Vraylar : Uses, Side Effects, Interactions & More


Important warning for older adults with dementia:

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 can lead to changes in mood and personality) who take antipsychotics (medicines for mental illness) such as Vraylar (Cariprazine). you have a higher chance of death during treatment. Older adults with dementia may also have a higher chance of having a stroke or mini-stroke during treatment.

Vraylar is not approved by the Food and Drug Administration (FDA) for the treatment of behavioral disorders in older adults with dementia. Talk to the doctor who prescribed this medicine if you, a family member, or a loved one have dementia and are being treated with Vraylar. For more information, visit the FDA website: http://www.fda.gov/Drugs.

Important warning for people with episodes of depression:

A small number of children, adolescents and young adults (up to 24 years of age) who took antidepressants (‘mood elevators’) such as Vraylar during clinical studies became suicidal (thinking about harming or killing themselves or planning or trying do what ). Children, adolescents, and young adults who take antidepressants to treat depression or other mental illnesses may be more likely to become suicidal than children, adolescents, and young adults who do not take antidepressants to treat these conditions. However, there are also risks when depression is not treated in children and adolescents. Talk to your child’s doctor about these risks and whether your child should take an antidepressant. Vraylar has not been studied in children under 18 years of age.

You should know that your mental health can change unexpectedly when you take Vraylar (Cariprazine) or other antidepressants, even if you are an adult over 24 years of age. You may be suicidal, especially at the beginning of your treatment and any time your dose is increased or decreased. You, your family, or your caregiver should call your doctor right away if you experience any of the following symptoms: new or worsening depression; thinking about, or planning or attempting to, hurt or commit suicide; extreme worry; agitation; panic attacks; Difficulty falling asleep or staying asleep; aggressive behavior; irritability; act without thinking; severe restlessness; and a frenzy of abnormal excitement. Make sure your family or caregiver knows what symptoms may be serious so they can call your doctor if you are unable to seek treatment on your own.

Your healthcare provider will want to see you often while you are taking Vraylar, especially at the beginning of your treatment. Make sure to keep all appointments for office visits with your doctor.

Your doctor or pharmacist will give you the manufacturer’s patient information sheet (Medication Guide) when you start treatment with Vraylar. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also get the Medication Guide from the FDA website: http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm.

Regardless of your age, before taking an antidepressant, you or your doctor should discuss the risks and benefits of treating your condition with an antidepressant or other treatments with your doctor. You should also talk about the risks and benefits of not treating your condition. You should know that having depression or another mental illness greatly increases your risk of becoming suicidal. This risk is higher if you or someone in your family has or has ever had bipolar disorder (mood that changes from depressed to abnormally excited) or mania (frantic, abnormally excited mood) or has thought or tried to commit suicide. Talk to your doctor about your condition, symptoms, and personal and family medical history. You and your doctor will decide what type of treatment is right for you.

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Talk to your doctor about the risks of taking Vraylar.

Why is this medication prescribed?

Vraylar (Cariprazine) is used to treat schizophrenia (a mental illness that causes disturbed or unusual thoughts, loss of interest in life, and strong or inappropriate emotions). Vraylar is also used to treat episodes of depression in people with bipolar I disorder (manic depressive disorder; an illness that causes episodes of mania, episodes of depression, and other abnormal moods). It is also used as a short-term treatment for episodes of mania or mixed episodes (symptoms of mania and depression that occur together) in people with bipolar I disorder. Vraylar (Cariprazine) 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?

Vraylar (Cariprazine) comes as capsules to take by mouth. It is usually taken once a day with or without food. Take Vraylar at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any parts you don’t understand. Take Vraylar exactly as directed. Do not take more or less, or take it more often than prescribed by your doctor.

Your doctor will likely prescribe a low dose of Vraylar and gradually increase it depending on how well the medicine works for you and the side effects you experience.

Vraylar can help control your symptoms, but it will not cure your condition. It may take several weeks or longer before you feel the full benefit of Vraylar. Keep taking Vraylar even if you feel fine. Do not stop taking Vraylar without consulting your doctor. Talk to your doctor if you do not feel better during your treatment with Vraylar.

