Vraylar

1 What is Vraylar?

Brand: Vraylar

Generic: Cariprazine

Vraylar is used to treat symptoms of psychotic (mental) disorders, such as schizophrenia, mania, or bipolar disorder. This medicine should not be used to treat behavioral problems in older adults with dementia.

It changes some of the chemicals in the brain that causes psychotic disorders. This medicine is available only with your doctor's prescription. This product is available in the capsule dosage form.

2 What to Know Before Using

Before using Vraylar, you must know all about the risks and complications associated with it. This is a decision you and your doctor will make.

For this medicine, the following should be considered:

Allergies: Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, tell your healthcare professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric Population: Appropriate studies have not been performed on the relationship of age to the effects of cariprazine in the pediatric population. Safety and efficacy have not been established.

Geriatric Population: Appropriate studies on the relationship of age to the effects of cariprazine have not been performed in the geriatric population, but geriatric-specific problems are not expected to limit the usefulness of cariprazine in the elderly.

However, elderly patients are more likely to have age-related kidney, liver, or heart problems, which may require caution and an adjustment in the dose for patients receiving cariprazine.

Breastfeeding: There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions: Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur.

In these cases, your doctor may want to change the dose or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below.

The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases.

If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Boceprevir
  • Carbamazepine
  • Clarithromycin
  • Cobicistat
  • Conivaptan
  • Fosphenytoin
  • Idelalisib
  • Indinavir
  • Itraconazole
  • Ketoconazole
  • Lopinavir
  • Nefazodone
  • Nelfinavir
  • Phenytoin
  • Posaconazole
  • Rifampin
  • Ritonavir
  • Saquinavir
  • St John's Wort
  • Telaprevir
  • Telithromycin
  • Voriconazole

Other Interactions: Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur.

Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems: The presence of other medical problems may affect the use of this medicine.

Make sure you tell your doctor if you have any other medical problems, especially:

  • Blood vessel or circulation problems 
  • Dehydration 
  • Heart attack, history of 
  • Heart disease 
  • Heart failure 
  • Heart rhythm problems 
  • Hypovolemia (low amount of blood) 
  • Stroke, history of—May cause side effects to become worse
  • Diabetes 
  • Hyperglycemia (high blood sugar) 
  • Hypotension (low blood pressure) 
  • Leukopenia (low white blood cells) 
  • Neuroleptic malignant syndrome (NMS), history of 
  • Seizures, history of 
  • Tardive dyskinesia (movement disorder), history of 
  • The trouble with swallowing—Use with caution. May make these conditions worse.

3 Proper Usage

Proper usage of Vraylar requires strict adherence to your doctor’s orders. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

To do so may increase the chance of side effects. You may take this medicine with or without food.

Dosing: The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label.

The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For oral dosage form (capsules):

For bipolar disorder and schizophrenia:

  • Adults—At first, 1.5 milligrams (mg) once a day. Your doctor will adjust your dose as needed. However, the dose is usually not more than 6 mg per day.
  • Children—Use and dose must be determined by your doctor.

Missed Dose: If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage: Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing. Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed. Ask your healthcare professional how you should dispose of any medicine you do not use.

4 Precautions to Take

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Neuroleptic Malignant syndrome: Check with your doctor right away if you have convulsions (seizures), difficulty with breathing, a fast heartbeat, a high fever, high or low blood pressure, increased sweating, loss of bladder control, severe muscle stiffness, unusually pale skin, or tiredness. These could be symptoms of a serious condition called neuroleptic malignant syndrome (NMS).

Tardive dyskinesia: This medicine may cause tardive dyskinesia (a movement disorder). Check with your doctor right away if you have lip smacking or puckering, puffing of the cheeks, rapid or worm-like movements of the tongue, uncontrolled chewing movements, or uncontrolled movements of the arms and legs.

For diabetic patients: This medicine may cause high blood sugar levels (hyperglycemia). Check with your doctor right away if you have increased thirst or increased urination. If you notice a change in the results of your urine or blood sugar tests, or if you have any questions, check with your doctor.

Weight gain: This medicine may increase your weight. Your doctor may need to check your weight on a regular basis while you are using this medicine. Talk to your doctor about ways to prevent weight gain.

Blood problems: Cariprazine can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. If you can, avoid people with infections. Check with your doctor right away if you think you are getting an infection, or if you have a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.

Dizziness: Dizziness, lightheadedness, or fainting may occur, especially when you get up suddenly from a lying or sitting position. Getting up slowly may help.

If this problem continues or gets worse, check with your doctor. This medicine may cause dizziness, drowsiness, trouble with thinking, or trouble with controlling body movements.

Make sure you know how you react to this medicine before you drive, use machines, or do anything else that requires you to be alert, well-coordinated, or able to think clearly.

Sweating: This medicine might reduce how much you sweat and make you feel too hot. You might feel dizzy, weak, tired, or confused, or begin to vomit or have an upset stomach. Do not get too hot while exercising and avoid places with high temperatures. Call your doctor if you become overheated and cannot cool down.

Pregnancy: Make sure your doctor knows if you are pregnant. Do not use this medicine during the later part of a pregnancy unless your doctor tells you to.

Other medicines: Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

5 Potential Side Effects

As with many medications, there are several potential side effects associated with Vraylar. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common:

  • blurred vision
  • chills
  • dizziness
  • drooling
  • fever
  • headache
  • inability to move the eyes
  • inability to sit still
  • increased blinking or spasms of the eyelid
  • loss of balance control
  • muscle trembling, jerking, or stiffness
  • need to keep moving
  • nervousness
  • pounding in the ears
  • restlessness
  • shuffling walk
  • slow or fast heartbeat
  • sticking out of the tongue
  • the stiffness of the limbs
  • trouble with breathing, speaking or swallowing
  • twisting movements of the body
  • uncontrolled movements, especially of the face, neck, arms, or legs
  • unusual facial expressions

Less common:

  • bladder pain
  • bloody or cloudy urine
  • difficult, burning, or painful urination
  • fast, pounding, or irregular heartbeat or pulse
  • frequent urge to urinate
  • lower back or side pain
  • muscle aches
  • sore throat
  • stuffy or a runny nose
  • unusual tiredness or weakness

Incidence not known:

  • confusion
  • convulsions
  • double vision
  • drooling
  • high fever
  • increased sweating
  • lip smacking or puckering
  • muscle trembling, jerking, or stiffness
  • puffing of the cheeks
  • rapid or worm-like movements of the tongue
  • severe muscle stiffness
  • uncontrolled chewing movements
  • unusually pale skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine.

Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common:

  • abdominal or stomach pain
  • diarrhea
  • difficulty having a bowel movement (stool)
  • nausea
  • sleepiness or unusual drowsiness
  • trouble sleeping

Less common:

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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