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Aripiprazole Extended-Release Injection

Pronunciation

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

Aripiprazole Extended-Release Injection 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 Extended-Release Injection is not approved to treat mental problems caused by dementia.


Aripiprazole Extended-Release Injection is used for:

Treating schizophrenia. It may also be used for other conditions as determined by your doctor.

Aripiprazole Extended-Release Injection is an atypical antipsychotic. Exactly how it works is not known. It affects certain substances in the brain.

Do NOT use Aripiprazole Extended-Release Injection if:

  • you are allergic to any ingredient in Aripiprazole Extended-Release Injection

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

Before using Aripiprazole Extended-Release Injection:

Some medical conditions may interact with Aripiprazole Extended-Release Injection. 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), high or low blood pressure, high blood cholesterol or triglyceride levels, blood vessel problems, stroke, or low white blood cell levels
  • if you have a history of seizures, neuroleptic malignant syndrome (NMS), dementia, Alzheimer disease, depression or other mental or mood disorders, or suicidal thoughts or attempts
  • if you or a family member has a history of diabetes or high blood sugar, or you are very overweight
  • if you are dehydrated or have low blood volume, drink alcohol, or smoke, or you will be exposed to high temperatures
  • if you have never taken aripiprazole by mouth

Some MEDICINES MAY INTERACT with Aripiprazole Extended-Release Injection. 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, fluoxetine, itraconazole, ketoconazole, paroxetine, or quinidine because they may increase the risk of Aripiprazole Extended-Release Injection's side effects
  • Carbamazepine or rifampin because they may decrease Aripiprazole Extended-Release Injection's effectiveness
  • Alpha-blockers (eg, terazosin) or medicine for high blood pressure because the risk of their side effects may be increased by Aripiprazole Extended-Release Injection

This may not be a complete list of all interactions that may occur. Ask your health care provider if Aripiprazole Extended-Release Injection 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 Extended-Release Injection:

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

  • Aripiprazole Extended-Release Injection comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Aripiprazole Extended-Release Injection refilled.
  • Aripiprazole Extended-Release Injection is given as an injection at your doctor's office, hospital, or clinic. Contact your health care provider if you have any questions.
  • If you miss a dose of Aripiprazole Extended-Release Injection, call your doctor to find out what to do.

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

Important safety information:

  • Aripiprazole Extended-Release Injection may cause drowsiness, dizziness, or light-headedness. These effects may be worse if you take it with alcohol or certain medicines. Use Aripiprazole Extended-Release Injection 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 Extended-Release Injection.
  • Check with your doctor before you use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Aripiprazole Extended-Release Injection; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
  • Aripiprazole Extended-Release Injection may cause dizziness, light-headedness, 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 more often than prescribed without checking with your doctor.
  • NMS is a possibly fatal syndrome that can be caused by Aripiprazole Extended-Release Injection. 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 Extended-Release Injection 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 Extended-Release Injection 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 Extended-Release Injection.
  • Older adults with dementia taking medicines like this one have had a higher number of strokes. Sometimes these strokes have been deadly. Aripiprazole Extended-Release Injection is not approved to treat mental problems caused by dementia. Talk with your doctor.
  • Do not become overheated or dehydrated in hot weather or while you are being active; heatstroke may occur.
  • Aripiprazole Extended-Release Injection 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 such as fever, sore throat, rash, or chills.
  • Aripiprazole Extended-Release Injection 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 Extended-Release Injection may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
  • Aripiprazole Extended-Release Injection may cause weight gain in some patients. You may need regular weight checks while taking Aripiprazole Extended-Release Injection.
  • Lab tests may be performed while you use Aripiprazole Extended-Release Injection. 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 Extended-Release Injection with caution in the ELDERLY; they may be more sensitive to its effects, especially uncontrolled muscle movements or seizures.
  • PREGNANCY and BREAST-FEEDING: It is not known if Aripiprazole Extended-Release Injection 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 Extended-Release Injection while you are pregnant. Using Aripiprazole Extended-Release Injection during the third trimester may result in uncontrolled muscle movements or withdrawal symptoms in the newborn. Discuss any questions or concerns with your doctor. Aripiprazole Extended-Release Injection is found in breast milk. Do not breast-feed while taking Aripiprazole Extended-Release Injection.

Possible side effects of Aripiprazole Extended-Release Injection:

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:

Constipation; dizziness; drowsiness; headache; light-headedness; nausea; pain, redness, or swelling at the injection site; restlessness; 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; unusual hoarseness); 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 or bleeding; 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. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

See also: Side effects (in more detail)

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), or emergency room immediately.

Proper storage of Aripiprazole Extended-Release Injection:

Aripiprazole Extended-Release Injection is handled and stored by a health care provider. You will not store it at home. Keep all medicines out of the reach of children and away from pets.

General information:

  • If you have any questions about Aripiprazole Extended-Release Injection, please talk with your doctor, pharmacist, or other health care provider.
  • Aripiprazole Extended-Release Injection 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 Extended-Release Injection 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 Extended-Release Injection. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Aripiprazole Extended-Release Injection. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your health care provider for complete information about the risks and benefits of using Aripiprazole Extended-Release Injection.

Review Date: August 8, 2016

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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