RISPERIDONE oral

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    Last updated: February 2024

     

    Prescription under medical supervision

     

     
    Due to the numerous and potentially severe adverse effects of risperidone, patients should be kept under close surveillance.

     

    Therapeutic action

    • Atypical antipsychotic

    Indications

    • Acute and chronic psychosis and acute manic episode, in the event of intolerance or treatment failure with other antipsychotics (preferably use haloperidol for these indications) 

    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 manic episode

    • Adult: 2 mg once daily. Increase in increments of 1 mg per week if necessary (max. 6 mg daily).

     

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

    Duration

    • Acute psychosis: at least 3 months
    • Chronic psychosis: at least one year
    • Manic episode: 8 weeks after remission of symptoms

     

    Discontinue treatment gradually (over 4 weeks). If signs of relapse occur, increase the dose then decrease it more gradually.

    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 older patients, patients with hypokalaemia, hypotension, renal or hepatic impairment, history of seizures. 
    • May cause:  drowsiness (caution when driving/operating machinery), 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 case of extrapyramidal symptoms, try reducing the dose of risperidone or, if the extrapyramidal symptoms are severe, add 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 (increased risk of adverse effects).
    • Pregnancy: re-evaluate whether the treatment is still necessary; if it is continued, use the lowest effective dose. Observe the neonate the first few days (risk of agitation, tremors, hypertonia/hypotonia, respiratory difficulties, sleeping disorders, etc.) if the mother was under treatment in the 3rd trimester. If treatment starts during pregnancy, preferably use haloperidol. 
    • Breast-feeding: if absolutely necessary, do not exceed 6 mg daily. 

    Storage

     
    –  Below 25 °C