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Generic Name: Aripiprazole Tablets (ay-ree-PIP-ray-zole)
Brand Name: Abilify

Abilify is an atypical antipsychotic. When used in elderly patients with psychosis related to dementia, atypical antipsychotics have been shown to increase the risk of death. Most deaths were related to heart problems (eg, heart failure) or infections (eg, pneumonia).

Abilify is not approved for the treatment of patients with psychosis related to dementia.

Abilify is used for:

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

Abilify is a psychotropic. The exact way Abilify works is not fully known. It appears to balance certain chemicals in the brain that affect many brain processes.

Do NOT use Abilify if:

  • you are allergic to any ingredient in Abilify

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

Before using Abilify :

Some medical conditions may interact with Abilify . 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 heart problems, a history of stroke, dementia, dehydration, seizures, Alzheimer disease, swallowing problems, diabetes, depression or other mental/mood disorders, or a history of suicidal thoughts or attempts
  • if you have had an allergic reaction to medicines called neuroleptics

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

  • Carbamazepine because the effectiveness of Abilify may be decreased
  • Imidazoles (eg, ketoconazole), quinidine, selective serotonin reuptake inhibitors (SSRIs) (eg, fluoxetine), or voriconazole because the side effects or toxic effects of Abilify may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Abilify 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 Abilify :

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

  • Abilify may be taken with or without food.
  • Take this medicine regularly in order to get the most benefit from it. To help you remember, take it at the same time each day.
  • It may take several weeks for Abilify to work.
  • Continue to take Abilify even if you feel well.
  • If you miss a dose of Abilify , take it as soon as possible. If it is almost time for your next dose, skip the missed dose and 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 Abilify .

Important safety information:

  • Abilify may cause drowsiness, dizziness, lightheadedness, or blurred vision. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Abilify .
  • Avoid drinking alcohol or taking other medications that cause drowsiness (eg, sedatives, tranquilizers) while taking Abilify . Abilify will add to the effects of alcohol and other depressants. Ask your pharmacist if you have questions about which medicines are depressants.
  • Neuroleptic malignant syndrome (NMS) is a potentially deadly syndrome associated with Abilify . Symptoms include increased body heat; muscle rigidness; altered mental abilities, including lack of response to your surroundings; irregular pulse and blood pressure; increased heart rate; sweating; irregular heart rhythm. Contact your doctor at once if any of these symptoms occur.
  • Involuntary and uncontrollable movements may develop in patients taking Abilify . Occurrence is highest among the elderly, especially women. The risk of developing these involuntary movements and the likelihood they will become permanent are increased with long-term use and with high doses. However it is possible to develop these symptoms after short-term treatment at low doses. Contact your health care provider at once if any of the following occur: Involuntary movements of tongue, face, mouth or jaw (eg, protrusion of tongue, puffing of cheeks, puckering of mouth, chewing movements), sometimes accompanied by involuntary movements of the arms and legs.
  • Abilify may reduce sweating. Do not become overheated in hot weather, during exercise, or during other activities because the risk of heatstroke may be increased.
  • Abilify may increase your risk of developing diabetes or increase blood sugar levels. High blood sugar levels can cause serious problems if left untreated. Contact your doctor for more information.
  • Diabetes patients - Abilify may affect your blood sugar. Check blood sugar levels closely and ask your doctor before adjusting the dose of your diabetes medicine.
  • LAB TESTS, including fasting blood sugar levels, may be performed to monitor your progress. Be sure to keep all doctor and lab appointments.
  • Use Abilify with caution in the ELDERLY because they may be more sensitive to its effects.
  • Abilify is not recommended for use in CHILDREN; safety and effectiveness have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using Abilify during pregnancy. It is unknown if Abilify is excreted in breast milk. Do not breast-feed while taking Abilify .

Possible side effects of Abilify :

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:

Blurred vision; change in weight; constipation; coughing; dizziness; drowsiness; headache; increased amount of saliva; indigestion; lightheadedness; nausea; restlessness; runny nose; sore throat; tremor; trouble sleeping; upset stomach; vomiting.

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

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abnormal walking; chest pain; confusion or mental changes (eg, anxiety, agitation); convulsions; decreased amount of urine; difficulty swallowing; drooling; fever; incoordination; increased thirst, urination, or appetite; increased sweating or body temperature; involuntary movements of the tongue, face, mouth, jaw, arms, legs, or back (eg, puffing of cheeks, puckering of mouth, chewing movements); light-headedness or fainting when rising from a seated or lying position; loss of control over urination; muscle pain or tenderness; muscle tremor, jerking, or stiffness; pale skin; seizures; severe restlessness; shortness of breath; slow or fast heartbeat; swelling of the arms or legs; thoughts of hurting yourself; unusual bruising under your skin; unusual tiredness or weakness; vision 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 drowsiness; persistent vomiting.

Proper storage of Abilify :

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

General information:

  • If you have any questions about Abilify , please talk with your doctor, pharmacist, or other health care provider.
  • Abilify 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 Abilify . 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.

Issue Date: November 1, 2006
Database Edition
Copyright © 2006 Wolters Kluwer Health, Inc.

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