APX-QUETIAPINE

What it is

APX-QUETIAPINE contains quetiapine fumarate equivalent to 25 mg, 100 mg, 150 mg, 200 mg and 300 mg quetiapine free base respectively. APX-QUETIAPINE is supplied as film-coated tablets in five strengths: 25 mg (peach coloured round tablets), 100 mg (yellow coloured round tablets), 150 mg (pale yellow coloured round tablets), 200 mg (white coloured round tablets), and 300 mg (white coloured capsoid tablets).

Approved indications APX-QUETIAPINE is indicated for:

— <cite index="1-8">Maintenance treatment of bipolar I disorder in adults, as monotherapy or in combination with lithium or sodium valproate, for the prevention of relapse or recurrence of manic, depressive or mixed episodes. — Treatment of depressive episodes associated with bipolar disorder in adults. — Treatment of acute mania associated with bipolar I disorder in adults as monotherapy or in combination with lithium or sodium valproate. — Monotherapy treatment of acute mania associated with bipolar I disorder in children and adolescents aged 10 to 17 years. — Treatment of schizophrenia in adults and adolescents aged 13 to 17 years. </cite>

Dosing overview

Dosing varies by indication and patient population. For maintenance treatment of bipolar disorder in adults, quetiapine should be administered twice daily, with a usual effective dose in the range of 300 to 800 mg per day. For bipolar depression in adults, quetiapine should be administered once daily at bedtime, titrated from 50 mg on day 1 to 300 mg on day 4, with doses adjustable up to 600 mg per day depending on clinical response and tolerability. For acute mania in adults, quetiapine is administered twice daily with a starting dose of 100 mg on day 1, increasing to 400 mg by day 4, further adjustable up to 800 mg by day 6, with a usual effective dose in the range of 400 to 800 mg per day. For schizophrenia in adults, quetiapine is administered twice daily, starting at 50 mg on day 1 and reaching 300 mg by day 4, then titrated to the usual effective dose of 300 to 450 mg per day, adjustable within a range of 150 to 750 mg per day depending on response and tolerability.

Key safety warnings

Quetiapine may induce orthostatic hypotension associated with dizziness, tachycardia and syncope, especially during the initial dose titration period. Syncope has been commonly reported, and orthostatic hypotension, dizziness and syncope may lead to falls. In post-marketing experience, cases of QT prolongation have been reported with overdose, in patients with concomitant illness, and in patients taking medicines known to cause electrolyte imbalance or increase QT interval. Caution should be exercised when quetiapine is prescribed in patients with cardiovascular disease or family history of QT prolongation. Cardiomyopathy and myocarditis have been reported in clinical trials and during post-marketing experience. In patients with suspected cardiomyopathy or myocarditis, discontinuation of quetiapine should be considered. Severe cutaneous adverse reactions (SCARs), 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. Quetiapine should be discontinued if severe cutaneous adverse reactions occur. 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. Hyperglycaemia, in some cases extreme and associated with ketoacidosis, hyperosmolar coma or death, has been reported in patients treated with quetiapine.

Contraindications

Quetiapine is contraindicated in patients who are hypersensitive to any component of APX-QUETIAPINE.

PBS listing

Information regarding PBS listing status, including item numbers, restriction types and ex-manufacturer price, is not contained in the provided source documents.

Regulatory history

APX-QUETIAPINE was first registered on the Australian Register of Therapeutic Goods on 13 February 2014 in five strength variants (25 mg, 100 mg, 150 mg, 200 mg and 300 mg), sponsored by Pharmacor.