Aripiprazole Dosage

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Usual Adult Dose for:

Usual Pediatric Dose for:

Additional dosage information:

Usual Adult Dose for Schizophrenia

Initial Dose: 10 or 15 mg tablet or solution orally once a day
Maintenance Dose: 10 to 30 mg per day. However, clinical trials found doses exceeding 10 or 15 mg per day were no more effective than 10 or 15 mg per day.

Dosage increases should not be made before two weeks (the time needed to achieve steady state).

IM extended-release:
Initial and maintenance dose: 400 mg monthly (no sooner than 26 days after the previous injection). After the first injection, continue treatment with oral aripiprazole (10 mg to 20 mg) or other oral antipsychotic for 14 consecutive days to maintain therapeutic antipsychotic concentrations during initiation of therapy.
MISSED DOSES:
If the second or third doses are missed:
-If more than 4 weeks and less than 5 weeks have elapsed since the last injection, administer as soon as possible.
-If more than 5 weeks have elapsed since the last injection, restart concomitant oral aripiprazole for 14 days with the next administered injection.
If the fourth or subsequent doses are missed:
-If more than 4 weeks and less than 6 weeks have elapsed since the last injection, administer as soon as possible.
-If more than 6 weeks have elapsed since the last injection, restart concomitant oral aripiprazole for 14 days with the next administered injection.

Usual Adult Dose for Bipolar Disorder

Starting and target dose: 15 mg tablet orally once a day as monotherapy or as adjunctive therapy with lithium or valproate. The dose can be increased to 30 mg tablet (or 25 mg solution) per day based on clinical response. The safety of doses above 30 mg per day has not been evaluated in clinical trials.

Usual Adult Dose for Agitated State

Treatment of agitation associated with schizophrenia or bipolar disorder (manic or mixed):
Initial dose: 5.25 mg to 15 mg IM once
If needed, dose may be repeated no more frequently than every 2 hours
Maximum dose: 30 mg IM per day

Usual Adult Dose for Depression

For use as adjunctive treatment for patients already taking an antidepressant:

Initial Dose: 2 mg per day to 5 mg per day
Maintenance Dose: 2 mg per day to 15 mg per day

Dose adjustments of up to 5 mg per day should occur gradually, at intervals of no less than 1 week.

The long-term efficacy of aripiprazole for the adjunctive treatment of major depressive disorder has not been established.

Usual Pediatric Dose for Schizophrenia

13 to 17 years:
Initial Dose: 2 mg tablet or solution orally once a day
After 2 days: Titrate to 5 mg per day
After 4 days: Titrate to 10 mg per day

Subsequent dosage increases should be administered in 5 mg increments.

Maintenance Dose: 10 to 30 mg per day. However, the 30 mg per day was not shown to be more effective than 10 mg per day.

Usual Pediatric Dose for Bipolar Disorder

Acute treatment of manic and mixed episodes associated with Bipolar Disorder with or without psychotic features as monotherapy or as adjunctive therapy with lithium or valproate:
10 to 17 years:
Initial Dose: 2 mg tablet or solution orally once a day
After 2 days: Titrate to 5 mg per day
After 4 days: Titrate to 10 mg per day

Subsequent dosage increases should be administered in 5 mg increments up to 30 mg tablet (or 25 mg solution) per day. However, the 30 mg per day was not shown to be more effective than 10 mg per day.

Usual Pediatric Dose for Autism

Treatment of irritability associated with autistic disorder (including aggression, deliberate self injurious behavior, temper tantrums, and quickly changing moods):
6 to 17 years:
Initial dose: 2 mg daily for 7 days, followed by 5 mg daily; subsequent dose increases may be made in 5 mg increments every 7 days, up to a maximum of 15 mg/day

Usual Pediatric Dose for Tourette's Syndrome

Tourette's syndrome, tic disorders: Children and Adolescents 7-18 years: Limited information exists in literature: Dose is not established; small, open labeled clinical trials and retrospective observational studies suggest low doses (2.5-5 mg/day) may be efficacious. Studies used the following doses: Initial dose: 1.25 to 5 mg/day; daily doses were increased by 1.25 to 2.5 mg weekly or by 5 mg every 2 weeks. Maximum dose: 15 to 20 mg/day. Reported mean required doses ranged from 3.3 to 11.7 mg/day.

Renal Dose Adjustments

No adjustment recommended

Liver Dose Adjustments

No adjustment recommended

Dose Adjustments

In general, no dosage adjustment is required on the basis of a patient's age, gender, race, smoking status, hepatic function, or renal function.

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

Dose adjustments for IM extended-release in patients who are CYP450 2D6 poor metabolizers and in patients taking concomitant CYP450 3A4 inhibitors or CYP450 2D6 inhibitors for greater than 14 days:
-CYP450 2D6 Poor Metabolizers: 300 mg
-CYP450 2D6 Poor Metabolizers taking concomitant CYP450 3A4 inhibitors: 200 mg
-Patients Taking 400 mg:
Strong CYP450 2D6 or CYP450 3A4 inhibitors: 300 mg
CYP450 2D6 and CYP450 3A4 inhibitors: 200 mg
CYP450 3A4 inducers: Avoid use
-Patients Taking 300 mg:
Strong CYP450 2D6 or CYP450 3A4 inhibitors: 200 mg
CYP450 2D6 and CYP450 3A4 inhibitors: 160 mg
CYP450 3A4 inducers: Avoid use
-Dosage adjustments are not recommended for patients with concomitant use of CYP450 3A4 inhibitors, CYP450 2D6 inhibitors or CYP450 3A4 inducers for less than 14 days.

Dialysis

Data not available

Other Comments

The oral solution may be given on a mg per mg basis in place of the 5, 10, 15, or 20 mg tablet strengths. Solution doses can be substituted for the tablet doses on a mg per mg basis up to 25 mg of the tablet. Patients receiving 30 mg tablets should receive 25 mg of the solution.

Aripiprazole oral tablets and oral solution may be administered with or without food.

Clinicians should instruct patients to only open the foil packet containing aripiprazole discmelt oral tablets just prior to ingestion. It is recommended not to push the tablets through the foil or to split the tablets. The tablets should not come in contact with moisture and should be handled with dry hands. The tablet should be placed under the tongue immediately following removal from the foil packet. While not recommended, a small amount of liquid may be ingested with the tablet.

Use of aripiprazole for extended periods should be periodically reevaluated for the long-term usefulness of the drug in this individual patient.

The efficacy of aripiprazole for the maintenance treatment of schizophrenia in the pediatric population has not been determined.

Each mL of the oral solution contains sucrose 400 mg and fructose 200 mg.

Aripiprazole extended-release IM: For deep intramuscular gluteal injection by healthcare professionals only. Inject immediately after reconstitution. To be administered once monthly.

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