| IMPORTANT WARNING
| WHY is this medicine prescribed?
| HOW should this medicine be used?
| Are there OTHER USES for this medicine?
| What SPECIAL DIETARY instructions should I follow?
| What should I do IF I FORGET to take a dose?
| What SIDE EFFECTS can this medicine cause?
| What should I do in case of OVERDOSE?
| What OTHER INFORMATION should I know?
- Abilify Maintena®
Studies have shown that older adults with dementia (a brain disorder that affects the ability to remember, think clearly, communicate, and perform daily activities and that may cause changes in mood and personality) who take or receive antipsychotics (medications for mental illness) such as aripiprazole have an increased chance of death during treatment. Older adults with dementia may also have a greater chance of having a stroke or ministroke during treatment with antipsychotics.
Aripiprazole injection and aripiprazole extended-release (long-acting) injection are not approved by the Food and Drug Administration (FDA) for the treatment of behavior disorders in older adults with dementia. Talk to the doctor who prescribed this medication if you, a family member, or someone you care for has dementia and is receiving aripiprazole. For more information visit the FDA website: Web Site.
Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with aripiprazole injection or aripiprazole extended-release injection and each time you receive an injection. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer's website to obtain the Medication Guide.
Talk to your doctor about the risks of receiving aripiprazole injection or aripiprazole extended-release injection.
WHY is this medicine prescribed?
Aripiprazole extended-release injections (Abilify Maintena, Aristada) are used to treat schizophrenia (a mental illness that causes disturbed or unusual thinking, loss of interest in life, and strong or inappropriate emotions). Aripiprazole injection (Abilify) is used to treat episodes of agitation in people who have schizophrenia or in people who have bipolar I disorder (manic depressive disorder; a disease that causes episodes of depression, episodes of severe mania, and other abnormal moods) and are experiencing an episode of mania (abnormally excited or irritated mood). Aripiprazole is in a class of medications called atypical antipsychotics. It works by changing the activity of certain natural substances in the brain.
HOW should this medicine be used?
Aripiprazole injection comes as a solution (liquid) to be injected into a muscle by a healthcare provider. Aripiprazole extended-release injection come as a powder to be mixed with water (Abilify Maintena) and as a suspension (liquid) (Aristada) to be injected into a muscle by a healthcare provider. Aripiprazole injection is usually given as needed for agitation. If you are still agitated after you receive your first dose, you may be given one or more additional doses. Aripiprazole extended-release injection is usually given either once every 4 weeks (Abilify Maintena) or once every 4 or 6 weeks (Aristada).
Aripiprazole extended-release injection may help control your symptoms but will not cure your condition. Continue to keep appointments to receive aripiprazole extended-release injection even if you feel well. Talk to your doctor if you do not feel like you are getting better during your treatment with aripiprazole extended-release injection.
Are there OTHER USES for this medicine?
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
What SPECIAL PRECAUTIONS should I follow?
Before receiving aripiprazole injection or aripiprazole extended-release injection,
- tell your doctor and pharmacist if you are allergic to aripiprazole, any other medications, or any of the ingredients in aripiprazole injection or aripiprazole extended-release injection. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
- tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: carbamazepine (Carbatrol, Epitol, Tegretol), clarithromycin (Biaxin, in Prevpac), fluoxetine (Prozac, Sarafem, Symbyax), itraconazole (Onmel, Sporanox), ketoconazole (Extina, Nizoral, Xolegel), lorazepam (Ativan), medications to control high blood pressure, paroxetine (Brisdelle, Paxil), quinidine (in Nuedexta), and rifampin (Rifadin, Rimactane, in Rifamate, in Rifater). Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Many other medications may also interact with aripiprazole, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.
- tell your doctor if you have a low number of white blood cells or if any other medication has ever caused a decrease in your white blood cells. Also tell your doctor if you or anyone in your family has or has ever had diabetes, and if you have or have ever had a stroke, a ministroke, heart disease or a heart attack, an irregular heartbeat, low or high blood pressure, seizures, difficulty swallowing, a high level of fats (cholesterol and triglycerides) in your blood, or a medical condition that may affect you receiving an injection in your arm or buttocks. Tell your doctor if you have severe vomiting, diarrhea or signs of dehydration now, or if you develop these symptoms at any time during your treatment.
