Active Ingredient: Cenobamate
Cenobamate is indicated for the adjunctive treatment of focal-onset seizures with or without secondary generalisation in adult patients with epilepsy who have not been adequately controlled despite a history of treatment with at least 2 anti-epileptic medicinal products.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Oral, 12.5 milligrams cenobamate, once daily, over the duration of 2 weeks. Afterwards, oral, 25 milligrams cenobamate, once daily, over the duration of 2 weeks. Afterwards, oral, 50 milligrams cenobamate, once daily, over the duration of 2 weeks. Afterwards, oral, 100 milligrams cenobamate, once daily, over the duration of 2 weeks. Afterwards, oral, 150 milligrams cenobamate, once daily, over the duration of 2 weeks. Afterwards, oral, 200 milligrams cenobamate, once daily. The maximum allowed total dose is 400 milligrams cenobamate daily.
The recommended starting dose of cenobamate is 12.5 mg per day, titrated gradually to the recommended target dose of 200 mg per day. Based on clinical response, dose may be increased to a maximum of 400 mg per day.
The recommended titration schedule is provided in th following table, which should not be exceeded because of the potential for serious adverse reactions.
Recommended dosage in adults with focal-onset seizures in epilepsy:
| Treatment phase | Dose (per day, oral) | Duration |
|---|---|---|
| Treatment initiation | 12,5 mg | Weeks 1 and 2 |
| 25 mg | Weeks 3 and 4 | |
| Titration | 50 mg | Weeks 5 and 6 |
| 100 mg | Weeks 7 and 8 | |
| 150 mg | Weeks 9 and 10 | |
| Target dose | 200 mg | Weeks 11 and 12 and onwards |
| Dose optimisation δόσης | Some patients, who do not reach optimal seizure control, may benefit from doses above 200 mg (increased by increments of 50 mg/day every two weeks) up to a maximum of 400 mg daily. | |
If patients miss one dose, it is recommended that they take a single dose as soon as they remember, unless it is less than 12 hours until their next regularly scheduled dose.
It is recommended that discontinuation be undertaken gradually to minimise the potential for rebound seizures (i.e. over at least 2 weeks), unless safety concerns require abrupt withdrawal.
Cenobamate should typically be taken once daily as single oral dose at any time. However, it should preferably be taken at the same time each day. It may be taken with or without food. The tablet should be swallowed with a glass of water.
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