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Aristada (Generic Aripiprazole Injection)

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WARNING

According to studies, older people with dementia who take or receive antipsychotics (medications for mental illness) like aripiprazole have a higher risk of dying while undergoing treatment. Dementia is a brain disorder that affects a person’s memory, ability to think clearly, communicate, and perform daily tasks. It may also cause changes in mood and personality. Additionally, older people with dementia may be more likely to experience a stroke or ministroke while using antipsychotic medications.

The Food and Drug Administration (FDA) has not approved aripiprazole extended-release (long-acting) injectable for the management of behavioural issues in dementia-affected older individuals. If you, a family member, or a person you care for has dementia and is taking aripiprazole, speak with the doctor who recommended it. Visit the FDA website at http://www.fda.gov/Drugs for further details.

When you start therapy with aripiprazole extended-release injection and each time you receive an injection, your doctor or pharmacist will give you the manufacturer’s patient information leaflet (Medication Guide). If you have any questions, carefully read the material and contact your doctor or pharmacist. The Medication Guide is also available on the manufacturer’s website or the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm).

The dangers of receiving an injection of aripiprazole extended-release should be discussed with your doctor.

Why is this medication prescribed?

Schizophrenia is treated with aripiprazole extended-release injectable (Abilify Maintena, Aristada, Aristada Initio), either by itself or in conjunction with other aripiprazole preparations (a mental illness that causes disturbed or unusual thinking, loss of interest in life, and strong or inappropriate emotions). Injections of aripiprazole extended-release (Abilify Maintena) is also used to treat bipolar I patients on a continuing basis (manic-depressive disorder; a disease that causes episodes of depression, episodes of mania, and other abnormal moods). Atypical antipsychotics are a class of drugs that includes aripiprazole. It functions by altering the way that a few organic brain chemicals behave.

How should this medicine be used?

Aripiprazole extended-release injection is available as a powder (Abilify Maintena) that must be dissolved in water and as a suspension (Aristada, Aristada Initio) that must be injected into a muscle by a medical professional.

It is typical to administer an injection of aripiprazole extended-release (Abilify Maintena) once every four weeks. Your doctor will advise you to take aripiprazole tablets orally for up to two weeks prior to receiving your first injection if you have never received aripiprazole before. Additionally, during the first two weeks following the administration of your first injection of aripiprazole extended-release injection, you will need to take aripiprazole tablets or another antipsychotic medicine by mouth (Abilify Maintena).

The extended-release injectable of aripiprazole (Aristada) is typically administered once every 4, 6 or 8 weeks. Your doctor will advise you to take aripiprazole tablets orally for up to two weeks prior to receiving your first injection if you have never received aripiprazole before. Additionally, during the first two weeks following the administration of your first injection of aripiprazole extended-release injection, you will need to take aripiprazole tablets or another antipsychotic medicine by mouth (Aristada). As an alternative, while beginning treatment with aripiprazole extended-release injection, you could take one aripiprazole tablet by mouth and a single dose of aripiprazole extended-release injection (Aristada Initio) (Aristada).

Although it won’t treat your disease, aripiprazole extended-release injectable may help you manage your symptoms. Even if you feel well, keep your aripiprazole extended-release injection appointments. If you do not feel like you are improving while receiving aripiprazole extended-release injection medication, consult your doctor.

Other uses for this medicine

Ask your doctor or pharmacist for more details if you believe this drug should be used for something else.

What special precautions should I follow?

