Xcopri

Xcopri is a prescription medication used to treat partial-onset seizures in adults.

Xcopri belongs to a group of medications called anticonvulsants. It works by decreasing abnormal electrical activity in the brain.

This medication comes as a tablet to take by mouth. It is usually taken once daily with or without food, at around the same time every day. Swallow the tablets whole with liquid; do not split, chew, or crush them.

Common side effects include sleepiness, dizziness, double vision and headache. Do not drive, operate machinery, or do other dangerous activities until you know how Xcopri affects you.

Xcopri is a prescription medication used to treat partial-onset seizures in adults.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Xcopri. See the "Xcopri Precautions" section.

Common side effects include:

• feeling sleepy and tired 
• dizziness 
• double vision 
• headache

Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of Xcopri.

For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. 

Especially tell your doctor if you take: 

• carbamazepine (Equetro, Tegretol, Teril)
• clobazam (Sympazan)
• lamotrigine (Lamictal)
• phenobarbital
• phenytoin (Dilantin, Phenytek)
• sedatives
• sleeping pills
• tranquilizers

This is not a complete list of Xcopri drug interactions. Ask your doctor or pharmacist for more information.

Bonsity may cause serious side effects including:

Serious or life threatening allergic reactions which may affect organs and other parts of your body like the liver or blood cells. You may or may not have a rash with these types of reactions.
Call your healthcare provider right away and go to the nearest emergency room if you have any of the following:

These symptoms may be the first signs of a serious reaction. A healthcare provider should examine you to decide if you should continue taking Xcopri.

• swelling of your face, eyes, lips, or tongue
• trouble swallowing or breathing
• a skin rash
• hives
• fever, swollen glands, or sore throat that does not go away or comes and goes
• painful sores in the mouth or around your eyes
• yellowing of your skin or eyes
• unusual bruising or bleeding
• severe fatigue or weakness
• severe muscle pain
• frequent infections that do not go away

Like other antiepileptic drugs, Xcopri may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. 
Call a healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you:

• thoughts about suicide or dying
• attempts to commit suicide
• new or worse depression
• new or worse anxiety
• feeling agitated or restless
• panic attacks
• trouble sleeping (insomnia)
• new or worse irritability
• acting aggressive, being angry, or violent
• acting on dangerous impulses
• an extreme increase in activity and talking (mania)
• other unusual changes in behavior or mood
• Suicidal thoughts or actions may be caused by things other than medicines. If you have suicidal thoughts or actions, your healthcare provider may check for other causes.

Watch for early symptoms of suicidal thoughts and actions. Pay attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. Keep all follow-up visits with your healthcare provider as scheduled.

Call your healthcare provider between visits as needed, especially if you are worried about symptoms. 

Xcopri may cause problems with the electrical system of the heart (QT shortening). Call your healthcare provider if you have symptoms of QT shortening including fast heartbeat (heart palpitations) that last a long time or fainting. 

Xcopri may cause nervous system problems. Xcopri may cause problems that can affect your nervous system. Symptoms of nervous system problems include:

• dizziness
• trouble walking or with coordination
• feeling sleepy and tired
• trouble concentrating, remembering, and thinking clearly
• vision problems

Do not stop taking Xcopri without first talking to your healthcare provider.

• Stopping Xcopri suddenly can cause serious problems.
• Stopping a seizure medicine suddenly can cause seizures that will not stop (status epilepticus).

Xcopri is a federally controlled substance (CV) because it can be abused or lead to dependence. Keep Xcopri in a safe place to prevent misuse and abuse. Tell your healthcare provider if you have ever abused or been dependent on alcohol, prescription medicines, or street drugs. Selling or giving away Xcopri may harm others and is against the law.

Do not take Xcopri if you:

• are allergic to cenobamate, any of the other ingredients in Xcopri. 
• have a genetic problem (called familial short QT syndrome) that affects the electrical system of the heart.

Do not drive, operate machinery, or do other dangerous activities until you know how Xcopri affects you. Xcopri may slow your thinking and motor skills and may affect your vision.

Do not drink alcohol or take other medicines that can make you sleepy or dizzy while taking Xcopri without first talking to your healthcare provider.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Xcopri, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Xcopri, tell your healthcare provider about all your medical conditions, including if you: 

• have or had depression, mood problems, or suicidal thoughts or actions.
• have liver, kidney, or blood problems.
• have had an allergic reaction to a medicine which caused a rash or affected internal organs, like the liver or blood cells. 
• use birth control medicine. Xcopri may cause your birth control medicine to be less effective. Talk to your healthcare provider about the best birth control method to use while taking Xcopri.
• are pregnant or plan to become pregnant. It is not known if Xcopri will harm your unborn baby. Tell your healthcare provider right away if you become pregnant while taking Xcopri. You and your healthcare provider will decide if you should take Xcopri while you are pregnant.
  • If you become pregnant while taking Xcopri, talk to your healthcare provider about registering with the North American Antiepileptic Drug (NAAED) Pregnancy Registry. The purpose of this registry is to collect information about the safety of antiepileptic medicine during pregnancy. You can enroll in this registry by calling 1-888-233-2334 or go to www.aedpregnancyregistry.org
• are breastfeeding or plan to breastfeed. It is not known if Xcopri passes into breastmilk. Talk to your healthcare provider about the best way to feed your baby while taking Xcopri.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Tell your healthcare provider if you are pregnant or plan to become pregnant. It is not known if Xcopri will harm your unborn baby. Tell your healthcare provider right away if you become pregnant while taking Xcopri. You and your healthcare provider will decide if you should take Xcopri while you are pregnant.

In animal studies, pregnant animals were given Xcopri and the babies showed adverse effects on development (increased embryofetal mortality, decreased fetal and offspring body weights, neurobehavioral and reproductive impairment in offspring) at clinically relevant drug exposures.

• If you become pregnant while taking Xcopri, talk to your healthcare provider about registering with the North American Antiepileptic Drug (NAAED) Pregnancy Registry. The purpose of this registry is to collect information about the safety of antiepileptic medicine during pregnancy. You can enroll in this registry by calling 1-888-233-2334 or go to www.aedpregnancyregistry.org

Tell your healthcare provider if you are breastfeeding or plan to breastfeed. It is not known if Xcopri passes into breastmilk. Talk to your healthcare provider about the best way to feed your baby while taking Xcopri.

• Take Xcopri exactly as your healthcare provider tells you to take it.
• It is very important to increase your dose of Xcopri slowly, as instructed by your healthcare provider.
• Do not stop taking Xcopri without talking to your healthcare provider. Stopping Xcopri suddenly can cause serious problems, including seizures that will not stop (status epilepticus).
• Your healthcare provider may change your dose, if needed.
• Your healthcare provider will tell you how much Xcopri to take.
• Xcopri can be taken at any time of day, with or without food. 
• Swallow tablets whole with liquid. Do not crush or chew. 
• Talk with your healthcare provider about what you should do if you miss a dose.

Take this medication exactly as prescibed by your doctor. Follow the directions on your prescription label carefully. 

The recommended maintenance dosage is 200 mg once daily. The maximum daily dosage is 400 mg once daily.

Your healthcare provider will decide on your starting dose and gradually increase your dose until you reach your maintenance dose.

If you take too much Xcopri, call your healthcare provider or local poison control center, or seek emergency medical attention right away.

• Store Xcopri at room temperature between 68℉ to 77℉ (20℃ to 25℃).
• Safely throw away medicine that is out of date or no longer needed.
• Keep Xcopri and all medicines out of the reach of children.