Active Ingredient: Tetrabenazine
For this indication, competent medicine agencies globally authorize below treatments:
For:
Oral, 12.5 milligrams tetrabenazine, once daily, over the duration of 1 week. Afterwards, oral, 12.5 milligrams tetrabenazine, 2 times daily, over the duration of 1 week. Afterwards, oral, 12.5 milligrams tetrabenazine, 3 times daily, over the duration of 1 week. Afterwards, oral, between 37.5 milligrams tetrabenazine and 200 milligrams tetrabenazine, divided daily, 3 doses in total. The maximum allowed total dose is 200 milligrams tetrabenazine daily.
Dosing of tetrabenazine involves careful titration of therapy to determine an individualised dose for each patient. When first prescribed, tetrabenazine therapy should be titrated slowly over several weeks to allow the identification of a dose for chronic use that reduces chorea and is well tolerated.
Dosage and administration are variable and only a guide is given. Starting doses should be 12.5 mg to 25 mg per day and should be titrated up slowly every 4 to 7 days to allow identification of dose that is efficacious and well tolerated. After titration is initiated, the total daily dose should be given in two to three divided doses. Titration can be up to 200 mg per day or dose-limiting adverse events, whichever happens first. If the adverse event does not resolve, after dose reduction, consideration should be given to withdrawing tetrabenazine treatment.
If there is no improvement at the maximum dose in seven days, it is unlikely that the compound will be of benefit to the patient, either by increasing the dose or by extending the duration of treatment.
Discontinuation of tetrabenazine is associated with the return of chorea (without significant worsening compared to baseline). Other adverse reactions to sudden treatment withdrawal are possible but unlikely and generally mild.
Following treatment interruption of greater than 5 days or a treatment interruption occurring due to a change in the patient’s medical condition or concomitant medications, tetrabenazine therapy should be retitrated when resumed. The dose should be initiated at 12.5 mg twice a day, wait 7 days then titrate up by 12.5 mg per day.
If adverse events such as akathisia, restlessness, parkinsonism, depression, insomnia, anxiety, or intolerable sedation occur, titration should be stopped and the dose should be reduced.
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