Pending revision, the material in this section should be considered in light of more recently available information in the MEDWATCH notification at the beginning of this monograph.
Seizure Disorders
Management (in combination with other anticonvulsants) of partial seizures in adults and children 2–16 years of age.
Management (in combination with other anticonvulsants) of primary generalized tonic-clonic seizures in adults and children 2–16 years of age.
Management (in combination with other anticonvulsants) of seizures associated with Lennox-Gastaut syndrome in adults and children ≥2 years of age.
Migraine Prophylaxis
Prophylaxis of migraine headache in adults.
Efficacy in the acute management (i.e., abortive therapy) of migraine headache not established.
Dosage and Administration
General
Pending revision, the material in this section should be considered in light of more recently available information in the MEDWATCH notification at the beginning of this monograph.
Monitoring of plasma topiramate concentrations is not necessary when topiramate is added to an existing anticonvulsant regimen; however, addition of topiramate to phenytoin therapy may require adjustment of phenytoin dosage.
Addition or withdrawal of phenytoin and/or carbamazepine during adjunctive therapy may require adjustment of topiramate dosage. (See Specific Drugs under Interactions.)
Adjust dosage carefully and individualize according to patient response and tolerance.
Too rapid titration (e.g., over 3–6 weeks) to achieve target dosage and/or excessive target dosage may contribute to a higher incidence of adverse effects.
Administration
Oral Administration
Administer orally without regard to meals.
Capsule/sprinkle formulation is bioequivalent to immediate-release tablet and may be substituted as a therapeutic equivalent.
Capsules
Swallow capsules whole.
Alternatively, open capsule and sprinkle entire contents on soft food (e.g., applesauce, custard, ice cream, oatmeal, yogurt, pudding); swallow immediately without chewing.
Drinking fluids immediately may help to ensure that all of the mixture is swallowed.
Do not store the sprinkle/food mixture for use at a later time.
Tablets
Tablets preferably should be swallowed intact and not broken or chewed because of the bitter taste.
If patient has difficulty in swallowing tablets, the tablets may be crushed and mixed with oatmeal or applesauce; use immediately since stability cannot be ensured.
If tablets are broken, use immediately since stability beyond a brief period cannot be ensured. Discard any unused portion.
Dosage
Pending revision, the material in this section should be considered in light of more recently available information in the MEDWATCH notification at the beginning of this monograph.
Pediatric Patients
Seizure Disorders
Partial Seizures, Primary Generalized Tonic-Clonic Seizures, or Seizures Associated with Lennox-Gastaut Syndrome
Oral
Initially, 25 mg (or less based on a range of 1–3 mg/kg daily) given nightly for the first week in children 2–16 years of age. Increase dosage at 1- or 2-week intervals in increments of 1–3 mg/kg daily, administered in 2 divided doses, to achieve optimal clinical response.
Maintenance, 5–9 mg/kg daily in 2 divided doses.
Alternatively, some clinicians recommend an initial dosage of 0.5–1 mg/kg daily, with slow titration (in increments of 1–3 mg/kg every other week or in increments of 0.5–1 mg/kg per week) to obtain optimal efficacy with minimal adverse effects.
Adults
Seizure Disorders
Partial Seizures
Oral
Initially, 25–50 mg daily. Increase dosage at weekly intervals in increments of 25–50 mg to achieve optimal clinical response.
Recommended maintenance dosage is 200–400 mg daily, administered in 2 equally divided doses (morning and evening).
Titration in increments of 25 mg/week is associated with a lower incidence of cognitive and psychiatric adverse effects and lower discontinuance rates but may delay the time to reach an effective dosage.
Dosages >400 mg daily generally have not produced substantial additional improvement, but may improve seizure control in some patients, if tolerated.
Primary Generalized Tonic-Clonic Seizures
Oral
Initially, 25–50 mg daily. Increase dosage at weekly intervals in increments of 25–50 mg to achieve optimal clinical response.
Recommended maintenance dosage is 400 mg daily, administered in 2 equally divided doses (morning and evening).
Titration in increments of 25 mg/week is associated with a lower incidence of cognitive and psychiatric adverse effects and lower discontinuance rates but may delay the time to reach an effective dosage.
Seizures Associated with Lennox-Gastaut Syndrome
Oral
Manufacturer makes no specific dosage recommendations; in 1 controlled trial, topiramate was initiated at dosage of 1 mg/kg and titrated over 2 weeks to target dosage of approximately 6 mg/kg daily.
Migraine Prophylaxis
Oral
Recommended total daily dosage is 100 mg, administered in 2 divided doses. Titrate therapy using the following schedule in Table 1.
Table 1. Topiramate Dosage Titration Schedule for Migraine Prophylaxis in Adults
Week
Morning Dose
Evening Dose
1
None
25 mg
2
25 mg
25 mg
3
25 mg
50 mg
4
50 mg
50 mg
Titrate dosage based on clinical outcome. Use longer intervals between dose adjustments if required.
Prescribing Limits
Adults
Seizure Disorders
Oral
Dosages >1.6 g daily in patients with seizure disorders have not been studied.
Special Populations
Hepatic Impairment
Clearance may be decreased; however, manufacturer makes no specific recommendations regarding dosage adjustment.
Renal Impairment
If Clcr is <70 mL/minute per 1.73 m2, decrease daily adult dosage by 50%. Patients with renal impairment will require a longer time to reach steady state at each dosage level.
Patients undergoing hemodialysis may require a supplemental dose following dialysis session; base amount on duration of dialysis, clearance rate of dialysis system, and the patient’s effective renal clearance of topiramate.
Geriatric Patients
If Clcr <70 mL/minute per 1.73 m2, dosage adjustment may be necessary. (See Renal Impairment under Dosage and Administration.)
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