aripiprazole

Pronunciation

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

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 disorder (manic depression). It is also used together with other medications to treat major depressive disorder in adults.

Aripiprazole is also used to treat irritability and symptoms of aggression, mood swings, temper tantrums, and self-injury related to autistic disorder in children who are at least 6 years old.

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.

Slideshow: Can Prescription Drugs Lead to Weight Gain?

Some young people have thoughts about suicide when taking medicine for a major depressive disorder and other psychiatric disorders. Your doctor will need to check your progress at regular visits while you are using aripiprazole. Your family or other caregivers should also be alert to changes in your mood or symptoms.

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

You should not take aripiprazole if you are allergic to it.

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:

  • liver or kidney disease;

  • heart disease, high or low blood pressure, heart rhythm problems;

  • high cholesterol or triglycerides (a type of fat in the blood);

  • a history of low white blood cell (WBC) counts;

  • a history of heart attack or stroke;

  • a history of breast cancer;

  • seizures or epilepsy;

  • a personal or family history of diabetes; or

  • trouble swallowing.

Some young people have thoughts about suicide when taking medicine for a major depressive disorder and other psychiatric disorders. Your doctor will need to check your progress at regular visits while you are using aripiprazole. Your family or other caregivers should also be alert to changes in your mood or symptoms.

The liquid form (oral solution) of this medication may contain up to 15 grams of sugar per dose. Before taking aripiprazole oral solution, tell your doctor if you have diabetes.

Aripiprazole may cause you to have high blood sugar (hyperglycemia). Talk to your doctor if you have any signs of hyperglycemia such as increased thirst or urination, excessive hunger, or weakness. If you are diabetic, check your blood sugar levels on a regular basis while you are taking aripiprazole.

The orally disintegrating tablet form of this medication may contain over 3 milligrams of phenylalanine per tablet. Before taking Abilify Discmelt, tell your doctor if you have phenylketonuria.

FDA pregnancy category C. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

Taking antipsychotic medication during 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. However, you may have withdrawal symptoms or other problems if you stop taking your medicine during pregnancy. If you become pregnant while taking aripiprazole, do not stop taking it without your doctor's advice.

Aripiprazole can pass into breast milk and may harm a nursing baby. You should not breast-feed while using this medicine.

How should I take aripiprazole?

Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Do not take aripiprazole for longer than 6 weeks unless your doctor has told you to.

Aripiprazole can be taken with or without food.

Measure liquid medicine with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.

To take the orally disintegrating tablet (Abilify Discmelt):

  • Keep the tablet in its blister pack until you are ready to take it. Open the package and peel back the foil. Do not push a tablet through the foil or you may damage the tablet.

  • Use dry hands to remove the tablet and place it in your mouth.

  • Do not swallow the tablet whole. Allow it to dissolve in your mouth without chewing. If desired, you may drink liquid to help swallow the dissolved tablet.

Use aripiprazole regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

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

Store at room temperature away from moisture and heat. Aripiprazole liquid may be used for up to 6 months after opening, but not after the expiration date on the medicine label.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

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), trouble breathing, or fainting.

What should I avoid while taking 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. Get up slowly and steady yourself to prevent a fall.

Drinking alcohol can increase certain side effects of aripiprazole.

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 taking aripiprazole.

Aripiprazole side effects

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

Stop using aripiprazole and call your doctor at once if you have:

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

  • severe agitation, distress, or restless feeling;

  • twitching or uncontrollable movements of your eyes, lips, tongue, face, arms, or legs;

  • mask-like appearance of the face, trouble swallowing, problems with speech;

  • seizure (convulsions);

  • thoughts about suicide or hurting yourself;

  • low blood cell counts--sudden weakness or ill feeling, fever, chills, sore throat, swollen gums, painful mouth sores, red or 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, drowsiness, dry skin, weight loss.

Common side effects may include:

  • weight gain;

  • blurred vision;

  • drooling;

  • dizziness, drowsiness; or

  • sleep problems (insomnia).

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.

See also: Side effects (in more detail)

Aripiprazole dosing 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

What other drugs will affect aripiprazole?

Taking this medicine with other drugs that make you sleepy can worsen this effect. Ask your doctor before taking aripiprazole with a sleeping pill, narcotic pain medicine, muscle relaxer, or medicine for anxiety, depression, or seizures.

Many other drugs can interact with aripiprazole. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your medications and any you start or stop using during treatment with aripiprazole.

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: 10.01. Revision Date: 2014-06-13, 8:45:47 AM.

Hide
(web2)