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, whichis a mental disorder. It is also used to treat the mania phase of bipolardisorder (manic-depressive illness). This medicine should NOTbe 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 decidingto use a medicine, the risks of using the medicine must be weighed againstthe good it will do. This is a decision you and your healthcare professionalwill make. For aripiprazole, the following should be considered:

Allergies?Tell your healthcare professional if you have everhad any unusual or allergic reaction to aripiprazole. Also tell your healthcareprofessional and pharmacist if you are allergic to any other substances, suchas foods, preservatives, or dyes.

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

Breast-feeding?It is not known whether aripiprazole passes intohuman breast milk. This medicine does pass into the milk of rats. Aripiprazoleis not recommended during breast-feeding, because it may cause unwanted effectsin nursing babies.

Children?Studies on this medicine have only been done inadult patients, and there is no specific information comparing the use ofaripiprazole in children with use in other age groups.

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

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

• Alcohol?May increase the side effects of aripiprazole

• Antihypertensive medications with alpha₁-adrenergicreceptor antagonism (Doxazosin [e.g., Cardura], Prazosin [e.g., Minipress],Terazosin [e.g., Hytrin])?These medicines may increase the chance ofhypotension (unusually low blood pressure)

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

• Central nervous system (CNS) stimulation (medicines that wake youup) or
• Central nervous system (CNS) depression (medicines that cause drowsiness)?Usingthese medicines at the same time as aripiprazole should be done with cautionand may increase side effects of aripiprazole

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

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

• Medications with anticholinergic activity (medicines used to dryup a runny nose, some medicines for depression, or some medicines for abdominalor stomach spasms or cramps)?These medicines may cause your body temperatureto rise (heat stroke).

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

• Alcohol or drug abuse or dependence, history of?This medicinemay 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 riskof adverse events

• Blood vessel disease or
• Conduction abnormalities (abnormalities of the heart's electricalimpulses) 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 worseand cause serious side effects

• Drug abuse or dependence, history of?May be more likely todevelop dependence on this medicine

• Exposure to extreme heat or
• Strenuous exercise?Increased risk of heat stroke because aripiprazoleeffects the body's ability to cool itself

• Neuroleptic Malignant Syndrome (NMS), history of?May causecondition to worsen

Proper Use of This Medicine

Dosing?Take this medicine only as directed byyour 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 directionson the label. The following information includes only the average dosesof aripiprazole. If your dose is different, do not changeit 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, withoutregard 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, withoutregard 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 itas soon as possible. However, if it is almost time for your next dose, skipthe missed dose and go back to your regular dosing schedule. Do not doubledoses.

Storage?To store this medicine:

• Keep out of the reach of children.
• Do not store in the bathroom, near the kitchen sink, or in otherdamp places. Heat or moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Ask yourhealth care professional how you should dispose of any medicine you do notuse. 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 checkyou at regular visitsto allow for changes in your dose and help reduceany unwanted effects.

This medicine may add to the effects of alcohol and other central nervoussystem (CNS) depressants (medicines that make you drowsy or less alert). Someexamples 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 whileyou are taking this medicine.

Aripiprazole may cause drowsiness, trouble in thinking, or trouble in controllingmovements. Make sure you know how you react to this medicinebefore 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 (especiallyif you are an older adult taking this medicine for psychosis [mental disturbances]related to dementia), contact your doctor immediately. It could increase yourrisk 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 orhot weather since overheating may result in heat stroke.

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

Side Effects of This Medicine

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

Check with your healthcareprofessional immediately if any of the following side effects occur:

More common

Difficulty speaking; drooling; loss of balance control; muscle trembling,jerking, or stiffness; restlessness; shuffling walk; stiffness of limbs; twisting movements of body; uncontrolledmovements, especially of face, neck, and back

Less common

Blurred vision; dizziness; headache; nervousness; pounding in the ears; slow or fast heartbeat

Rare

Convulsions; difficulty in breathing; fast heartbeat; high fever; high or low blood pressure; increased sweating; lip smacking or puckering; loss of bladder control; muscle spasmor jerking of all extremities; puffing of cheeks; rapid or worm-like movements of tongue; severe muscle stiffness; sudden lossof consciousness; tiredness; uncontrolled chewing movements; uncontrolled movementsof arms and legs; unusually pale skin

Incidence not known

Difficulty swallowing; hives or welts; itching, puffiness or swelling of the eyelids oraround the eyes, face, lips, or tongue; itching skin; large, hive-like swelling on face, eyelids, lips,tongue, throat, hands, legs, feet, sex organs; rednessof skin; shortness of breath; skin rash; tightness in chest; trouble in breathing; unusual tiredness or weakness; wheezing

Symptoms of overdose

Get emergency help immediately if any of the followingsymptoms of overdose occur

Diarrhea; difficulty in speaking; drooling; fast, pounding, or irregularheartbeat or pulse; lack or loss of strength; loss of balance control; loss of consciousness; muscle trembling, jerking, or stiffness; nausea; restlessness; shuffling walk; stiffness of limbs; sleepiness or unusual drowsiness; twistingmovements of body; uncontrolled movements, especiallyof face, neck, and back; vomiting

Other side effects mayoccur that usually do not need medical attention. These side effects may goaway during treatment as your body adjusts to the medicine. However, checkwith your healthcare professional if any of the following side effects continueor are bothersome.

More common

Acid or sour stomach; anxiety; belching; difficulty having a bowelmovement (stool); dry mouth; fear; headache; heartburn; hyperventilation; inabilityto sit still; indigestion; irregular heartbeats; irritability; lack or loss of strength; lightheadedness; nausea; need to keep moving; nervousness; rash; restlessness; shaking; sleepiness or unusual drowsiness; sleeplessness; stomach discomfort, upset, or pain; trouble sleeping; unable to sleep; vomiting; weight gain

Less common

Accidental injury; bloating or swellingof face, arms, hands, lower legs, or feet; blurredvision; body aches or pain; congestion; coughing ; difficulty in moving; dryness or soreness of throat; fever; hoarseness; increased salivation; joint pain; muscle aching or cramping; muscle painsor stiffness; rapid weight gain; runny nose; stuffy nose; sneezing; swollen joints; tender, swollen glands in neck; tingling of handsor feet; tremor; troublein swallowing; unusual weight gain or loss; voice changes

Other side effects not listed above may also occur insome patients. If you notice any other effects, check with your healthcareprofessional.