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Aripiprazole orally disintegrating tablets

Pronunciation

Generic Name: aripiprazole (AR-i-PIP-ra-zole)
Brand Name: Abilify Discmelt

Aripiprazole orally disintegrating tablets is an 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 orally disintegrating tablets is not approved to treat mental problems caused by dementia.

Antidepressants may increase the risk of suicidal thoughts or actions in children, teenagers, and young adults. However, depression and certain other mental problems may also increase the risk of suicide. Talk with the patient's doctor to be sure that the benefits of using aripiprazole orally disintegrating tablets outweigh the risks.

Families and caregivers must closely watch patients who take aripiprazole orally disintegrating tablets. It is important to keep in close contact with the patient's doctor. Tell the doctor right away if the patient has symptoms like worsened depression, suicidal thoughts, or changes in behavior. Discuss any questions with the patient's doctor.

Aripiprazole orally disintegrating tablets is not approved for use in all children. If aripiprazole orally disintegrating tablets is prescribed for your child, talk with the doctor to be sure that aripiprazole orally disintegrating tablets is right for your child.


Aripiprazole orally disintegrating tablets is used for:

Treating schizophrenia, bipolar disorder, and irritability associated with autistic disorder. It is also used along with other medicines to treat depression. It may also be used for other conditions as determined by your doctor.

Aripiprazole orally disintegrating tablets is an atypical antipsychotic. Exactly how it works is not known. It affects certain substances in the brain.

Do NOT use aripiprazole orally disintegrating tablets if:

  • you are allergic to any ingredient in aripiprazole orally disintegrating tablets

Contact your doctor or health care provider right away if this applies to you.

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Before using aripiprazole orally disintegrating tablets:

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

  • if you are pregnant, planning 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, heart attack), low blood pressure, blood vessel problems, or stroke
  • if you have a history of low white blood cell levels, including low white blood cell levels caused by any medicine
  • if you have a history of seizures, dementia, Alzheimer disease, depression or other mental or 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 orally disintegrating tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Anticholinergics (eg, benztropine, methscopolamine) because the risk of overheating may be increased
  • Benzodiazepines (eg, lorazepam), clarithromycin, imidazole antifungals (eg, ketoconazole), quinidine, selective serotonin reuptake inhibitors (SSRIs) (eg, fluoxetine), or voriconazole because they may increase the risk of aripiprazole orally disintegrating tablets's side effects
  • Carbamazepine, hydantoins (eg, phenytoin), or rifampin because they may decrease aripiprazole orally disintegrating tablets's effectiveness
  • Alpha-blockers (eg, terazosin) because the risk of their side effects may be increased by aripiprazole orally disintegrating tablets

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

Use aripiprazole orally disintegrating tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Aripiprazole orally disintegrating tablets comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get aripiprazole orally disintegrating tablets refilled.
  • Take aripiprazole orally disintegrating tablets by mouth with or without food.
  • Taking aripiprazole orally disintegrating tablets at the same time each day will help you remember to take it.
  • Take aripiprazole orally disintegrating tablets 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 orally disintegrating tablets be taken without liquid. However, it may be taken with liquid if needed.
  • Continue to take aripiprazole orally disintegrating tablets even if you feel well. Do not miss any doses.
  • If you miss a dose of aripiprazole orally disintegrating tablets, 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 aripiprazole orally disintegrating tablets.

Important safety information:

  • Aripiprazole orally disintegrating tablets may cause drowsiness, dizziness, or lightheadedness. These effects may be worse if you take it with alcohol or certain medicines. Use aripiprazole orally disintegrating tablets with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Do not drink alcohol while you are using aripiprazole orally disintegrating tablets.
  • Check with your doctor before you use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using aripiprazole orally disintegrating tablets; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
  • Aripiprazole orally disintegrating tablets 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.
  • Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.
  • Children, teenagers, and young adults who take aripiprazole orally disintegrating tablets may be at increased risk for suicidal thoughts or actions. Watch all patients who take aripiprazole orally disintegrating tablets closely. Contact the doctor at once if new, worsened, or sudden symptoms, such as depressed mood; anxious, restless, or irritable behavior; panic attacks; or any unusual change in mood or behavior, occur. Contact the doctor right away if any signs of suicidal thoughts or actions occur.
  • Neuroleptic malignant syndrome (NMS) is a possibly fatal syndrome that can be caused by aripiprazole orally disintegrating tablets. 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 orally disintegrating tablets 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 orally disintegrating tablets 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 orally disintegrating tablets.
  • Do not become overheated or dehydrated in hot weather or while you are being active; heatstroke may occur.
  • Aripiprazole orally disintegrating tablets may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.
  • Aripiprazole orally disintegrating tablets 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 orally disintegrating tablets may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
  • Aripiprazole orally disintegrating tablets may cause weight gain in some patients. You may need regular weight checks while taking aripiprazole orally disintegrating tablets.
  • This product contains phenylalanine. If you must have a diet that is low in phenylalanine, ask your pharmacist if it is in your product.
  • Lab tests, including fasting blood sugar levels and complete blood cell counts, may be performed while you use aripiprazole orally disintegrating tablets. 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 orally disintegrating tablets with caution in the ELDERLY; they may be more sensitive to its effects, especially uncontrolled muscle movements or seizures.
  • Aripiprazole orally disintegrating tablets should be used with extreme caution in CHILDREN younger than 6 years old; safety and effectiveness in these children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: It is not known if aripiprazole orally disintegrating tablets 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 orally disintegrating tablets while you are pregnant. Using aripiprazole orally disintegrating tablets during the third trimester may result in uncontrolled muscle movements or withdrawal symptoms in the newborn. Discuss any questions or concerns with your doctor. It is not known if aripiprazole orally disintegrating tablets is found in breast milk. Do not breast-feed while taking aripiprazole orally disintegrating tablets.

Possible side effects of aripiprazole orally disintegrating tablets:

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 appetite (in children); increased saliva production; lightheadedness; nausea; sore throat (in children); stomach upset; tiredness; 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; fainting; fast, slow, or irregular heartbeat; fever, chills, or sore throat; increased sweating; involuntary movements of the tongue, face, mouth, jaw, arms, legs, or back (eg, chewing movements, puckering of mouth, puffing of cheeks); loss of control over urination; loss of coordination; muscle tremor, jerking, or stiffness; new or worsening mental or mood problems (eg, anxiety, depression, agitation, panic attacks, aggressiveness, impulsiveness, irritability, hostility, exaggerated feeling of well-being, inability to sit still); one-sided weakness; seizures; severe or persistent restlessness; shortness of breath; suicidal thoughts or attempts; swelling of the hands, ankles, or feet; symptoms of high blood sugar (eg, increased thirst, urination, or appetite; unusual weakness); 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 about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include aggression; confusion; fast, slow, or irregular heartbeat; loss of consciousness; seizures; severe drowsiness, dizziness, or vomiting; tremor; trouble breathing; unusual mental changes.

Proper storage of aripiprazole orally disintegrating tablets:

Store aripiprazole orally disintegrating tablets at 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 orally disintegrating tablets out of the reach of children and away from pets.

General information:

  • If you have any questions about aripiprazole orally disintegrating tablets, please talk with your doctor, pharmacist, or other health care provider.
  • Aripiprazole orally disintegrating tablets 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.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take aripiprazole orally disintegrating tablets or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about aripiprazole orally disintegrating tablets. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to aripiprazole orally disintegrating tablets. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using aripiprazole orally disintegrating tablets.

Issue Date: July 2, 2014
Database Edition 14.3.1.001
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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