RIXADONE

What it is

RIXADONE contains risperidone in tablet strengths of 0.5 mg, 1 mg, 2 mg, 3 mg, or 4 mg.

Approved indications

— Treatment of schizophrenia and related psychoses. — Short-term treatment of acute mania associated with bipolar I disorder. — Treatment (up to 12 weeks) of psychotic symptoms, or persistent agitation or aggression unresponsive to non-pharmacological approaches in patients with moderate to severe dementia of the Alzheimer type. — Treatment of conduct and other disruptive disorders in children (over 5 years), adolescents and adults with sub-average intellectual functioning or mental retardation in whom destructive behaviours such as aggression, impulsivity and self-injurious behaviours are prominent. — Treatment of behavioural disorders associated with autism in children and adolescents.

Dosing overview

Dosing varies substantially by indication and patient population. For schizophrenia in adults, patients may start with risperidone 1 mg twice daily, with dosage increased on the second day to 2 mg twice daily, and then maintained unchanged or further individualised as needed. In stable patients, risperidone may be given once daily or twice daily, with a recommended daily dose between 4 and 6 mg. For bipolar mania, risperidone should be administered once daily, starting with 2 mg, with dosage adjustments at intervals of not less than 24 hours and in increments of 1 mg/day, with a recommended dosing range of 2 to 6 mg/day. For behavioural disturbances in dementia, a starting dose of 0.25 mg twice daily is recommended, adjusted by increments of 0.25 mg twice daily not more frequently than every other day if needed, with an optimum dose of 0.5 mg twice daily for most patients. For conduct and other disruptive behaviour disorders in subjects weighing 50 kg or more, a starting dose of 0.5 mg once daily is recommended, adjusted by increments of 0.5 mg once daily not more frequently than every other day if needed, with an optimum dose of 1 mg once daily for most patients.

Key safety warnings

Due to the alpha-blocking activity of risperidone, orthostatic hypotension can occur, especially during the initial dose titration period, and clinically significant hypotension has been observed with concomitant use of risperidone and antihypertensive treatment. Events of leukopenia, neutropenia and agranulocytosis have been reported with antipsychotic agents, including risperidone, with agranulocytosis reported very rarely during post-marketing surveillance. Patients with a history of a clinically significant low white blood cell count or drug-induced leukopenia/neutropenia should be monitored during the first few months of therapy. Neuroleptic malignant syndrome is a potentially fatal symptom complex that has been reported with antipsychotic drugs, including risperidone, with clinical manifestations including hyperthermia, muscle rigidity, altered mental status and evidence of autonomic instability. Hyperglycaemia, in some cases extreme and associated with ketoacidosis or hyperosmolar coma or death, has been reported in patients treated with atypical antipsychotics including risperidone. Significant weight gain has been reported, and monitoring weight gain is advisable when risperidone is being used. Elderly patients with dementia treated with atypical antipsychotic medicines have an increased mortality compared to placebo, with incidence of mortality of 4.0% for risperidone-treated patients and 3.1% for placebo-treated patients in placebo-controlled trials.

Contraindications

Known hypersensitivity to risperidone or any of its excipients.

PBS listing

Information regarding PBS listing, including strength, item number, restriction type, and ex-manufacturer price, is not available in the provided source documents.

Regulatory history

RIXADONE risperidone tablets in strengths of 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg were first listed on the ARTG on 3 September 2013.