Aripiprazole

pronounced as (ay ri pip' ray zole)

Brand Name(s): Abilify®, Abilify Mycite®, also available generically

Why is this medicine prescribed?

Aripiprazole is used to treat the symptoms of schizophrenia (a mental illness that causes disturbed or unusual thinking, loss of interest in life, and strong or inappropriate emotions) in adults and teenagers 13 years of age and older. It is also used alone or with other medications to treat episodes of mania or mixed episodes (symptoms of mania and depression that happen together) in adults, teenagers, and children 10 years of age and older with bipolar disorder (manic-depressive disorder; a disease that causes episodes of depression, episodes of mania, and other abnormal moods). Aripiprazole is also used with an antidepressant to treat depression when symptoms cannot be controlled by the antidepressant alone. Aripiprazole is also used to treat children 6 to 17 years of age who have autistic disorder (a developmental problem that causes difficulty communicating and interacting with others). Aripiprazole may help control irritable behavior such as aggression, temper tantrums, and frequent mood changes in these children. Aripiprazole is also used to treat children 6 to 18 years of age who have Tourette's disorder (a condition characterized by the need to perform repeated motions or to repeat sounds or words). Aripiprazole is in a class of medications called atypical antipsychotics. It works by changing the activity of certain natural substances in the brain.

Are there other uses for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

How should this medicine be used?

Aripiprazole comes as a tablet, a solution (liquid), an orally disintegrating tablet (tablet that dissolves quickly in the mouth) to take by mouth. It is usually taken once a day with or without food. Apriprazole also comes as a tablet that contains a sensor device to take by mouth to be used in adults to provide information about how the medication is taken. Take aripiprazole at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take aripiprazole exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Do not try to push the orally disintegrating tablet through the foil. Instead, use dry hands to peel back the foil packaging. Immediately take out the tablet and place the entire tablet on your tongue. Do not try to split the tablet. The tablet will quickly dissolve and can be swallowed without liquid. If necessary, liquid can be used to take the orally disintegrating tablet.

Swallow the tablets and the tablet with a sensor whole; do not divide, crush, or chew.

The tablets that contain a small sensor come with a patch (a wearable sensor) that detects a signal from the tablet and a smartphone application (app) to display information about how you are taking the medication. The app must be downloaded onto your smartphone before you start the medication. Apply your patch to the left side of the body above the lower edge of the rib cage only when prompted by the smartphone app instructions. Do not place the patch on areas where the skin is scraped, cracked, inflamed, or irritated or in a location that overlaps the area of the most recently removed patch. Change the patch weekly or sooner, if needed. The app reminds you to change the patch and explains how to apply and remove the patch correctly. Keep the patch on when showering, swimming, or exercising. If undergoing a magnetic resonance imaging (MRI; a medical test that uses powerful magnets to take pictures of the inside of the body), remove the patch and replace it with a new one as soon as possible. If the patch causes skin irritation, remove it and tell your doctor. After you take the medication, the tablets can be detected in the body by the app within 30 minutes to 2 hours. If the tablet is not detected after ingestion, do not take another dose. Talk to your doctor if you have any questions about how to take the tablets and use the patch or smartphone app.

Your doctor may start you on a low dose of aripiprazole and gradually increase or decrease your dose depending on how well the medication works for you and the side effects you experience.

Aripiprazole may help control your symptoms but will not cure your condition. It may take 2 weeks or longer before you feel the full benefit of aripiprazole. Continue to take aripiprazole even if you feel well. Do not stop taking aripiprazole without talking to your doctor.

What special precautions should I follow?

