ABILIFY Aripiprazole 5mg Tablet 1's
RXDRUG-DRP-6282-1pc
Discreet Packaging
FDA-registered Products
FDA-licensed Pharmacies
Indications/Uses
Schizophrenia: Aripiprazole (Abilify) is indicated for the treatment of schizophrenia. The efficacy of Aripiprazole (Abilify) was established in four 4-6 week trials in adults and one 6-week trial in adolescents (13 to 17 years). Maintenance efficacy was demonstrated in one trial in adults and can be extrapolated to adolescents [see Pharmacology: Pharmacodynamics: Clinical Studies: Schizophrenia under Actions].
Bipolar I Disorder: Acute Treatment of Manic and Mixed Episodes: Aripiprazole (Abilify) is indicated for the acute treatment of manic and mixed episodes associated with bipolar I disorder, both as monotherapy and as an adjunct to lithium or valproate. Efficacy as monotherapy was established in four 3-week monotherapy trials in adults and one 4-week monotherapy trial in pediatric patients (10 to 17 years). Efficacy as adjunctive therapy was established in one 6-week adjunctive trial in adults [see Pharmacology: Pharmacodynamics: Clinical Studies: Bipolar Disorder under Actions].
Maintenance Treatment of Bipolar I Disorder: Aripiprazole (Abilify) is indicated for the maintenance treatment of bipolar I disorder, both as monotherapy and as an adjunct to either lithium or valproate. Maintenance efficacies were demonstrated in one monotherapy maintenance trial and in one adjunctive maintenance trial in adults [see Pharmacology: Pharmacodynamics: Clinical Studies: Bipolar Disorder under Actions].
Special Considerations in Treating Pediatric Schizophrenia, Bipolar I Disorder, and Irritability Associated with Autistic Disorder: Psychiatric disorders in children and adolescents are often serious mental disorders with variable symptom profiles that are not always congruent with adult diagnostic criteria. It is recommended that psychotropic medication therapy for pediatric patients only be initiated after a thorough diagnostic evaluation has been conducted and careful consideration given to the risks associated with medication treatment. Medication treatment for pediatric patients with schizophrenia, bipolar I disorder, and irritability associated with autistic disorder (except for Abilify OS) is indicated as part of a total treatment program that often includes psychological, educational, and social interventions.
Adjunctive Treatment of Major Depressive Disorder: Aripiprazole (Abilify) is indicated for use as an adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD). Efficacy was established in two 6-week trials in adults with MDD who had an inadequate response to antidepressant therapy during the current episode [see Pharmacology: Pharmacodynamics: Clinical Studies: Adjunctive Treatment of Major Depressive Disorder under Actions].
Oral Solution is not approved for this indication.
Irritability Associated with Autistic Disorder: Aripiprazole (Abilify) is indicated for the treatment of irritability associated with autistic disorder. Efficacy was established in two 8-week trials in pediatric patients (aged 6 to 17 years) with irritability associated with autistic disorder (including symptoms of aggression towards others, deliberate self-injuriousness, temper tantrums, and quickly changing moods) [see Pharmacology: Pharmacodynamics: Clinical Studies: Irritability Associated with Autistic Disorder under Actions].
Oral Solution is not approved for this indication.
Tourette's Disorder: Aripiprazole (Abilify) is indicated for the treatment of Tourette's disorder. Efficacy was established in one 8-week (7 to 17 years of age) and one 10-week (6 to 18 years of age) placebo-controlled trials in pediatric patients (aged 6 to 18 years) with Tourette’s disorder [see Pharmacology: Pharmacodynamics: Clinical Studies: Tourette's Disorder under Actions].
Oral Solution is not approved for this indication.
Bipolar I Disorder: Acute Treatment of Manic and Mixed Episodes: Aripiprazole (Abilify) is indicated for the acute treatment of manic and mixed episodes associated with bipolar I disorder, both as monotherapy and as an adjunct to lithium or valproate. Efficacy as monotherapy was established in four 3-week monotherapy trials in adults and one 4-week monotherapy trial in pediatric patients (10 to 17 years). Efficacy as adjunctive therapy was established in one 6-week adjunctive trial in adults [see Pharmacology: Pharmacodynamics: Clinical Studies: Bipolar Disorder under Actions].
Maintenance Treatment of Bipolar I Disorder: Aripiprazole (Abilify) is indicated for the maintenance treatment of bipolar I disorder, both as monotherapy and as an adjunct to either lithium or valproate. Maintenance efficacies were demonstrated in one monotherapy maintenance trial and in one adjunctive maintenance trial in adults [see Pharmacology: Pharmacodynamics: Clinical Studies: Bipolar Disorder under Actions].
Special Considerations in Treating Pediatric Schizophrenia, Bipolar I Disorder, and Irritability Associated with Autistic Disorder: Psychiatric disorders in children and adolescents are often serious mental disorders with variable symptom profiles that are not always congruent with adult diagnostic criteria. It is recommended that psychotropic medication therapy for pediatric patients only be initiated after a thorough diagnostic evaluation has been conducted and careful consideration given to the risks associated with medication treatment. Medication treatment for pediatric patients with schizophrenia, bipolar I disorder, and irritability associated with autistic disorder (except for Abilify OS) is indicated as part of a total treatment program that often includes psychological, educational, and social interventions.
Adjunctive Treatment of Major Depressive Disorder: Aripiprazole (Abilify) is indicated for use as an adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD). Efficacy was established in two 6-week trials in adults with MDD who had an inadequate response to antidepressant therapy during the current episode [see Pharmacology: Pharmacodynamics: Clinical Studies: Adjunctive Treatment of Major Depressive Disorder under Actions].
Oral Solution is not approved for this indication.
Irritability Associated with Autistic Disorder: Aripiprazole (Abilify) is indicated for the treatment of irritability associated with autistic disorder. Efficacy was established in two 8-week trials in pediatric patients (aged 6 to 17 years) with irritability associated with autistic disorder (including symptoms of aggression towards others, deliberate self-injuriousness, temper tantrums, and quickly changing moods) [see Pharmacology: Pharmacodynamics: Clinical Studies: Irritability Associated with Autistic Disorder under Actions].
Oral Solution is not approved for this indication.
Tourette's Disorder: Aripiprazole (Abilify) is indicated for the treatment of Tourette's disorder. Efficacy was established in one 8-week (7 to 17 years of age) and one 10-week (6 to 18 years of age) placebo-controlled trials in pediatric patients (aged 6 to 18 years) with Tourette’s disorder [see Pharmacology: Pharmacodynamics: Clinical Studies: Tourette's Disorder under Actions].
