Source: Medicines and Medical Devices Safety Authority (NZ) Revision Year: 2019 Publisher: Douglas Pharmaceuticals Ltd, P O Box 45 027, Auckland 0651, New Zealand, Phone: (09) 835 0660
Movement disorders associated with organic central nervous system conditions, e.g. Huntington’s chorea, hemiballismus and senile chorea. Tetrabenazine is also indicated for the treatment of moderate to severe tardive dyskinesia, which is disabling and/or socially embarrassing. The condition should be persistent despite withdrawal of antipsychotic therapy, or in cases where withdrawal of antipsychotic medication is not a realistic option; also where the condition persists despite reduction in dosage of antipsychotic medication or switching to atypical antipsychotic medication.
Dosage and administration are variable and only a guide is given. An initial starting dose of 25 mg three times a day is recommended. This can be increased by 25 mg a day every three or four days until 200 mg a day is being given or the limit of tolerance, as dictated by unwanted effects, is reached, whichever is the lower dose. 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.
Recommended starting dose of 12.5 mg a day subsequently titrated according to response. Medication should be discontinued if there is no clear benefit or if the side-effects cannot be tolerated.
No specific studies have been performed in the elderly, but tetrabenazine has been administered to elderly patients in standard dosage without apparent ill effect. Parkinson-like adverse reactions are quite common in these patients and could be dose-limiting.
No studies have been performed in patients with renal impairment. Caution is advised in the treatment of these patients. It is recommended that, if tetrabenazine is administered to patients with poor renal function, the upward titration of tetrabenazine should be slow and a lower daily dose may be required.
In patients with mild and moderate hepatic impairment half the initial dose and a slower up titration of the dose is recommended. Patients with severe hepatic impairment have not been studied, therefore additional caution is advised in these patients.
No adequate controlled studies have been performed in children. The treatment is not recommended in children.
The tablets are for oral administration.
Signs and symptoms of overdosage may include nausea, vomiting, diarrhoea, drowsiness, sweating, hypotension, confusion, hallucinations, hypothermia and sedation. Treatment is symptomatic.
For advice on the management of overdose please contact the National Poisons Centre on 0800 POISON (0800 764766).
36 months.
Store at or below 25°C.
HDPE bottle pack with child-resistant caps, containing 112 tablets.
Any unused medicine or waste material should be disposed of in accordance with local requirements.
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