Therapeutic action
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
Dosage
Acute or chronicpsychosis
- 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 (cautionwhen 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 extra pyramidal 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 treatmentin 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