DrugindexOnline^{2nd edition}

Generic Name: Aripiprazole Orally Disintegrating Tablets (AR-i-PIP-ra-zole)
Brand Name: Abilify Discmelt

Aripiprazole is an atypical antipsychotic. It may increase the risk of death when used to treat mental problems caused by dementia in elderly patients. Most of the deaths were linked to heart problems or infection. Aripiprazole is not approved to treat mental problems caused by dementia.

Aripiprazole is used for:

Treating schizophrenia and certain symptoms of bipolar disorder. It may also be used for other conditions as determined by your doctor.

Aripiprazole is an atypical antipsychotic. Exactly how Aripiprazole works is not known. It may affect certain chemicals in the brain.

Do NOT use Aripiprazole if:

• you are allergic to any ingredient in Aripiprazole

Contact your doctor or health care provider right away if any of these apply to you.

Before using Aripiprazole :

Some medical conditions may interact with Aripiprazole . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, plan to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have a history of heart problems (eg, heart failure, irregular heartbeat, recent heart attack), blood vessel problems, or stroke
• if you have a history of seizures, dementia, Alzheimer disease, depression or other mental/mood disorders, or suicidal thoughts or attempts
• if you have trouble swallowing or a history of neuroleptic malignant syndrome (NMS)
• if you are dehydrated, are taking medicine for high blood pressure, have low blood volume, or have a history of phenylketonuria
• if you or a family member has a history of diabetes or you are very overweight

Some MEDICINES MAY INTERACT with Aripiprazole . Tell your health care provider if you are taking any other medicines, especially any of the following:

• Anticholinergics (eg, methscopolamine, benztropine) because the risk of overheating may be increased
• Imidazole antifungals (eg, ketoconazole), quinidine, selective serotonin reuptake inhibitors (SSRIs) (eg, fluoxetine), or voriconazole because they may increase the risk of Aripiprazole 's side effects
• Carbamazepine because it may decrease Aripiprazole 's effectiveness

This may not be a complete list of all interactions that may occur. Ask your health care provider if Aripiprazole may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Aripiprazole :

Use Aripiprazole as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Aripiprazole by mouth with or without food.
• Taking Aripiprazole at the same time each day will help you remember to take it.
• Take Aripiprazole on a regular schedule to get the most benefit from it.
• Do not remove the tablet from the blister until you are ready to take a dose. To open the blister, peel back the foil to expose the tablet. Do not push the tablet through the blister. This could damage the tablet.
• Make sure your hands are dry before you handle the tablet. Do not break, crush, or chew the tablet. Place the entire tablet on your tongue and allow it to dissolve.
• It is recommended that Aripiprazole be taken without liquid. However, it may be taken with liquid if needed.
• Continue to take Aripiprazole even if you feel well. Do not miss any doses.
• If you miss a dose of Aripiprazole , take it as soon as possible. If it is almost time for your next dose, skip the missed dose. Go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Aripiprazole .

Important safety information:

• Aripiprazole may cause drowsiness, dizziness, lightheadedness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Aripiprazole with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Aripiprazole ; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
• Aripiprazole may cause dizziness, lightheadedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.
• Several weeks may pass before your symptoms improve. Do NOT take more than the recommended dose, change your dose, or use for longer than prescribed without checking with your doctor.
• Aripiprazole has phenylalanine in it. If you must have a diet that is low in phenylalanine, check with your doctor or pharmacist.
• NMS is a possibly fatal syndrome that can be caused by Aripiprazole . Symptoms may include fever; stiff muscles; confusion; abnormal thinking; fast or irregular heartbeat; and sweating. Contact your doctor at once if you have any of these symptoms.
• Some patients who take Aripiprazole may develop muscle movements that they cannot control. This is more likely to happen in elderly patients, especially women. The chance that this will happen or that it will become permanent is greater in those who take Aripiprazole in higher doses or for a long time. Muscle problems may also occur after short-term treatment with low doses. Tell your doctor at once if you have muscle problems with your arms; legs; or your tongue, face, mouth, or jaw (eg, tongue sticking out, puffing of cheeks, mouth puckering, chewing movements) while taking Aripiprazole .
• Do not become overheated in hot weather or while you are being active; heatstroke may occur.
• Aripiprazole may raise your blood sugar or increase your risk of developing diabetes. High blood sugar may make you feel confused, drowsy, or thirsty. It can also make you flush, breathe faster, or have a fruit-like breath odor. If these symptoms occur, tell your doctor right away.
• Diabetes patients - Aripiprazole may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
• Lab tests, including fasting blood sugar levels, may be performed while you use Aripiprazole . These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Use Aripiprazole with caution in the ELDERLY; they may be more sensitive to its effects, especially uncontrolled muscle movements.
• Aripiprazole should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: It is not known if Aripiprazole can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Aripiprazole while you are pregnant. It is not known if Aripiprazole is found in breast milk. Do not breast-feed while taking Aripiprazole .

Possible side effects of Aripiprazole :

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Abnormal dreams; blurred vision; constipation; dizziness; drowsiness; headache; increased saliva production; lightheadedness; nausea; stomach upset; trouble sleeping; vomiting; weight gain.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abnormal thinking; chest pain; confusion; fast, slow, or irregular heartbeat; fever; increased sweating; increased thirst, urination, or appetite; involuntary movements of the tongue, face, mouth, jaw, arms, legs, or back (eg, puffing of cheeks, puckering of mouth, chewing movements); loss of control over urination; loss of coordination; mental or mood changes (eg, anxiety, depression, hostility); muscle tremor, jerking, or stiffness; one-sided weakness; seizures; severe restlessness; shortness of breath; suicidal thoughts or attempts; swelling of the hands, ankles, or feet; trouble swallowing; trouble walking; unusual bruising; unusual tiredness or weakness; vision or speech changes.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately. Symptoms may include aggression; fast, slow, or irregular heartbeat; loss of consciousness; seizures; severe drowsiness or vomiting; tremor; unusual mental changes.

Proper storage of Aripiprazole :

Store Aripiprazole at room temperature, 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Aripiprazole out of the reach of children and away from pets.

General information:

• If you have any questions about Aripiprazole , please talk with your doctor, pharmacist, or other health care provider.
• Aripiprazole is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Aripiprazole . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.