Oral Solution is not approved for this indication.
Dosage/Direction for Use
Schizophrenia: Adults: The recommended starting and target dose for Aripiprazole (Abilify) is 10 or 15 mg/day administered on a once-a-day schedule without regard to meals. Aripiprazole (Abilify) has been systematically evaluated and shown to be effective in a dose range of 10 to 30 mg/day, when administered as the tablet formulation; however, doses higher than 10 or 15 mg/day were not more effective than 10 or 15 mg/day. Dosage increases should generally not be made before 2 weeks, the time needed to achieve steady-state [see Pharmacology: Pharmacodynamics: Clinical Studies: Schizophrenia under Actions].
Maintenance Treatment: Maintenance of efficacy in schizophrenia was demonstrated in a trial involving patients with schizophrenia who had been symptomatically stable on other antipsychotic medications for periods of 3 months or longer. These patients were discontinued from those medications and randomized to either Aripiprazole (Abilify) 15 mg/day or placebo, and observed for relapse [see Pharmacology: Pharmacodynamics: Clinical Studies: Schizophrenia under Actions]. Patients should be periodically reassessed to determine the continued need for maintenance treatment.
Adolescents: The recommended target dose of Aripiprazole (Abilify) is 10 mg/day. Aripiprazole was studied in adolescent patients 13 to 17 years of age with schizophrenia at daily doses of 10 mg and 30 mg. The starting daily dose of the tablet formulation in these patients was 2 mg, which was titrated to 5 mg after 2 days and to the target dose of 10 mg after 2 additional days. Subsequent dose increases should be administered in 5 mg increments. The 30 mg/day dose was not shown to be more efficacious than the 10 mg/day dose. Aripiprazole (Abilify) can be administered without regard to meals [see Pharmacology: Pharmacodynamics: Clinical Studies: Schizophrenia under Actions]. Patients should be periodically reassessed to determine the need for maintenance treatment.
Switching from Other Antipsychotics: There are no systematically collected data to specifically address switching patients with schizophrenia from other antipsychotics to Aripiprazole (Abilify) or concerning concomitant administration with other antipsychotics. While immediate discontinuation of the previous antipsychotic treatment may be acceptable for some patients with schizophrenia, more gradual discontinuation may be most appropriate for others. In all cases, the period of overlapping antipsychotic administration should be minimized.
Bipolar I Disorder: Acute Treatment of Manic and Mixed Episodes: Adults: The recommended starting dose in adults is 15 mg given once daily as monotherapy and 10 mg to 15 mg given once daily as adjunctive therapy with lithium or valproate. Aripiprazole (Abilify) can be given without regard to meals. The recommended target dose of Aripiprazole (Abilify) is 15 mg/day, as monotherapy or as adjunctive therapy with lithium or valproate. The dose may be increased to 30 mg/day based on clinical response. The safety of doses above 30 mg/day has not been evaluated in clinical trials.
Pediatrics: The recommended starting dose in pediatric patients (10 to 17 years) as monotherapy is 2 mg/day, with titration to 5 mg/day after 2 days, and a target dose of 10 mg/day after 2 additional days. Recommended dosing as adjunctive therapy to lithium or valproate is the same. Subsequent dose increases, if needed, should be administered in 5 mg/day increments. Aripiprazole (Abilify) can be given without regard to meals [see Pharmacology: Pharmacodynamics: Clinical Studies: Bipolar Disorder under Actions].
Dosage Adjustments for Cytochrome P450 Considerations: Dosage adjustments are recommended in patients who are known CYP2D6 poor metabolizers and in patients taking concomitant CYP3A4 inhibitors or CYP2D6 inhibitors or strong CYP3A4 inducers (see Table 8). When the coadministered drug is withdrawn from the combination therapy, Aripiprazole (Abilify) dosage should then be adjusted to its original level. When the coadministered CYP3A4 inducer is withdrawn, Aripiprazole (Abilify) dosage should be reduced to the original level over 1 to 2 weeks. Patients who may be receiving a combination of strong, moderate, and weak inhibitors of CYP3A4 and CYP2D6 (e.g., a strong CYP3A4 inhibitor and a moderate CYP2D6 inhibitor or a moderate CYP3A4 inhibitor with a moderate CYP2D6 inhibitor), the dosing may be reduced to one-quarter (25%) of the usual dose initially and then adjusted to achieve a favorable clinical response.
Maintenance Treatment: Maintenance of efficacy in schizophrenia was demonstrated in a trial involving patients with schizophrenia who had been symptomatically stable on other antipsychotic medications for periods of 3 months or longer. These patients were discontinued from those medications and randomized to either Aripiprazole (Abilify) 15 mg/day or placebo, and observed for relapse [see Pharmacology: Pharmacodynamics: Clinical Studies: Schizophrenia under Actions]. Patients should be periodically reassessed to determine the continued need for maintenance treatment.
Adolescents: The recommended target dose of Aripiprazole (Abilify) is 10 mg/day. Aripiprazole was studied in adolescent patients 13 to 17 years of age with schizophrenia at daily doses of 10 mg and 30 mg. The starting daily dose of the tablet formulation in these patients was 2 mg, which was titrated to 5 mg after 2 days and to the target dose of 10 mg after 2 additional days. Subsequent dose increases should be administered in 5 mg increments. The 30 mg/day dose was not shown to be more efficacious than the 10 mg/day dose. Aripiprazole (Abilify) can be administered without regard to meals [see Pharmacology: Pharmacodynamics: Clinical Studies: Schizophrenia under Actions]. Patients should be periodically reassessed to determine the need for maintenance treatment.
Switching from Other Antipsychotics: There are no systematically collected data to specifically address switching patients with schizophrenia from other antipsychotics to Aripiprazole (Abilify) or concerning concomitant administration with other antipsychotics. While immediate discontinuation of the previous antipsychotic treatment may be acceptable for some patients with schizophrenia, more gradual discontinuation may be most appropriate for others. In all cases, the period of overlapping antipsychotic administration should be minimized.
Bipolar I Disorder: Acute Treatment of Manic and Mixed Episodes: Adults: The recommended starting dose in adults is 15 mg given once daily as monotherapy and 10 mg to 15 mg given once daily as adjunctive therapy with lithium or valproate. Aripiprazole (Abilify) can be given without regard to meals. The recommended target dose of Aripiprazole (Abilify) is 15 mg/day, as monotherapy or as adjunctive therapy with lithium or valproate. The dose may be increased to 30 mg/day based on clinical response. The safety of doses above 30 mg/day has not been evaluated in clinical trials.
