Aripiprazole (7 brand names, 7 dosage forms, 3 routes)
Available dosage forms: FILM, TABLET, SUSPENSION, EXTENDED RELEASE, TABLET, ORALLY DISINTEGRATING, FOR SUSPENSION, EXTENDED RELEASE, SOLUTION, INJECTABLE.
Routes of administration: ORAL, INTRAMUSCULAR, ORALLY DISINTEGRATING.
Brand Names
- ABILIFY
- ABILIFY ASIMTUFII
- ABILIFY MAINTENA KIT
- ABILIFY MYCITE KIT
- ARIPIPRAZOLE
- MEZOFY
- OPIPZA
Boxed Warning
Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Aripiprazole is not approved for the treatment of patients with dementia-related psychosis [see Warnings and Precautions ( 5.1)] . Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term studies. These studies did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in patients over age 24 years; there was a reduction in risk with antidepressant use in patients aged 65 years and older [see Warnings and Precautions ( 5.3)]. In patients of all ages who are started on antidepressant therapy, monitor closely for worsening, and for emergence of suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and communication with the prescriber [see Warnings and Precautions ( 5.3)].
Indications and Usage
Aripiprazole tablets are indicated for the treatment of: Schizophrenia Acute Treatment of Manic and Mixed Episodes associated with Bipolar I Disorder Adjunctive Treatment of Major Depressive Disorder Irritability Associated with Autistic Disorder Treatment of Tourette’s Disorder
Contraindications
Aripiprazole tablets is contraindicated in patients with a history of a hypersensitivity reaction to aripiprazole. Reactions have ranged from pruritus/urticaria to anaphylaxis [see Adverse Reactions ( 6.2)].
Adverse Reactions
The following adverse reactions are discussed in more detail in other sections of the labeling: Increased Mortality in Elderly Patients with Dementia-Related Psychosis [see Boxed Warning and Warnings and Precautions ( 5.1)] Cerebrovascular Adverse Events, Including Stroke [ see Warnings and Precautions ( 5.2)] Suicidal Thoughts and Behaviors in Children, Adolescents, and Young Adults [see Boxed Warning and Warnings and Precautions ( 5.3)] Neuroleptic Malignant Syndrome (NMS) [ see Warnings and Precautions ( 5.4)] Tardive Dyskinesia [see Warnings and Precautions ( 5.5)] Metabolic Changes [see Warnings and Precautions ( 5.6)] Pathological Gambling and Other Compulsive Behaviors [see Warnings and Precautions ( 5.7)] Orthostatic Hypotension [see Warnings and Precautions ( 5.8)] Falls [ see Warnings and Precautions ( 5.9)] Leukopenia, Neutropenia, and Agranulocytosis [see Warnings and Precautions ( 5.10)] Seizures/Convulsions [ see Warnings and Precautions ( 5.11)] Potential for Cognitive and Motor Impairment [see Warnings and Precautions ( 5.12)] Body Temperature Regulation [see Warnings and Precautions ( 5.13)] Suicide [see Warnings and Precautions ( 5.14)] Dysphagia [see Warnings and Precautions ( 5.15)]
Mechanism of Action
The mechanism of action of aripiprazole in schizophrenia or bipolar mania, is unclear. However, the efficacy of aripiprazole in the listed indications could be mediated through a combination of partial agonist activity at D 2and 5-HT 1Areceptors and antagonist activity at 5-HT 2Areceptors.
Overdosage
MedDRA terminology has been used to classify the adverse reactions. Human Experience In clinical trials and in postmarketing experience, adverse reactions of deliberate or accidental overdosage with oral aripiprazole have been reported worldwide. These include overdoses with aripiprazole alone and in combination with other substances. No fatality was reported with aripiprazole alone. The largest known dose with a known outcome involved acute ingestion of 1,260 mg of aripiprazole (42 times the maximum recommended daily dose) by a patient who fully recovered. Deliberate or accidental overdosage was also reported in children (age 12 years and younger) involving aripiprazole ingestions up to 195 mg with no fatalities. Common adverse reactions (reported in at least 5% of all overdose cases) reported with oral aripiprazole overdosage (alone or in combination with other substances) include vomiting, somnolence, and tremor. Other clinically important signs and symptoms observed in one or more patients with aripiprazole overdoses (alone or with other substances) include acidosis, aggression, aspartate aminotransferase increased, atrial fibrillation, bradycardia, coma, confusional state, convulsion, blood creatine phosphokinase increased, depressed level of consciousness, hypertension, hypokalemia, hypotension, lethargy, loss of consciousness, QRS complex prolonged, QT prolonged, pneumonia aspiration, respiratory arrest, status epilepticus, and tachycardia. Management of Overdosage No specific information is available on the treatment of overdose with aripiprazole. An electrocardiogram should be obtained in case of overdosage and if QT interval prolongation is present, cardiac monitoring should be instituted. Otherwise, management of overdose should concentrate on supportive therapy, maintaining an adequate airway, oxygenation and ventilation, and management of symptoms. Close medical supervision and monitoring should continue until the patient recovers. Charcoal:In the event