Before receiving aripiprazole extended-release injection,

  • If you have an allergy to aripiprazole, any other drugs, or any of the ingredients in aripiprazole extended-release injectable, let your doctor and pharmacist know right away. For a list of the ingredients, consult the Medication Guide or speak with your pharmacist.
  • Inform your doctor and pharmacist about all prescription and over-the-counter drugs, vitamins, dietary supplements, and herbal products that you are now taking or intend to use. Incorporate any of the following: rifampin; carbamazepine (Carbatrol, Epitol, Tegretol); clarithromycin (Biaxin, in Prevpac); fluoxetine (Prozac, Sarafem, Symbyax); itraconazole (Onmel, Sporanox); ketoconazole; lorazepam (Ativan); some drugs to treat high blood pressure like carvedilol (Coreg), lisinopri (Rifadin, Rimactane, in Rifamate, in Rifater). Your physician might need to adjust the dosage of your drugs or keep a close eye on you for side effects. Tell your doctor about all the drugs you are taking, including any not on this list, as many other drugs may also interact with aripiprazole.
  • If you have persistent diarrhoea or vomiting or suspect dehydration, let your doctor know right away. Additionally, let your doctor know if you currently or ever had any of the following conditions: difficulty staying balanced, dyslipidemia (high cholesterol levels), heart disease, heart failure, a heart attack, an irregular heartbeat, high or low blood pressure, a stroke, a ministroke, seizures, low white blood cell count, high blood pressure, high or low blood cholesterol, high blood sugar, or any condition that makes it difficult for you to swallow. Inform your doctor if you or any family members currently use or have previously used illicit substances, excessively abused alcohol or prescription medications, have diabetes, OCPD, ICD, bipolar disorder, or an impulsive personality.Additionally, let your doctor know if you’ve ever had to stop using a mental health medicine due to serious adverse effects.
  • If you are pregnant, especially if you are in the last few months of your pregnancy, planning to become pregnant, or breastfeeding, let your doctor know. Call your doctor right away if you find out you’re pregnant while taking aripiprazole.
  • Inform the surgeon or dentist that you are taking aripiprazole if you are having surgery, including dental surgery.
    You should be aware that receiving an aripiprazole extended-release injection may cause drowsiness and impair your capacity for critical thinking, decision-making, and quick response. Prior to understanding how this drug affects you, avoid using machinery or driving a car.
  • Alcohol may intensify the drowsiness brought on by this prescription, so you should be aware of that. During your aripiprazole treatment, refrain from drinking alcohol.
  • You should be aware that using an extended-release aripiprazole injection could make you feel faint when you stand up suddenly from lying down, especially immediately after receiving the injection. After receiving your injection, you should lay down until you feel better if you feel lightheaded or sleepy. You should slowly move out of bed throughout your treatment, letting your feet rest on the floor for a while, and then standing up.
  • You should be aware that even if you do not currently have diabetes, you could develop hyperglycemia (increases in your blood sugar) while taking this medication. Diabetes is more common in people with schizophrenia than in those without it, and taking aripiprazole extended-release injectable or comparable drugs may make diabetes more likely. If you experience any of the following symptoms while receiving treatment: intense thirst, frequent urination, intense hunger, blurred vision, or weakness, call your doctor right once. Calling your doctor as soon as you experience any of these symptoms is crucial because elevated blood sugar can result in the deadly disease known as ketoacidosis. If ketoacidosis is not treated right away, it could become life-threatening. Dry mouth, nausea, vomiting, shortness of breath, fruity-smelling breath, and diminished consciousness are all signs of ketoacidosis.
  • It’s important to be aware that some people who used drugs like aripiprazole extended-release injection developed gambling issues or other strong compulsive or out-of-character desires or behaviours, like increased sexual urges or behaviours, excessive shopping, and binge eating. If you are unable to control your behaviour or are experiencing strong cravings to shop, eat, have sex, or gamble, call your doctor. Informing your family about this risk can enable them to seek medical attention even if you are unaware that your gambling or any other strong cravings or strange actions have become a problem.
  • You should be aware that an extended-release aripiprazole injection may make it more difficult for your body to cool off when it becomes really heated. If you want to engage in strenuous activity or be exposed to high temperatures, let your doctor know. If you have any of the following symptoms, make sure to drink lots of water and contact your doctor: feeling extremely hot, heavily perspiring, not perspiration even though it is hot, dry mouth, excessive thirst, or decreased urination.

What special dietary instructions should I follow?

Keep eating normally unless your doctor instructs you otherwise.

What should I do if I forget a dose?

If you forget to keep an appointment to receive aripiprazole extended-release injection (Abilify Maintena, Aristrada), call your doctor to schedule another appointment as soon as possible.

What side effects can this medication cause?

The extended-release injection of aripiprazole may have adverse effects. If any of these symptoms are severe or do not go away, let your doctor know right once:

  • Bruising, redness, and pain at the injection site
  • Gaining weight
  • Higher appetite
  • Extreme fatigue
  • Abdominal pain
  • Constipation
  • Vomiting
  • Mouth ache
  • Joint, muscular, or back pain
  • Having trouble falling or staying asleep
  • Feeling lightheaded, unstable, or having difficulties balancing

Some adverse effects can be very harmful. Call your doctor right away or seek emergency medical attention if you experience any of these symptoms or those noted in the IMPORTANT WARNING or SPECIAL PRECAUTIONS sections:

  • Rash
  • Itching
  • Hives
  • Swelling of the hands, feet, ankles, lower legs, cheeks, neck, tongue, lips, eyes, and/or eyes
  • Breathing or swallowing challenges
  • Muscle rigidity
  • Excessive perspiration
  • Abnormal heartbeat
  • Confusion
  • Falling
  • Unusual facial or bodily movements that you cannot control
  • Body part shaking that is uncontrollable
  • Restlessness
  • I must stand up and leave
  • Slow motions
  • An infection-related sore throat, fever, chills, or other symptoms
  • Seizures

Other adverse effects could be brought on by aripiprazole extended-release injection. If you experience any strange issues while taking this medicine, contact your doctor right away.

You or your doctor can submit a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting programme online or by phone if you have a serious side event (1-800-332-1088).

In case of emergency/overdose

Call the poison control hotline at 1-800-222-1222 in the event of an overdose. Additionally, information can be found online at https://www.poisonhelp.org/help. Call 911 right once if the person has collapsed, experienced a seizure, is having difficulty breathing, or cannot be roused.

Overdose signs could include the following:

  • Confusion
  • Disorientation
  • Vomiting
  • Sluggish or erratic motions
  • Drowsiness
  • Seizures
  • Aggressive attitude
  • Coma (loss of consciousness for a period of time)

What other information should I know?

Keep all of your appointments with your physician and the lab. To monitor how your body is responding to the aripiprazole extended-release injectable, your doctor might request specific lab tests.

Any queries you may have regarding aripiprazole extended-release injectable, ask your pharmacist.

You should keep a written record of every medication you take, including any over-the-counter (OTC) items, prescription drugs, and dietary supplements like vitamins and minerals. This list should be brought with you whenever you see a doctor or are admitted to the hospital. You should always have this information with you in case of emergencies.

Brand names

  • Abilify®
  • Abilify Maintena®
  • Aristada®
  • Aristad Initio®
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