Change to starting dose for Abilify

The Summary of Product Characteristics for the antipsychotic Abilify (aripiprazole) has been revised to include a new starting dose and new safety information

The recommended starting dose for Abilify (aripiprazole) in the treatment of schizophrenia has been changed to 10 mg or 15 mg once daily, with a maintenance dose of 15 mg once daily. Previously, the recommended starting dose was 15mg once daily.

Enhanced efficacy at doses higher than 15 mg once daily has not been demonstrated but some patients may benefit from higher doses of up to 30 mg once daily.

The Summary of Product Characteristics for Abilify has also been amended to warn doctors treating elderly patients with psychosis associated with Alzheimer's dementia that such patients have an increased risk of mortality.

This change follows the results of clinical trials showing a death rate of 3.5% in elderly patients with psychosis treated with aripiprazole compared with a death rate of 1.7% in placebo-treated patients.

Further information: Otsuka
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