TORRENIA ODT

What it is

TORRENIA ODT is an orally disintegrating tablet containing olanzapine at strengths of 5 mg, 10 mg, 15 mg, or 20 mg per tablet. The tablet should be placed in the mouth, where it will rapidly disperse in saliva so it can be easily swallowed. Alternatively, it may be dispersed in a full glass of water or other suitable beverage (orange juice, apple juice, milk or coffee) immediately before administration.

Approved indications

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

Dosing overview

TORRENIA ODT may be given without regard to meals.

Key safety warnings

Hyperglycaemia, in some cases extreme and associated with ketoacidosis or hyperosmolar coma or death, has been reported in patients treated with olanzapine. Patients with established diabetes should be monitored regularly for worsening of glucose control, patients with risk factors for diabetes should undergo fasting blood glucose testing at the beginning and periodically during treatment, and any patient treated should be monitored for symptoms of hyperglycaemia including polydipsia, polyuria, polyphagia and weakness. Undesirable alterations in lipids have been observed in olanzapine-treated patients, with greater mean increases in fasting total cholesterol, LDL cholesterol, and triglycerides compared to placebo. Appropriate clinical monitoring is recommended. 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. Neuroleptic malignant syndrome, a potentially fatal symptom complex, is associated with olanzapine and presents with 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 the seizure threshold, as seizures have been reported rarely. Drug Reaction with Eosinophilia and Systemic Symptoms has been reported with olanzapine exposure and consists of a combination of three or more of the following: cutaneous reaction, eosinophilia, fever, lymphadenopathy and one or more systemic complications such as hepatitis, nephritis, pneumonitis, myocarditis, and pericarditis. In elderly patients with dementia-related psychosis, the incidence of death in olanzapine-treated patients was significantly greater than placebo-treated patients (3.5% vs. 1.5%), with risk factors including age over 80 years, sedation, concomitant benzodiazepine use, or presence of pulmonary conditions. TORRENIA ODT is not approved for the treatment of patients with dementia-related psychosis.

Contraindications

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

PBS listing

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

Regulatory history

TORRENIA ODT was first registered on the ARTG on 18 January 2012, with two variants registered: TORRENIA ODT 5 mg (ARTG 177796) and TORRENIA ODT 10 mg (ARTG 177797).