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Aripiprazole
Overview
What is Aripiprazole?
Aripiprazole is a psychotropic drug that is available as tablets. Aripiprazole USP is 7-[4-[4-(2,3-dichlorophenyl)-1piperazinyl]butoxy]-3,4-dihydrocarbostyril. The empirical formula is C
H
Cl
N
O
and its molecular weight is 448.39. The chemical structure is:
Aripiprazole Tablets, USP are available in 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg strengths. Inactive ingredients include corn starch, colloidal silicon dioxide, isopropyl alcohol, lactose monohydrate, microcrystalline cellulose, magnesium stearate, povidone. Colorants include ferric oxide (yellow or red) and FD&C Blue No. 2 Aluminum Lake.
What does Aripiprazole look like?
What are the available doses of Aripiprazole?
Aripiprazole Tablets, USP are available as described in Table 3.
What should I talk to my health care provider before I take Aripiprazole?
Additional pediatric use information is approved for Otsuka America Pharmaceutical, Inc.’s ABILIFY
(aripiprazole) product. However, due to Otsuka America Pharmaceutical, Inc.’s marketing exclusivity rights, this drug product is not labeled with that information.
How should I use Aripiprazole?
Aripiprazole tablets are indicated for the treatment of:
Additional pediatric use information is approved for Otsuka America Pharmaceutical, Inc.’s ABILIFY
(aripiprazole) product. However, due to Otsuka America Pharmaceutical, Inc.’s marketing exclusivity rights, this drug product is not labeled with that information.
Adults
The recommended starting and target dose for aripiprazole is 10 mg/day or 15 mg/day administered on a once-a-day schedule without regard to meals. Aripiprazole has been systematically evaluated and shown to be effective in a dose range of 10 mg/day to 30 mg/day, when administered as the tablet formulation; however, doses higher than 10 mg/day or 15 mg/day were not more effective than 10 mg/day or 15 mg/day. Dosage increases should generally not be made before 2 weeks, the time needed to achieve steady-state [
].
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 15 mg/day or placebo, and observed for relapse [
]. Patients should be periodically reassessed to determine the continued need for maintenance treatment.
Adolescents
The recommended target dose of aripiprazole 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 can be administered without regard to meals [
]. 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 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.
Additional pediatric use information is approved for Otsuka America Pharmaceutical, Inc.’s ABILIFY
(aripiprazole) product. However, due to Otsuka America Pharmaceutical, Inc.’s marketing exclusivity rights, this drug product is not labeled with that information.
What interacts with Aripiprazole?
Sorry No Records found
What are the warnings of Aripiprazole?
Sorry No Records found
What are the precautions of Aripiprazole?
Sorry No Records found
What are the side effects of Aripiprazole?
Sorry No records found
What should I look out for while using Aripiprazole?
Aripiprazole is contraindicated in patients with a history of a hypersensitivity reaction to aripiprazole. Reactions have ranged from pruritus/urticaria to anaphylaxis [
].
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 [
].
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 [
].
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 [
].
What might happen if I take too much Aripiprazole?
MedDRA terminology has been used to classify the adverse reactions.
How should I store and handle Aripiprazole?
Store at 25°C (77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) PredniSONE Tablets are available in the following strengths and package sizes:20 mg (peach, round, scored, debossed “5092” on one side and debossed “V” on the reverse side)Bottle of 10 - 68788-9179-1Bottle of 12 - 68788-9179-7Bottle of 15 - 68788-9179-6Bottle of 20 - 68788-9179-2Bottle of 21 - 68788-9179-8Bottle of 30 - 68788-9179-3Bottle of 40 - 68788-9179-4Bottle of 90 - 68788-9179-9PredniSONE Tablets are available in the following strengths and package sizes:20 mg (peach, round, scored, debossed “5092” on one side and debossed “V” on the reverse side)Bottle of 10 - 68788-9179-1Bottle of 12 - 68788-9179-7Bottle of 15 - 68788-9179-6Bottle of 20 - 68788-9179-2Bottle of 21 - 68788-9179-8Bottle of 30 - 68788-9179-3Bottle of 40 - 68788-9179-4Bottle of 90 - 68788-9179-9PredniSONE Tablets are available in the following strengths and package sizes:20 mg (peach, round, scored, debossed “5092” on one side and debossed “V” on the reverse side)Bottle of 10 - 68788-9179-1Bottle of 12 - 68788-9179-7Bottle of 15 - 68788-9179-6Bottle of 20 - 68788-9179-2Bottle of 21 - 68788-9179-8Bottle of 30 - 68788-9179-3Bottle of 40 - 68788-9179-4Bottle of 90 - 68788-9179-9PredniSONE Tablets are available in the following strengths and package sizes:20 mg (peach, round, scored, debossed “5092” on one side and debossed “V” on the reverse side)Bottle of 10 - 68788-9179-1Bottle of 12 - 68788-9179-7Bottle of 15 - 68788-9179-6Bottle of 20 - 68788-9179-2Bottle of 21 - 68788-9179-8Bottle of 30 - 68788-9179-3Bottle of 40 - 68788-9179-4Bottle of 90 - 68788-9179-9PredniSONE Tablets are available in the following strengths and package sizes:20 mg (peach, round, scored, debossed “5092” on one side and debossed “V” on the reverse side)Bottle of 10 - 68788-9179-1Bottle of 12 - 68788-9179-7Bottle of 15 - 