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Aripiprazole Dosage

Applies to the following strength(s): 5 mg ; 10 mg ; 15 mg ; 20 mg ; 30 mg ; 2 mg ; 1 mg/mL ; 9.75 mg/1.3 mL ; 300 mg ; 400 mg

The information at Drugs.com is not a substitute for medical advice. ALWAYS consult your doctor or pharmacist.

Usual Adult Dose for:

Usual Pediatric Dose for:

Additional dosage information:

Usual Adult Dose for Schizophrenia

Immediate-release:
Initial Dose: 10 or 15 mg orally once a day
Target Dose: 10 to 15 mg per day; effective dose range 10 to 30 mg per day; however, clinical trials have not found doses exceeding 10 or 15 mg per day to be more effective; dose increases, if needed should be at 2-week intervals to allow time to achieve steady state
Maximum Dose: 30 mg per day

Once monthly IM formulation:
-Prior to initiating extended-release therapy, establish tolerability with oral formulation; it may take up to 2 weeks to fully assess tolerability due to the half-life of aripiprazole.
-This drug should be administered by a health care professional

Initial dose: 400 mg IM
-During the initial dose period, antipsychotic treatment should continue for 14 consecutive days to maintain therapeutic antipsychotic drug concentrations; give oral aripiprazole 10 to 20 mg orally once a day for 14 days OR for patients already stable on another oral antipsychotic and known to tolerate aripiprazole, continue treatment for 14 days.

Maintenance Dose: 400 mg IM once a month and no sooner than 26 days after the previous injection
-if there are adverse reactions, consider a dose reduction to 300 mg IM once a month

MISSED DOSES:
Second or Third dose:
-If more than 4 weeks and less than 5 weeks have elapsed, administer as soon as possible.
-If more than 5 weeks since the last injection, restart concomitant oral aripiprazole for 14 days with the next administered injection.
Fourth or subsequent doses:
-If more than 4 weeks and less than 6 weeks have elapsed, administer as soon as possible.
-If more than 6 weeks since the last injection, restart concomitant oral aripiprazole for 14 days with the next administered injection.

Comments:
-The oral solution and oral tablets can be substituted on a mg-per-mg basis up to the 25 mg dose level; patients receiving 30 mg tablets should receive 25 mg of the oral solution.
-Dosage adjustments are recommended in patients who are known CYP450 2D6 poor metabolizers and taking concomitant CYP450 inhibitors or inducers; see dosage adjustment section for specific adjustments.

Use: For the treatment of schizophrenia

Usual Adult Dose for Bipolar Disorder

Monotherapy:
Initial dose: 15 mg orally once a day
Target dose: 15 mg orally once a day; may increase dose based on clinical response; dose increases, if needed should be at 2-week intervals to allow time to achieve steady state
Maximum dose: 30 mg per day

Adjunctive therapy with Lithium or Valproate:
Initial dose: 10 to 15 mg orally once a day
Target dose: 15 mg orally once a day; may increase dose based on clinical response; dose increases, if needed should be at 2-week intervals to allow time to achieve steady state
Maximum dose: 30 mg per day

Comments:
-The safety of doses greater than 30 mg per day has not been studied.
-The dose recommended for maintenance treatment is the same dose needed to stabilize patients during acute treatment; periodically reassess need for maintenance treatment.
-The oral solution and oral tablets can be substituted on a mg-per-mg basis up to the 25 mg dose level; patients receiving 30 mg tablets should receive 25 mg of the oral solution.
-Dosage adjustments are recommended in patients who are known CYP450 2D6 poor metabolizers and taking concomitant CYP450 inhibitors or inducers; see dosage adjustment section for specific adjustments.

Uses: This drug may be used as monotherapy or as an adjunct to lithium or valproate for the acute treatment of manic and mixed episodes associated with bipolar I disorder and for maintenance treatment of bipolar I disorder.

Usual Adult Dose for Agitated State

For agitation associated with schizophrenia or bipolar mania:
Initial dose: 9.75 mg IM
Doses ranging from 5.25 mg to 15 mg may be considered when clinical factors warrant; no additional benefit has been demonstrated for 15 mg compared to 9.75 mg
Repeat doses: If additional doses are needed, allow at least 2 hours to elapse between dosing; the efficacy of repeated doses has not been studied.
Maximum dose: 30 mg per day

Comments: If ongoing therapy is clinically indicated, oral therapy should replace injections as soon as possible.

