QUETIAPINE SANDOZ

What it is

QUETIAPINE INTAS tablets contain quetiapine fumarate equivalent to 25 mg, 100 mg, 200 mg and 300 mg quetiapine free base respectively. The 25 mg tablets are pink and round, the 100 mg tablets are yellow and round, the 200 mg and 300 mg tablets are white to off-white and round or capsule-shaped, all presented as film-coated tablets. The tablets contain lactose as an excipient with known effect.

Approved indications

— Maintenance treatment of bipolar I disorder 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. — Treatment of acute mania associated with bipolar I disorder 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.

Dosing overview

QUETIAPINE INTAS can be administered with or without food. **Bipolar disorder maintenance treatment:** QUETIAPINE INTAS should be administered twice daily, with the usual effective dose within the range of 300 to 800 mg per day for prevention of relapse or recurrence of manic, depressive and mixed episodes. **Bipolar depression:** QUETIAPINE INTAS should be administered once daily at bedtime, titrated as follows: 50 mg on day 1, 100 mg on day 2, 200 mg on day 3 and 300 mg on day 4, with possible adjustment up to 600 mg per day in increments of 100 mg per day depending on clinical response and tolerability. **Acute mania:** QUETIAPINE INTAS should be administered twice daily, with total daily doses of 100 mg (day 1), 200 mg (day 2), 300 mg (day 3) and 400 mg (day 4), with further dosage adjustments up to 800 mg per day by day 6 in increments of no greater than 200 mg per day, and the usual effective dose in the range of 400 to 800 mg per day. **Schizophrenia:** QUETIAPINE INTAS should be administered twice daily, with total daily doses of 50 mg (day 1), 100 mg (day 2), 200 mg (day 3) and 300 mg (day 4), titrated from day 4 onwards to the usual effective dose of 300 to 450 mg per day. In elderly patients, QUETIAPINE INTAS should be used with caution, especially during initial dosing, with the rate of dose titration and daily therapeutic dose potentially slower and lower than in younger patients. In patients with hepatic impairment, treatment should be started on 25 mg per day, with dose increases in increments of 25 to 50 mg per day to an effective dose.

Key safety warnings

QUETIAPINE INTAS may induce orthostatic hypotension associated with dizziness, tachycardia and syncope, especially during initial dose titration, which may lead to falls. Severe cutaneous adverse reactions including Stevens-Johnson syndrome, toxic epidermal necrolysis and drug reaction with eosinophilia and systemic symptoms are potentially life-threatening and have been reported during QUETIAPINE INTAS exposure, presenting as extensive cutaneous rash or exfoliative dermatitis, fever and lymphadenopathy; discontinuation is required if these occur. The risk of suicide attempt is inherent in depression and may persist until significant remission occurs; patients with depression may experience worsening of depressive symptoms or emergence of suicidal ideation and behaviour, and should be closely monitored for clinical worsening and suicidality, especially at the beginning of treatment or at times of dose changes. Cases of venous thromboembolism have been reported with antipsychotic drugs; all possible risk factors for venous thromboembolism should be identified before and during QUETIAPINE INTAS treatment. Hyperglycaemia, in some cases extreme and associated with ketoacidosis, hyperosmolar coma or death, has been reported in patients treated with atypical antipsychotics including QUETIAPINE INTAS; epidemiological studies suggest an increased risk of treatment-emergent hyperglycaemia-related adverse events. Neuroleptic malignant syndrome has been associated with QUETIAPINE INTAS treatment, characterised by hyperthermia, altered mental status, muscular rigidity, autonomic instability and increased creatine phosphokinase; discontinuation and appropriate medical treatment are required. Elderly patients with dementia-related psychosis treated with atypical antipsychotics are at increased risk of death compared to placebo, with drug-treated patients at 1.6 to 1.7 times the mortality risk, primarily from cardiovascular or infectious causes.

Contraindications

QUETIAPINE INTAS is contraindicated in patients hypersensitive to any component of the product.

PBS listing

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

Regulatory history

QUETIAPINE INTAS was first registered on the Australian Register of Therapeutic Goods on 2 April 2014, with registrations covering 25 mg, 100 mg, 200 mg and 300 mg tablet strengths in blister pack format.