68788-9179-6Bottle of 20 - 68788-9179-2Bottle of 21 - 68788-9179-8Bottle of 30 - 68788-9179-3Bottle of 40 - 68788-9179-4Bottle of 90 - 68788-9179-9PredniSONE Tablets are available in the following strengths and package sizes:20 mg (peach, round, scored, debossed “5092” on one side and debossed “V” on the reverse side)Bottle of 10 - 68788-9179-1Bottle of 12 - 68788-9179-7Bottle of 15 - 68788-9179-6Bottle of 20 - 68788-9179-2Bottle of 21 - 68788-9179-8Bottle of 30 - 68788-9179-3Bottle of 40 - 68788-9179-4Bottle of 90 - 68788-9179-9PredniSONE Tablets are available in the following strengths and package sizes:20 mg (peach, round, scored, debossed “5092” on one side and debossed “V” on the reverse side)Bottle of 10 - 68788-9179-1Bottle of 12 - 68788-9179-7Bottle of 15 - 68788-9179-6Bottle of 20 - 68788-9179-2Bottle of 21 - 68788-9179-8Bottle of 30 - 68788-9179-3Bottle of 40 - 68788-9179-4Bottle of 90 - 68788-9179-9PredniSONE Tablets are available in the following strengths and package sizes:20 mg (peach, round, scored, debossed “5092” on one side and debossed “V” on the reverse side)Bottle of 10 - 68788-9179-1Bottle of 12 - 68788-9179-7Bottle of 15 - 68788-9179-6Bottle of 20 - 68788-9179-2Bottle of 21 - 68788-9179-8Bottle of 30 - 68788-9179-3Bottle of 40 - 68788-9179-4Bottle of 90 - 68788-9179-9PredniSONE Tablets are available in the following strengths and package sizes:20 mg (peach, round, scored, debossed “5092” on one side and debossed “V” on the reverse side)Bottle of 10 - 68788-9179-1Bottle of 12 - 68788-9179-7Bottle of 15 - 68788-9179-6Bottle of 20 - 68788-9179-2Bottle of 21 - 68788-9179-8Bottle of 30 - 68788-9179-3Bottle of 40 - 68788-9179-4Bottle of 90 - 68788-9179-9PredniSONE Tablets are available in the following strengths and package sizes:20 mg (peach, round, scored, debossed “5092” on one side and debossed “V” on the reverse side)Bottle of 10 - 68788-9179-1Bottle of 12 - 68788-9179-7Bottle of 15 - 68788-9179-6Bottle of 20 - 68788-9179-2Bottle of 21 - 68788-9179-8Bottle of 30 - 68788-9179-3Bottle of 40 - 68788-9179-4Bottle of 90 - 68788-9179-9
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
The mechanism of action of aripiprazole in schizophrenia, is unknown. However, the efficacy of aripiprazole could be mediated through a combination of partial agonist activity at D
and 5-HT
receptors and antagonist activity at 5-HT
receptors. Actions at receptors other than D
, 5-HT
, and 5-HT
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 alpha
receptors).
Non-Clinical Toxicology
Aripiprazole is contraindicated in patients with a history of a hypersensitivity reaction to aripiprazole. Reactions have ranged from pruritus/urticaria to anaphylaxis [ ].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 [ ].
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 [ ].
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 [ ].
Increased Mortality
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 BOXED WARNING].
Safety Experience in Elderly Patients with Psychosis Associated with Alzheimer’s Disease
In three, 10-week, placebo-controlled studies of aripiprazole in elderly patients with psychosis associated with Alzheimer’s disease (n=938; mean age: 82.4 years; range: 56 to 99 years), the adverse reactions that were reported at an incidence of ≥ 3% and aripiprazole incidence at least twice that for placebo were lethargy [placebo 2%, aripiprazole 5%], somnolence (including sedation) [placebo 3%, aripiprazole 8%], and incontinence (primarily, urinary incontinence) [placebo 1%, aripiprazole 5%], excessive salivation [placebo 0%, aripiprazole 4%], and lightheadedness [placebo 1%, aripiprazole 4%].
The safety and efficacy of aripiprazole in the treatment of patients with psychosis associated with dementia have not been established. If the prescriber elects to treat such patients with aripiprazole, assess for the emergence of difficulty swallowing or excessive somnolence, which could predispose to accidental injury or aspiration [ ].
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 labeling:
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 has been evaluated for safety in 13,543 adult patients who participated in multiple-dose, clinical trials in schizophrenia, other indications, Dementia of the Alzheimer’s type, Parkinson’s disease, and alcoholism, and who had approximately 7619 patient-years of exposure to oral aripiprazole. A total of 3390 patients were treated with oral aripiprazole for at least 180 days and 1933 patients treated with oral aripiprazole had at least 1 year of exposure.
Aripiprazole has been evaluated for safety in 1,686 patients (6 to 18 years) who participated in multiple-dose, clinical trials in schizophrenia, or other indications and who had approximately 1,342 patient-years of exposure to oral aripiprazole. A total of 959 pediatric patients were treated with oral aripiprazole for at least 180 days and 556 pediatric patients treated with oral aripiprazole had at least 1 year of exposure.
The conditions and duration of treatment with aripiprazole 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.
Additional pediatric use information is approved for Otsuka America Pharmaceutical, Inc.’s ABILIFY (aripiprazole) product. However, due to Otsuka America Pharmaceutical, Inc.’s marketing exclusivity rights, this drug product is not labeled with that information.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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