AURO-ARIPIPRAZOLE

What it is

Aripiprazole is a novel antipsychotic agent with unique pharmacologic properties and a chemical structure that differs from current antipsychotic agents. AURO-ARIPIPRAZOLE is available as tablets containing 2, 5, 10, 15, 20 and 30 mg aripiprazole.

Approved indications

— Treatment of schizophrenia including maintenance of clinical improvement during continuation therapy.

Dosing overview

The recommended starting dose for aripiprazole tablets is 10 or 15 mg/day administered on a once-a-day schedule without regard to meals. Doses in the range of 10 to 30 mg/day have been effective in clinical trials, with daily dosage adjusted on the basis of individual clinical status within the range of 10–30 mg daily. Dosage increases should not be made before 2 weeks, the time needed to achieve steady state. The maintenance dose for aripiprazole tablets is 15 mg/day.

Key safety warnings

Elderly patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death compared to placebo. Analyses of seventeen placebo-controlled trials revealed a risk of death in the drug-treated patients of between 1.6 to 1.7 times that seen in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Aripiprazole is not approved for the treatment of patients with dementia-related psychosis. The risk of tardive dyskinesia increases with long-term exposure to antipsychotic treatment. If signs and symptoms of tardive dyskinesia appear in a patient on aripiprazole, a dose reduction or drug discontinuation should be considered. A potentially fatal symptom complex sometimes referred to as Neuroleptic Malignant Syndrome (NMS) has been reported in association with administration of antipsychotic drugs including aripiprazole. Rare cases of NMS occurred during aripiprazole treatment in the worldwide clinical database. Hyperglycaemia, in some cases extreme and associated with ketoacidosis or hyperosmolar coma or death, has been reported in patients treated with atypical antipsychotic agents including aripiprazole. Patients with an established diagnosis of diabetes mellitus who are started on atypical antipsychotics should be monitored regularly for worsening of glucose control. Patients with risk factors for diabetes mellitus (such as obesity or family history of diabetes) who are starting treatment with atypical antipsychotics should undergo fasting blood glucose testing at the beginning of treatment and periodically during treatment. Potentially due to its α₁-adrenergic receptor antagonism, aripiprazole may be associated with orthostatic hypotension. The incidence of orthostatic hypotension-associated events from short-term, placebo-controlled trials of adult patients on oral aripiprazole included orthostatic hypotension (1%), postural dizziness (0.5%), and syncope (0.5%).

Contraindications

Aripiprazole is contraindicated in patients who are hypersensitive to aripiprazole or any of the excipients.

Regulatory history

AURO-ARIPIPRAZOLE was first registered on the ARTG on 2013-08-09, with 12 product entries across 2, 5, 10, 15, 20 and 30 mg tablet formulations in both bottle and blister pack presentations.