Use: For the treatment of agitation associated with schizophrenia or bipolar disorder, manic or mixed.

Usual Adult Dose for Depression

As adjunctive treatment for patients already taking an antidepressant:
Initial dose: 2 to 5 mg orally once a day
Target dose: 5 to 10 mg orally once a day; titrate in increments up to 5 mg per day at intervals of no less than 1 week
Maximum dose: 15 mg per day

Comments: -Patients should be periodically reassessed to determine need for continued treatment.
-The oral solution and oral tablets can be substituted on a mg-per-mg basis up to the 25 mg dose level.

Use: As an adjunct to antidepressant therapy for the treatment of major depressive disorder.

Usual Pediatric Dose for Schizophrenia

Age: 13 years or older:
Initial Dose: 2 mg orally once a day
After 2 days: Titrate to 5 mg orally once a day
After 4 days: Titrate to 10 mg orally once a day
Target Dose: 10 mg orally once a day; effective dose range 10 to 30 mg per day; however, clinical trials have not found doses exceeding 10 mg per day to be more effective; dose increases, if needed should be in 5 mg increments at 2-week intervals in order to allow time to achieve steady state
Maximum Dose: 30 mg per day

Comments:
-Maintenance treatment in the adolescent population has not been evaluated; extrapolating from adult data, it is recommended that responding patients be continued beyond the acute response, but at the lowest dose needed to maintain remission.
-Periodically reassess need for maintenance treatment.
-The oral solution and oral tablets can be substituted on a mg-per-mg basis up to the 25 mg dose level; patients receiving 30 mg tablets should receive 25 mg of the oral solution.
-Dosage adjustments are recommended in patients who are known CYP450 2D6 poor metabolizers and taking concomitant CYP450 inhibitors or inducers; see dosage adjustment section for specific adjustments.

Use: For the treatment of schizophrenia

Usual Pediatric Dose for Bipolar Disorder

Age: 10 years or older: As monotherapy or as adjunctive therapy with lithium or valproate:
Initial Dose: 2 mg orally once a day
After 2 days: Titrate to 5 mg orally once a day
After 4 days: Titrate to 10 mg orally once a day
Target Dose: 10 mg orally once a day; dose increases, if needed should be in 5 mg increments at 2-week intervals in order to allow time to achieve steady state
Maximum Dose: 30 mg per day

Comments: The dose for maintenance treatment is the same dose needed to stabilize patients during acute treatment; periodically reassess need for maintenance treatment.
-The oral solution and oral tablets can be substituted on a mg-per-mg basis up to the 25 mg dose level; patients receiving 30 mg tablets should receive 25 mg of the oral solution.
-Dosage adjustments are recommended in patients who are known CYP450 2D6 poor metabolizers and taking concomitant CYP450 inhibitors or inducers; see dosage adjustment section for specific adjustments.

Uses: This drug may be used as monotherapy or as an adjunct to lithium or valproate for the acute treatment of manic and mixed episodes associated with bipolar I disorder and for maintenance treatment of bipolar I disorder.

Usual Pediatric Dose for Autism

Age: 6 to 17 years: Dose should be individualized according to tolerability and response.
Initial dose: 2 mg orally once a day
Dose titration: Increase dose to 5 mg orally once a day, with subsequent increases to 10 mg or 15 mg orally once a day if needed; dose adjustments in increments of up to 5 mg per day should occur at intervals of no less than 1 week.
Maximum Dose: 15 mg orally once a day

Comments: The efficacy of maintenance treatment of irritability associated with autistic disorder has not been evaluated; patients should be periodically reassessed to determine need for continued treatment.
-The oral solution and oral tablets can be substituted on a mg-per-mg basis up to the 25 mg dose level.
-Dosage adjustments are recommended in patients who are known CYP450 2D6 poor metabolizers and taking concomitant CYP450 inhibitors or inducers; see dosage adjustment section for specific adjustments.

