Abilify (Aripiprazole) Drug Information

Why is this medication prescribed?

Abilify (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). Abilify (aripiprazole) is also used with an antidepressant to treat depression when symptoms cannot be controlled by the antidepressant alone. Abilify (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). Abilify (aripiprazole) may help control irritable behavior such as aggression, temper tantrums, and frequent mood changes in these children. Abilify (aripiprazole) is in a class of medications called atypical antipsychotics. It works by changing the activity of certain natural substances in the brain.

How should this medicine be used?

Abilify (aripiprazole) comes as a tablet, a solution (liquid), and 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. Take Abilify (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 Abilify (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.

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

Abilify (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 Abilify (aripiprazole). Continue to take Abilify (aripiprazole) even if you feel well. Do not stop taking Abilify (aripiprazole) without talking to your doctor.

Other uses for this medicine

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

What special precautions should I follow?

Before taking Abilify (aripiprazole):

• tell your doctor and pharmacist if you are allergic to Abilify (aripiprazole), any other medications, or any of the ingredients in Abilify (aripiprazole) tablets, orally disintegrating tablets, or oral solution. Ask your doctor or pharmacist 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. Be sure to mention any of the following: antidepressants (mood elevators); antifungals such as itraconazole (Sporanox) and ketoconazole (Nizoral); antihistamines; bupropion (Wellbutrin); carbamazepine (Tegretol); clarithromycin (Biaxin); fluoxetine (Prozac, Sarafem); HIV protease inhibitors such as atazanavir (Reyataz), indinavir (Crixivan), nelfinavir (Viracept), ritonavir (Norvir), and saquinavir (Invirase); ipratropium (Atrovent); medications for anxiety, high blood pressure, irritable bowel syndrome, mental illness, motion sickness, Parkinson's disease, seizures, ulcers, or urinary problems; nefazodone; paroxetine (Paxil, Pexeva); quinidine;rifampin (Rifadin, Rimactane); sedatives; sleeping pills; telithromycin (Ketek); and tranquilizers. Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Many other medications may also interact with Abilify (aripiprazole), so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.
• tell your doctor if you use or have ever used street drugs or have overused prescription medication and 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,or any condition that makes it difficult for you to swallow. Tell your doctor if you or anyone in your family has or has ever had diabetes. 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 breast-feeding. If you become pregnant while taking Abilify (aripiprazole), call your doctor. Abilify (aripiprazole) may cause problems in newborns following delivery if it is taken during the last months of pregnancy.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking Abilify (aripiprazole).
• you should know that Abilify (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 alcohol can add to the drowsiness caused by this medication. Do not drink alcohol while taking Abilify (aripiprazole).
• 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 Abilify (aripiprazole) or similar medications may increase this risk. Tell your doctor immediately if you have any of the following symptoms while you are taking Abilify (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 Abilify (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 Abilify (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 Abilify (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 mental retardation), you should know that the orally disintegrating tablets contain phenylalanine. If you have diabetes, you should know that Abilify (aripiprazole) solution contains sugar.
• you should know that when Abilify (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.

What special dietary instructions should I follow?

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

Be sure to drink plenty of water every day while you are taking this medication

What should I do if I forget 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 side effects can this medication cause?

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

• headache
• nervousness
• drowsiness
• dizziness
• heartburn
• constipation
• diarrhea
• stomach pain
• weight gain
• increased appetite
• increased salivation
• pain, especially in the arms, legs, or joints

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:

• seizures
• slow, fast, or irregular heartbeat
• chest pain
• changes in vision
• unusual movements of your body or face that you cannot control
• high fever
• muscle stiffness
• confusion
• sweating
• rash
• hives
• itching
• swelling of the eyes, face, mouth, lips, tongue, throat, hands, feet, ankles, or lower legs
• difficulty breathing or swallowing
• tightening of the neck muscles
• tightness in the throat

Abilify (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 [at http://www.fda.gov/Safety/MedWatch] or by phone [1-800-332-1088].

What storage conditions are needed for this medicine?

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). Always store the orally disintegrating tablets in their sealed package, and use them immediately after opening the package. Throw away any medication that is outdated or no longer needed. Throw away any unused Abilify (aripiprazole) solution 6 months after you open the bottle or when the expiration date marked on the bottle has passed, whichever is sooner. Talk to your pharmacist about the proper disposal of your medication.

In case of emergency/overdose

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

Symptoms of overdose may include:

• 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 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 Abilify (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.

Brand Names

• Abilify®