Pediatrics: The recommended starting dose in pediatric patients (10 to 17 years) as monotherapy is 2 mg/day, with titration to 5 mg/day after 2 days, and a target dose of 10 mg/day after 2 additional days. Recommended dosing as adjunctive therapy to lithium or valproate is the same. Subsequent dose increases, if needed, should be administered in 5 mg/day increments. Aripiprazole (Abilify) can be given without regard to meals [see Pharmacology: Pharmacodynamics: Clinical Studies: Bipolar Disorder under Actions].
Dosage Adjustments for Cytochrome P450 Considerations: Dosage adjustments are recommended in patients who are known CYP2D6 poor metabolizers and in patients taking concomitant CYP3A4 inhibitors or CYP2D6 inhibitors or strong CYP3A4 inducers (see Table 8). When the coadministered drug is withdrawn from the combination therapy, Aripiprazole (Abilify) dosage should then be adjusted to its original level. When the coadministered CYP3A4 inducer is withdrawn, Aripiprazole (Abilify) dosage should be reduced to the original level over 1 to 2 weeks. Patients who may be receiving a combination of strong, moderate, and weak inhibitors of CYP3A4 and CYP2D6 (e.g., a strong CYP3A4 inhibitor and a moderate CYP2D6 inhibitor or a moderate CYP3A4 inhibitor with a moderate CYP2D6 inhibitor), the dosing may be reduced to one-quarter (25%) of the usual dose initially and then adjusted to achieve a favorable clinical response.
When adjunctive Aripiprazole (Abilify) is administered to patients with major depressive disorder, Aripiprazole (Abilify) should be administered without dosage adjustment as specified in Adjunctive Treatment of Major Depressive Disorder previously.
Dosing of Oral Solution: The oral solution can be substituted for tablets on a mg-per-mg basis up to the 25 mg dose level. Patients receiving 30 mg tablets should receive 25 mg of the solution [see Pharmacology: Pharmacokinetics under Actions].
Dosing of Orally Disintegrating Tablets: The dosing for Aripiprazole (Abilify Discmelt) Orally Disintegrating Tablets is the same as for the oral tablets [see Schizophrenia, Bipolar I Disorder, Adjunctive Treatment of Major Depressive Disorder and Irritability Associated with Autistic Disorder previously].
Other Indications of Abilify Tablet/Abilify Discmelt only: Adjunctive Treatment of Major Depressive Disorder: Adults: The recommended starting dose for Aripiprazole (Abilify) as adjunctive treatment for patients already taking an antidepressant is 2 to 5 mg/day. The recommended dosage range is 2 to 15 mg/day. Dosage adjustments of up to 5 mg/day should occur gradually, at intervals of no less than 1 week [see Pharmacology: Pharmacodynamics: Clinical Studies: Adjunctive Treatment of Major Depressive Disorder under Actions]. Patients should be periodically reassessed to determine the continued need for maintenance treatment.
Irritability Associated with Autistic Disorder: Pediatric Patients (6 to 17 years): The recommended dosage range for the treatment of pediatric patients with irritability associated with autistic disorder is 5 to 15 mg/day.
Dosing should be initiated at 2 mg/day. The dose should be increased to 5 mg/day, with subsequent increases to 10 or 15 mg/day if needed. Dose adjustments of up to 5 mg/day should occur gradually, at intervals of no less than 1 week [see Pharmacology: Pharmacodynamics: Clinical Studies: Irritability Associated with Autistic Disorder under Actions]. Patients should be periodically reassessed to determine the continued need for maintenance treatment.
Tourette's Disorder: Pediatric Patients (6 to 18 years): The recommended dosage range for Tourette's Disorder is 5 to 20 mg/day.
For patients weighing less than 50 kg, dosing should be initiated at 2 mg/day with a target dose of 5 mg/day after 2 days. The dose can be increased to 10 mg/day in patients who do not achieve optimal control of tics. Dosage adjustments should occur gradually at intervals of no less than 1 week.
For patients weighing 50 kg or more, dosing should be initiated at 2 mg/day for 2 days, and then increased to 5 mg/day for 5 days, with a target dose of 10 mg/day on day 8. The dose can be increased up to 20 mg/day for patients who do not achieve optimal control of tics. Dosage adjustments should occur gradually in increments of 5 mg/day at intervals of no less than 1 week. [see Pharmacology: Pharmacodynamics: Clinical Studies: Tourette's Disorder under Actions].
Patients should be periodically reassessed to determine the continued need for maintenance treatment.
Dosing of Oral Solution: The oral solution can be substituted for tablets on a mg-per-mg basis up to the 25 mg dose level. Patients receiving 30 mg tablets should receive 25 mg of the solution [see Pharmacology: Pharmacokinetics under Actions].
Dosing of Orally Disintegrating Tablets: The dosing for Aripiprazole (Abilify Discmelt) Orally Disintegrating Tablets is the same as for the oral tablets [see Schizophrenia, Bipolar I Disorder, Adjunctive Treatment of Major Depressive Disorder and Irritability Associated with Autistic Disorder previously].
Other Indications of Abilify Tablet/Abilify Discmelt only: Adjunctive Treatment of Major Depressive Disorder: Adults: The recommended starting dose for Aripiprazole (Abilify) as adjunctive treatment for patients already taking an antidepressant is 2 to 5 mg/day. The recommended dosage range is 2 to 15 mg/day. Dosage adjustments of up to 5 mg/day should occur gradually, at intervals of no less than 1 week [see Pharmacology: Pharmacodynamics: Clinical Studies: Adjunctive Treatment of Major Depressive Disorder under Actions]. Patients should be periodically reassessed to determine the continued need for maintenance treatment.
Irritability Associated with Autistic Disorder: Pediatric Patients (6 to 17 years): The recommended dosage range for the treatment of pediatric patients with irritability associated with autistic disorder is 5 to 15 mg/day.
Dosing should be initiated at 2 mg/day. The dose should be increased to 5 mg/day, with subsequent increases to 10 or 15 mg/day if needed. Dose adjustments of up to 5 mg/day should occur gradually, at intervals of no less than 1 week [see Pharmacology: Pharmacodynamics: Clinical Studies: Irritability Associated with Autistic Disorder under Actions]. Patients should be periodically reassessed to determine the continued need for maintenance treatment.
Tourette's Disorder: Pediatric Patients (6 to 18 years): The recommended dosage range for Tourette's Disorder is 5 to 20 mg/day.
