Active Ingredient: Tiagabine
Tiagabine is an anti-epileptic drug indicated as add-on therapy for partial seizures with or without secondary generalisation where control is not achieved by optimal doses of at least one other anti-epileptic drug.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Regimen A: In case that there is drug induction of cytochrome p450 CYP3A enzyme, oral, between 5 milligrams tiagabine and 10 milligrams tiagabine, divided daily to meals, 1 to 2 doses in total, over the duration of 1 week. Afterwards, in case that there is drug induction of cytochrome p450 CYP3A enzyme, oral, between 10 milligrams tiagabine and 20 milligrams tiagabine, divided daily to meals, 2 to 3 doses in total, over the duration of 1 week. Afterwards, in case that there is drug induction of cytochrome p450 CYP3A enzyme, oral, between 15 milligrams tiagabine and 30 milligrams tiagabine, divided daily to meals, 2 to 3 doses in total, over the duration of 1 week. Afterwards, in case that there is drug induction of cytochrome p450 CYP3A enzyme, oral, between 20 milligrams tiagabine and 40 milligrams tiagabine, divided daily to meals, 2 to 3 doses in total, over the duration of 1 week. Afterwards, in case that there is drug induction of cytochrome p450 CYP3A enzyme, oral, between 25 milligrams tiagabine and 45 milligrams tiagabine, divided daily to meals, 2 to 3 doses in total, over the duration of 1 week. Afterwards, in case that there is drug induction of cytochrome p450 CYP3A enzyme, oral, between 30 milligrams tiagabine and 45 milligrams tiagabine, divided daily to meals, 2 to 3 doses in total.
Regimen B: Oral, between 5 milligrams tiagabine and 10 milligrams tiagabine, divided daily to meals, 1 to 2 doses in total, over the duration of 1 week. Afterwards, oral, between 10 milligrams tiagabine and 20 milligrams tiagabine, divided daily to meals, 2 to 3 doses in total, over the duration of 1 week. Afterwards, oral, between 15 milligrams tiagabine and 30 milligrams tiagabine, divided daily to meals, 2 to 3 doses in total.
As CYP3A4/5 is involved in the metabolism of tiagabine, it is recommended that the dose of tiagabine is adjusted when it is taken in combination with CYP3A4/5 inducers.
Following a given dose of tiagabine, the estimated plasma concentration in non-induced patients is more than twice that in patients receiving enzyme-inducing agents. To achieve similar systemic exposures of tiagabine, non-induced patients require lower and less frequent doses of tiagabine than induced patients. These patients may also require a slower titration of tiagabine compared to that of induced patients. Dosage adjustment of tiagabine should be considered whenever a change in patient’s metabolic enzyme-inducing status occurs as a result of the addition, discontinuation, or dose change of the enzyme-inducing agent.
The initial daily dose is 5-10 mg tiagabine, followed by weekly increments of 5-10 mg/day. The usual maintenance dose in patients taking enzyme-inducing drugs is 30-45 mg/day. In patients not taking enzyme-inducing drugs, the maintenance dose should initially be reduced to 15-30 mg/day. The initial daily dose should be taken as a single dose or divided into two doses. The daily maintenance dose should be divided into two or three single doses.
Although there is no evidence of withdrawal seizures following tiagabine, it is recommended to taper off treatment over a period of 2-3 weeks.
The pharmacokinetic properties of tiagabine do not seem to be significantly modified in the elderly. However, only limited information is available on the use of tiagabine in elderly patients. It is therefore recommended to use tiagabine with caution in this age group.
Should be taken orally with meals.
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