Use: Treatment of irritability associated with autistic disorder (including aggression, deliberate self injurious behavior, temper tantrums, and quickly changing moods):

Usual Pediatric Dose for Tourette's Syndrome

Age: 6 to 18 years:
-For patients weighing less than 50 kg:
Initial Dose: 2 mg orally once a day
After 2 days: Titrate to recommended dose of 5 mg orally once a day; in patients who do not achieve optimal control of tics; may increase dose to 10 mg once a day; dose adjustments should occur gradually at intervals of no less than 1 week
Maximum Dose: 10 mg orally once a day

-For patients weighing 50 kg or more:
Initial Dose: 2 mg orally once a day
After 2 days: Titrate to 5 mg orally once a day
On day 8: Titrate to recommended dose of 10 mg orally once a day; in patients who do not achieve optimal control of tics; may increase dose in increments of 5 mg per day at intervals of no less than 1 week
Maximum Dose: 20 mg orally once a day

Comments: Periodically assess patients to determine continued need for maintenance treatment.
-The oral solution and oral tablets can be substituted on a mg-per-mg basis up to the 25 mg dose level.
-Dosage adjustments are recommended in patients who are known CYP450 2D6 poor metabolizers and taking concomitant CYP450 inhibitors or inducers; see dosage adjustment section for specific adjustments.

Use: Treatment of Tourette's disorder

Renal Dose Adjustments

No adjustment recommended

Liver Dose Adjustments

No adjustment recommended

Dose Adjustments

IMMEDIATE RELEASE formulations:
-The dosing for oral tablets is the same as the dosing for the oral disintegrating tablets.
-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 oral solution.

CYP450 Dose Adjustments: Oral Formulations:
-Known CYP450 2D6 poor metabolizers (PM): Administer one-half usual dose
-Known CYP450 2D6 PM receiving concomitant strong CYP450 3A4 inhibitors: Administer one-quarter usual dose
-Concomitantly receiving strong CYP450 2D6 or 3A4 inhibitors: Administer one-half usual dose
-Concomitantly receiving strong CYP450 2D6 and 3A4 inhibitors: Administer one-quarter usual dose
-Concomitantly receiving CYP450 3A4 inducer: Double the usual dose over 1 to 2 weeks
IMPORTANT NOTES:
-When coadministered drug is withdrawn, aripiprazole dose should be adjusted to the original level over 1 to 2 weeks.
-Patients receiving a combination of strong, moderate, and weak inhibitors of CYP450 3A4 and CYP450 2D6 may need an initial dose reduction to one-quarter of the usual dose with adjustments to achieve a clinical response.
-When aripiprazole is administered to patients with major depressive disorder, dose adjustments are not recommended.

EXTENDED-RELEASE:
- IM extended-release: If there are adverse reactions with the 400 mg dose, consider reducing to 300 mg once monthly.

CYP450 Dose Adjustments:
-Known CYP450 2D6 poor metabolizers (PM): Adjust dose to 300 mg monthly
-Known CYP450 2D6 PM receiving concomitant CYP450 3A4 inhibitors for greater than 14 days: Adjust dose to 200 mg monthly
For patients receiving 400 mg IM once monthly:
-Concomitant strong CYP450 2D6 or CYP450 3A4 inhibitor for greater than 14 days: Adjust dose to 300 mg monthly
-Concomitant CYP450 2D6 and CYP450 3A4 inhibitors for greater than 14 days: Adjust dose to 200 mg monthly
-Avoid adding CYP450 3A4 inducers
For patients receiving 300 mg IM once monthly:
-Concomitant strong CYP450 2D6 or CYP450 3A4 inhibitors for greater than 14 days: Adjust dose to 200 mg monthly
-Concomitant strong CYP450 2D6 and CYP450 3A4 inhibitors for greater than 14 days: Adjust dose to 160 mg monthly
-Avoid adding CYP450 3A4 inducers
IMPORTANT NOTES:
-Dose adjustments are not needed for patients with concomitant use of CYP450 3A4 inhibitors, CYP450 2D6 inhibitors or CYP450 3A4 inducers for less than 14 days.
-If the CYP450 3A4 or CYP450 2D6 inhibitor is withdrawn, the aripiprazole dose may need to be increased.
-Avoid concomitant use of CYP450 3A4 inducers for greater than 14 days as aripiprazole concentrations may decrease below effective levels.

Switching from Other Antipsychotics:
There are no specific recommendations for switching antipsychotics or concomitant administration with other antipsychotics so while immediate discontinuation of the previous antipsychotic may be acceptable for some patients, more gradual discontinuation may be most appropriate for others; in all cases it is best to minimize the overlap period.

