RISPERIDONE oral

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    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-feeding: if absolutely necessary, do not exceed 6 mg daily. 

    Storage

     
    –  Below 25 °C