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Vraylar

Common Name:

cariprazine

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How does this medication work? What will it do for me?

Cariprazine belongs to the class of medications called antipsychotics. It is used to treat schizophrenia and bipolar disorder. It does not cure these medical conditions, but helps to manage symptoms by affecting the actions of certain chemical messengers in the brain.

Schizophrenia can cause symptoms such as hallucinations (e.g., hearing, seeing, or sensing things that are not there), delusions, unusual suspiciousness, and emotional withdrawal. People with this condition may also feel depressed, anxious, or tense. Bipolar disorder was previously referred to as manic depressive illness; it causes alternating episodes of mania and depression. Cariprazine is used for short-term treatment of both manic and depressive symptoms.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

What form(s) does this medication come in?

1.5 mg
Each size # 4, white, opaque, hard gelatin capsule with a black “FL 1.5” imprint on the body of the capsule, with a rectified radial orientation, and filled with a white to off-white powder, contains cariprazine HCl, which is equivalent to 1.5 mg of cariprazine base. Nonmedicinal ingredients: gelatin, magnesium stearate, pregelatinized starch and titanium dioxide; printing ink: black iron oxide, propylene glycol, and shellac.

3 mg
Each size # 4 capsule, white opaque body and green to blue green opaque cap, with a black “FL 3” imprint on the body of the capsule with a rectified radial orientation, filled with a white to off-white powder, contains cariprazine HCl equivalent to 3 mg of cariprazine base. Nonmedicinal ingredients: gelatin, magnesium stearate, pregelatinized starch, titanium dioxide, FD&C blue 1, FD&C red 40, and yellow iron oxide; printing ink: black iron oxide, propylene glycol, and shellac.

4.5 mg
Each Size # 4 capsule, green to blue-green opaque capsule with a white “FL 4.5” imprint on the body of the capsule with a rectified radial orientation, filled with a white to off-white powder, contains cariprazine HCl equivalent to 4.5 mg of cariprazine base. Nonmedicinal ingredients: gelatin, magnesium stearate, pregelatinized starch, titanium dioxide, FD&C blue 1, FD&C red 40, and yellow iron oxide; printing ink: povidone, propylene glycol, shellac, sodium hydroxide, and titanium dioxide.

6 mg
Each Size # 3 capsule with a white opaque body and a purple opaque cap, with a black “FL 6” imprint on the body of the capsule with a rectified radial orientation, filled with a white to off-white powder, contains cariprazine HCl equivalent to 6 mg of cariprazine base. Nonmedicinal ingredients: gelatin, magnesium stearate, pregelatinized starch, titanium dioxide, black iron oxide, FD&C blue 1, and FD&C red 3; printing ink: black iron oxide, propylene glycol, and shellac.

How should I use this medication?

The recommended starting dose of this medication for the treatment of schizophrenia is 1.5 mg taken by mouth, once daily. Depending on how the medication affects you, your doctor may increase the dose gradually, to a maximum of 6 mg daily.

For bipolar mania, the starting dose is 1.5 mg daily. This may be increased up to a maximum of 6 mg daily depending on your response to the medication. For bipolar depression, the starting dose is 1.5 mg taken by mouth once daily. Your doctor may increase the dose gradually to a maximum of 3 mg daily.

Cariprazine may be taken with or without food, and should be taken at approximately the same time every day.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor. If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one.

Store this medication at room temperature, protect it from light and moisture, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Who should NOT take this medication?