For patients weighing less than 50 kg, dosing should be initiated at 2 mg/day with a target dose of 5 mg/day after 2 days. The dose can be increased to 10 mg/day in patients who do not achieve optimal control of tics. Dosage adjustments should occur gradually at intervals of no less than 1 week.
For patients weighing 50 kg or more, dosing should be initiated at 2 mg/day for 2 days, and then increased to 5 mg/day for 5 days, with a target dose of 10 mg/day on day 8. The dose can be increased up to 20 mg/day for patients who do not achieve optimal control of tics. Dosage adjustments should occur gradually in increments of 5 mg/day at intervals of no less than 1 week. [see Pharmacology: Pharmacodynamics: Clinical Studies: Tourette's Disorder under Actions].
Patients should be periodically reassessed to determine the continued need for maintenance treatment.
Overdosage
MedDRA terminology has been used to classify the adverse reactions.
In clinical trials and in postmarketing experience, adverse reactions of deliberate or accidental overdosage with oral Aripiprazole (Abilify) have been reported worldwide. These include overdoses with oral Aripiprazole (Abilify) alone and in combination with other substances. No fatality was reported with Aripiprazole (Abilify) alone. The largest known dose with a known outcome involved acute ingestion of 1260 mg of oral Aripiprazole (Abilify) (42 times the maximum recommended daily dose) by a patient who fully recovered. Deliberate or accidental overdosage was also reported in children (age 12 and younger) involving oral Aripiprazole (Abilify) ingestions up to 195 mg with no fatalities.
Common adverse reactions (reported in at least 5% of all overdose cases) reported with oral Aripiprazole (Abilify) 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 (Abilify) 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 (Abilify). 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 of an overdose of Aripiprazole (Abilify), an early charcoal administration may be useful in partially preventing the absorption of aripiprazole. Administration of 50 g of activated charcoal, one hour after a single 15 mg oral dose of Aripiprazole (Abilify), decreased the mean AUC and Cmax of aripiprazole by 50%.
Hemodialysis: Although there is no information on the effect of hemodialysis in treating an overdose with Aripiprazole (Abilify), hemodialysis is unlikely to be useful in overdose management since aripiprazole is highly bound to plasma proteins.
In clinical trials and in postmarketing experience, adverse reactions of deliberate or accidental overdosage with oral Aripiprazole (Abilify) have been reported worldwide. These include overdoses with oral Aripiprazole (Abilify) alone and in combination with other substances. No fatality was reported with Aripiprazole (Abilify) alone. The largest known dose with a known outcome involved acute ingestion of 1260 mg of oral Aripiprazole (Abilify) (42 times the maximum recommended daily dose) by a patient who fully recovered. Deliberate or accidental overdosage was also reported in children (age 12 and younger) involving oral Aripiprazole (Abilify) ingestions up to 195 mg with no fatalities.
Common adverse reactions (reported in at least 5% of all overdose cases) reported with oral Aripiprazole (Abilify) 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 (Abilify) 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 (Abilify). 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 of an overdose of Aripiprazole (Abilify), an early charcoal administration may be useful in partially preventing the absorption of aripiprazole. Administration of 50 g of activated charcoal, one hour after a single 15 mg oral dose of Aripiprazole (Abilify), decreased the mean AUC and Cmax of aripiprazole by 50%.
Hemodialysis: Although there is no information on the effect of hemodialysis in treating an overdose with Aripiprazole (Abilify), hemodialysis is unlikely to be useful in overdose management since aripiprazole is highly bound to plasma proteins.
Administration
May be taken with or without food: Abilify Discmelt: Place tab on the tongue immediately upon opening the blister & allow to disintegrate then, swallow w/o liqd. Do not split tab.
Contraindications
Aripiprazole (Abilify) is contraindicated in patients with a history of a hypersensitivity reaction to aripiprazole. Reactions have ranged from pruritus/urticaria to anaphylaxis [see Postmarketing Experience under Adverse Reactions].
Warnings
Increased Mortality in Elderly Patients with Dementia-Related Psychosis and Suicidal Thoughts and Behaviors with Antidepressant Drugs: Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Aripiprazole (Abilify) is not approved for the treatment of patients with dementia-related psychosis [see Increased Mortality in Elderly Patients with Dementia-Related Psychosis under Precautions].
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; there was a reduction in risk with antidepressant use in patients aged 65 and older [see Suicidal Thoughts and Behaviors in Children, Adolescents, and Young Adults under Precautions].
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 Suicidal Thoughts and Behaviors in Children, Adolescents, and Young Adults under Precautions].
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; there was a reduction in risk with antidepressant use in patients aged 65 and older [see Suicidal Thoughts and Behaviors in Children, Adolescents, and Young Adults under Precautions].
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 Suicidal Thoughts and Behaviors in Children, Adolescents, and Young Adults under Precautions].
Special Precautions
Increased Mortality in Elderly Patients with Dementia-Related Psychosis: Increased Mortality: Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Aripiprazole (Abilify) is not approved for the treatment of patients with dementia-related psychosis [see Warnings].
Safety Experience in Elderly Patients with Psychosis Associated with Alzheimer's Disease: In three, 10-week, placebo-controlled studies of Aripiprazole (Abilify) in elderly patients with psychosis associated with Alzheimer's disease (n=938; mean age: 82.4 years; range: 56-99 years), the adverse reactions that were reported at an incidence of ≥3% and Aripiprazole (Abilify) incidence at least twice that for placebo were lethargy [placebo 2%, Aripiprazole (Abilify) 5%], somnolence (including sedation) [placebo 3%, Aripiprazole (Abilify) 8%], and incontinence (primarily, urinary incontinence) [placebo 1%, Aripiprazole (Abilify) 5%], excessive salivation [placebo 0%, Aripiprazole (Abilify) 4%], and lightheadedness [placebo 1%, Aripiprazole (Abilify) 4%].
The safety and efficacy of Aripiprazole (Abilify) in the treatment of patients with psychosis associated with dementia have not been established. If the prescriber elects to treat such patients with Aripiprazole (Abilify), assess for the emergence of difficulty swallowing or excessive somnolence, which could predispose to accidental injury or aspiration [see Warnings].
Cerebrovascular Adverse Events, Including Stroke: In placebo-controlled clinical studies (two flexible dose and one fixed dose study) of dementia-related psychosis, there was an increased incidence of cerebrovascular adverse events (e.g., stroke, transient ischemic attack), including fatalities, in Aripiprazole (Abilify)-treated patients (mean age: 84 years; range: 78-88 years). In the fixed-dose study, there was a statistically significant dose response relationship for cerebrovascular adverse events in patients treated with Aripiprazole (Abilify). Aripiprazole (Abilify) is not approved for the treatment of patients with dementia-related psychosis [see Warnings].
