:
|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|
Pediatric Patients Ages 6 to less than 10 Years
Dosing of topiramate as initial monotherapy in pediatric patients 6 to less than 10 years of age with partial onset or primary generalized tonic-clonic seizures was based on a pharmacometric bridging approach [see Clinical Studies (14.1)].
Dosing in patients 6 to less than 10 years is based on weight. During the titration period, the initial dose of TROKENDI XR® should be 25 mg/day administered nightly for the first week. Based upon tolerability, the dosage can be increased to 50 mg/day 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 1).
|Weight (kg)||Total Daily Dose
Minimum Maintenance Dose
|Total Daily Dose
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|
Dosing in Adjunctive Therapy Epilepsy
Adults 17 Years of Age and Over with Partial Onset Seizures, Primary Generalized Tonic-Clonic Seizures, or Lennox-Gastaut Syndrome
The recommended total daily dose of TROKENDI XR® as adjunctive therapy in adults with partial onset seizures or Lennox-Gastaut Syndrome is 200 mg to 400 mg orally once daily and with primary generalized tonic-clonic seizures is 400 mg orally once daily.
Initiate therapy at 25 mg to 50 mg once daily followed by titration to an effective dose in increments of 25 mg to 50 mg every week. Daily topiramate doses above 1600 mg have not been studied.
In the study of primary generalized tonic-clonic seizures using topiramate, the assigned dose was reached at the end of 8 weeks [see Clinical Studies (14.4)].
Pediatric Patients 6 to 16 Years of Age - Partial Onset Seizures, Primary Generalized Tonic-Clonic Seizures, or Lennox-Gastaut Syndrome
The recommended total daily dose of TROKENDI XR® as adjunctive therapy for pediatric patients with partial onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome is approximately 5 mg/kg to 9 mg/kg orally once daily. Begin titration 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. Subsequently, increase the dosage at 1- or 2-week intervals by increments of 1 mg/kg to 3 mg/kg to achieve optimal clinical response. Dose titration should be guided by clinical outcome. If required, longer intervals between dose adjustments can be used.
In the study of primary generalized tonic-clonic seizures, the assigned dose of 6 mg/kg once daily was reached at the end of 8 weeks [see Clinical Studies (14.4)].
Dosing in Migraine
The recommended total daily dose of TROKENDI XR® as treatment for prophylaxis of migraine headache in adults and adolescents 12 years of age and older is 100 mg once daily. The recommended titration rate for TROKENDI XR® for migraine prophylaxis to 100 mg once daily is:
Migraine Prophylaxis Titration Schedule for Adults and Adolescents 12 Years of Age and Older
Week 1: 25mg once daily
Week 2: 50mg once daily
Week 3: 75mg once daily
Week 4: 100mg once daily
Dose and titration rate should be guided by clinical outcome. If required, longer intervals between dose adjustments can be used.
Administration with Alcohol
Alcohol use should be completely avoided within 6 hours prior to and 6 hours after TROKENDI XR® administration [see Warnings and Precautions (5.5)].
Dose Modifications in Patients with Renal Impairment
In patients with renal impairment (creatinine clearance less than 70 mL/min/1.73 m2), one-half of the usual adult dose is recommended. Such patients will require a longer time to reach steady-state at each dose.
Prior to dosing, obtain an estimated GFR measurement in patients at high risk for renal insufficiency (e.g., older patients, or those with diabetes mellitus, hypertension, or autoimmune disease).
Dosage Modifications in Patients Undergoing Hemodialysis
Topiramate is cleared by hemodialysis at a rate that is 4 to 6 times greater than in patients with normal renal function. Accordingly, a prolonged period of dialysis may cause topiramate concentration to fall below that required to maintain an antiseizure effect. To avoid rapid drops in topiramate plasma concentration during hemodialysis, a supplemental dose of topiramate may be required. The actual adjustment should take into account the:
- duration of dialysis period
- clearance rate of the dialysis system being used
- effective renal clearance of topiramate in the patient being dialyzed
Laboratory Testing Prior to Treatment Initiation
Measurement of baseline and periodic serum bicarbonate during TROKENDI XR® treatment is recommended [see Warnings and Precautions (5.4)].
Dosing Modifications in Patients Taking Phenytoin and/or Carbamazepine
The co-administration of TROKENDI XR® with phenytoin may require an adjustment of the dose of phenytoin to achieve optimal clinical outcome. Addition or withdrawal of phenytoin and/or carbamazepine during adjunctive therapy with TROKENDI XR® may require adjustment of the dose of TROKENDI XR®.
Monitoring for Therapeutic Blood Levels
It is not necessary to monitor topiramate plasma concentrations to optimize TROKENDI XR® therapy.
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- Drug class: carbonic anhydrase inhibitor anticonvulsants