DELUCON

What it is

DELUCON is an atypical antipsychotic agent. It is available in strengths of 25 mg, 100 mg, 150 mg, 200 mg and 300 mg of quetiapine as fumarate. Quetiapine and its active metabolite norquetiapine exhibit affinity for brain serotonin (5HT2) and dopamine D1 and D2 receptors; this combination of receptor antagonism with higher selectivity for 5HT2 relative to D2 receptors is believed to contribute to the clinical antipsychotic properties and low extrapyramidal side effects liability of quetiapine compared to typical antipsychotics.

Approved indications

**Bipolar disorder (adults)** — Maintenance treatment of bipolar I disorder, as monotherapy or in combination with lithium or sodium valproate, for the prevention of relapse/recurrence of manic, depressive or mixed episodes. — Treatment of depressive episodes associated with bipolar disorder. — Treatment of acute mania associated with bipolar I disorder as monotherapy or in combination with lithium or sodium valproate. **Bipolar disorder (children/adolescents aged 10 to 17 years)** — Monotherapy treatment of acute mania associated with bipolar I disorder. **Schizophrenia** — Treatment of schizophrenia in adults and adolescents aged 13 to 17 years.

Dosing overview

The safety and efficacy of doses greater than 800 mg/day have not been evaluated. Dose adjustment may be required based on individual clinical response and tolerability. Since quetiapine is extensively metabolised by the liver, higher plasma levels are expected in the hepatically impaired population, and dosage adjustment may be needed in these patients.

Key safety warnings

**Orthostatic hypotension and syncope** Quetiapine may induce orthostatic hypotension associated with dizziness, tachycardia and, in some patients, syncope especially during the initial dose titration period. Orthostatic hypotension, dizziness and syncope may lead to falls. **Suicide risk** The risk of suicide attempt is inherent in depression and may persist until significant remission occurs. The risk must be considered in all depressed patients. Patients with depression may experience worsening of their depressive symptoms and/or the emergence of suicidal ideation and behaviour, whether or not they are taking antidepressant medications, and this risk may persist until significant remission occurs. As improvement may not occur during the first few weeks or more of treatment, patients should be closely monitored for clinical worsening and suicidality, especially at the beginning of a course of treatment or at the time of dose changes. Prescriptions for quetiapine should be written for the smallest quantity of tablets consistent with good patient management, in order to reduce the risk of overdose. **Metabolic effects** Hyperglycaemia, in some cases extreme and associated with ketoacidosis or hyperosmolar coma or death, has been reported in patients treated with atypical antipsychotics including quetiapine. Patients with an established diagnosis of diabetes mellitus who are started on atypical antipsychotics should be monitored regularly for worsening of glucose control. Patients with risk factors for diabetes mellitus (e.g. obesity, family history of diabetes) who are starting treatment with atypical antipsychotics should undergo fasting blood glucose testing at the beginning of treatment and periodically during treatment. Increases in triglycerides and cholesterol, and decreases in fasting HDL cholesterol have been observed in clinical trials with quetiapine. Monitoring is recommended at baseline and periodically during treatment for all patients. Lipid changes should be managed as clinically appropriate. **Neuroleptic malignant syndrome** Neuroleptic malignant syndrome has been associated with antipsychotic treatment, including quetiapine. Clinical manifestations include hyperthermia, altered mental status, muscular rigidity, autonomic instability, and increased creatine phosphokinase. In such an event, quetiapine should be discontinued and appropriate medical treatment given. **Increased mortality in elderly patients with dementia-related psychosis** Elderly patients with dementia-related psychosis treated with atypical antipsychotics are at an increased risk of death compared to placebo. A meta-analysis of seventeen placebo controlled trials with dementia related behavioural disorders showed a risk of death in the drug-treated patients of approximately 1.6 to 1.7 times that seen in placebo-treated patients. Quetiapine is not approved for the treatment of elderly patients with dementia-related psychosis or behavioural disorders.

Contraindications

DELUCON is contraindicated in patients who are hypersensitive to any component of this product. Quetiapine tablets contain lactose. Patients with rare hereditary problems of galactose intolerance, the lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicine.

Regulatory history

DELUCON was first listed on the ARTG on 2011-10-18 in six presentations: 25 mg, 100 mg, 150 mg and 300 mg tablet bottles, plus 150 mg and 200 mg tablet bottles and blister packs.