Partial seizures, primary generalised tonic-clonic seizures, Lennox-Gastaut syndrome

Active Ingredient: Topiramate

Indication for Topiramate

Population group: only children (1 year - 12 years old) , adolescents (12 years - 18 years old)

Adjunctive therapy in children aged 2 years and above, adolescents and adults with partial onset seizures with or without secondary generalization or primary generalized tonic-clonic seizures and for the treatment of seizures associated with Lennox-Gastaut syndrome.

For this indication, competent medicine agencies globally authorize below treatments:

0.5-9 mg/kg in 2 divided doses daily

Route of admnistration

Oral

Defined daily dose

0.5 - 9 mg per kg of body weight

Dosage regimen

From 0.25 To 4.5 mg per kg of body weight 2 time(s) per day every day

Loading dose

0.5 mg per kg of body weight

Detailed description

Monotherapy epilepsy

General

When concomitantAEDs are withdrawn to achieve monotherapy with topiramate, consideration should be given to the effects this may have on seizure control. Unless safety concerns require an abrupt withdrawal of the concomitant AED, a gradual discontinuation at the rate of approximately one-third of the concomitant AED dose every 2 weeks is recommended.

When enzyme inducing medicinal products are withdrawn, topiramate levels will increase. A decrease in topiramate dosage may be required if clinically indicated.

Dose and titration rate in children should be guided by clinical outcome. Treatment of children over 6 years of age should begin at 0.5 to 1 mg/kg nightly for the first week. The dosage should then be increased at 1 or 2 week intervals by increments of 0.5 to 1 mg/kg/day, administered in two divided doses. If the child is unable to tolerate the titration regimen, smaller increments or longer intervals between dose increments can be used.

The recommended initial target dose range for topiramate monotherapy in children over 6 years of age is 100 mg/day depending on clinical response, (this is about 2 mg/kg/day in children 6-16 years).

Adjunctive therapy epilepsy (partial onset seizures with or without secondary generalization, primary generalized tonicclonic seizures, or seizures associated with Lennox-Gastaut syndrome)

The recommended total daily dose of topiramate as adjunctive therapy is approximately 5 to 9 mg/kg/day in two divided doses. Titration should begin at 25 mg (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 clinical response.

Daily doses up to 30 mg/kg/day have been studied and were generally well tolerated.

Dosage considerations

It can be taken without regard to meals.

Active ingredient

Topiramate

Topiramate is classified as a sulfamate-substituted monosaccharide. The precise mechanism by which topiramate exerts its antiseizure and migraine prophylaxis effects are unknown.

Read more about Topiramate

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