Aripiprazole (patient information)

IMPORTANT WARNING

Studies have shown that older adults with dementia (a brain disorder that affects the ability to remember, think clearly, communicate, and perform daily activities and that may cause changes in mood and personality) who take antipsychotics (medications for mental illness) such as aripiprazole have an increased chance of death during treatment. Older adults with dementia may also have a greater chance of having a stroke or mini-stroke or other severe side effects during treatment. If you experience any of the following symptoms, call your doctor immediately: slow or difficult speech, sudden dizziness or faintness, weakness or numbness of an arm or leg. drowsiness, or difficulty swallowing.

Aripiprazole is not approved by the Food and Drug Administration (FDA) for the treatment of behavior problems in older adults with dementia. Talk to the doctor who prescribed this medication if you, a family member, or someone you care for has dementia and is taking aripiprazole. For more information visit the FDA website: http://www.fda.gov/cder

Why this medication is 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). It is also used to treat episodes of mania (frenzied, abnormally excited, or irritated mood) or mixed episodes (symptoms of mania and depression that happen together) in patients with bipolar disorder (manic depressive disorder; a disease that causes episodes of depression, episodes of mania, and other abnormal moods). Aripiprazole is in a class of medications called atypical antipsychotics. It works by changing the activity of certain natural substances in the brain.

How this medication should be used

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 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 it on your tongue. The tablet will quickly dissolve and can be swallowed without liquid. If necessary, liquid can be used to take the orally disintegrating tablet. Do not split, chew, or crush the tablet.

Your doctor may start you on a low dose of aripiprazole and increase your dose after at least 2 weeks.

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.

Other uses for this medicine

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

Special Precautions

Before taking aripiprazole:

• tell your doctor and pharmacist if you are allergic to aripiprazole or any other medications.
• 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: amiodarone (Cordarone, Pacerone); antidepressants (mood elevators); antifungals such as fluconazole (Diflucan), itraconazole (Sporanox), and ketoconazole (Nizoral); antihistamines; bupropion (Wellbutrin); carbamazepine (Tegretol); celecoxib (Celebrex); chlorpromazine (Thorazine); cimetidine (Tagamet); clarithromycin (Biaxin); clomipramine (Anafranil); cyclosporine (Neoral, Sandimmune); danazol (Danocrine); delavirdine (Rescriptor); dexamethasone (Decadron); diltiazem (Cardizem, Dilacor, Tiazac); doxorubicin (Adriamycin); erythromycin (E.E.S., E-Mycin, Erythrocin); ethosuximide (Zarontin); fluoxetine (Prozac, Sarafem); fluvoxamine (Luvox); HIV protease inhibitors such as indinavir (Crixivan) and ritonavir (Norvir); ipratropium (Atrovent); isoniazid (INH, Nydrazid); lorazepam (Ativan); medications for anxiety, blood pressure, irritable bowel disease, mental illness, motion sickness, Parkinson's disease, seizures, ulcers, or urinary problems; metoclopramide (Reglan); methadone (Dolophine); metronidazole (Flagyl); nefazodone; hormonal contraceptives (birth control pills, patches, implants, rings and injections); paroxetine (Paxil); phenobarbital (Luminal, Solfoton); phenytoin (Dilantin); primidone (Mysoline); quinidine (Cardioquin, Quinaglute, Quinidex); ranitidine (Zantac); rifabutin (Mycobutin); rifampin (Rifadin, Rimactane); sedatives; sertraline (Zoloft); sleeping pills; terbinafine (Lamisil); tranquilizers; troglitazone (Rezulin) (not available in the United States); troleandomycin (TAO) (not available in the United States); verapamil (Calan, Covera, Isoptin, Verelan); and zafirlukast (Accolate). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• 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, high or low blood pressure, a stroke, a mini-stroke, seizures, or any condition that makes it difficult for you to swallow, or 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 or plan to become pregnant. If you become pregnant while taking aripiprazole, call your doctor. Do not breast-feed while taking aripiprazole.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking aripiprazole.
• 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 alcohol can add to the drowsiness caused by this medication. Do not drink alcohol while taking 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 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 mental retardation), you should know that the orally disintegrating tablets contain phenylalanine. If you have diabetes, you should know that aripiprazole solution contains sugar.

Special dietary instructions

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 to do if you 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.

Side Effects

Minor Side Effects

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

• headache
• nervousness
• difficulty falling asleep or staying asleep
• drowsiness
• lightheadedness
• restlessness
• nausea
• heartburn
• constipation
• stomach pain
• weight gain
• dry mouth
• loss of appetite
• increased salivation
• joint pain

Severe Side Effects

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
• swelling of the hands, feet, ankles, or lower legs
• changes in vision
• unusual movements of your body or face that you cannot control
• high fever
• muscle stiffness
• confusion
• sweating
• rash
• hives
• itching
• difficulty breathing or swallowing

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/MedWatch/report.htm] or by phone [1-800-332-1088].

Storage conditions needed for 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). 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 aripiprazole solution 6 months after you open the bottle, even if the expiration date marked on the bottle has not passed. 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 can not control
• confusion
• seizures
• loss of consciousness

Other information

Keep all appointments with your doctor.

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

Brand names

• Abilify®