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 BRAND NAMES
- International: Abilify
- Italy: Abilify
- Lebanon: Abilify 10, 15, 20, 30mg
- US: Abilify PI, Abilify Maintena PI
 MECHANISM OF ACTION
The mechanism of action of 'Arpiprazole differs from all other antipsychotics; typical antipsychotics (neuroleptics) and atypical ones act by blocking dopamine D2 receptors. Aripiprazole instead exerts a partial agonist action on D2 receptors.
As a partial agonist, Aripiprazole can act either as an agonist and as antagonist, depending on the concentration of dopamine. When dopamine levels are low, aripiprazole stimulates dopamine receptors, whereas when they are high, Aripiprazole inhibits dopamine receptors. It is thought that the positive symptoms also called manic episodes, characterized by aggression and agitation in patients with bipolar disorder are caused by overactivity of the dopaminergic mesolimbic pathway, while negative symptoms characterized by affective flattening, apathy, alogia, last of interests in life and social isolation are related to hypoactivity of the mesocortical dopaminergic tract.
Aripiprazole acts also as a partial agonist on serotonin 5HT1a receptors and as an antagonist on 5HT2a receptors.
- Adjunctive therapy to antidepressants in adults with Major Depressive Disorder who have had an inadequate response to antidepressant therapy
- Acute treatment of manic or mixed episodes associated with Bipolar I Disorder as monotherapy and as an adjunct to lithium or valproate in adult and pediatric patients 10 to 17 years of age
- Maintenance treatment of Bipolar I Disorder, both as monotherapy and as an adjunct to lithium or valproate
- Treatment of Schizophrenia in adults and adolescents 13 to 17 years of age. Aripiprazole can improve symptoms such as: hallucinations, delusions, and disorganized thinking; in some people, improvement in social isolation, reduced speech productivity and motivation may also occur.
- Treatment of irritability associated with Autistic Disorder in pediatric patients 6 to 17 years of age
- Treatment of Tourette’s Disorder in pediatric patients 6 to 18 years of age
Special Considerations for Pediatric Uses: Treatment for pediatric patients should be initiated only after a thorough diagnostic evaluation and careful consideration of the risks and benefits of treatment. Medication should be part of a treatment program that also includes psychological, educational, and social interventions
|Schizophrenia – adults||10-15 mg/day||10-15 mg/day||30 mg/day|
|Schizophrenia – adolescents||2 mg/day||10 mg/day||30 mg/day|
|Bipolar mania – adults: monotherapy||15 mg/day||15 mg/day||30 mg/day|
|Bipolar mania – adults: adjunct to lithium or valproate||10-15 mg/day||15 mg/day||30 mg/day|
|Bipolar mania – pediatric patients: monotherapy or as an adjunct to lithium or valproate||2 mg/day||10 mg/day||30 mg/day|
|As an adjunct to antidepressants for the treatment of major depressive disorder – adults||2-5 mg/day||5-10 mg/day||15 mg/day|
|Irritability associated with autistic disorder – pediatric patients||2 mg/day||5-10 mg/day||15 mg/day|
|Agitation associated with schizophrenia or bipolar mania – adults|| 9.75 mg/1.3 mL
| 30 mg/day|
|Tourette’s disorder||Patients < 50 kg||2 mg/day||5 mg/day||10 mg/day|
|Patients ≥ 50 kg||2 mg/day||10 mg/day||20 mg/day|
- Hypersensitivity to Aripiprazole
 WARNINGS AND PRECAUTIONS
- Elderly Patients with Dementia-Related Psychosis: Increased incidence of cerebrovascular adverse events (eg, stroke, transient ischemic attack, including fatalities)
- Suicidality and Antidepressants: Increased risk of suicidality in children, adolescents, and young adults with major depressive disorder
- Neuroleptic Malignant Syndrome: Manage with immediate discontinuation and close monitoring
- Tardive Dyskinesia: Discontinue if clinically appropriate
- Hyperglycemia and Diabetes Mellitus: Monitor glucose regularly in patients with and at risk for diabetes
- Orthostatic Hypotension: Use with caution in patients with known cardiovascular or cerebrovascular disease
- 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
- Seizures/Convulsions: Use cautiously in patients with a history of seizures or with conditions that lower the seizure threshold
- Potential for Cognitive and Motor Impairment: Use caution when operating machinery
- Suicide: The possibility of a suicide attempt is inherent in schizophrenia and bipolar disorder. Closely supervise high-risk patients
Aripiprazole is a substrate of CYP2D6 and CYP3A4. Coadministration with medications that inhibit (e.g. paroxetine, fluoxetine, ketoconazole) or induce (e.g. carbamazepine) these metabolic enzymes are known to increase and decrease, respectively, plasma levels of aripiprazole.
 PREGNANCY AND LACTATION
- Pregnancy Category C (US). Aripiprazole should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
- Nursing Mothers: Aripiprazole was excreted in milk of rats during lactation. It is not known whether aripiprazole or its metabolites are excreted in human milk. It is recommended that women receiving aripiprazole should not breast-feed.
 SIDE EFFECTS
Commonly observed adverse reactions (incidence ≥5% and at least twice that for placebo) were :
- 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.