ORAP Tablet Ref.[8505] Active ingredients: Pimozide

Posology

Orap is intended for once daily oral administration in adults and children over 12 years of age.

Since individual response to antipsychotic drugs is variable, dosage should be individually determined and is best initiated and titrated under close clinical supervision. In determining the initial dose, consideration should be given to the patient’s age, severity of symptoms and previous response to other neuroleptic drugs. Dose increases should be made at weekly intervals or longer, and by increments of 2-4 mg in the daily dose.

The patient should be reviewed regularly to ensure the minimum effective dose is being used.

Chronic schizophrenia

The dose ranges between 2 and 20 mg daily, with 2 mg as a starting dose. This may be increased according to response and tolerance to achieve an optimum response.

Other psychoses, paranoid states and monosymptomatic hypochondriacal psychoses (MHP)

An initial dose of 4 mg daily which may then be gradually increased, if necessary, according to response, to a maximum of 16 mg daily.

Use in elderly

Elderly patients require half the normal starting dose of pimozide.

Paediatric population (less than 12 years old)

No data are available.

Method of Administration

Oral use.

In general, the signs and symptoms of overdose with Orap would be an exaggeration of known pharmacological effects, the most prominent of which would be severe extrapyramidal symptoms, hypotension or sedation. The risk of cardiac arrhythmias, possibly associated with QT-prolongation and ventricular arrhythmias including Torsade de Pointes, should be considered. The patient may appear comatose with respiratory depression and hypotension which could be severe enough to produce a shock-like state.

Treatment

There is no specific antidote to pimozide. Establishment of a patent airway and if necessary, mechanically assisted respiration, are advised. Continuous electrocardiographic monitoring should be performed due to the risk of QT interval prolongation and ventricular arrhythmias including Torsade de Pointes and continued until the ECG returns to normal. Hypotension and circulatory collapse may be counteracted by the use of intravenous fluids, plasma or concentrated albumin, and vasopressor agents such as noradrenaline.

Adrenaline should not be used.

In cases of severe extrapyramidal symptoms, anti-Parkinson medication should be administered.

Because of the long half-life of pimozide, patients who have taken an overdose should be observed for at least 4 days.

36 months.

Do not store above 30°C.

PVC/aluminium foil blister packs, containing 28*, 100 or 250* tablets.

^* not marketed

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.