-There are 2 IM formulations; the immediate-release and a once monthly extended-release formulation are not interchangeable.

Precautions

US BOXED WARNINGS: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS and SUICIDAL THOUGHTS AND BEHAVIORS
-ELDERLY PATIENTS with dementia-related psychosis are at an increased risk of death. Analyses of 17 placebo-controlled trials (modal duration of 10 weeks) largely in patients taking atypical antipsychotic drugs, revealed a risk of death 1.6 to 1.7 times greater in the drug-treated patient than in the placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5% compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the death appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the finding of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. This drug is not approved for the treatment of patients with dementia-related psychosis.
-SUICIDALITY: Antidepressants increase the risk of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults compared to placebo in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of this drug in a child, adolescent, or young adult must balance this risk with the clinical need. Studies did not show an increase in the risk of suicidality in adults age 24 or older. There was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Aripiprazole is not approved for use in pediatric patients with depression.

Safety and efficacy of immediate-release aripiprazole have not been established:
-In patients younger than 18 years with major depressive disorder or agitation associated with schizophrenia or bipolar mania.
-In patients younger than 13 years with schizophrenia
-In patients younger than 10 years with bipolar I disorder
-In patients younger than 6 years with irritability associated with autistic disorder or Tourette's disorder

Safety and efficacy of once-monthly extended-release IM aripiprazole have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

OTHER COMMENTS:
Administration advice:
May take with or without food
-Oral tablets: Swallow whole
-Oral solution 1 mg/mL: Use calibrated dosing cup
-Oral disintegrating tablet: Remove tablet from blister by peeling back the foil just prior to administration; do not push tablet through foil as this could damage tablet. With dry hands, place tablet on tongue and allow to disintegrate; liquid is not needed, but can be taken if needed.
-Missed doses: Take the missed dose as soon as remembered, if it is almost time for the next dose, skip the missed dose and take the next dose at the regular time; do not take 2 doses at the same time.

IM administration: There are 2 IM formulations with different dosages, dosing frequencies, and indications; these products should not be interchanged.
-Immediate-release (9.75 mg/1.3 mL): Inject IM slowly, deep into muscle mass; do not give IV or subcutaneously

Extended-Release Injectable Suspension (Abilify Maintena(R))
-Available as pre-filled dual chamber syringes in 300 mg and 400 mg strengths
-Available as single-use vials in 300 mg and 400 mg strengths
-Administer by deep IM gluteal injection once a month; should be administered by a health care professional using the appropriate enclosed safety needle; do not administer IV or subcutaneously

Storage requirements:
-Oral solution: Opened bottles can be used for up to 6 months after opening; do not use beyond the expiration date on the bottle
-Immediate-release injection (9.75 mg/1.3 mL vials): Protect from light by storing in original packaging until ready for use.
-Extended-Release (Abilify Maintena(R)) pre-filled dual chamber syringes: Store below 30C (86F); do not freeze; protect form light by storing in original packaging until ready to use.
-Extended-Release (Abilify Maintena(R)) vials: Store at 25C (77F); do not freeze

Reconstitution/preparation techniques: The manufacturer product information should be consulted.

General:
-Patients should be periodically reassessed to determine continued need for treatment.

Monitoring:
-Hematologic: CBC frequently during the first few months in patients with preexisting low WBC and/or a prior history of drug-induced leukopenia or neutropenia.
-Metabolic: Monitor for increases in blood sugar, weight, and lipids
-Psychiatric: Monitor for clinical worsening and suicidality; close supervision of high-risk patients should accompany drug therapy.
-Monitor for pathological gambling, especially in those with a history of this behavior.

Patient advice:
-Patients, families, and caregivers should report worsening of depression, suicidal ideation, or any unusual changes in behavior, especially during early antidepressant treatment and when doses are adjusted up or down.
-Patients should be advised to speak with health care providers if they plan to take any new medications including over the counter medications as there are potential drug interactions requiring dose adjustments.
-This drug may impair judgment, thinking, or motor skills; have patient avoid driving or operating machinery until adverse effects are determined.
-Advise patient to speak to physician or health care professional if pregnant, intend to become pregnant, or are breastfeeding.
-Advise patient that this drug may cause metabolic changes such as increases in blood sugar, body weight and lipids.
-Patients should avoid overheating and dehydration.

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