Description
Tetrabenazine
1.1 Therapeutic indications
Tetrabenazine is indicated for hyperkinetic motor disorders with Huntington’s chorea.
Tetrabenazine is also indicated for the treatment of moderate or severe late dyskinesia, which is disabling and / or socially embarrassing
– the situation continues despite the discontinuation of antipsychotic treatment
– discontinuation of antipsychotic drugs is not a realistic option
– the situation persists despite a decrease in antipsychotic drug dosage or
– the situation continues despite the transition to atypical antipsychotic drugs
1.2 Posology and method of administration
Tablets are for oral use. Therapy should be supervised by a doctor experienced in the treatment of hyperkinetic disorders.
Drug amounts information
Adults
Huntington’s Korea
Dosage and administration are individual in each patient and therefore only one guide is provided.
An initial starting dose of 12.5 mg is recommended one to three times a day. This can be increased by 12.5 mg every three or four days until the optimum effect is observed or until the effects of intolerance (sedation, Parkinsonism, depression) occur.
The maximum daily dose is 200 mg per day.
If the maximum dose does not improve within seven days, the compound is unlikely to benefit the patient by increasing the dose or prolonging the treatment time.
Tardive Dyskinesia
The recommended starting dose of 12.5 mg per day is then titrated according to the response. The drug should be discontinued if there is no clear benefit or if the side effects cannot be tolerated.
Elderly population
No specific study has been performed in the elderly, but tetrabenazine has been administered to elderly patients at standard dosage without visible patient effect. Parkinson’s-like adverse reactions are quite common in these patients and may be dose-limiting.
Pediatric population
Safety and effectiveness in children have not yet been established. No data available.
Treatment is not recommended in children.
Patients with liver failure
In patients with mild to moderate hepatic impairment, half the initial dose and slower titration of the dose are recommended. Patients with severe hepatic impairment have not been studied, so additional attention is recommended in these patients (see also sections 4.4 and 5.2).
Patients with kidney failure
No studies have been performed in patients with kidney failure. Care is recommended in the treatment of these patients.











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