XCopri

Brand Name

XCopri

Common Name

cenobamate

In this drug factsheet:

• How does this medication work? What will it do for me?
• How should I use this medication?
• What form(s) does this medication come in?
• Who should NOT take this medication?
• What side effects are possible with this medication?
• Are there any other precautions or warnings for this medication?
• What other drugs could interact with this medication?

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

Cenobamate belongs to the class of medications called anti-epileptic agents. It is used in addition to other seizure medications to treat partial-onset seizures that are not controlled with other medications. It works on the nervous system (CNS) in the brain to reduce the number and severity of seizures.

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.

How should I use this medication?

The usual starting dose is 12.5 mg taken by mouth once daily, for 2 weeks. The dose is then doubled every 2 weeks until you reach a dose that is effective, with minimal side effects. Most people can remain on a dose of 200 mg daily, however, if necessary, a maximum daily dose of 400 mg may be taken. Cenobamate may be taken with or without food and should be taken at approximately the same time every day. Swallow the tablets whole with some liquid. Do not split, crush, or chew the tablets.

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 less than 12 hours before 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.

What form(s) does this medication come in?

12.5 mg
Each uncoated, round, white-to-off-white tablet, with SK on one side and '12' on the other side, contains 12.5 mg of cenobamate. Nonmedicinal ingredients:  colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, purified water, and sodium starch glycolate.

25 mg
Each film-coated, round, brown tablet, with SK on one side and '25' on the other side, contains 25 mg of cenobamate. Nonmedicinal ingredients:  colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, purified water, and sodium starch glycolate; film coating: FD&C blue indigo carmine, aluminum lake, iron oxide red, iron oxide yellow, macrogol/PEG, polyvinyl alcohol-partially hydrolyzed, talc and titanium dioxide.

50 mg
Each film-coated, round, yellow tablet, with SK on one side and '50' on the other side, contains 50 mg of cenobamate.  Nonmedicinal ingredients:  colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, purified water, and sodium starch glycolate; film coating: iron oxide yellow, macrogol/PEG, polyvinyl alcohol – partially hydrolyzed, talc and titanium dioxide.

100 mg
Each film-coated, round, brown tablet, with SK on one side and '100' on the other side, contains 100 mg of cenobamate. Nonmedicinal ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, purified water, and sodium starch glycolate; film coating: FD&C blue indigo carmine, aluminum lake, iron oxide red, iron oxide yellow, macrogol/PEG, polyvinyl alcohol-partially hydrolyzed, talc and titanium dioxide.

150 mg
Each film-coated, round, light-orange tablet, with SK on one side and '150' on the other side, contains 150 mg of cenobamate. Nonmedicinal ingredients:  colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, purified water, and sodium starch glycolate; film coating: iron oxide red, iron oxide yellow, macrogol/PEG, polyvinyl alcohol – partially hydrolyzed, talc and titanium dioxide.

200 mg
Each film-coated, modified-oval, light-orange tablet, with SK on one side and '200' on the other side, contains 200 mg of cenobamate. Nonmedicinal ingredients:  colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, purified water, and sodium starch glycolate; film coating: iron oxide red, iron oxide yellow, macrogol/PEG, polyvinyl alcohol – partially hydrolyzed, talc and titanium dioxide.

Who should NOT take this medication?

Do not take this medication if you:

• are allergic to cenobamate or any ingredients of the medication
• have been diagnosed with familial short QT syndrome or have a history of the irregular heart rhythm called short QT syndrome

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.

