OLANZACOR

What it is

Olanzacor contains olanzapine, chemically 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno [2,3-b] [1,5] benzodiazepine. Olanzapine is an atypical antipsychotic, antimanic and mood stabilising agent that demonstrates a broad pharmacological profile across a number of receptor systems. Olanzacor is available as white to off white coloured, film coated, round shaped, biconvex tablets in strengths of 2.5 mg, 5 mg, 7.5 mg and 10 mg for oral administration.

Approved indications

— Treatment of schizophrenia and related psychoses. — Short-term treatment of acute manic episodes associated with Bipolar I Disorder, used 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 daily administered as a single daily dose without regard to meals, with daily dosage subsequently adjusted on the basis of individual clinical status within the range of 5–20 mg daily. For acute mania associated with Bipolar I Disorder, the recommended starting dose is 10 or 15 mg once daily as monotherapy or 10 mg once daily in combination with lithium or valproate, given without regard to meals, with dose adjustments at intervals of not less than 24 hours and increments or decrements of 5 mg daily when necessary. For preventing recurrence in bipolar disorder in patients already in remission, the suggested starting dose is 10 mg once daily, with subsequent daily dosage adjusted on the basis of clinical status within a range of 5–20 mg per day.

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 such as obesity or family history of diabetes 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. The potential consequences of weight gain should be considered prior to starting olanzapine, patients should receive regular monitoring of weight, and 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, has clinical manifestations of hyperpyrexia, muscle rigidity, altered mental status and evidence of autonomic instability. Olanzapine should be used cautiously in patients who have a history of seizures or are subject to factors which may lower the seizure threshold, as seizures have been reported to occur rarely in such patients.

Contraindications

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

PBS listing

No source document contains information regarding PBS listing details.

Regulatory history

Olanzacor was first included in the Australian Register of Therapeutic Goods on 12 December 2014. The brand Olanzacor, sponsored by Pharmacor, comprises four registered strengths: 2.5 mg, 5 mg, 7.5 mg and 10 mg film-coated tablets in blister packs, all first listed on 2014-12-12 under licence category RE.