Suicidal Thoughts and Behaviors in Children, Adolescents, and Young Adults: Patients with major depressive disorder (MDD), both adult and pediatric, may experience worsening of their depression and/or the emergence of suicidal ideation and behavior (suicidality) or unusual changes in behavior, whether or not they are taking antidepressant medications, and this risk may persist until significant remission occurs. Suicide is a known risk of depression and certain other psychiatric disorders, and these disorders themselves are the strongest predictors of suicide. There has been a long-standing concern, however, that antidepressants may have a role in inducing worsening of depression and the emergence of suicidality in certain patients during the early phases of treatment. Pooled analyses of short-term, placebo-controlled trials of antidepressant drugs (SSRIs and others) showed that these drugs increase the risk of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults (ages 18-24) with MDD and other psychiatric disorders. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction with antidepressants compared to placebo in adults aged 65 and older. The pooled analyses of placebo-controlled trials in children and adolescents with MDD, Obsessive Compulsive Disorder (OCD), or other psychiatric disorders included a total of 24 short-term trials of 9 antidepressant drugs in over 4400 patients.
Safety Experience in Elderly Patients with Psychosis Associated with Alzheimer's Disease: In three, 10-week, placebo-controlled studies of Aripiprazole (Abilify) in elderly patients with psychosis associated with Alzheimer's disease (n=938; mean age: 82.4 years; range: 56-99 years), the adverse reactions that were reported at an incidence of ≥3% and Aripiprazole (Abilify) incidence at least twice that for placebo were lethargy [placebo 2%, Aripiprazole (Abilify) 5%], somnolence (including sedation) [placebo 3%, Aripiprazole (Abilify) 8%], and incontinence (primarily, urinary incontinence) [placebo 1%, Aripiprazole (Abilify) 5%], excessive salivation [placebo 0%, Aripiprazole (Abilify) 4%], and lightheadedness [placebo 1%, Aripiprazole (Abilify) 4%].
The safety and efficacy of Aripiprazole (Abilify) in the treatment of patients with psychosis associated with dementia have not been established. If the prescriber elects to treat such patients with Aripiprazole (Abilify), assess for the emergence of difficulty swallowing or excessive somnolence, which could predispose to accidental injury or aspiration [see Warnings].
Cerebrovascular Adverse Events, Including Stroke: In placebo-controlled clinical studies (two flexible dose and one fixed dose study) of dementia-related psychosis, there was an increased incidence of cerebrovascular adverse events (e.g., stroke, transient ischemic attack), including fatalities, in Aripiprazole (Abilify)-treated patients (mean age: 84 years; range: 78-88 years). In the fixed-dose study, there was a statistically significant dose response relationship for cerebrovascular adverse events in patients treated with Aripiprazole (Abilify). Aripiprazole (Abilify) is not approved for the treatment of patients with dementia-related psychosis [see Warnings].
Suicidal Thoughts and Behaviors in Children, Adolescents, and Young Adults: Patients with major depressive disorder (MDD), both adult and pediatric, may experience worsening of their depression and/or the emergence of suicidal ideation and behavior (suicidality) or unusual changes in behavior, whether or not they are taking antidepressant medications, and this risk may persist until significant remission occurs. Suicide is a known risk of depression and certain other psychiatric disorders, and these disorders themselves are the strongest predictors of suicide. There has been a long-standing concern, however, that antidepressants may have a role in inducing worsening of depression and the emergence of suicidality in certain patients during the early phases of treatment. Pooled analyses of short-term, placebo-controlled trials of antidepressant drugs (SSRIs and others) showed that these drugs increase the risk of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults (ages 18-24) with MDD and other psychiatric disorders. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction with antidepressants compared to placebo in adults aged 65 and older. The pooled analyses of placebo-controlled trials in children and adolescents with MDD, Obsessive Compulsive Disorder (OCD), or other psychiatric disorders included a total of 24 short-term trials of 9 antidepressant drugs in over 4400 patients.
Use In Pregnancy & Lactation
Pregnancy: Pregnancy Category C.
Risk Summary: Neonates exposed to antipsychotic drugs (including Aripiprazole (Abilify)) during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms. Adequate and well controlled studies with Aripiprazole (Abilify) have not been conducted in pregnant women. Animal reproduction studies were conducted with aripiprazole in rats and rabbits during organogenesis, and in rats during the pre-and post-natal period. Oral and intravenous aripiprazole administration during organogenesis in rats and/or rabbits at doses higher than the maximum recommended human dose (MRHD) produced fetal death, decreased fetal weight, undescended testicles, delayed skeletal ossification, skeletal abnormalities, and diaphragmatic hernia. Oral and intravenous aripiprazole administration during the pre- and post-natal period in rats at doses higher than the maximum recommended human dose (MRHD) produced prolonged gestation, stillbirths, decreased pup weight, and decreased pup survival. Administer Aripiprazole (Abilify) during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Clinical Considerations: Fetal/Neonatal Adverse Reactions: Extrapyramidal and/or withdrawal symptoms, including agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress and feeding disorder have been reported in neonates who were exposed to antipsychotic drugs (including Aripiprazole (Abilify)) during the third trimester of pregnancy. These symptoms have varied in severity. Some neonates recovered within hours or days without specific treatment; others required prolonged hospitalization. Monitor neonates for extrapyramidal and/or withdrawal symptoms.
Data: Animal Data: In animal studies, aripiprazole demonstrated developmental toxicity, including possible teratogenic effects in rats and rabbits.
Pregnant rats were treated with oral doses of 3, 10, and 30 mg/kg/day (1, 3, and 10 times the maximum recommended human dose [MRHD] on a mg/m2 basis) of aripiprazole during the period of organogenesis. Gestation was slightly prolonged at 30 mg/kg/day. Treatment at the high dose of 30 mg/kg/day caused a slight delay in fetal development (decreased fetal weight), undescended testes, and delayed skeletal ossification (also seen at 10 mg/kg/day). There were no adverse effects on embryofetal or pup survival. Delivered offspring had decreased body weights (10 and 30 mg/kg/day), and increased incidences of hepatodiaphragmatic nodules and diaphragmatic hernia at 30 mg/kg (the other dose groups were not examined for these findings). Postnatally, delayed vaginal opening was seen at 10 and 30 mg/kg/day and impaired reproductive performance (decreased fertility rate, corpora lutea, implants, live fetuses, and increased post-implantation loss, likely mediated through effects on female offspring) was seen at 30 mg/kg/day. Some maternal toxicity was seen at 30 mg/kg/day however, there was no evidence to suggest that these developmental effects were secondary to maternal toxicity.
