SEROQUEL

What it is

SEROQUEL is a film-coated tablet containing quetiapine fumarate equivalent to 25 mg, 100 mg, 200 mg and 300 mg quetiapine free base.

Approved indications

SEROQUEL is indicated for 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. It is also indicated for treatment of depressive episodes associated with bipolar disorder and treatment of acute mania associated with bipolar I disorder as monotherapy or in combination with lithium or sodium valproate. For children and adolescents aged 10 to 17 years, SEROQUEL is indicated for monotherapy treatment of acute mania associated with bipolar I disorder. SEROQUEL is indicated for treatment of schizophrenia in adults and adolescents aged 13 to 17 years.

Dosing overview

For prevention of relapse/recurrence of manic, depressive and mixed episodes in bipolar disorder maintenance treatment, the usual effective dose is within the range of 300 to 800 mg/day. For bipolar depression, SEROQUEL should be titrated as follows: 50 mg (Day 1), 100 mg (Day 2), 200 mg (Day 3) and 300 mg (Day 4), with the dose adjustable up to 600 mg/day in increments of 100 mg/day depending on clinical response and tolerability. For acute mania in adults, the usual effective dose is in the range of 400 to 800 mg/day. For schizophrenia in adults, the usual effective dose is 300 to 450 mg/day.

Key safety warnings

Quetiapine should be used with caution in patients with known cardiovascular disease, cerebrovascular disease, or other conditions predisposing to hypotension. Quetiapine may induce orthostatic hypotension associated with dizziness, tachycardia and, in some patients, syncope, especially during the initial dose titration period. Severe cutaneous adverse reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis and drug reaction with eosinophilia and systemic symptoms are potentially life threatening adverse drug reactions that have been reported during quetiapine exposure. SEROQUEL should be discontinued if severe cutaneous adverse reactions occur. Neuroleptic malignant syndrome has been associated with antipsychotic treatment, including quetiapine, with clinical manifestations including hyperthermia, altered mental status, muscular rigidity, autonomic instability, and increased creatine phosphokinase. 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, and close monitoring for clinical worsening and suicidality is especially important at the beginning of treatment or at the time of dose changes. 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. Elderly patients with dementia-related psychosis treated with atypical antipsychotics are at an increased risk of death compared to placebo, with a meta-analysis of seventeen placebo controlled trials showing a risk of death in the drug-treated patients of approximately 1.6 to 1.7 times that seen in placebo-treated patients.

Contraindications

SEROQUEL is contraindicated in patients who are hypersensitive to any component of this product.

PBS listing

SEROQUEL immediate-release tablets are listed on the PBS in strengths of 25 mg, 100 mg, 200 mg and 300 mg, each with one item, under streamlined restrictions. Ex-manufacturer prices are: 25 mg A$14.33, 100 mg A$18.34, 200 mg A$21.80, and 300 mg A$27.89. Modified-release tablets are also listed at 50 mg (A$15.54), 150 mg (A$23.95), 200 mg (A$28.44), 300 mg (A$34.02) and 400 mg (A$43.19), each with one item, under streamlined restrictions.

Regulatory history

SEROQUEL 25 mg, 100 mg and 200 mg tablets were first listed on the ARTG on 3 February 2000. The 300 mg strength was registered on 22 November 2001. Modified-release formulations (50 mg, 150 mg, 200 mg and 300 mg) were registered on 30 January 2008, and the 400 mg modified-release tablet was also registered on that date, with the 150 mg modified-release tablet added on 15 June 2009.