ZYPINE

What it is

ZYPINE is olanzapine, supplied as tablets and orally disintegrating tablets (ODT). ZYPINE tablets contain 2.5 mg, 5 mg, 7.5 mg or 10 mg of olanzapine. ZYPINE ODT contains 5 mg, 10 mg, 15 mg or 20 mg olanzapine. Olanzapine is an atypical antipsychotic, antimanic and mood stabilising agent.

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. — Prevention of recurrence of manic, mixed or depressive episodes in Bipolar I Disorder.

Dosing overview

For patients 65 years of age and over, a low starting dose of 5 mg daily should be considered when clinical factors warrant.

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 established diabetes should be monitored regularly for worsening glucose control; those with diabetes risk factors should undergo fasting blood glucose testing at the beginning and periodically during treatment; and all patients should be monitored for symptoms of hyperglycaemia including polydipsia, polyuria, polyphagia and weakness. Undesirable alterations in lipids have been observed; olanzapine-treated patients had greater mean increases in fasting total cholesterol, LDL cholesterol and triglycerides compared to placebo-treated patients. Appropriate clinical monitoring is recommended. Potential consequences of weight gain should be considered prior to starting olanzapine; patients should receive regular weight monitoring; and significant weight gain was observed across all baseline body mass index categories in clinical trials. Neuroleptic malignant syndrome, a potentially fatal syndrome complex, is associated with antipsychotic drugs including olanzapine, with clinical manifestations including hyperpyrexia, muscle rigidity, altered mental status and evidence of autonomic instability. Olanzapine should be used cautiously in patients with a history of seizures or factors that may lower seizure threshold, as seizures have been reported rarely in such patients. In placebo-controlled clinical trials in elderly patients with dementia-related psychosis, the incidence of death in olanzapine-treated patients was significantly greater than in placebo-treated patients (3.5 versus 1.5%, respectively). In placebo-controlled studies in elderly patients with dementia-related psychosis, there was a higher incidence of cerebrovascular adverse events in patients treated with olanzapine compared to placebo (1.3 versus 0.4%, respectively).

Contraindications

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

PBS listing

Information regarding PBS listing is not provided in the available source documents.

Regulatory history

ZYPINE tablets (2.5 mg, 5 mg, 7.5 mg and 10 mg) were first registered on the ARTG on 7 November 2011. ZYPINE ODT (5 mg and 10 mg) were first registered on 29 November 2011, and the 15 mg and 20 mg formulations were registered on 20–21 June 2012.