Do not take this medication if you:

  • are allergic to cariprazine or any ingredients of the medication
  • are taking any of the following medications:
    • "azole" antifungal medications (e.g., itraconazole, ketoconazole)
    • bosentan
    • carbamazepine
    • cimetidine
    • diltiazem
    • efavirenz
    • HIV protease inhibitors (e.g., atazanavir, ritonavir, saquinavir)
    • macrolide antibiotics (e.g., clarithromycin, erythromycin)
    • phenobarbital
    • phenytoin
    • rifampin
    • St. John’s wort

What side effects are possible with this medication?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

  • appetite changes
  • back or abdominal pain
  • constipation
  • diarrhea
  • drowsiness
  • fatigue
  • frequent urination
  • headache 
  • heartburn
  • joint pain or stiffness
  • nausea
  • pain in the arms, legs, feet, or hands
  • painful menstrual periods
  • restlessness
  • stuffy or runny nose
  • sweating
  • toothache
  • trouble sleeping
  • vision changes
  • vomiting
  • weight gain

Although most of the side effects listed below don’t happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

  • falls and bone fractures caused by falls
  • fast heartbeat
  • feeling agitated
  • difficulty swallowing
  • movement disorders (e.g., continuous muscle spasms and contractions; slow movements; irregular, jerky movements; tremor; inability to move eyes; increased blinking; puffing of cheeks; shuffling walk; muscle twitching; spasms or abnormal movements of the face, neck, or body; rigid muscles) 
  • signs of liver problems (e.g., nausea, vomiting, diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools)
  • signs of muscle damage (e.g., unexplained muscle pain, tenderness or weakness, or brown or discoloured urine)
  • symptoms of low blood pressure (dizziness or lightheadedness when rising from a lying or sitting position, blurred vision, nausea, vomiting) 
  • symptoms of high blood pressure (e.g., shortness of breath, dizziness or fainting, swelling in ankles and legs, bluish colour to lips and skin, fast or pounding heartbeat)
  • symptoms of high blood sugar (e.g., frequent urination, increased thirst, excessive eating, unexplained weight loss, poor wound healing, infections, fruity breath odour)
  • trouble speaking or swallowing

Stop taking the medication and seek immediate medical attention if any of the following occur:

  • long-lasting (greater than 4 hours) and painful erection of the penis
  • seizures
  • signs of a blood clot in blood vessels, such as chest pain, abnormal heart rhythm, pain and swelling in one leg muscle
  • signs of neuroleptic malignant syndrome (e.g., confusion, reduced consciousness, high fever, or muscle stiffness) 
  • signs of stroke (e.g., sudden weakness or numbness of the face, arms, or legs, and speech or vision problems)
  • signs of a severe skin reaction such as blistering, peeling, a rash covering a large area of the body, a rash that spreads quickly, or a rash combined with fever or discomfort
  • symptoms of a severe allergic reaction (hives; difficulty breathing; difficulty swallowing; swelling of the face, mouth, throat, or tongue)
  • thoughts of suicide or self-harm

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for this medication?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Abnormal heart rhythms: This medication may cause an abnormal heart rhythm problem called QT prolongation. If you have a history of QT prolongation, slow or irregular heartbeat, irregular heart rhythm, heart failure, heart attack, heart disease, taking other medications known to cause QT prolongation, or a family history of sudden cardiac death at less than 50 years of age, discuss with your doctor how this medication may affect your medical condition, or how your medical condition may affect the dosing and effectiveness of this medication. Your doctor will perform tests at regular intervals to monitor for any changes in your heart rhythm. 

Alcohol and other medications that cause drowsiness: Do not combine this medication with alcohol or other medications that cause drowsiness (e.g., antidepressants, sleeping pills, anxiety medications) since additive drowsiness can occur and be dangerous.

Blood clots: Cariprazine can increase the chance of blood clot formation, causing reduction of blood flow to organs or the extremities. 

If you have a history of clotting, you may be at increased risk of experiencing blood clot-related problems such as heart attack, stroke, or clots in the deep veins of your leg. Discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

If you experience symptoms such as sharp pain and swelling in the leg, difficulty breathing, chest pain, blurred vision or difficulty speaking, contact your doctor immediately.

Body temperature: Cariprazine, like other antipsychotic medications, may interfere with your body’s ability to regulate body temperature. People who exercise vigorously, who are exposed to extreme heat, are dehydrated, or are taking anticholinergic medications (e.g., benztropine, oxybutynin) are more at risk. Contact your doctor as soon as possible if you feel very hot and are unable to cool down.

