RISPERIDONE oral

Prescription under medical supervision

Therapeutic action

– Atypical antipsychotic

Indications

– Acute or chronic psychosis
– Acute moderate to severe manic episode

Forms and strengths

– 1 mg and 2 mg tablets

Dosage

– Acute or chronic psychosis
Adult: 1 mg 2 times daily. Gradually increase up to 3 mg 2 times daily if necessary (max. 10 mg daily).

– Acute moderate to severe manic episode
Adult: 2 mg once daily; increase in increments of 1 mg daily if necessary (max. 6 mg daily).

– Reduce the doses by half (initial dose and increments) in elderly patients and in patients with hepatic or renal impairment (max. 4 mg daily).

Duration

– Acute psychosis: minimum 3 months; chronic psychosis: minimum one year; manic episode: 3 to 6 weeks. The treatment should be discontinued gradually (over 4 weeks). If signs of relapse occur, increase the dose.

Contra-indications, adverse effects, precautions

– Do not administer to patients with cardiac disorders (heart failure, recent myocardial infarction, conduction disorders, bradycardia, etc.), dementia (e.g. Alzheimer's disease), Parkinson's disease and history of neuroleptic malignant syndrome.
– Administer with caution and carefully monitor use in elderly patients, patients with hypokalaemia, hypotension, renal or hepatic impairment, history of seizures. 
– May cause:  drowsiness, insomnia, headache, extrapyramidal symptoms, agitation, anxiety, orthostatic hypotension, weight gain, hyperprolactinaemia, sexual dysfunction; neuroleptic malignant syndrome (unexplained hyperthermia with neuromuscular disorders), rare but requiring immediate treatment discontinuation.
– In the event of extrapyramidal symptoms, combine with biperiden or trihexyphenidyl.
– Avoid or monitor combination with:
• central nervous system depressants (opioid analgesics, sedatives, H1 antihistamines, etc.);
• fluoxetine, paroxetine, sertraline, verapamil (increased plasma concentrations of risperidone);
• carbamazepine, rifampicin, phenobarbital, phenytoin (decreased plasma concentrations of risperidone);
• antihypertensive drugs (risk of hypotension); drugs that prolong the QT interval (amiodarone, chloroquine, erythromycin, fluconazole, mefloquine, pentamidine, quinine, etc.). 
– Avoid alcohol during treatment.
– Pregnancy: re-evaluate whether the treatment is still necessary; if it is continued, monitor the neonate the first few days (risk of hypertonia, tremors, sedation).
– Breast-feedingif absolutely necessary, do not exceed 6 mg daily. 

Remarks

– Storage: below 25 °C -