Abilify Psychotropic Drug Information

Elderly patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death compared to placebo.

Analyses of seventeen placebo-controlled trials (modal duration of 10 weeks) in these patients revealed a risk of death in the drug-treated patients of between 1.6 to 1.7 times that seen in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (eg, heart failure, sudden death) or infectious (eg, pneumonia) in nature. ABILIFY is not approved for the treatment of patients with dementia-related psychosis.

What is the most important information I should know about Abilify?

• Call your doctor immediately if you experience uncontrollable movements of the mouth, tongue, cheeks, jaw, arms, or legs; fever; muscle rigidity; sweating; irregular pulse; or fast or irregular heartbeats.
• Use caution when driving, operating machinery, or performing other hazardous activities. Abilify may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities.
• Dizziness may be more likely to occur when you rise from a sitting or lying position. Rise slowly to prevent dizziness and a possible fall.
• Avoid alcohol while taking Abilify. Alcohol may increase drowsiness and dizziness while taking Abilify.
• Avoid becoming overheated while taking Abilify. Abilify may affect body temperature regulation. Use caution in hot weather and during exercise. Drink plenty of fluids.

What is Abilify?

• Abilify is an antipsychotic medication. It works by changing the actions of chemicals in the brain.
• Abilify is used to treat the symptoms of schizophrenia .
  • Abilify may also be used for purposes other than those listed in this medication guide.

What should I discuss with my healthcare provider before taking Abilify?

• Before taking Abilify, tell your doctor if you have
  • liver disease;
  • heart disease or other heart problems such as high blood pressure , angina, previous heart attack, or irregular heartbeats; or
  • seizures or epilepsy.
• You may not be able to take Abilify, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.
• Abilify is in the FDA pregnancy category C. This means that it is not known whether Abilify will be harmful to an unborn baby. Do not take Abilify without first talking to your doctor if you are pregnant or could become pregnant during treatment.
• It is not known whether Abilify passes into breast milk. Do not take Abilify without first talking to your doctor if you are breast-feeding a baby.

How should I take Abilify?

• Take Abilify exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you
• Take each dose with a full glass of water.
• Abilify can be taken with or without food.
• Abilify is usually taken once a day. Follow your doctor's instructions.
• It is important to take Abilify regularly to get the most benefit.
• Do not stop taking Abilify without first talking to your doctor, even if you are feeling well. Even after your symptoms improve, you may require continuous treatment for quite some time.
• Store Abilify at room temperature away from moisture and heat.

What happens if I miss a dose?

• Take the missed dose as soon as you remember, during the same day. If you do not remember until the next day, skip the missed dose and take only the regular daily dose. Do not take a double dose of the medication.

What happens if I overdose?

• Seek emergency medical attention.
• Symptoms of an Abilify overdose include drowsiness and vomiting.

What should I avoid while taking Abilify?

• Use caution when driving, operating machinery, or performing other hazardous activities. Abilify may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities.
• Dizziness may be more likely to occur when you rise from a sitting or lying position. Rise slowly to prevent dizziness and a possible fall.
• Avoid alcohol while taking Abilify. Alcohol may increase drowsiness and dizziness while taking Abilify.
• Avoid becoming overheated while taking Abilify. Abilify may affect body temperature regulation. Use caution in hot weather and during exercise. Drink plenty of fluids.

What are the possible side effects of Abilify?

• Call your doctor immediately if you experience uncontrollable movements of the mouth, tongue, cheeks, jaw, arms, or legs; muscle spasms of the face or neck; severe restlessness or tremor; fever; muscle rigidity; sweating; irregular pulse; or fast or irregular heartbeats.
• If you experience any of the following serious side effects, stop taking Abilify and seek emergency medical attention or contact your doctor immediately:
  • an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives); or
  • difficulty swallowing; or
  • seizures.
• Other, less serious side effects may be more likely to occur. Continue to take Abilify and talk to your doctor if you experience
  • headache;
  • blurred vision;
  • tremor or weakness;
  • dizziness or drowsiness;
  • nausea, vomiting, or constipation;
  • difficulty sleeping; or
  • weight gain.
• Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

What other drugs will affect Abilify?

Many drugs may affect the way that Abilify is metabolized ("broken down") in the body, leading to higher or lower than expected levels of the medication in the blood. Talk to your doctor before taking any other medicines during treatment with Abilify.

Abilify may increase the effects of medicines that are used to control high blood pressure . This could lead to very low blood pressure , dizziness, fainting, and other symptoms. Tell your doctor if you are taking a medication to lower blood pressure or to treat another heart condition.

Abilify may increase the effects of drugs that cause drowsiness, including antidepressants, alcohol, antihistamines, sedatives (medicines that treat insomnia), pain relievers, anxiety medicines, muscle relaxants, and any other drug that makes you feel sleepy or relaxed. Tell your doctor about all medicines that you are taking and do not take any medicine without first talking to your doctor.

Drugs other than those listed here may also interact with Abilify. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including herbal products.

WARNING: Increased Mortality in Elderly Patients with Dementia-Related Psychosis