OZIDAL

What it is

OZIDAL is a medicine containing risperidone. Each tablet contains 0.5 mg, 1 mg, 2 mg, or 3 mg of risperidone.

Approved indications

— Treatment of schizophrenia and related psychoses. — Short-term treatment of acute mania associated with bipolar 1 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 behaviour 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

The absorption of risperidone is not affected by food and thus OZIDAL can be given with or without food. Elderly patients should start at 0.5 mg twice daily, adjustable with 0.5 mg twice daily increments to 1–2 mg twice daily.

Key safety warnings

Orthostatic hypotension can occur due to the alpha-blocking activity of risperidone, especially during initial dose titration. Clinically significant hypotension has been observed post-marketing with concomitant use of risperidone and antihypertensive treatment. Risperidone should be used with caution in patients with known cardiovascular disease and dosage should be gradually titrated as recommended. Events of leukopenia, neutropenia and agranulocytosis have been reported with antipsychotic agents, including risperidone. Agranulocytosis has been reported very rarely (less than 1 in 10,000 patients) during post-marketing surveillance. Patients with a history of clinically significant low white blood cell count or drug-induced leukopenia/neutropenia should be monitored during the first few months of therapy and discontinuation of risperidone should be considered at the first sign of clinically significant decline in white blood cell count in the absence of other causative factors. Cases of venous thromboembolism have been reported with antipsychotic drugs. Since patients treated with antipsychotics often present with acquired risk factors for venous thromboembolism, all possible risk factors should be identified before and during treatment with risperidone and preventative measures undertaken. 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. Epidemiological studies suggest an increased risk of treatment-emergent hyperglycaemia-related adverse events in patients treated with atypical antipsychotics. Significant weight gain has been reported. 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. In placebo-controlled trials with risperidone in this population, the incidence of mortality was 4.0% for risperidone-treated patients and 3.1% for placebo-treated patients. In placebo-controlled trials in elderly patients with dementia there was a significantly higher incidence of cerebrovascular adverse events, such as stroke and transient ischaemic attacks. Cerebrovascular adverse events occurred in 3.3% of patients treated with risperidone and 1.2% of patients treated with placebo.

Contraindications

OZIDAL is contraindicated in patients with a known hypersensitivity to the medicine or any of its excipients.

PBS listing

Information regarding PBS listing for OZIDAL is not available in the provided source documents.

Regulatory history

OZIDAL risperidone tablets in strengths of 0.5 mg, 1 mg, 2 mg, and 3 mg were first listed on the ARTG on 7 April 2009 under licence category RE (Registered Export).