U.S. Food and Drug Administration Approves ABILIFY(R) (aripiprazole) for Adolescent Patients With Sch...(r injection 7.5mg/mL. In adult patients ...),Health

Date:11/6/2007

r injection 7.5 mg/mL. In adult patients, the recommended ABILIFY oral target dose is 15 mg to 30 mg/day in Bipolar I Disorder and 10 mg to 15 mg/day in schizophrenia. In adolescent patients with schizophrenia, the recommended ABILIFY oral target dose is 10 mg/day (with a starting dose of 2 mg/day which was titrated to 5 mg after 2 days and to the target dose of 10 mg after 2 additional days). The 30 mg/day dose was not shown to be more efficacious than the 10 mg/day dose. In adult patients with agitation associated with bipolar mania or schizophrenia, the ABILIFY Injection initial dose is 9.75 mg/1.3 mL. If ongoing ABILIFY therapy is clinically indicated, oral ABILIFY in a range of 10 mg to 30 mg/day should replace ABILIFY Injection as soon as possible. The safety of doses of ABILIFY oral or ABILIFY Injection above 30 mg/day has not been evaluated in clinical trials.

IMPORTANT SAFETY INFORMATION and INDICATIONS for ABILIFY

INDICATIONS:

-- ABILIFY is indicated for acute and maintenance treatment of

schizophrenia in adults

-- ABILIFY is indicated for the treatment of schizophrenia in adolescents

13 to 17 years of age

-- ABILIFY is indicated for acute and maintenance treatment of bipolar

disorder with or without psychotic features

ABILIFY Injection is indicated for the treatment of adults with agitation associated with schizophrenia or bipolar disorder, manic or mixed.

IMPORTANT SAFETY INFORMATION:

Elderly patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death compared to placebo. ABILIFY is not approved for the treatment of patients with dementia-related psychosis (see Boxed WARNING).

Cerebrovascular adverse events (eg, stroke, transient ischemic attack),

including fatalities, have been reported at an increased incidence in

clinical trials of elderly patients with dementia-related psychosis

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SOURCE Otsuka Pharmaceutical Co., Ltd. Copyright©2007 PR Newswire. All rights reserved

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