ARIPIPRAZOLE EXTENDED RELEASE - INJECTION

ARIPIPRAZOLE EXTENDED RELEASE - INJECTION

PHONETIC PRONUNCIATION: (AR-i-PIP-ra-zole)

COMMON BRAND NAME(S): Abilify Maintena, Aristada

GENERIC NAME(S): aripiprazole

Uses

USES: Extended-release aripiprazole injection is used to treat a mental/mood disorder called schizophrenia. This medication can decrease hallucinations (hearing/seeing things that are not there) and improve your concentration. It also helps you to think more clearly, feel less nervous, and take a more active part in everyday life. Some brands of this medication are also used to treat bipolar disorder. It can help to decrease extreme changes in mood and help you feel less agitated. Extended-release aripiprazole injection is a long-acting psychiatric medication known as an atypical antipsychotic. It works by helping to restore the balance of certain natural substances in the brain.


How to use ARIPIPRAZOLE EXTENDED RELEASE - INJECTION

HOW TO USE: Read the Medication Guide provided by your pharmacist before you start using aripiprazole and each time you get a refill. If you have any questions, ask your doctor or pharmacist. The extended-release injection should only be used if you have already taken aripiprazole by mouth without any serious side effects. Aripiprazole is given by injection into the buttock or upper arm muscle by a health care professional, usually once every month. Some doses may be given once every 6 weeks or once every 2 months. Do not rub/massage the injection site after your dose. After your first injection, your doctor may direct you to continue to take your antipsychotic medication by mouth (such as aripiprazole tablet/solution) for 2 to 3 weeks. This will help maintain the right level of medication in your body as you switch from receiving medication by mouth to receiving it by injection. Follow your doctor's instructions carefully. The dosage is based on your medical condition, response to treatment, and other medications you may be taking. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). It may take several weeks to get the full benefit of this medication. Use this medication regularly to get the most benefit from it. To help you remember, mark the days on the calendar when you need to receive the medication. Tell your doctor if your condition does not improve or if it worsens.

Side Effects

SIDE EFFECTS: See also Warning section. Dizziness, lightheadedness, drowsiness, tiredness, blurred vision, weight gain, shaking (tremors), and redness/pain/swelling at the injection site may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly. Dizziness and lightheadedness can increase the risk of falling. Get up slowly when rising from a sitting or lying position. Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Tell your doctor right away if you have any serious side effects, including: fainting, trouble swallowing, restlessness (especially in the legs), seizures, trouble controlling certain urges (such as gambling, sex, eating or shopping), interrupted breathing during sleep. This medication may rarely make your blood sugar rise, which can cause or worsen diabetes. Tell your doctor right away if you have symptoms of high blood sugar such as increased thirst/urination. If you already have diabetes, check your blood sugar regularly as directed and share the results with your doctor. Your doctor may need to adjust your diabetes medication, exercise program, or diet. This medication may rarely cause a condition known as tardive dyskinesia. In some cases, this condition may be permanent. Tell your doctor right away if you develop any unusual uncontrolled movements (especially of the face, mouth, tongue, arms, or legs). This medication may rarely cause a serious condition called neuroleptic malignant syndrome (NMS). Get medical help right away if you develop any of the following: fever, muscle cramps/stiffness/pain/tenderness/weakness, severe tiredness, severe confusion, sweating, fast/irregular heartbeat, dark urine, signs of kidney problems (such as change in the amount of urine). A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: fever, swollen lymph nodes, rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

PRECAUTIONS: See also Warning and Side Effects sections. Before using aripiprazole, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: problems with receiving injections into the buttocks, problems with blood flow in the brain (such as cerebrovascular disease, stroke), blood clotting problems (such as hemophilia, low platelets), diabetes (including family history), heart problems (such as low blood pressure, coronary artery disease), nervous system problems (such as dementia, NMS, seizures), obesity, low white blood cell count (including history of low white blood cell count caused by medications), swallowing problems, breathing trouble during sleep (sleep apnea). This drug may make you dizzy or drowsy or blur your vision. Alcohol or marijuana can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness or clear vision until you can do it safely. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana. This medication may make you sweat less, making you more likely to get heat stroke. Avoid doing things that may cause you to overheat, such as hard work or exercise in hot weather, or using hot tubs. When the weather is hot, drink a lot of fluids and dress lightly. If you overheat, quickly look for a place to cool down and rest. Get medical help right away if you have a fever that does not go away, mental/mood changes, headache, or dizziness. Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Older adults may be more sensitive to the side effects of this drug, especially seizures, drowsiness, dizziness, lightheadedness, confusion, tardive dyskinesia, swallowing problems, and other serious (rarely fatal) side effects. (See also Warning section.) Drowsiness, dizziness, lightheadedness, and confusion can increase the risk of falling. During pregnancy, this medication should be used only when clearly needed. Babies born to mothers who have used this drug during the last 3 months of pregnancy may rarely develop symptoms including muscle stiffness or shakiness, drowsiness, feeding/breathing difficulties, or constant crying. If you notice any of these symptoms in your newborn especially during their first month, tell the doctor right away. Since untreated mental/mood problems (such as schizophrenia) can be a serious condition, do not stop taking this medication unless directed by your doctor. If you are planning pregnancy, become pregnant, or think you may be pregnant, immediately discuss with your doctor the benefits and risks of using this medication during pregnancy. This medication passes into breast milk. Breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

Interactions

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval. A product that may interact with this drug is: metoclopramide. Tell your doctor or pharmacist if you are taking other products that cause drowsiness such as opioid pain or cough relievers (such as codeine, hydrocodone), alcohol, marijuana, drugs for sleep or anxiety (such as alprazolam, lorazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), or antihistamines (such as cetirizine, diphenhydramine). Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.

Overdose

OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: very fast heartbeat, loss of consciousness.

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Faq for ARIPIPRAZOLE EXTENDED RELEASE - INJECTION

Aripiprazole extended-release injection is a medication used to treat schizophrenia and bipolar disorder. It is administered as an injection and provides a long-acting form of the drug.

The injection is given by a healthcare professional, usually into the muscle of the buttocks. It is typically administered once every four to six weeks.

Aripiprazole extended-release injection offers several advantages compared to daily oral medication. It helps maintain stable blood levels of the drug, reducing the risk of relapse, and offers convenience by reducing the need for daily dosing.

Common side effects may include headache, drowsiness, dizziness, weight gain, and restlessness. However, it is important to discuss any concerns with your healthcare provider, as side effects can vary.

Aripiprazole extended-release injection provides a gradual release of the medication over several weeks. It can take up to six months for the drug to be completely eliminated from the body.

Aripiprazole extended-release injection is generally prescribed for adults aged 18 and older. The safety and efficacy in pediatric patients have not been established.

The use of aripiprazole extended-release injection during pregnancy or breastfeeding should be discussed with a healthcare provider. They can evaluate the potential risks and benefits for the individual.

If a dose is missed, it is important to contact your healthcare provider to discuss the best course of action. They may recommend an alternative temporary treatment until the next scheduled injection.

The onset of action of aripiprazole extended-release injection varies for each individual. It typically takes several weeks for the medication to reach its full therapeutic effect.


Warning

WARNING: There may be a slightly increased risk of serious, possibly fatal side effects (such as stroke, heart failure, fast/irregular heartbeat, pneumonia) when this medication is used by older adults with dementia. This medication is not approved for the treatment of dementia-related behavior problems. Discuss the risks and benefits of this medication, as well as other effective and possibly safer treatments for dementia-related behavior problems, with the doctor.


Disclaimer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.