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Freebase Commons Common /common

  • Abilify (Cardinal Health), manufactured drug form of Aripiprazole, 10mg/tablet aripiprazole tablet, NDC 55154-2021

Freebase Commons Business /business

Freebase Commons Medicine /medicine

Section name Section URI Prominent warning Highlight text Subject manufactured drug Section LOINC code
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  • Indications and Usage, Bipolar I Disorder, Adjunctive Therapy (1.2) 02/2011 Dosage and Administration, Bipolar I Disorder, Adjunctive Therapy (2.2) 02/2011 Dosage and Administration, Dosage Adjustment (2.6) 02/2011
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  • 43683-2
  • Warnings: Increased Mortality In Elderly Patients With Dementia-related Psychosis And Suicidality And Antidepressant Drugs
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  • WARNINGS: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS and SUICIDALITY AND ANTIDEPRESSANT DRUGS See full prescribing information for complete boxed warning . Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. ABILIFY is not approved for the treatment of patients with dementia-related psychosis. (5.1) Children, adolescents, and young adults taking antidepressants for major depressive disorder (MDD) and other psychiatric disorders are at increased risk of suicidal thinking and behavior. (5.2)
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  • 34066-1
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  • ABILIFY is an atypical antipsychotic indicated as oral formulations for the: Treatment of schizophrenia (1.1) Adults: Efficacy was established in four 4-6 week trials and one maintenance trial in patients with schizophrenia (14.1) 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) 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) 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) 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) 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) 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) Adults: Efficacy was established in three 24-hour trials in agitated patients with schizophrenia or manic/mixed episodes of bipolar I disorder (14.5)
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  • Oral formulations: Administer once daily without regard to meals (2) IM injection: Wait at least 2 hours between doses. Maximum daily dose 30 mg (2.5)
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  • Tablets: 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg (3) Orally Disintegrating Tablets: 10 mg and 15 mg (3) Oral Solution: 1 mg/mL (3) Injection: 9.75 mg/1.3 mL single-dose vial (3)
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  • 43678-2
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  • Known hypersensitivity to ABILIFY (4)
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  • 34070-3
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  • Elderly Patients with Dementia-Related Psychosis: Increased incidence of cerebrovascular adverse events (eg, stroke, transient ischemic attack, including fatalities) (5.1) Suicidality and Antidepressants: Increased risk of suicidality in children, adolescents, and young adults with major depressive disorder (5.2) Neuroleptic Malignant Syndrome: Manage with immediate discontinuation and close monitoring (5.3) Tardive Dyskinesia: Discontinue if clinically appropriate (5.4) Hyperglycemia and Diabetes Mellitus: Monitor glucose regularly in patients with and at risk for diabetes (5.5) Orthostatic Hypotension: Use with caution in patients with known cardiovascular or cerebrovascular disease (5.6) Leukopenia, Neutropenia, and Agranulocytosis: have been reported with antipsychotics including ABILIFY. Patients with a history of a clinically significant low white blood cell count (WBC) or a drug-induced leukopenia/neutropenia should have their complete blood count (CBC) monitored frequently during the first few months of therapy and discontinuation of ABILIFY should be considered at the first sign of a clinically significant decline in WBC in the absence of other causative factors (5.7) Seizures/Convulsions: Use cautiously in patients with a history of seizures or with conditions that lower the seizure threshold (5.8) Potential for Cognitive and Motor Impairment: Use caution when operating machinery (5.9) Suicide: The possibility of a suicide attempt is inherent in schizophrenia and bipolar disorder. Closely supervise high-risk patients (5.11)
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  • 43685-7
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  • Commonly observed adverse reactions (incidence ≥5% and at least twice that for placebo) were (6.2): Adult patients with schizophrenia: akathisia Pediatric patients (13 to 17 years) with schizophrenia: extrapyramidal disorder, somnolence, and tremor Adult patients (monotherapy) with bipolar mania: akathisia, sedation, restlessness, tremor, and extrapyramidal disorder Adult patients (adjunctive therapy with lithium or valproate) with bipolar mania: akathisia, insomnia, and extrapyramidal disorder Pediatric patients (10 to 17 years) with bipolar mania: somnolence, extrapyramidal disorder, fatigue, nausea, akathisia, blurred vision, salivary hypersecretion, and dizziness Adult patients with major depressive disorder (adjunctive treatment to antidepressant therapy): akathisia, restlessness, insomnia, constipation, fatigue, and blurred vision Pediatric patients (6 to 17 years) with autistic disorder: sedation, fatigue, vomiting, somnolence, tremor, pyrexia, drooling, decreased appetite, salivary hypersecretion, extrapyramidal disorder, and lethargy Adult patients with agitation associated with schizophrenia or bipolar mania: nausea. To report SUSPECTED ADVERSE REACTIONS, contact Bristol-Myers Squibb at 1-800-721-5072 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
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  • 34084-4
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  • Strong CYP3A4 (eg, ketoconazole) or CYP2D6 (eg, fluoxetine) inhibitors will increase ABILIFY drug concentrations; reduce ABILIFY dose to one-half of the usual dose when used concomitantly (2.6, 7.1), except when used as adjunctive treatment with antidepressants (2.6). If a strong CYP3A4 inhibitor and strong CYP2D6 inhibitor are co-administered or a known CYP2D6 poor metabolizer is receiving a concomitant strong CYP3A4 inhibitor, the ABILIFY dose should be reduced to one-quarter (25%) of the usual dose (2.6, 12.3). CYP3A4 inducers (eg, carbamazepine) will decrease ABILIFY drug concentrations; double ABILIFY dose when used concomitantly (2.6, 7.1)
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  • 34073-7
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  • 43684-0

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