In pregnant rats receiving aripiprazole injection intravenously (3, 9, and 27 mg/kg/day) during the period of organogenesis, decreased fetal weight and delayed skeletal ossification were seen at the highest dose where it also caused maternal toxicity.
Pregnant rabbits were treated with oral doses of 10, 30, and 100 mg/kg/day (2, 3, and 11 times human exposure at MRHD based on AUC and 6, 19, and 65 times the MRHD based on mg/m2) of aripiprazole during the period of organogenesis. At the high dose of 100 mg/kg/day decreased maternal food consumption, and increased abortions were seen as well as increased fetal mortality, decreased fetal weight (also seen at 30 mg/kg/day), increased incidence of a skeletal abnormality (fused sternebrae) (also seen at 30 mg/kg/day).
In pregnant rabbits receiving aripiprazole injection intravenously (3, 10, and 30 mg/kg/day) during the period of organogenesis, the highest dose, which caused pronounced maternal toxicity, resulted in decreased fetal weight, increased fetal abnormalities (primarily skeletal), and decreased fetal skeletal ossification. The fetal no-effect dose was 10 mg/kg/day, which is 5 times the human exposure at the MRHD based on AUC and is 6 times the MRHD based on mg/m2.
In a study in which rats were treated peri- and post-natally with oral doses of 3, 10, and 30 mg/kg/day (1, 3, and 10 times the MRHD on a mg/m2 basis) of aripiprazole from gestation day 17 through day 21 postpartum, slight maternal toxicity, slightly prolonged gestation an increase in stillbirths and, decreases in pup weight (persisting into adulthood) and survival were seen at 30 mg/kg/day.
In rats receiving aripiprazole injection intravenously (3, 8, and 20 mg/kg/day) from gestation day 6 through day 20 postpartum, an increase in stillbirths was seen at 8 and 20 mg/kg/day, and decreases in early postnatal pup weights and survival were seen at 20 mg/kg/day; these effects were seen in presence of maternal toxicity. There were no effects on postnatal behavioral and reproductive development.
Labor and Delivery: The effect of Aripiprazole (Abilify) on labor and delivery in humans is unknown.
Nursing Mothers: Aripiprazole (Abilify) is present in human breast milk. Because of the potential for serious adverse reactions in nursing infants from Aripiprazole (Abilify), a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Risk Summary: Neonates exposed to antipsychotic drugs (including Aripiprazole (Abilify)) during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms. Adequate and well controlled studies with Aripiprazole (Abilify) have not been conducted in pregnant women. Animal reproduction studies were conducted with aripiprazole in rats and rabbits during organogenesis, and in rats during the pre-and post-natal period. Oral and intravenous aripiprazole administration during organogenesis in rats and/or rabbits at doses higher than the maximum recommended human dose (MRHD) produced fetal death, decreased fetal weight, undescended testicles, delayed skeletal ossification, skeletal abnormalities, and diaphragmatic hernia. Oral and intravenous aripiprazole administration during the pre- and post-natal period in rats at doses higher than the maximum recommended human dose (MRHD) produced prolonged gestation, stillbirths, decreased pup weight, and decreased pup survival. Administer Aripiprazole (Abilify) during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Clinical Considerations: Fetal/Neonatal Adverse Reactions: Extrapyramidal and/or withdrawal symptoms, including agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress and feeding disorder have been reported in neonates who were exposed to antipsychotic drugs (including Aripiprazole (Abilify)) during the third trimester of pregnancy. These symptoms have varied in severity. Some neonates recovered within hours or days without specific treatment; others required prolonged hospitalization. Monitor neonates for extrapyramidal and/or withdrawal symptoms.
Data: Animal Data: In animal studies, aripiprazole demonstrated developmental toxicity, including possible teratogenic effects in rats and rabbits.
Pregnant rats were treated with oral doses of 3, 10, and 30 mg/kg/day (1, 3, and 10 times the maximum recommended human dose [MRHD] on a mg/m2 basis) of aripiprazole during the period of organogenesis. Gestation was slightly prolonged at 30 mg/kg/day. Treatment at the high dose of 30 mg/kg/day caused a slight delay in fetal development (decreased fetal weight), undescended testes, and delayed skeletal ossification (also seen at 10 mg/kg/day). There were no adverse effects on embryofetal or pup survival. Delivered offspring had decreased body weights (10 and 30 mg/kg/day), and increased incidences of hepatodiaphragmatic nodules and diaphragmatic hernia at 30 mg/kg (the other dose groups were not examined for these findings). Postnatally, delayed vaginal opening was seen at 10 and 30 mg/kg/day and impaired reproductive performance (decreased fertility rate, corpora lutea, implants, live fetuses, and increased post-implantation loss, likely mediated through effects on female offspring) was seen at 30 mg/kg/day. Some maternal toxicity was seen at 30 mg/kg/day however, there was no evidence to suggest that these developmental effects were secondary to maternal toxicity.
In pregnant rats receiving aripiprazole injection intravenously (3, 9, and 27 mg/kg/day) during the period of organogenesis, decreased fetal weight and delayed skeletal ossification were seen at the highest dose where it also caused maternal toxicity.
Pregnant rabbits were treated with oral doses of 10, 30, and 100 mg/kg/day (2, 3, and 11 times human exposure at MRHD based on AUC and 6, 19, and 65 times the MRHD based on mg/m2) of aripiprazole during the period of organogenesis. At the high dose of 100 mg/kg/day decreased maternal food consumption, and increased abortions were seen as well as increased fetal mortality, decreased fetal weight (also seen at 30 mg/kg/day), increased incidence of a skeletal abnormality (fused sternebrae) (also seen at 30 mg/kg/day).
In pregnant rabbits receiving aripiprazole injection intravenously (3, 10, and 30 mg/kg/day) during the period of organogenesis, the highest dose, which caused pronounced maternal toxicity, resulted in decreased fetal weight, increased fetal abnormalities (primarily skeletal), and decreased fetal skeletal ossification. The fetal no-effect dose was 10 mg/kg/day, which is 5 times the human exposure at the MRHD based on AUC and is 6 times the MRHD based on mg/m2.
In a study in which rats were treated peri- and post-natally with oral doses of 3, 10, and 30 mg/kg/day (1, 3, and 10 times the MRHD on a mg/m2 basis) of aripiprazole from gestation day 17 through day 21 postpartum, slight maternal toxicity, slightly prolonged gestation an increase in stillbirths and, decreases in pup weight (persisting into adulthood) and survival were seen at 30 mg/kg/day.
