These highlights do not include all the information needed to use ABILIFY safely and effectively. See full prescribing information for ABILIFY.
ABILIFY
® (aripiprazole) Tablets
ABILIFY DISCMELT
® (aripiprazole) Orally Disintegrating Tablets
ABILIFY
® (aripiprazole) Oral Solution
ABILIFY
® (aripiprazole) Injection FOR INTRAMUSCULAR USE ONLY
Initial U.S. Approval: 2002
WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS and SUICIDAL THOUGHTS AND BEHAVIORS
See full prescribing information for complete boxed warning.
RECENT MAJOR CHANGES
Dosage and Administration, Pediatric (6 to 17 years), Irritability Associated with Autistic Disorder (2.4) - 06/2014
INDICATIONS AND USAGE
ABILIFY is an atypical antipsychotic indicated as oral formulations for the:
Treatment of schizophrenia (1.1)
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Adults: Efficacy was established in four 4-6 week trials and one maintenance trial in patients with schizophrenia (14.1)
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Adolescents (ages 13-17): Efficacy was established in one 6-week trial in patients with schizophrenia (14.1)
Acute treatment of manic or mixed episodes associated with bipolar I disorder as monotherapy and as an adjunct to lithium or valproate (1.2)
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Adults: Efficacy was established in four 3-week monotherapy trials and one 6-week adjunctive trial in patients with manic or mixed episodes (14.2)
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Pediatric Patients (ages 10-17): Efficacy was established in one 4-week monotherapy trial in patients with manic or mixed episodes (14.2)
Maintenance treatment of bipolar I disorder, both as monotherapy and as an adjunct to lithium or valproate (1.2)
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Adults: Efficacy was established in one maintenance monotherapy trial and in one maintenance adjunctive trial (14.2)
Adjunctive treatment of major depressive disorder (MDD) (1.3)
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Adults: Efficacy was established in two 6-week trials in patients with MDD who had an inadequate response to antidepressant therapy during the current episode (14.3)
Treatment of irritability associated with autistic disorder (1.4)
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Pediatric Patients (ages 6-17 years): Efficacy was established in two 8-week trials in patients with autistic disorder (14.4)
as an injection for the:
Acute treatment of agitation associated with schizophrenia or bipolar I disorder (1.5)
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Adults: Efficacy was established in three 24-hour trials in agitated patients with schizophrenia or manic/mixed episodes of bipolar I disorder (14.5)
DOSAGE AND ADMINISTRATION
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Initial
Dose
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Recommended
Dose
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Maximum
Dose
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Schizophrenia – adults (2.1)
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10-15 mg /day
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10-15 mg /day
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30 mg /day
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Schizophrenia – adolescents (2.1)
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2 mg /day
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10 mg /day
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30 mg /day
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Bipolar mania – adults: monotherapy (2.2)
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15 mg /day
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15 mg /day
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30 mg /day
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Bipolar mania – adults: adjunct to lithium or valproate (2.2)
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10-15 mg /day
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15 mg /day
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30 mg /day
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Bipolar mania – pediatric patients: monotherapy or as an adjunct to lithium or valproate (2.2)
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2 mg /day
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10 mg /day
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30 mg /day
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As an adjunct to antidepressants for the treatment of major depressive disorder – adults (2.3)
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2-5 mg /day
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5-10 mg /day
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15 mg /day
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Irritability associated with autistic disorder – pediatric patients (2.4)
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2 mg /day
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5-10 mg /day
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15 mg /day
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Agitation associated with schizophrenia or bipolar mania – adults (2.5)
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9.75 mg /1.3 mL
injected IM
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30 mg /day
injected IM
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Oral formulations: Administer once daily without regard to meals (2)
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