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Important word of caution for elderly people with dementia:

According to studies, older people with dementia who take antipsychotic drugs like brexpiprazole (medications for mental illness) have a higher risk of dying while receiving treatment. Dementia is a brain disorder that affects a person’s memory, ability to think clearly, communicate, and carry out 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 brexpiprazole 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 brexpiprazole, speak with the doctor who recommended it. Visit the FDA website at for further details.

Important word of caution for those who are depressed:

A few youngsters, teenagers, and young adults (up to 24 years old) who were given antidepressants during clinical research developed suicide thoughts (thinking about harming or killing oneself or planning or trying to do so). Children, teenagers, and young adults who take antidepressants to treat depression or other mental diseases may have a higher risk of committing suicide than those who do not take these medications. However, experts disagree on how significant this risk is and how much it has to be taken into account when determining whether or not a kid or adolescent should take an antidepressant. Brexpiprazole is often not prescribed for use in treating depression in people under the age of 18, although in some circumstances, a doctor may determine that it is the most effective treatment option for a child’s condition.

Even if you are an adult above the age of 24, you should be aware that taking brexpiprazole or other antidepressants may cause unanticipated changes in your mental health. Suicidal thoughts may come to mind, especially at the start of treatment and whenever your dose is changed. Any of the following symptoms should prompt you, your family, or your carer to call your doctor immediately away: New or worsening depression, anxiety, thoughts of harming or killing oneself, plans or attempts to do so, excessive worry, agitation, panic attacks, trouble falling or staying asleep, aggressive behaviour, irritability, acting without thinking, extreme restlessness, and mania are all possible symptoms (frenzied, abnormally excited mood). Make sure your family or carer is aware of any symptoms that could be significant so they can contact the doctor on your behalf if you are unable to call for help.

The risks of taking brexpiprazole should be discussed with your doctor.

Why is this medication prescribed?

Brexpiprazole is used to treat schizophrenia symptoms in adults and children 13 years of age and older. Schizophrenia is a mental condition that results in disturbed or strange thinking, lack of interest in life, and strong or inappropriate emotions. When an antidepressant cannot manage symptoms, it is also used in conjunction with one to treat depression. Atypical antipsychotics are a class of drugs that includes brexpiprazole. It functions by altering the way that a few organic brain chemicals behave.

How should this medicine be used?

Brexpiprazole is available as an oral tablet. Typically, it is given once day. Brexpiprazole should be taken every day at roughly the same time. Ask your doctor or pharmacist to explain any instructions on your prescription label that you are unsure about following. Follow the medication’s directions precisely. Never take it in larger or less amounts or more frequently than directed by your doctor.

Depending on how well the medication works for you and any side effects you have, your doctor may start you on a low dose of brexpiprazole and gradually increase it.

Although it manages these disorders, brexpiprazole does not treat schizophrenia or depression. Brexpiprazole should be used even if you feel OK. Without consulting your doctor, do not discontinue taking brexpiprazole.

