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|Abilify

ARIPIPRAZOLE (Systemic)†

Some commonly used brand names are:

In the U.S.—

• Abilify

† Not commercially available in Canada.

Category

• Antipsychotic

Description

Aripiprazole (ay-ri-PIP-ray-zole) is used to treat schizophrenia, which is a mental disorder. It is also used to treat the mania phase of bipolar disorder (manic-depressive illness). This medicine should NOT be used to treat behavioral problems in older adult patients who have dementia.

This medicine is available only with your healthcare professional"s prescription, in the following dosage forms:

• Oral
• Oral solution (U.S.)
• Tablets (U.S.)

Before Using This Medicine

In deciding to use a medicine, the risks of using the medicine must be weighed against the good it will do. This is a decision you and your healthcare professional will make. For aripiprazole, the following should be considered:

Allergies—Tell your healthcare professional if you have ever had any unusual or allergic reaction to aripiprazole. Also tell your healthcare professional and pharmacist if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Studies with aripiprazole have not been done in pregnant women. Some unwanted effects have been reported in animal studies, but the risk to human babies is not clear. Before taking this medicine, make sure your healthcare professional knows if you are pregnant or if you may become pregnant.

Breast-feeding—It is not known whether aripiprazole passes into human breast milk. This medicine does pass into the milk of rats. Aripiprazole is not recommended during breast-feeding, because it may cause unwanted effects in nursing babies.

Children—Studies on this medicine have only been done in adult patients, and there is no specific information comparing the use of aripiprazole in children with use in other age groups.

Older adults—Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing the use of aripiprazole in the elderly with use in other age groups. Older patients who take this medicine for psychosis (mental disturbances) related to their dementia may be at risk for serious side effects and their doctor will need to use extra caution. This medicine should not be used for behavioral problems in older adults with dementia.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your healthcare professional may want to change the dose, or other precautions may be necessary. When you are taking aripiprazole, it is especially important that your healthcare professional and pharmacist know if you are using any of the following:

• Alcohol—May increase the side effects of aripiprazole

• Antihypertensive medications with alpha₁ -adrenergic receptor antagonism (Doxazosin [e.g., Cardura], Prazosin [e.g., Minipress], Terazosin [e.g., Hytrin])—These medicines may increase the chance of hypotension (unusually low blood pressure)

• Carbamazepine (e.g., Tegretol) or
• Other agents that induce CYP3A4—These medicines may cause there to be less aripiprazole in your body

• Central nervous system (CNS) stimulation (medicines that wake you up) or
• Central nervous system (CNS) depression (medicines that cause drowsiness)—Using these medicines at the same time as aripiprazole should be done with caution and may increase side effects of aripiprazole

• CYP3A4 inhibitors such as
• Itraconazole (e.g., Sporanox)
• Ketoconazole (e.g., Nizoral)—These medicines may cause increased blood levels of aripiprazole

• CYP2D6 inhibitors including
• Fluoxetine (e.g., Prozac) or
• Paroxetine (e.g., Paxil) or
• Quinidine (e.g., Quinaglute)—These medicines may cause increased blood levels of aripiprazole

• Medications with anticholinergic activity (medicines used to dry up a runny nose, some medicines for depression, or some medicines for abdominal or stomach spasms or cramps)—These medicines may cause your body temperature to rise (heat stroke).

Other medical problems—The presence of other medical problems may affect the use of aripiprazole. Make sure you tell your healthcare professional if you have any other medical problems, especially:

• Alcohol or drug abuse or dependence, history of—This medicine may make these conditions worse

• Alzheimer"s disease—Risk of seizures, aspiration pneumonia, accidental injury, difficulty swallowing, or excessive drowsiness may be increased

• Conditions that lower the seizure threshold or
• Seizures, history of—Seizures may increase

• Aspiration pneumonia, risk or history of—May increase risk of adverse events

• Blood vessel disease or
• Conduction abnormalities (abnormalities of the heart"s electrical impulses) or
• Dehydration or
• Heart disease or
• Heart failure or
• Hypovolemia (decrease in the volume of blood) or
• Ischemic heart disease, history of or
• Myocardial infarction (heart attack), history of—Risk of hypotension (abnormally low blood pressure) is increased

• Diabetes or family history of diabetes—May make condition worse and cause serious side effects

• Drug abuse or dependence, history of—May be more likely to develop dependence on this medicine

• Exposure to extreme heat or
• Strenuous exercise—Increased risk of heat stroke because aripiprazole effects the body"s ability to cool itself

• Neuroleptic Malignant Syndrome (NMS), history of—May cause condition to worsen

Proper Use of This Medicine

Dosing—Take this medicine only as directed by your doctor in order to improve your condition as much as possible. Do not take more of it and do not take it more often than your doctor ordered.

Aripiprazole may be taken with or without food, on a full or an empty stomach. If your doctor tells you to take it a certain way, follow your doctor"s instructions.

The dose of aripiprazole will be different for different patients. Follow your healthcare professional"s orders or the directions on the label . The following information includes only the average doses of aripiprazole. If your dose is different, do not change it unless your healthcare professional tells you to do so.

• For oral dosage form (solution):
  • For schizophrenia:
    • Adults—Oral, 10 to 15 milligrams (mg) a day, once a day, without regard to food. Dose increases should not be made before 2 weeks.
  • For bipolar mania:
    • Adults—Oral, 25 mg a day, once a day, without regard to food.
• For oral dosage form (tablets):
  • For schizophrenia:
    • Adults—Oral, 10 to 15 milligrams (mg) a day, once a day, without regard to food. Dose increases should not be made before 2 weeks.
  • For bipolar mania:
    • Adults—Oral, 30 mg a day, once a day, without regard to food.

Missed dose—If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—To store this medicine:

• Keep out of the reach of children.
• Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Ask your health care professional how you should dispose of any medicine you do not use. Be sure that any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

It is very important that your healthcare professional check you at regular visits to allow for changes in your dose and help reduce any unwanted effects.

This medicine may add to the effects of alcohol and other central nervous system (CNS) depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; barbiturates; medicine for seizures; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any CNS depressants while you are taking this medicine.

Aripiprazole may cause drowsiness, trouble in thinking, or trouble in controlling movements. Make sure you know how you react to this medicine before you drive, use machines, or do other jobs that require you to be alert, well-coordinated, or able to think well.

If you experience difficulty swallowing or extreme sleepiness (especially if you are an older adult taking this medicine for psychosis [mental disturbances] related to dementia), contact your doctor immediately. It could increase your risk for serious unwanted effects.

This medicine may make it more difficult for your body to cool itself down. Use care not to become overheated during exercise or hot weather since overheating may result in heat stroke.

For diabetic patients: This medicine may affect blood sugar levels. Also, the oral solution contains sugar.

Side Effects of This Medicine

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Developed: 06/02/2003
Revised: 05/04/2005

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