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aripiprazole (injection)

Generic Name: aripiprazole (injection) (AR i PIP ra zole)
Brand Name: Abilify Maintena, Aristada

What is aripiprazole?

Aripiprazole is an antipsychotic medication. It works by changing the actions of chemicals in the brain.

Aripiprazole is used to treat the symptoms of psychotic conditions such as schizophrenia and bipolar I disorder (manic depression) in adults.

Aripiprazole may also be used for purposes not listed in this medication guide.

What is the most important information I should know about aripiprazole?

Aripiprazole is not approved for use in psychotic conditions related to dementia. Aripiprazole may increase the risk of death in older adults with dementia-related conditions.

What should I discuss with my healthcare provider before receiving aripiprazole?

You should not be treated with aripiprazole if you are allergic to it.

Tell your doctor if you have never taken aripiprazole (Abilify) before.

Aripiprazole is not approved for use in psychotic conditions related to dementia. Aripiprazole may increase the risk of death in older adults with dementia-related conditions.

To make sure aripiprazole is safe for you, tell your doctor if you have ever had:

  • heart disease, a heart attack or stroke;

  • high or low blood pressure;

  • liver or kidney disease;

  • high blood sugar, diabetes (or a family history of diabetes);

  • a seizure; or

  • low white blood cell (WBC) counts.

Aripiprazole may cause you to have high blood sugar (hyperglycemia). If you are diabetic, check your blood sugar levels on a regular basis while you are receiving aripiprazole.

Using antipsychotic medicine in the last 3 months of pregnancy may cause problems in the newborn, such as withdrawal symptoms, breathing problems, feeding problems, fussiness, tremors, and limp or stiff muscles. Tell your doctor if you are pregnant or plan to become pregnant.

If you are pregnant, your name may be listed on a pregnancy registry. This is to track the outcome of the pregnancy and to evaluate any effects of aripiprazole on the baby.

Aripiprazole can pass into breast milk, but effects on the nursing baby are not known. Tell your doctor if you are breast-feeding.

How is aripiprazole given?

Aripiprazole is injected into a muscle once every month. A healthcare provider will give you this injection.

If you have never used aripiprazole before, your doctor may want to you also take this medicine by mouth (in a tablet or liquid form) for 2 weeks after your first injection.

Keep using all of your other anti-psychotic medications for at least 2 weeks after your first injection of aripiprazole.

Drink plenty of liquids. You can easily become dehydrated while using aripiprazole.

Your doctor will need to check your progress while you are using aripiprazole.

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your aripiprazole injection.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include drowsiness, vomiting, aggression, confusion, tremors, fast or slow heart rate, seizure (convulsions), weak or shallow breathing, or fainting.

What should I avoid while receiving aripiprazole?

This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Dizziness or severe drowsiness can cause falls, fractures, or other injuries.

Avoid drinking alcohol. Dangerous side effects could occur.

Avoid becoming overheated or dehydrated. Drink plenty of fluids, especially in hot weather and during exercise. It is easier to become dangerously overheated and dehydrated while you are using aripiprazole.

Aripiprazole side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

High doses or long-term use of aripiprazole can cause a serious movement disorder that may not be reversible. Call your doctor at once if you have uncontrollable muscle movements of your lips, tongue, eyes, face, arms, or legs. The longer you use aripiprazole, the more likely you are to develop a serious movement disorder. The risk of this side effect is higher in women and older adults.

Call your doctor at once if you have:

  • feeling uncomfortably warm or hot;

  • trouble swallowing;

  • unusual muscle twitching;

  • a seizure;

  • severe nervous system reaction--very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out;

  • low blood cell counts--sudden weakness or ill feeling, fever, chills, sore throat, painful mouth sores, swollen gums, skin sores, cold or flu symptoms, cough, trouble breathing; or

  • high blood sugar--increased thirst, increased urination, hunger, dry mouth, fruity breath odor.

You may have increased sexual urges, unusual urges to gamble, or other intense urges while using this medicine. Talk with your doctor if this occurs.

Common side effects may include:

  • mild pain where the injection was given;

  • weight gain; or

  • drowsiness.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Side Effects (complete list)

Aripiprazole dosing information

Usual Adult Dose for Schizophrenia:

ORAL FORMULATIONS:
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.
-Maximum dose: 30 mg/day

PARENTERAL FORMULATIONS:
Aripiprazole Extended-Release IM Suspension:
-Initial dose: 400 mg IM once; continue aripiprazole 10 to 20 mg orally once a day for 14 days
-Maintenance dose: 300 to 400 mg IM once a month; should not be given sooner than 26 days after the previous injection

Aripiprazole Lauroxil Extended-Release IM Suspension:
-Patients stable on oral aripiprazole 10 mg/day: Initial dose 441 mg IM once; continue aripiprazole 10 mg orally once a day for 21 days.
-Patients stable on oral aripiprazole 15 mg/day: Initial dose 662 mg IM once; continue aripiprazole 15 mg orally once a day for 21 days.
-Patients stable on oral aripiprazole at least 20 mg/day: Initial dose 882 mg IM; continue oral aripiprazole once a day for 21 days.
-Maintenance doses: 441 mg, 662 mg, or 882 mg IM monthly, 882 mg IM every 6 weeks, or 1064 mg IM every 2 months; this drug should not be given sooner than 14 days after the previous injection.

