OZIN

What it is

OZIN is an atypical antipsychotic, antimanic and mood stabilising agent that demonstrates a broad pharmacological profile across a number of receptor systems. OZIN tablets contain either 2.5 mg, 5 mg, 7.5 mg or 10 mg of olanzapine. Olanzapine is well absorbed after oral administration, reaching peak plasma concentrations within 5 to 8 hours, and absorption is not affected by food.

Approved indications

— Treatment of schizophrenia and related psychoses. — Short-term treatment of acute manic episodes associated with Bipolar I Disorder, alone or in combination with lithium or valproate. — Preventing recurrence of manic, mixed or depressive episodes in Bipolar I Disorder.

Dosing overview

For schizophrenia and related disorders, the recommended starting dose is 5–10 mg/day, administered as a single daily dose without regard to meals, with daily dosage subsequently adjusted within the range of 5–20 mg daily based on individual clinical status. For acute mania associated with Bipolar I Disorder, the recommended starting dose is 10 or 15 mg administered once daily as monotherapy or 10 mg administered once daily in combination therapy with lithium or valproate, and it may be given without regard to meals. Antimanic efficacy was demonstrated in a dose range of 5 mg to 20 mg/day in clinical trials, and the safety of doses above 20 mg/day has not been evaluated in clinical trials. For preventing recurrence in bipolar disorder in patients already in remission, the suggested starting dose is 10 mg once daily, with subsequent dosage adjusted within a range of 5 mg to 20 mg per day based on clinical status.

Key safety warnings

Hyperglycaemia, in some cases extreme and associated with ketoacidosis or hyperosmolar coma or death, has been reported in patients treated with atypical antipsychotics including olanzapine. Patients with an established diagnosis of diabetes mellitus who are started on atypical antipsychotics should be monitored regularly for worsening of glucose control, and patients with risk factors for diabetes mellitus who are starting treatment with atypical antipsychotics should undergo fasting blood glucose testing at the beginning of treatment and periodically during treatment. Undesirable alterations in lipids have been observed in olanzapine-treated patients in placebo-controlled trials, with olanzapine-treated patients having a greater mean increase in fasting total cholesterol, LDL cholesterol, and triglycerides compared to placebo-treated patients. Potential consequences of weight gain should be considered prior to starting olanzapine, and as with all antipsychotics, patients receiving olanzapine should receive regular monitoring of weight; in clinical trials significant weight gain was observed across all baseline Body Mass Index categories in olanzapine-treated patients. Neuroleptic malignant syndrome, a potentially fatal symptom complex associated with antipsychotic drugs including olanzapine, presents with hyperpyrexia, muscle rigidity, altered mental status and evidence of autonomic instability; additional signs may include elevated creatine kinase, myoglobinuria and acute renal failure, and in such an event or with unexplained high fever without additional clinical manifestations, all antipsychotic drugs including olanzapine should be discontinued. Olanzapine should be used cautiously in patients who have a history of seizures or are subject to factors which may lower the seizure threshold, and seizures have been reported to occur rarely in such patients when treated with olanzapine. In elderly patients with dementia-related psychosis, the efficacy of olanzapine has not been established, and in placebo-controlled clinical trials of such patients, the incidence of death in olanzapine-treated patients was significantly greater than placebo-treated patients (3.5% versus 1.5%).

Contraindications

OZIN is contraindicated in those patients with a known hypersensitivity to any ingredient of the product.

PBS listing

No source document provides information on PBS listing status, item numbers, restriction types, or ex-manufacturer pricing for OZIN.

Regulatory history

OZIN was first included in the Australian Register of Therapeutic Goods on 15 November 2011. ARTG registrations include OZIN 2.5, 5, 7.5 and 10 mg tablet formulations in bottle presentations, all first listed 15 November 2011 under licence category RE.