Take care to avoid overheating during strenuous exercise or in hot temperatures, and avoid becoming dehydrated by drinking enough fluids.

Diabetes: Cariprazine may increase blood sugar for people with diabetes or those who are at risk for diabetes. If you have diabetes, monitor your blood sugar frequently as recommended by your doctor. If you experience symptoms of high blood sugar (e.g., increased urination, increased thirst, increased eating, and weakness) while taking this medication, contact your doctor.

Drowsiness/reduced alertness: Cariprazine may cause drowsiness, light-headedness, or impaired judgement, which could interfere with your ability to do activities requiring alertness, such as driving a car. Avoid these activities if the medication affects you in this way. Avoid alcohol while taking cariprazine as it may increase your drowsiness.

Infection: Rarely, this medication will reduce the number of cells that fight infection in the body (white blood cells). Tell your doctor if you notice more frequent signs of an infection, such as fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness. Your doctor will do blood tests regularly to monitor the number of specific types of blood cells in your blood.

Low blood pressure: Some people taking cariprazine may experience sudden blood pressure drops when getting up from a sitting or lying position. These blood pressure drops could lead to dizziness, lightheadedness, and falls. If you experience this problem, try getting up more slowly. If it persists or if you faint, contact your doctor.

If you have or have had heart disease, stroke, "mini-stroke", or are at risk of experiencing low blood pressure (e.g., dehydration, taking medications for high blood pressure), discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Neuroleptic malignant syndrome (NMS): This medication may cause a potentially fatal reaction called neuroleptic malignant syndrome (NMS). If you develop symptoms of NMS, such as muscle stiffness, fever, confusion, sweating, or irregular heartbeat, stop taking this medication and seek immediate medical attention.

Seizures: Seizures have occurred for people taking cariprazine. If you have a history of seizures, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. If you experience a seizure while taking this medication, get immediate medical attention.

Suicidal behaviour: People taking this medication as part of treatment for depression may feel agitated (restless, anxious, aggressive, emotional, and feeling not like themselves), or they may want to hurt themselves or others. These symptoms may occur within several weeks after starting this medication. If you experience these side effects or notice them in a family member who is taking this medication, contact your doctor immediately. You should be closely monitored by your doctor for emotional and behaviour changes while taking this medication.

Swallowing problems: People taking cariprazine may have difficulty swallowing. Seniors and people on other antipsychotic medications should be closely monitored by their doctor for swallowing problems while they are using this medication. If you experience difficulty swallowing while taking this medication, contact your doctor.

Tardive dyskinesia: People taking this medication may develop tardive dyskinesia, a syndrome of uncontrolled body movements. This syndrome may be irreversible. If you develop uncontrolled or unusual body movements, contact your doctor as soon as possible.

Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.

Women who may become pregnant should use effective birth control while taking cariprazine and for at least 12 weeks after stopping the medication. It is not known if this medication affects how well hormonal birth control works. Because of the potential for this medication to affect hormonal birth control (e.g., implants, birth control pills), a second type of birth control should be used.

Breast-feeding: It is not known if cariprazine passes into breast milk. If you are a breast-feeding mother and are taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using this medication have not been established for children.

Seniors There may be a higher risk of strokes, heart attacks, and deaths associated with the use of cariprazine by people with dementia. Talk to your doctor about the risks and benefits of using this medication.

What other drugs could interact with this medication?

There may be an interaction between cariprazine and any of the following: 