Comments:
-The oral solution and oral tablets can be substituted on a mg-per-mg basis up 25 mg; patients receiving 30 mg tablets should receive 25 mg of the oral solution.
-Oral formulation dose increases, if needed should be at 2-week intervals to allow time to achieve steady state.
-Prior to initiating therapy with extended-release IM formulations, establish tolerability with oral formulation; it may take up to 2 weeks to fully assess tolerability due to the half-life of aripiprazole.
-Dose regimen adjustments (including addition of oral supplementation) will be needed for missed doses; see dose adjustments section.

Use: Treatment of schizophrenia

Usual Adult Dose for Bipolar Disorder:

ORAL FORMULATIONS:
Immediate-Release:
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/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.
-Maximum dose: 30 mg/day

PARENTERAL FORMULATIONS:
Aripiprazole Extended-Release IM Suspension:
-Initial dose: 400 mg IM once; continue aripiprazole 10 to 20 mg orally once a day for 14 days
-Maintenance dose: 300 to 400 mg IM once a month; should not be given sooner than 26 days after the previous injection

Comments:
-The safety of oral doses greater than 30 mg per day has not been studied.
-Dose increases of oral formulations, if needed, should be at 2-week intervals to allow time to achieve steady state.
-The dose recommended for maintenance treatment is the same dose needed to stabilize patients during acute treatment; healthcare providers should periodically reassess need for maintenance treatment.
-The oral solution and oral tablets can be substituted on a mg-per-mg basis up to 25 mg; patients receiving 30 mg tablets should receive 25 mg of the oral solution.

Uses:
-Acute treatment of manic and mixed episodes associated with bipolar I disorder
-Maintenance monotherapy treatment of bipolar I disorder

Usual Adult Dose for Agitated State:

PARENTERAL FORMULATIONS:
Immediate-Release:
-Initial dose: 9.75 mg IM once
-Maintenance dose: 5.25 to 15 mg IM once
-Maximum dose: 30 mg/day

Comments:
-If ongoing therapy is clinically indicated, oral therapy should replace injections as soon as possible.
-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.
-If additional doses are needed, allow at least 2 hours to elapse between dosing; the efficacy of repeated doses has not been studied.

Use: Treatment of agitation associated with schizophrenia or bipolar mania

Usual Adult Dose for Depression:

ORAL FORMULATIONS:
Immediate-Release:
-Initial dose: 2 to 5 mg orally once a day
---Doses may be adjusted in increments up to 5 mg per day at intervals of no less than 1 week.
-Maintenance dose: 2 to 15 mg once a day
-Maximum dose: 15 mg/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 25 mg.

Use: Adjunctive treatment of major depressive disorder

Usual Pediatric Dose for Schizophrenia:

13 to 17 years:
-Initial dose: 2 mg orally once a day; after 2 days, titrate to 5 mg orally once a day, then titrate to 10 mg orally once a day after an additional 2 days
-Maintenance dose: 10 mg orally once a day
-Maximum dose: 30 mg/day

Comments:
-The effective dose range was 10 to 30 mg per day; however, clinical trials have not found doses exceeding 10 mg per day to be more effective.
-After initiation, dose increases, if needed, should be in 5 mg increments at 2-week intervals in order to allow time to achieve steady state.
-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.
-Healthcare providers should periodically reassess need for maintenance treatment.
-The oral solution and oral tablets can be substituted on a mg-per-mg basis up to 25 mg; patients receiving 30 mg tablets should receive 25 mg of the oral solution.

Use: Treatment of schizophrenia

Usual Pediatric Dose for Bipolar Disorder:

10 to 17 years:
Monotherapy OR 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, then titrate to 10 mg orally once a day after an additional 2 days
-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/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 25 mg; patients receiving 30 mg tablets should receive 25 mg of the oral solution.

Use: Acute treatment of manic and mixed episodes associated with bipolar I disorder

Usual Pediatric Dose for Autism:

6 to 17 years:
-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. If needed, dose adjustments in increments of up to 5 mg per day should occur at intervals of no less than 1 week.
-Maintenance dose: 5 to 15 mg orally once a day
-Maximum dose: 15 mg orally/day

Comments:
-Doses should be individualized according to tolerability and response.
-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 25 mg.

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:

6 to 18 years:
Less than 50 kg:
-Initial dose: 2 mg orally once a day; after 2 days, titrate to 5 mg orally once a day. Healthcare providers may increase the dose to 10 mg once a day in patients who do not achieve optimal control of tics.
---Dose adjustments should occur gradually at intervals of no less than 1 week.
-Maximum dose: 10 mg/day

50 kg or more:
-Initial dose: 2 mg orally once a day; after 2 days, titrate to 5 mg orally once a day, then titrate to 10 mg orally once a day on day 8. Healthcare providers may increase the dose to 20 mg once a day in patients who do not achieve optimal control of tics.
---Dose adjustments should occur gradually in increments of 5 mg per day at intervals of no less than 1 week.
-Maximum dose: 20 mg/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 25 mg.

Use: Treatment of Tourette's disorder

What other drugs will affect aripiprazole?

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Many drugs can interact with aripiprazole. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide. Tell your doctor about all your current medicines and any medicine you start or stop using.

Where can I get more information?

  • Your pharmacist can provide more information about aripiprazole.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 1.01.

Last reviewed: September 07, 2017
Date modified: December 03, 2017

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