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 taking Vraylar,

  • Tell your doctor and pharmacist if you are allergic to Vraylar, any other medications, or any of the ingredients in Vraylar capsules. Ask your pharmacist for a list of the ingredients.
  • Tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, and nutritional supplements you are taking or plan to take. Be sure to mention any of the following: anticholinergics such as atropine (Atropen, Duodote, Enlon-Plus), benztropine (Cogentin), dicyclomine (Bentyl), glycopyrrolate (Robinul), hyoscyamine, propantheline (Pro-Banthine), and scopolamine (Transderm Scop) ; carbamazepine (Carbatrol, Epitol, Equetro, Tegretol, Teril); itraconazole (Onmel, Sporanox); ketoconazole; blood pressure medications; and rifampicin (Rifadin, Rimactane, in Rifamate, Rifater). Your doctor may need to change the doses of your medications or monitor you closely for side effects. Many other medications can also interact with Vraylar, 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 what herbal products you are taking, especially St. John’s wort.
  • Tell your doctor if you have a low white blood cell count or if you have ever developed a low white blood cell count as a side effect of a medicine you took. Tell your doctor if you have or have ever had seizures; a hit; a mini-accident a heart attack; heart failure; arrhythmia;; trouble keeping your balance; difficulty swallowing or heart, liver or kidney disease. Also tell your doctor if you have severe vomiting, diarrhea, or signs of dehydration at this time, 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, or if you plan to become pregnant or are breastfeeding. If you become pregnant while taking Vraylar, call your doctor. Vraylar can cause problems in newborns after delivery if it is taken during the last months of pregnancy.
  • You should know that Vraylar can make you drowsy and affect your ability to think clearly, make decisions and react quickly. Do not drive a car or operate machinery during your treatment with Vraylar until you know how this medicine affects you.
  • You should know that you may experience hyperglycemia (increased blood sugar) while receiving this medicine, 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 taking Vraylar or similar medications can increase this risk. Tell your doctor right away 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 that you call your doctor as soon as you have any of these symptoms, because high blood sugar levels can cause a serious condition called ketoacidosis. Ketoacidosis can be life-threatening if it is not treated at an early stage. Symptoms of ketoacidosis include: dry mouth, nausea and vomiting, shortness of breath, fruity-smelling breath, and decreased consciousness.
  • You should know that Vraylar can cause dizziness, lightheadedness, and fainting when you get up too quickly from lying down. This is more common when you start taking Vraylar. To avoid this problem, get out of bed slowly, resting your feet on the floor for a few minutes before standing up.
  • You should know that Vraylar can make it difficult for your body to cool down in very hot weather. Tell your doctor if you plan to exercise vigorously 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 a lot, not sweating despite the hot weather, dry mouth, excessive thirst, or decreased urination.
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What special dietary instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do if I forget a dose?

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What side effects can this medication cause?

Vraylar may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

  • extreme tiredness
  • restlessness
  • anxiety
  • agitation
  • difficulty falling asleep or staying asleep
  • dizziness, feeling unsteady, or having trouble keeping your balance
  • increased appetite
  • weight gain
  • constipation
  • indigestion
  • nausea
  • increased saliva or drooling
  • blurred vision

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING or SPECIAL PRECAUTIONS section, call your doctor immediately or get emergency medical treatment:

  • seizures
  • unusual movements of your body or face that you cannot control
  • slow movements or shuffling walk
  • loss of ability to move
  • falling
  • fever, sweating, confusion, fast breathing, fast or irregular heartbeat, and severe muscle stiffness
  • muscle weakness or aching
  • blank facial expression
  • difficulty swallowing or breathing
  • tightness in the throat
  • tongue that sticks out of the mouth
  • rash
  • itching
  • hives
  • swelling of the face, throat, tongue, lips, or eyes
  • dark or cola-colored urine
  • swelling in legs and feet
  • decreased urination

Vraylar may cause other side effects. Call your doctor if you have any unusual problems while taking this medicine.

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If you experience a serious side effect, you or your doctor can submit a report online to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting program (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

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

Keep this medicine in the container it came in, tightly closed, and out of the reach of children. Store at room temperature and away from excess heat and moisture (not in the bathroom).

Unnecessary medications must be disposed of in special ways to ensure that pets, children, and others cannot consume them. However, you should not flush this medicine down the toilet. Instead, the best way to dispose of your medications is through a drug take-back program. Talk to your pharmacist or contact your local garbage / recycling department to find out about take-back programs in your community. See the FDA Safe Drug Disposal website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medicines out of the sight and reach of children, since many containers (such as those containing weekly pills and those for eye drops, creams, patches and inhalers) are not resistant to children and small children can easily open them. To protect young children from poisoning, always close the safety caps and immediately place the medicine in a safe place, one that is upright and out of their sight and reach. http://www.upandaway.org

In case of emergency/overdose

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim collapsed, had a seizure, has trouble breathing, or cannot wake up, immediately call 911 for emergency services.

Symptoms of overdose may include the following:

  • sedation
  • feeling lightheaded, dizzy or faint when standing up from a sitting or lying down position

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 Vraylar.

It is important that you keep a written list of all prescription and over-the-counter (over-the-counter) medications you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should take this list with you each time you visit a doctor or if you go into hospital. It is also important information to take with you in case of emergencies.

Brand Names

  • Vraylar®

Disclaimer: DrLinex has made every effort to ensure that all information is factually accurate, comprehensive and up-to-date. However, this article should not be used as a licensed health care professional’s choice of knowledge and expertise. You should always consult your doctor or other health care professional before taking any medication. The information given here is subject to change and it has not been used to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions or adverse effects. The lack of warning or other information for any drug does not indicate that the combination of medicine or medication is safe, effective or appropriate for all patients or all specific uses.

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