  • alcohol
  • aliskiren
  • alpha-agonists (e.g., clonidine, methyldopa) 
  • alpha-blockers (e.g., alfuzosin, doxazosin, prazosin, tamsulosin) 
  • amphetamines (e.g., dextroamphetamine, lisdexamfetamine)
  • angiotensin converting enzyme inhibitors (ACEIs; captopril, ramipril) 
  • angiotensin receptor blockers (ARBs; e.g., candesartan, irbesartan, losartan) 
  • antihistamines (e.g., azelastine, cetirizine, doxylamine, diphenhydramine, hydroxyzine, loratadine)
  • anti-Parkinson’s medications (e.g., amantadine, apomorphine, bromocriptine, entacapone, levodopa, pramipexole, ropinirole) 
  • antipsychotics (e.g., chlorpromazine, clozapine, haloperidol, olanzapine, quetiapine, ) 
  • apalutamide
  • aprepitant
  • "azole" antifungals (e.g., fluconazole, ketoconazole, voriconazole)
  • barbiturates (e.g., butalbital, phenobarbital)
  • benzodiazepines (e.g., alprazolam, diazepam, lorazepam)
  • beta-adrenergic blockers (e.g., atenolol, propranolol, sotalol) 
  • bosentan
  • brimonidine
  • buprenorphine
  • bupropion
  • cabergoline
  • caffeine
  • calcium channel blockers (e.g., amlodipine, diltiazem, nifedipine, verapamil) 
  • cannabis
  • chloral hydrate
  • cimetidine
  • cobicistat
  • conivaptan
  • dexmethylphenidate
  • diabetes medications (e.g., acarbose, canagliflozin, glyburide, linagliptin, lixisenatide, insulin, metformin, rosiglitazone) 
  • diphenoxylate
  • diuretics (water pills; e.g., furosemide, hydrochlorothiazide, triamterene) 
  • donepezil
  • dronedarone
  • efavirenz
  • enzalutamide
  • eplerenone
  • esketamine
  • flunarizine
  • galantamine
  • grapefruit juice
  • guanfacine
  • HIV non-nucleoside reverse transcriptase inhibitors (e.g., efavirenz, etravirine, nevirapine)
  • HIV protease inhibitors (e.g., atazanavir, lopinavir, ritonavir, saquinavir)
  • hormonal birth control (e.g., birth control pills, IUDs, implants)
  • hydralazine
  • isosorbide dinitrate
  • lemborexant
  • letermovir
  • linezolid
  • lithium
  • macrolide antibiotics (e.g., azithromycin, clarithromycin, erythromycin)
  • methadone
  • methylphenidate
  • metoclopramide
  • mifepristone
  • mirtazapine
  • mitotane
  • monoamine oxidase inhibitors (MAOIs; e.g., moclobemide, rasagiline, selegiline, tranylcypromine)
  • muscle relaxants (e.g., baclofen, cyclobenzaprine, methocarbamol, orphenadrine, tizanidine) 
  • nabilone
  • narcotic pain relievers (e.g., codeine, fentanyl, morphine, oxycodone, tapentadol, tramadol)
  • nitroglycerin
  • obinutuzumab
  • pomalidomide
  • pregabalin
  • protein kinase inhibitors (e.g., bortezomib, ceritinib, crizotinib, dasatinib, idelalisib, imatinib, nilotinib, sunitinib) 
  • rifampin
  • riociguat
  • rivastigmine
  • sacubitril
  • St. John’s wort
  • scopolamine
  • seizure medications (e.g., carbamazepine, clobazam, levetiracetam, phenobarbital, phenytoin, primidone, topiramate, valproic acid, zonisamide) 
  • selective serotonin reuptake inhibitors (SSRIs; e.g., citalopram, fluoxetine, paroxetine, sertraline)
  • serotonin antagonists (antiemetics; e.g., granisetron, ondansetron)
  • serotonin/norepinephrine reuptake inhibitors (SNRIs; e.g., desvenlafaxine, duloxetine, venlafaxine)
  • tetrabenazine 
  • thalidomide
  • theophyllines (e.g., aminophylline, theophylline)
  • tretinoin
  • tricyclic antidepressants (e.g., amitriptyline, clomipramine, desipramine, imipramine) 
  • tryptophan
  • valerian
  • zolpidem
  • zopiclone

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

  • stop taking one of the medications,
  • change one of the medications to another,
  • change how you are taking one or both of the medications, or
  • leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

All material copyright MediResource Inc. 1996 – 2024. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Vraylar

Last Updated: 23/04/2024