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Information for Patients: Physicians are advised to discuss the following issues with patients for whom they prescribe Aripiprazole: Increased Mortality in Elderly Patients with Dementia-Related Psychosis: Patients and caregivers should be advised that elderly patients with dementia-related psychoses treated with antipsychotic drugs are at increased risk of death. Aripiprazole is not approved for elderly patients with dementia-related psychosis (see Use in Elderly Patients with Dementia-Related Psychosis under Precautions).
Clinical Worsening of Depression and Suicide Risk: Patients, their families, and their caregivers should be encouraged to be alert to the emergence of anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, mania, other unusual changes in behavior, worsening of depression, and suicidal ideation, especially early during antidepressant treatment and when the dose is adjusted up or down. Families and caregivers of patients should be advised to look for the emergence of such symptoms on a day-to-day basis, since changes may be abrupt. Such symptoms should be reported to the patient's prescriber or health professional, especially if they are severe, abrupt in onset, or were not part of the patient's presenting symptoms. Symptoms such as these may be associated with an increased risk for suicidal thinking and behavior and indicate a need for very close monitoring and possibly changes in the medication (see Clinical Worsening of Depression and Suicide Risk under Precautions).
Prescribers or other health professionals should inform patients, their families, and their caregivers about the benefits and risks associated with treatment with Aripiprazole and should counsel them in its appropriate use. A patient "Medication Guide about Antidepressant Medicines, Depression and other Serious Mental Illness, and Suicidal Thoughts or Actions" is available for Aripiprazole. The prescriber or health professional should instruct patients, their families, and their caregivers to read the Medication Guide and should assist them in understanding its contents. Patients should be given the opportunity to discuss the contents of the Medication Guide and to obtain answers to any questions they may have. It should be noted that Aripiprazole is not approved as a single agent for treatment of depression and has not been evaluated in pediatric major depressive disorder.
Interference with Cognitive and Motor Performance: Because aripiprazole may have the potential to impair judgment, thinking, or motor skills, patients should be cautioned about operating hazardous machinery, including automobiles, until they are reasonably certain that aripiprazole therapy does not affect them adversely (see Potential for Cognitive and Motor Impairment under Precautions).
Pregnancy: Patients should be advised to notify their physician if they become pregnant or intend to become pregnant during therapy with Aripiprazole (see Use in Specific Populations under Precautions and Use in Pregnancy & Lactation).
Nursing: Patients should be advised not to breast-feed an infant if they are taking Aripiprazole (see Use in Specific Populations: Use in Pregnancy: Non-teratogenic Effects: Nursing Mothers under Precautions and Use in Pregnancy & Lactation).
Concomitant Medication: Patients should be advised to inform their physicians if they are taking, or plan to take, any prescription or over-the-counter drugs, since there is a potential for interactions (see Interactions).
Alcohol: Patients should be advised to avoid alcohol while taking Aripiprazole (see Potential for Aripiprazole to Affect Other Drugs: Alcohol under Interactions).
Heat Exposure and Dehydration: Patients should be advised regarding appropriate care in avoiding overheating and dehydration (see Body Temperature Regulation under Precautions).
Medication Guide: Read this before you start taking Aripiprazole and each time you get a refill. There may be new information. This does not take the place of talking to your healthcare provider about your medical condition or treatment.
What is the most important information I should know about Aripiprazole? (For other side effects, also see "What are the possible side effects of Aripiprazole?"). Serious side effects may happen when you take Aripiprazole, including: Increased risk of death in elderly patients with dementia-related psychosis: Medicines like Aripiprazole can raise the risk of death in elderly people who have lost touch with reality (psychosis) due to confusion and memory loss (dementia). Aripiprazole is not approved for the treatment of patients with dementia-related psychosis.
Risk of suicidal thoughts or actions: Antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or actions: 1. Antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, and young adults within the first few months of treatment.
2. Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions. Some people may have a particularly high risk of having suicidal thoughts or actions. These include people who have (or have a family history of) bipolar illness (also called manic-depressive illness) or suicidal thoughts or actions.
3. How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member?
Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. This is very important when an antidepressant medicine is started or when the dose is changed.
Call the healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings.