In rats receiving aripiprazole injection intravenously (3, 8, and 20 mg/kg/day) from gestation day 6 through day 20 postpartum, an increase in stillbirths was seen at 8 and 20 mg/kg/day, and decreases in early postnatal pup weights and survival were seen at 20 mg/kg/day; these effects were seen in presence of maternal toxicity. There were no effects on postnatal behavioral and reproductive development.
Labor and Delivery: The effect of Aripiprazole (Abilify) on labor and delivery in humans is unknown.
Nursing Mothers: Aripiprazole (Abilify) is present in human breast milk. Because of the potential for serious adverse reactions in nursing infants from Aripiprazole (Abilify), a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Adverse Reactions
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The following adverse reactions are discussed in more detail in other sections of the monograph: Increased Mortality in Elderly Patients with Dementia-Related Psychosis [see Warnings and Precautions].
Cerebrovascular Adverse Events, Including Stroke [see Precautions].
Suicidal Thoughts and Behaviors in Children, Adolescents, and Young Adults [see Warnings and Precautions].
Neuroleptic Malignant Syndrome (NMS) [see Precautions].
Tardive Dyskinesia [see Precautions].
Metabolic Changes [see Precautions].
Pathological Gambling and Other Compulsive Behaviors [see Precautions].
Orthostatic Hypotension [see Precautions].
Falls [see Precautions].
Leukopenia, Neutropenia, and Agranulocytosis [see Precautions].
Seizures/Convulsions [see Precautions].
Potential for Cognitive and Motor Impairment [see Precautions].
Body Temperature Regulation [see Precautions].
Suicide [see Precautions].
Dysphagia [see Precautions].
The most common adverse reactions in adult patients in clinical trials (≥10%) were nausea, vomiting, constipation, headache, dizziness, akathisia, anxiety, insomnia, and restlessness.
The most common adverse reactions in the pediatric clinical trials (≥10%) were somnolence, headache, vomiting, extrapyramidal disorder, fatigue, increased appetite, insomnia, nausea, nasopharyngitis, and weight increased.
Aripiprazole (Abilify) has been evaluated for safety in 13,543 adult patients who participated in multiple-dose, clinical trials in schizophrenia, bipolar disorder, major depressive disorder, Dementia of the Alzheimer's type, Parkinson's disease, and alcoholism, and who had approximately 7619 patient-years of exposure to oral Aripiprazole (Abilify) and 749 patients with exposure to Aripiprazole (Abilify) injection. A total of 3390 patients were treated with oral Aripiprazole (Abilify) for at least 180 days and 1933 patients treated with oral Aripiprazole (Abilify) had at least 1 year of exposure.
Aripiprazole (Abilify) has been evaluated for safety in 1,686 patients (6 to 18 years) who participated in multiple-dose, clinical trials in schizophrenia, bipolar mania, autistic disorder, or Tourette's disorder and who had approximately 1,342 patient-years of exposure to oral Aripiprazole (Abilify). A total of 959 pediatric patients were treated with oral Aripiprazole (Abilify) for at least 180 days and 556 pediatric patients treated with oral Aripiprazole (Abilify) had at least 1 year of exposure.
The conditions and duration of treatment with Aripiprazole (Abilify) (monotherapy and adjunctive therapy with antidepressants or mood stabilizers) included (in overlapping categories) double-blind, comparative and noncomparative open-label studies, inpatient and outpatient studies, fixed- and flexible-dose studies, and short- and longer-term exposure.
Clinical Trials Experience: Adult Patients with Schizophrenia: The following findings are based on a pool of five placebo-controlled trials (four 4-week and one 6-week) in which oral Aripiprazole (Abilify) was administered in doses ranging from 2 to 30 mg/day.
Commonly Observed Adverse Reactions: The only commonly observed adverse reaction associated with the use of Aripiprazole (Abilify) in patients with schizophrenia (incidence of 5% or greater and Aripiprazole (Abilify) incidence at least twice that for placebo) was akathisia (Aripiprazole (Abilify) 8%; placebo 4%).
Adult Patients with Bipolar Mania: Monotherapy: The following findings are based on a pool of 3-week, placebo-controlled, bipolar mania trials in which oral Aripiprazole (Abilify) was administered at doses of 15 or 30 mg/day.
The following adverse reactions are discussed in more detail in other sections of the monograph: Increased Mortality in Elderly Patients with Dementia-Related Psychosis [see Warnings and Precautions].
Cerebrovascular Adverse Events, Including Stroke [see Precautions].
Suicidal Thoughts and Behaviors in Children, Adolescents, and Young Adults [see Warnings and Precautions].
Neuroleptic Malignant Syndrome (NMS) [see Precautions].
Tardive Dyskinesia [see Precautions].
Metabolic Changes [see Precautions].
Pathological Gambling and Other Compulsive Behaviors [see Precautions].
Orthostatic Hypotension [see Precautions].
Falls [see Precautions].
Leukopenia, Neutropenia, and Agranulocytosis [see Precautions].
Seizures/Convulsions [see Precautions].
Potential for Cognitive and Motor Impairment [see Precautions].
Body Temperature Regulation [see Precautions].
Suicide [see Precautions].
Dysphagia [see Precautions].
The most common adverse reactions in adult patients in clinical trials (≥10%) were nausea, vomiting, constipation, headache, dizziness, akathisia, anxiety, insomnia, and restlessness.
The most common adverse reactions in the pediatric clinical trials (≥10%) were somnolence, headache, vomiting, extrapyramidal disorder, fatigue, increased appetite, insomnia, nausea, nasopharyngitis, and weight increased.
Aripiprazole (Abilify) has been evaluated for safety in 13,543 adult patients who participated in multiple-dose, clinical trials in schizophrenia, bipolar disorder, major depressive disorder, Dementia of the Alzheimer's type, Parkinson's disease, and alcoholism, and who had approximately 7619 patient-years of exposure to oral Aripiprazole (Abilify) and 749 patients with exposure to Aripiprazole (Abilify) injection. A total of 3390 patients were treated with oral Aripiprazole (Abilify) for at least 180 days and 1933 patients treated with oral Aripiprazole (Abilify) had at least 1 year of exposure.
