Description
Cenobamate is used treat partial-onset seizures. This medicine is an anticonvulsant that works in the brain tissue to stop seizures.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Tablet
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. 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 health care 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
Appropriate studies have not been performed on the relationship of age to the effects of cenobamate in the pediatric population. Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of cenobamate in the elderly. However, elderly patients are more likely to have age-related heart, kidney, or liver problems, which may require caution and an adjustment in the dose for patients receiving cenobamate.
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 not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Lonafarnib
- Mavacamten
- Ranolazine
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.
- Amiodarone
- Atazanavir
- Atogepant
- Atrasentan
- Avacopan
- Avapritinib
- Bedaquiline
- Belzutifan
- Benzhydrocodone
- Buprenorphine
- Bupropion
- Cabozantinib
- Capivasertib
- Capmatinib
- Cariprazine
- Citalopram
- Clarithromycin
- Codeine
- Crinecerfont
- Cyclosporine
- Daridorexant
- Defactinib
- Desogestrel
- Deutivacaftor
- Dienogest
- Dihydrocodeine
- Diltiazem
- Drospirenone
- Duvelisib
- Elacestrant
- Encorafenib
- Ensartinib
- Entrectinib
- Erdafitinib
- Estetrol
- Estradiol
- Ethinyl Estradiol
- Ethynodiol
- Etonogestrel
- Fedratinib
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:
- Depression or
- Drug abuse or dependence or
- Heart rhythm problems (eg, QT shortening) or
- Mental illness—Use with caution. May make these conditions worse.
- Heart rhythm problems (eg, familial short QT syndrome)—Should not be used in patients with this condition.
- Kidney disease, end stage or
- Liver disease, severe—Use is not recommended in patients with these conditions.
- Kidney disease, mild to moderate or
- Liver disease, mild to moderate—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
Proper Use
Take this medicine exactly as directed by your doctor. 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.
This medicine comes with a Medication Guide. Read and follow the instructions carefully. Ask your doctor if you have any questions.
You may take this medicine with or without food.
If you are unable to swallow the tablet whole:
- You may crush the tablet and mix with 25 mL of water in a cup. Swirl the cup and swallow the mixture right away.
- Do not store the mixture for later use.
- Repeat until no pieces of tablet are left in the container.
You may also give the medicine through a nasogastric tube:
- You may crush the tablet and mix with 25 mL of water in a cup. Swirl the cup until the tablets are completely dissolved.
- Give the mixture right away with a syringe into the feeding tube.
- Add 10 mL water into the syringe. Swirl gently and give into the feeding tube. Repeat this step to make sure that no pieces of tablet are left in the syringe.
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 (tablets):
- For partial-onset seizures:
- Adults—12.5 milligrams (mg) once a day for 2 weeks. Your doctor will adjust your dose as needed and tolerated. However, the dose is usually not more than 400 mg per day.
- Children—Use and dose must be determined by your doctor.
- For partial-onset seizures:
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.
Precautions
It is very important that your doctor check your progress at regular visits. This is necessary to allow dose adjustments and to check for serious unwanted effects.
Serious skin reactions (including drug reaction with eosinophilia and systemic symptoms (DRESS) may occur during treatment with cenobamate. Tell your doctor right away if you have chest pain, chills, cough, fever, painful or difficult urination, sore throat, sores, ulcers, or white spots on the lips or in the mouth, swollen glands, trouble breathing, unusual bleeding or bruising, or unusual tiredness or weakness.
Contact your doctor right away if you have any changes to your heart rhythm. You might feel dizzy or faint, or you might have a fast or uneven heartbeat that last a long time. These may be symptoms of a heart rhythm problem called QT shortening.
This medicine may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. If you, your child, or your caregiver notice any of these unwanted effects, tell your doctor right away.
Cenobamate may cause blurred vision, double vision, or other changes in vision. It may also cause some people to become dizzy, drowsy, clumsy, or feel tired. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert or able to see well.
Do not stop taking cenobamate without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are taking before stopping completely. Stopping the medicine suddenly may cause your seizures to return or to occur more often.
This medicine will add to the effects of alcohol and other CNS depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds, sedatives, tranquilizers, or sleeping medicine, prescription pain medicine or narcotics, barbiturates, medicine for seizures, muscle relaxants, or anesthetics, including some dental anesthetics. Check with your doctor or dentist before taking any of the above while you are taking this medicine.
Birth control pills may not work while you are using cenobamate. To keep from getting pregnant, use another form of birth control including condoms, diaphragms, or contraceptive foams or jellies.
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.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. 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:
Less common
- Fast, irregular, pounding, or racing heartbeat or pulse
Incidence not known
- Black, tarry stools
- bloody or cloudy urine
- changes in behavior
- chest pain or discomfort
- chills
- confusion
- cough
- dark urine
- difficulty in breathing
- discouragement
- drowsiness
- false or unusual sense of well-being
- fast heartbeat
- feeling sad or empty
- fever
- general tiredness and weakness
- headache
- irritability
- lack of appetite
- light-colored stools
- loss of interest or pleasure
- muscle pain
- nausea and vomiting
- painful or difficult urination
- rash sore throat
- sores, ulcers, or white spots on the lips or in the mouth
- swelling of the face, feet, or lower legs
- swollen glands
- swollen, painful, or tender lymph glands in the neck, armpit, or groin
- thoughts of killing oneself
- tiredness
- trouble concentrating
- trouble sleeping
- unusual tiredness or weakness
- unusual weight gain
- upper right abdominal or stomach pain
- yellow eyes and 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
- Blurred vision
- change in walking and balance
- changes in patterns and rhythms of speech
- clumsiness or unsteadiness
- constipation
- dizziness or lightheadedness
- double vision
- feeling of constant movement of self or surroundings
- seeing double
- sensation of spinning
- shakiness and unsteady walk
- sleepiness or unusual drowsiness
- slurred speech
- trouble in speaking
- uncontrolled eye movements
- unsteadiness, trembling, or other problems with muscle control or coordination
Less common
- Acid or sour stomach
- back pain
- belching
- change in taste
- decreased appetite
- diarrhea
- dry mouth
- heartburn
- impaired memory
- indigestion
- itching skin
- lack or loss of strength
- loss of taste
- muscle aches
- problems with speech or speaking
- sore throat
- stomach discomfort, pain, or upset
- stuffy or runny nose
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.
DRG-20476988