Keep all follow-up visits with the healthcare provider as scheduled. Call the healthcare provider between visits as needed, especially if you have concerns about symptoms.
Call a healthcare provider right away if you or your family member has any of the following symptoms, especially if they are new, worse, or worry you: thoughts about suicide or dying; attempts to commit suicide; new or worse depression; new or worse anxiety; feeling very agitated or restless; panic attacks; trouble sleeping (insomnia); new or worse irritability; acting aggressive, being angry, or violent; acting on dangerous impulses; an extreme increase in activity and talking (mania); other unusual changes in behavior or mood.
What else do I need to know about antidepressant medicines? Never stop an antidepressant medicine without first talking to a healthcare provider. Stopping an antidepressant medicine suddenly can cause other symptoms.
Antidepressants are medicines used to treat depression and other illnesses. It is important to discuss all the risks of treating depression and also the risks of not treating it. Patients and their families or other caregivers should discuss all treatment choices with the healthcare provider, not just the use of antidepressants.
Antidepressant medicines have other side effects. Talk to the healthcare provider about the side effects of the medicine prescribed for you or your family member.
Antidepressant medicines can interact with other medicines. Know all of the medicines that you or your family member takes. Keep a list of all medicines to show the healthcare provider. Do not start new medicines without first checking with your healthcare provider.
Not all antidepressant medicines prescribed for children are FDA approved for use in children. Talk to your child's healthcare provider for more information.
What is Aripiprazole? Aripiprazole is a prescription medicine used to treat: schizophrenia in people age 13 years and older.
Bipolar I disorder in people age 10 years and older, including: manic or mixed episodes that happen with bipolar I disorder; manic or mixed episodes that happen with bipolar I disorder, when used with the medicine lithium or valproate; long-term treatment of bipolar I disorder.
Major depressive disorder in adults, as an add-on treatment to an antidepressant medicine when you do not get better with an antidepressant alone.
Irritability associated with autistic disorder in children and adolescents ages 6 to 17 years old.
Tourette's disorder in pediatric patients ages 6 to 18 years old.
Agitation associated with schizophrenia or bipolar disorder.
The symptoms of schizophrenia include: losing touch with reality (psychosis); seeing things or hearing voices that are not there (hallucinations); believing things that are not true (delusions); extreme mood swings that include feeling depressed and high or irritable mood; being suspicious (paranoia); disorganized speech and thinking; bizarre behavior.
The symptoms of bipolar I disorder include: extreme mood swings that include feeling depressed and high or irritable mood; talking too fast and too much; impulsive behavior; having more energy and restlessness than usual; needing less sleep than usual.
The symptoms of major depressive disorder (MDD) include: feeling of sadness and emptiness; loss of interest in activities that you once enjoyed and loss of energy; problems focusing and making decisions; feeling of worthlessness or guilt; changes in sleep or eating patterns; thoughts of death or suicide.
The symptoms of irritability associated with autistic disorder include: aggressive behavior towards others; intentionally trying to harm oneself; temper tantrums; quickly changing moods.
The symptoms of Tourette's disorder include: motor tics: eye blinking, head jerking, shoulder shrugging and facial grimacing; vocal tics: throat clearing, sniffing and tongue clicking.
What should I tell my healthcare provider before taking Aripiprazole? Before taking Aripiprazole, tell your healthcare provider if you have or had: diabetes or high blood sugar in you or your family; your healthcare provider should check your blood sugar before you start Aripiprazole and also during therapy; seizures (convulsions); low or high blood pressure; heart problems or stroke; pregnancy or plans to become pregnant. It is not known if Aripiprazole will harm your unborn baby, breast-feeding or plans to breast-feed. It is not known if Aripiprazole will pass into your breast milk. You and your healthcare provider should decide if you will take Aripiprazole or breast-feed. You should not do both; low white blood cell count; phenylketonuria, any other medical conditions.
Tell your healthcare provider about all the medicines that you take or recently have taken, including prescription medicines, non-prescription medicines, herbal supplements, and vitamins.
Aripiprazole and other medicines may affect each other causing possible serious side effects. Aripiprazole may affect the way other medicines work, and other medicines may affect how Aripiprazole works.