Before taking aripiprazole,

  • tell your doctor and pharmacist if you are allergic to aripiprazole, any other medications, or any of the ingredients in aripiprazole preparations. Ask your doctor or pharmacist or check the Medication Guide for a list of the ingredients.
  • tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take while taking aripiprazole. Your doctor may need to change the doses of your medications or monitor you carefully for side effects. .
  • The following nonprescription drugs or herbal products may interact with aripiprazole: allergy medications (diphenhydramine, loratadine, fexofenadine, chlorpheniramine or cetirizine), and St. John's wort. Be sure to let your doctor and pharmacist know that you are taking these products before you start taking aripiprazole. Do not start any of these medications while taking aripiprazole without discussing with your healthcare provider.
  • tell your doctor if you have severe diarrhea or vomiting or you think you may be dehydrated. . Also tell your doctor if you have or have ever had heart disease, heart failure, a heart attack, an irregular heartbeat, high or low blood pressure, a stroke, a ministroke, seizures, a low number of white blood cells, dyslipidemia (high cholesterol levels), trouble keeping your balance, or any condition that makes it difficult for you to swallow. Tell your doctor if you or anyone in your family use or have ever used street drugs or have overused prescription medication or alcohol or has or has ever had diabetes, obsessive compulsive disorder, impulse-control disorder, bipolar disorder, or an impulsive personality. Also tell your doctor if you have ever had to stop taking a medication for mental illness because of severe side effects.
  • tell your doctor if you are pregnant, especially if you are in the last few months of your pregnancy, or if you plan to become pregnant or are breastfeeding. If you become pregnant while taking aripiprazole, call your doctor. Aripiprazole may cause problems in newborns following delivery if it is taken during the last months of pregnancy.
  • you should know that aripiprazole may make you drowsy. Do not drive a car or operate machinery until you know how this medication affects you.
  • you should know that you may experience hyperglycemia (increases in your blood sugar) while you are taking this medication, even if you do not already have diabetes. If you have schizophrenia, you are more likely to develop diabetes than people who do not have schizophrenia, and taking aripiprazole or similar medications may increase this risk. Tell your doctor immediately if you have any of the following symptoms while you are taking aripiprazole: extreme thirst, frequent urination, extreme hunger, blurred vision, or weakness. It is very important to call your doctor as soon as you have any of these symptoms, because high blood sugar that is not treated can cause a serious condition called ketoacidosis. Ketoacidosis may become life-threatening if it is not treated at an early stage. Symptoms of ketoacidosis include dry mouth, nausea and vomiting, shortness of breath, breath that smells fruity, and decreased consciousness.
  • you should know that aripiprazole may cause dizziness, lightheadedness, and fainting when you get up too quickly from a lying position. This is more common when you first start taking aripiprazole. To avoid this problem, get out of bed slowly, resting your feet on the floor for a few minutes before standing up.
  • you should know that aripiprazole may make it harder for your body to cool down when it gets very hot. Tell your doctor if you plan to do vigorous exercise or be exposed to extreme heat.
  • if you have phenylketonuria (PKU, an inherited condition in which a special diet must be followed to prevent damage to your brain that can cause severe intellectual disability), you should know that the orally disintegrating tablets contain phenylalanine. If you have diabetes, you should know that aripiprazole solution contains sugar.
  • you should know that some people who have taken medications such as aripiprazole have developed gambling problems or other intense urges or behaviors that were compulsive or unusual for them, such as increased sexual urges or behaviors, excessive shopping, and binge eating. Call your doctor if you have intense urges to shop, eat, have sex, or gamble, or you are unable to control your behavior. Tell your family members about this risk so that they can call the doctor even if you do not realize that your gambling or any other intense urges or unusual behaviors such as have become a problem.
  • you should know that when aripiprazole is used to treat children, it should be used as part of a treatment program that may include counseling and special education. Be sure that your child follows all of his or her doctor's or therapist's instructions.
  • if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking aripiprazole.
  • you should know that alcohol can add to the drowsiness caused by this medication. Do not drink alcohol while taking aripiprazole.

What special dietary instructions should I follow?

Talk to your doctor about drinking grapefruit juice while taking this medicine.

What should I do if I forget to take a dose?

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What should I do in case of overdose?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help . If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include the following:

  • drowsiness
  • weakness
  • widened pupils (black circles in the middle of the eyes)
  • nausea
  • vomiting
  • changes in heartbeat
  • movements that you cannot control
  • confusion
  • seizures
  • loss of consciousness

What side effects can this medicine cause?

Aripiprazole may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

  • headache
  • nervousness
  • restlessness
  • dizziness, feeling unsteady, or having trouble keeping your balance
  • heartburn
  • constipation
  • diarrhea
  • stomach pain
  • weight gain
  • changes in appetite
  • increased salivation
  • pain, especially in the arms, legs, or joints
  • tiredness

Some side effects can be serious. If you experience any of the following symptoms or those listed in the IMPORTANT WARNING section or the SPECIAL PRECAUTIONS section, call your doctor immediately:

  • rash
  • hives
  • itching
  • swelling of the eyes, face, mouth, lips, tongue, throat, hands, feet, ankles, or lower legs
  • difficulty breathing or swallowing
  • seizures
  • changes in vision
  • uncontrollable shaking of the face, tongue, or other body parts
  • fever; stiff muscles; sweating; confusion; sweating; or fast, pounding, or irregular heartbeat
  • problems with coordination or increased falls
  • tightening of the neck muscles
  • throat tightness

Aripiprazole may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online ( http://www.fda.gov/Safety/MedWatch ) or by phone (1-800-332-1088).

What should I know about storage and disposal of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store the tablets, the solution, and the orally disintegrating tablets at room temperature and away from excess heat and moisture (not in the bathroom). Store the orally disintegrating tablets in their sealed package, and use them immediately after opening the package. Store the tablets with a sensor at room temperature; do not store in places with high humidity. Dispose of any unused aripiprazole solution 6 months after you open the bottle or when the expiration date marked on the bottle has passed, whichever is sooner.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website ( http://goo.gl/c4Rm4p ) for more information if you do not have access to a take-back program.

What other information should I know?

Keep all appointments with your doctor and the laboratory. Your doctor may order laboratory tests before and during your treatment with aripiprazole.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

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