- tell your doctor if you are pregnant, especially if you are in the last few months of your pregnancy, if you plan to become pregnant, or if you are breastfeeding. If you become pregnant during your treatment with aripiprazole, call your doctor.
- if you are having surgery, including dental surgery, tell the doctor or dentist that you are tell the doctor or dentist that you are being treated with aripiprazole.
- you should know that receiving aripiprazole injection or aripiprazole extended-release injection may make you drowsy and may affect your ability to think clearly, make decisions, and react quickly. Do not drive a car or operate machinery until you know how this medication affects you.
- you should know that alcohol can add to the drowsiness caused by this medication. Do not drink alcohol during your treatment with aripiprazole.
- you should know that aripiprazole injection and aripiprazole extended-release injection may cause dizziness, lightheadedness, fast or slow heartbeat, and fainting when you get up too quickly from a lying position, especially right after you receive your injection. If you feel dizzy or drowsy after you receive your injection, you will need to lie down until you feel better. During your treatment, you should get out of bed slowly, resting your feet on the floor for a few minutes before standing up.
- you should know that you may experience hyperglycemia (increases in your blood sugar) while you are receiving this medication, even if you do not already have diabetes. If you have schizophrenia, you are more likely to develop diabetes than people who do not have schizophrenia, and receiving aripiprazole injection, aripiprazole extended-release injection or similar medications may increase this risk. Tell your doctor immediately if you have any of the following symptoms during your treatment: extreme thirst, frequent urination, extreme hunger, blurred vision, or weakness. It is very important to call your doctor as soon as you have any of these symptoms, because high blood sugar can cause a serious condition called ketoacidosis. Ketoacidosis may become life-threatening if it is not treated at an early stage. Symptoms of ketoacidosis include: dry mouth, nausea and vomiting, shortness of breath, breath that smells fruity, and decreased consciousness.
- you should know that aripiprazole injection or aripiprazole extended-release injection may make it harder for your body to cool down when it gets very hot. Tell your doctor if you plan to do vigorous exercise or be exposed to extreme heat. Be sure to drink plenty of water and call your doctor if you experience any of the following symptoms: feeling very hot, sweating heavily, not sweating even though it is hot, dry mouth, excessive thirst, or decreased urination.
What SPECIAL DIETARY instructions should I follow?
Unless your doctor tells you otherwise, continue your normal diet.
What should I do IF I FORGET to take a dose?
If you forget to keep an appointment to receive aripiprazole extended-release injection, call your doctor to schedule another appointment as soon as possible.
What SIDE EFFECTS can this medicine cause?
Aripiprazole injection and aripiprazole extended-release injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- pain, swelling, redness at injection site
- weight gain
- increased appetite
- extreme tiredness
- stomach pain
- dry mouth
- back, muscle, or joint pain
- difficulty falling asleep or staying asleep
Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING or SPECIAL PRECAUTIONS sections, call your doctor immediately or get emergency medical treatment:
- swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, and/or lower legs
- difficulty swallowing or breathing
- muscle stiffness
- excessive sweating
- irregular heartbeat
- unusual movements of the face or body that you cannot control
- uncontrollable shaking of a part of the body
- need to get up and move
- slow movements
- sore throat, fever, chills, or other signs of infection
Aripiprazole injection and aripiprazole extended-release injection may cause other side effects. Call your doctor if you have any unusual problems while you are receiving this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online ( Web Site) or by phone (1-800-332-1088).
What should I do in case of OVERDOSE?
In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.
Symptoms of overdose may include:
- slowed or uncontrollable movements
- aggressive behavior
- coma (loss of consciousness for a period of time)
What OTHER INFORMATION should I know?
Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your body's response to aripiprazole injection or aripiprazole extended-release injection.
Ask your pharmacist any questions you have about aripiprazole injection or aripiprazole extended-release injection.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
AHFS® Consumer Medication Information. © Copyright, The American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.
Selected Revisions: December 15, 2015.
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Please be aware that this information is provided to supplement the care provided by your physician. It is neither intended nor implied to be a substitute for professional medical advice. CALL YOUR HEALTHCARE PROVIDER IMMEDIATELY IF YOU THINK YOU MAY HAVE A MEDICAL EMERGENCY. Always seek the advice of your physician or other qualified health provider prior to starting any new treatment or with any questions you may have regarding a medical condition.
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