Your healthcare provider can tell you if it is safe to take Aripiprazole with your other medicines. Do not start or stop any medicines while taking Aripiprazole without talking to your healthcare provider first. Know the medicines you take. Keep a list of your medicines to show your healthcare provider and pharmacist when you get a new medicine.
How should I take Aripiprazole? Take Aripiprazole exactly as your healthcare provider tells you to take it. Do not change the dose or stop taking Aripiprazole yourself.
Aripiprazole can be taken with or without food.
Aripiprazole tablets should be swallowed whole.
If you miss a dose of Aripiprazole, take the missed dose as soon as you remember. If it is almost time for the next dose,just skip the missed dose and take your next dose at the regular time. Do not take two doses of Aripiprazole at the same time.
If you take too much Aripiprazole, call your healthcare provider or poison control center right away, or go to the nearest hospital emergency room.
What should I avoid while taking Aripiprazole? Do not drive, operate heavy machinery, or do other dangerous activities until you know how Aripiprazole affects you. Aripiprazole may make you drowsy.
Do not drink alcohol while taking Aripiprazole.
Avoid getting over-heated or dehydrated. Do not over-exercise. In hot weather, stay inside in a cool place if possible. Stay out of the sun. Do not wear too much or heavy clothing. Drink plenty of water.
What are the possible side effects of Aripiprazole? Serious side effects have been reported with Aripiprazole including: Also see "What is the most important information I should know about Aripiprazole?" at the beginning of this Medication Guide.
Neuroleptic malignant syndrome (NMS): Tell your healthcare provider right away if you have some or all of the following symptoms: high fever, stiff muscles, confusion, sweating, changes in pulse, heart rate, and blood pressure. These may be symptoms of a rare and serious condition that can lead to death. Call your healthcare provider right away if you have any of these symptoms.
High blood sugar (hyperglycemia): Increases in blood sugar can happen in some people who take Aripiprazole. Extremely high blood sugar can lead to coma or death. If you have diabetes or risk factors for diabetes (such as being overweight or a family history of diabetes), your healthcare provider should check your blood sugar before you start Aripiprazole and during therapy.
Call your healthcare provider if you have any of these symptoms of high blood sugar while taking Aripiprazole: feel very thirsty; need to urinate more than usual; feel very hungry; feel weak or tired; feel sick to your stomach; feel confused, or your breath smells fruity.
Difficulty swallowing: may lead to aspiration and choking.
Tardive dyskinesia: Call your healthcare provider about any movements you cannot control in your face, tongue, or other body parts. These may be signs of a serious condition. Tardive dyskinesia may not go away, even if you stop taking Aripiprazole. Tardive dyskinesia may also start after you stop taking Aripiprazole.
Orthostatic hypotension (decreased blood pressure): lightheadedness or fainting when rising too quickly from a sitting or lying position.
Low white blood cell count.
Seizures (convulsions).
Common side effects with Aripiprazole in adults include: nausea; headache; vomiting; constipation; dizziness; inner sense of restlessness/need to move (akathisia); anxiety; insomnia; restlessness.
Common side effects with Aripiprazole in children include: feeling sleepy; headache; insomnia; vomiting; fatigue; increased appetite; insomnia; nausea; stuffy nose; weight gain; uncontrolled movement such as restlessness, tremor, muscle stiffness.
These are not all the possible side effects of Aripiprazole. For more information, ask your healthcare provider or pharmacist.
Call your doctor for medical advice about side effects.
How should I store Aripiprazole? Store Aripiprazole Tablets at temperature not exceeding 30°C.
Keep Aripiprazole and all medicines out of the reach of children.
General information about Aripiprazole: Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Aripiprazole for a condition for which it was not prescribed. Do not give Aripiprazole to other people, even if they have the same condition. It may harm them.
This Medication Guide summarizes the most important information about Aripiprazole. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about Aripiprazole that was written for healthcare professionals. For more information about Aripiprazole.
What are the ingredients in Aripiprazole? Active ingredient: aripiprazole.
Inactive ingredients: Tablets: cornstarch, hydroxypropyl cellulose, lactose monohydrate, magnesiwn stearate, and microcrystalline cellulose. Colorants include ferric oxide (yellow or red).