• back pain
• constipation
• decreased appetite
• diarrhea
• dizziness
• dry mouth
• fatigue
• headache
• nausea
• runny or stuffy nose
• sleepiness
• sore throat
• toothache
• trouble sleeping
• vomiting
• weakness

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:

• abdominal pain
• anxiety
• behaviour changes (e.g., aggression, hostility, irritability)
• blurred or double vision
• decreased coordination
• delusions (false or strange thoughts)
• difficult or slurred speech
• difficulty concentrating, remembering, or thinking clearly
• hallucinations (seeing or hearing things that aren’t there)
• paranoia (intense feeling of distrust or fear of persecution)
• rapid, repetitive eye movement
• shortness of breath
• signs of depression (e.g., poor concentration, changes in weight, changes in sleep, decreased interest in activities, thoughts of suicide)
• spinning sensation
• symptoms of irregular heartbeat (e.g., chest pain, dizziness, rapid, pounding heartbeat, shortness of breath)
• symptoms of a urinary tract infection (e.g. pain when urinating, urinating more often than usual, low back or flank pain)
• tremors

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

• 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 appendicitis (e.g., bloating, constipation or diarrhea, fever, loss of appetite, nausea, sudden pain in the right lower abdomen, vomiting)
• symptoms of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, swelling of the face and throat)
• thoughts of hurting yourself or others

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.

Behaviour and mood changes: This medication has been known to cause changes in behaviour. If you have a history of mental illness, 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. You may notice feelings of aggression, anger, anxiety, or irritability. Cenobamate has also been associated with hallucinations and feelings of paranoia. If you experience these side effects, contact your doctor.

Birth control: As with other seizure medications, cenobamate may reduce the effectiveness of hormonal birth control. People who are taking cenobamate and may become pregnant should use a barrier method of birth control in addition to hormonal birth control while taking this medication and for at least 3 weeks after the last dose.

Dependence and withdrawal: Cenobamate has been associated with physical dependence (a need to take regular doses to prevent physical symptoms) and may be linked to abuse, due to the ability of the drug to cause feelings of euphoria, relaxation, and drunkenness. Withdrawal symptoms may be experienced if the dose is significantly reduced or suddenly discontinued. These symptoms include memory loss, decreased appetite, sleep problems, tremors, and depression. Reducing the dose gradually under medical supervision can help prevent or decrease these withdrawal symptoms when this medication is no longer required.

Drowsiness/reduced alertness: Cenobamate may affect the mental or physical abilities needed to drive or operate machinery. Avoid driving, operating machinery, or performing other hazardous tasks until you have determined how this medication affects you.

Heart rhythm: Cenobamate can cause changes to the normal rhythm of the heart, including an irregular heartbeat called short QT syndrome. Short QT syndrome is a serious life-threatening condition that can cause fainting, seizures, and sudden death. If you are at risk for heart rhythm problems (e.g., people with heart failure, angina, low potassium or magnesium levels), 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.

Hypersensitivity reactions:  In rare cases, a severe type of allergic reaction called Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS syndrome) may occur. This reaction involves symptoms including fever, swollen glands, yellowing of the skin or eyes, flu-like symptoms with skin rash or blistering, or other organ involvement. These reactions are medical emergencies. Get immediate medical attention if you have symptoms of a severe allergic reaction. If you experience any unusual symptoms, contact your doctor.

Kidney function: Decreased kidney function or kidney disease may cause this medication to build up in the body causing side effects. If you have reduced kidney function, 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.

Liver function:  Liver disease or reduced liver function may cause this medication to build up in the body, causing side effects. If you have liver problems, 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.

Stopping the medication: Cenobamate should not be stopped suddenly, as this can cause seizures to increase in frequency and severity. If you need to stop taking this medication, it should be reduced gradually. Talk to your doctor about the best way to stop this medication.

Suicidal thoughts: There is a small risk that this medication may result in thoughts of suicide. If you experience these symptoms or any other behaviour change while taking this medication, contact your doctor immediately. Family members or caregivers of people who are taking this medication should contact the person's doctor immediately if they notice unusual behaviour changes.

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.

Breast-feeding: It is not known if cenobamate passes into breast milk. If you are breast-feeding and 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: The safety and effectiveness of this medication when used by seniors has not been well studied. Seniors may be more likely to experience side effects and may require doses that are lower than usual.

What other drugs could interact with this medication?

For a full list of interactions, use the Drug Interaction Checker available on the Drugs.com website.

If you are taking other 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.

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/XCopri