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 taking brexpiprazole,

  • If you have an allergy to brexpiprazole, any other medications, or any of the ingredients in brexpiprazole tablets, let your doctor and pharmacist know right away. Request a list of the components from your pharmacist.
  • Inform your doctor and pharmacist about all prescription and over-the-counter drugs, vitamins, herbal items, and dietary supplements you are currently taking or intend to use while taking brexipiprazole. Your physician might need to adjust the dosage of your drugs or keep a close eye on you for side effects.
  • Please let your doctor know if you are taking any herbal supplements, especially St. John’s wort.
  • Inform your doctor if you, anyone in your family, or anyone else has diabetes now or has ever had it. Inform your doctor if you have or have ever had a stroke, a ministroke (TIA), chest pain, heart disease, a heart attack, an irregular heartbeat, heart failure, issues with balance, any condition that makes it difficult for you to swallow, high or low blood pressure, seizures, a high level of fats (cholesterol and triglycerides) in your blood, a low number of white blood cells, kidney or liver disease, or any other condition that makes it difficult for you to Additionally, let your doctor know if you are currently experiencing severe diarrhoea or vomiting, or if you exhibit any other symptoms of dehydration.
  • Inform your doctor if you are expecting, especially if you are in the last few months of your pregnancy. Also let them know if you plan to get pregnant or if you are nursing a baby. Call your doctor if you get pregnant while taking brexpiprazole. If brexpiprazole is taken in the final months of pregnancy, it may have negative effects on babies after birth.
  • You need to be aware that brexpiprazole might make you sleepy. Until you know how this drug affects you, avoid operating machinery that could be dangerous or driving a car.
  • You should be aware that even if you do not currently have diabetes, you could develop hyperglycemia (increases in blood sugar) while taking this drug. Brexpiprazole or other comparable drugs may increase your risk of developing diabetes if you have schizophrenia, which increases your risk compared to persons without the condition. If you experience any of the following side effects while taking brexpiprazole: severe thirst, frequent urination, intense hunger, blurred vision, or weakness, call your doctor right away. Because high blood sugar can result in the hazardous disease known as ketoacidosis, it is crucial to contact your doctor as soon as you experience any of these symptoms. If ketoacidosis is not treated at an early stage, it could become life-threatening. Dry mouth, nausea, vomiting, shortness of breath, a fruity odour to the breath, and diminished consciousness are all signs of ketoacidosis.
  • Brexpiprazole may result in lightheadedness, fainting, and dizziness if you stand up suddenly from a laying posture. When you initially start taking brexpiprazole, this happens more frequently. Get out of bed gradually and rest your feet on the floor for a few minutes before standing up to help prevent this issue.
  • You should be aware that brexpiprazole may hinder your body’s ability to cool down when it becomes really hot. If you want to exercise or be in a very hot environment, let your doctor know.
  • You should be aware that brexpiprazole may result in weight gain. While using this drug, it’s vital to get your weight evaluated on a regular basis.

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 miss a dosage, take it as soon as you recall. If the next dose is soon due, skip the missed one and carry on with your regular dosing plan. To make up for a missing dose, do not take a second one.

What side effects can this medication cause?

There may be side effects from brexpiprazole. If any of these symptoms are severe or do not go away, let your doctor know right once:

  • Headache
  • Constipation
  • Heartburn
  • Tiredness
  • Body part shaking that is uncontrollable
  • Feeling lightheaded, unstable, or having difficulties balancing

Some adverse effects can be very harmful. Call your doctor right away if you have any of the following symptoms or those detailed in the IMPORTANT WARNINGS and SPECIAL PRECAUTIONS sections:

  • Rash
  • Hives
  • Itching
  • Edoema of the lower legs, hands, feet, ankles, throat, lips, tongue, or eyes
  • Breathing or swallowing challenges
  • Seizures
  • Breathing difficulty
  • Chills, a cough, a sore throat, and other symptoms of illness
  • Fever, perspiration, disorientation, rapid or erratic heartbeat, and extreme muscular stiffness
  • Uncontrollable facial or bodily motions that are out of the ordinary falling
  • Muscular tension in the neck
  • Throat constriction

Other negative effects of brexpiprazole are possible. 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).

What should I know about storage and disposal of this medication?

Keep this medication tightly closed in the original container and out of the reach of children. Store it away from excessive heat and moisture at room temperature (not in the bathroom).

Unused prescriptions must be disposed of carefully to prevent pets, kids, and other people from ingesting them. You should not, however, dispose of this medication in the toilet. Instead, utilising a medicine take-back programme is the easiest approach to get rid of your medication. To find out about take-back programmes in your area, speak with your pharmacist or the garbage/recycling department in your city. If you do not have access to a take-back programme, see the FDA’s Safe Disposal of Medicines website at for additional information.

As many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and are simple for young children to open, it is crucial to keep all medications out of sight and out of reach of children. Always lock safety caps and promptly stash medication up and away from young children where it is out of their sight and reach to prevent poisoning.

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 Call 911 right once if the person has collapsed, experienced a seizure, is having difficulty breathing, or cannot be roused.

What other information should I know?

Keep all of your appointments with your physician and the lab. To determine how well your body is responding to brexpiprazole, your doctor may request specific lab tests.

No one else should take your medication. Any queries you may have regarding medication refills should be directed to 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

  • Rexulti®
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