Aripiprazole (Abilify) has been evaluated for safety in 1,686 patients (6 to 18 years) who participated in multiple-dose, clinical trials in schizophrenia, bipolar mania, autistic disorder, or Tourette's disorder and who had approximately 1,342 patient-years of exposure to oral Aripiprazole (Abilify). A total of 959 pediatric patients were treated with oral Aripiprazole (Abilify) for at least 180 days and 556 pediatric patients treated with oral Aripiprazole (Abilify) had at least 1 year of exposure.
The conditions and duration of treatment with Aripiprazole (Abilify) (monotherapy and adjunctive therapy with antidepressants or mood stabilizers) included (in overlapping categories) double-blind, comparative and noncomparative open-label studies, inpatient and outpatient studies, fixed- and flexible-dose studies, and short- and longer-term exposure.
Clinical Trials Experience: Adult Patients with Schizophrenia: The following findings are based on a pool of five placebo-controlled trials (four 4-week and one 6-week) in which oral Aripiprazole (Abilify) was administered in doses ranging from 2 to 30 mg/day.
Commonly Observed Adverse Reactions: The only commonly observed adverse reaction associated with the use of Aripiprazole (Abilify) in patients with schizophrenia (incidence of 5% or greater and Aripiprazole (Abilify) incidence at least twice that for placebo) was akathisia (Aripiprazole (Abilify) 8%; placebo 4%).
Adult Patients with Bipolar Mania: Monotherapy: The following findings are based on a pool of 3-week, placebo-controlled, bipolar mania trials in which oral Aripiprazole (Abilify) was administered at doses of 15 or 30 mg/day.
Drug Interactions
Drugs Having Clinically Important Interactions with Aripiprazole (Abilify): See Table 28.
Drugs Having No Clinically Important Interactions with Aripiprazole (Abilify): Based on pharmacokinetic studies, no dosage adjustment of Aripiprazole (Abilify) is required when administered concomitantly with famotidine, valproate, lithium, lorazepam.
In addition, no dosage adjustment is necessary for substrates of CYP2D6 (e.g., dextromethorphan, fluoxetine, paroxetine, or venlafaxine), CYP2C9 (e.g., warfarin), CYP2C19 (e.g., omeprazole, warfarin, escitalopram), or CYP3A4 (e.g., dextromethorphan) when co-administered with Aripiprazole (Abilify). Additionally, no dosage adjustment is necessary for valproate, lithium, lamotrigine, lorazepam, or sertraline when co-administered with Aripiprazole (Abilify) [see Pharmacology: Pharmacokinetics under Actions].
In addition, no dosage adjustment is necessary for substrates of CYP2D6 (e.g., dextromethorphan, fluoxetine, paroxetine, or venlafaxine), CYP2C9 (e.g., warfarin), CYP2C19 (e.g., omeprazole, warfarin, escitalopram), or CYP3A4 (e.g., dextromethorphan) when co-administered with Aripiprazole (Abilify). Additionally, no dosage adjustment is necessary for valproate, lithium, lamotrigine, lorazepam, or sertraline when co-administered with Aripiprazole (Abilify) [see Pharmacology: Pharmacokinetics under Actions].
Storage
Tablets: Store at temperature not exceeding 30°C.
Oral Solution: Store at temperature not exceeding 30°C. Opened bottles of Aripiprazole (Abilify) Oral Solution can be used for up to 6 months after opening, but not beyond the expiration date on the bottle. The bottle and its contents should be discarded after the expiration date.
Oral Solution: Store at temperature not exceeding 30°C. Opened bottles of Aripiprazole (Abilify) Oral Solution can be used for up to 6 months after opening, but not beyond the expiration date on the bottle. The bottle and its contents should be discarded after the expiration date.
Action
Pharmacology: Mechanism of Action: The mechanism of action of aripiprazole in schizophrenia or bipolar mania, is unknown. However, the efficacy of aripiprazole could be mediated through a combination of partial agonist activity at D2 and 5-HT1A receptors and antagonist activity at 5-HT2A receptors. Actions at receptors other than D2, 5-HT1A, and 5-HT2A may explain some of the other clinical effects of aripiprazole (e.g., the orthostatic hypotension observed with aripiprazole may be explained by its antagonist activity at adrenergic alpha1 receptors).
Pharmacodynamics: Aripiprazole exhibits high affinity for dopamine D2 and D3, serotonin 5-HT1A and 5-HT2A receptors (Ki values of 0.34 nM, 0.8 nM, 1.7 nM, and 3.4 nM, respectively), moderate affinity for dopamine D4, serotonin 5-HT2C and 5-HT7, alpha1-adrenergic and histamine H1 receptors (Ki values of 44 nM, 15 nM, 39 nM, 57 nM, and 61 nM, respectively), and moderate affinity for the serotonin reuptake site (Ki=98 nM). Aripiprazole has no appreciable affinity for cholinergic muscarinic receptors (IC50>1000 nM). [Aripiprazole functions as a partial agonist at the dopamine D2 and the serotonin 5-HT1A receptors, and as an antagonist at serotonin 5-HT2A receptor.]
Clinical Studies: Efficacy of the oral formulations of Aripiprazole (Abilify) was established in the following adequate and well-controlled trials: Four short-term trials and one maintenance trial in adult patients and one short-term trial in adolescents (ages 13-17) with schizophrenia [see Schizophrenia].
Pharmacodynamics: Aripiprazole exhibits high affinity for dopamine D2 and D3, serotonin 5-HT1A and 5-HT2A receptors (Ki values of 0.34 nM, 0.8 nM, 1.7 nM, and 3.4 nM, respectively), moderate affinity for dopamine D4, serotonin 5-HT2C and 5-HT7, alpha1-adrenergic and histamine H1 receptors (Ki values of 44 nM, 15 nM, 39 nM, 57 nM, and 61 nM, respectively), and moderate affinity for the serotonin reuptake site (Ki=98 nM). Aripiprazole has no appreciable affinity for cholinergic muscarinic receptors (IC50>1000 nM). [Aripiprazole functions as a partial agonist at the dopamine D2 and the serotonin 5-HT1A receptors, and as an antagonist at serotonin 5-HT2A receptor.]
Clinical Studies: Efficacy of the oral formulations of Aripiprazole (Abilify) was established in the following adequate and well-controlled trials: Four short-term trials and one maintenance trial in adult patients and one short-term trial in adolescents (ages 13-17) with schizophrenia [see Schizophrenia].
MedsGo Class
Antipsychotics
Features
Brand
Abilify
Full Details
Dosage Strength
5 mg
Drug Ingredients
- Aripiprazole
Drug Packaging
Tablet 1's
Generic Name
Aripiprazole
Dosage Form
Tablet
Registration Number
DRP-6282
Drug Classification
Prescription Drug (RX)
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