In the U.S.—

• Antipsychotic

Aripiprazole ( ay-ri-PIP-ray-zole) is used to treat schizophrenia, which is a mental disorder.

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

Oral
• Tablets (U.S.)

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 with swallowing problems may be at risk for side effects.

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).

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

• Alzheimer's dementia or
• 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 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—The risk of hypotension (abnormally low blood pressure) is increased

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

Dosing—

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 (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

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.

If you will be taking this medicine for a long time, it is very important that your healthcare professional check you at regular visits. It is important to re-evaluate for long term usefulness of the drug.

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.

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

• Rare
  • Convulsions;  difficulty in breathing ;  fast heartbeat;  high fever ;  high or low blood pressure;  increased sweating;  loss of bladder control;  muscle spasm or jerking of all extremities;  severe muscle stiffness;  sudden loss of consciousness ;  tiredness;  unusually pale skin 
  
  

• Incidence Unknown
  • Lip smacking or puckering;  puffing of cheeks;  rapid or worm-like movements of tongue;  uncontrolled chewing movements;  uncontrolled movements of arms and legs 
  
  

• Symptoms of Overdose

  Get emergency help immediately if any of the following symptoms of overdose occur

  • Sleepiness or unusual drowsiness;  vomiting  
  
  

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your healthcare professional if any of the following side effects continue or are bothersome.

• Difficulty having a bowel movement (stool);  fear;  headache;  inability to sit still;  lack or loss of strength;  lightheadedness;  nausea;  need to keep moving;  nervousness;  rash;  restlessness;  sleepiness or unusual drowsiness;  sleeplessness;  trouble sleeping;  unable to sleep;  vomiting;  weight gain 

• Less common
  • Blurred vision;  coughing ;  fever;  runny nose;  stuffy nose;  sneezing;  tremor 
  
  

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