ARIZOLE

What it is

ARIZOLE is aripiprazole, available as tablets in strengths of 2, 5, 10, 15, 20 and 30 mg. Each tablet contains lactose monohydrate.

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 per day administered on a once-a-day schedule without regard to meals. Doses in the range of 10 to 30 mg per day have been effective in clinical trials, and daily dosage may be adjusted on the basis of individual clinical status within this range. Dosage increases should not be made before 2 weeks, the time needed to achieve steady state. There is no evidence that doses higher than 15 mg per day are more effective than the recommended starting dose of 10–15 mg. The maintenance dose for aripiprazole tablets is 15 mg per day. No dosage adjustment is required in adult patients with renal impairment. No dosage adjustment is required for adult patients with hepatic impairment. No dosage adjustment is required for patients 65 years of age and older.

Key safety warnings

Elderly patients with dementia-related psychosis treated with atypical antipsychotic drugs are at increased risk of death compared to placebo, with analyses of seventeen placebo-controlled trials revealing a risk of death in drug-treated patients of 1.6 to 1.7 times that seen in placebo-treated patients, and over a typical 10-week trial the rate of death in drug-treated patients was about 4.5% compared to about 2.6% in the placebo group. In three placebo-controlled trials of aripiprazole in elderly patients with psychosis associated with Alzheimer's disease, cerebrovascular adverse events including stroke and transient ischaemic attack, including fatalities, occurred in 1.3% of aripiprazole-treated patients compared with 0.6% of placebo-treated patients. The possibility of a suicide attempt is inherent in psychotic illnesses and close supervision of high-risk patients should accompany drug therapy. Prescriptions for aripiprazole should be written for the smallest quantity consistent with good patient management, in order to reduce the risk of overdose. A potentially fatal symptom complex referred to as Neuroleptic Malignant Syndrome (NMS) has been reported with antipsychotic drugs including aripiprazole, with rare cases occurring during aripiprazole treatment. Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental status, and evidence of autonomic instability. If a patient develops signs and symptoms indicative of NMS, all antipsychotic drugs, including aripiprazole, must be discontinued. 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. Hyperglycaemia, in some cases extreme and associated with ketoacidosis or hyperosmolar coma or death, has been reported in patients treated with atypical antipsychotics 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 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, with incidences from short-term placebo-controlled trials including orthostatic hypotension (1%), postural dizziness (0.5%), and syncope (0.5%). Sleep apnoea and related disorders have been reported in patients treated with aripiprazole. Aripiprazole should be used with caution in patients who have sleep apnoea or risk factors for developing sleep apnoea, which include overweight/obesity, males, and concomitant use of central nervous system depressants.

Contraindications

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

PBS listing

Information on Pharmaceutical Benefits Scheme listing is not provided in the available source documents.

Regulatory history

ARIZOLE aripiprazole tablets were first registered on the Australian Register of Therapeutic Goods on 9 August 2013, with registrations for 2 mg, 5 mg, 10 mg, 15 mg, 20 mg and 30 mg strengths in both blister pack and bottle presentations.