Cenobamate is used to treat partial-onset seizures in adults.

Cenobamate may also be used for purposes not listed in this medication guide.

Cenobamate can cause serious or life-threatening allergic reactions that can affect your liver, blood cells, or other parts of the body. Call your doctor or get emergency medical help if you have symptoms such as: severe weakness or muscle pain, a fever, swollen glands, unusual bruising or bleeding, swelling in your face or throat, trouble breathing, hives or a rash, yellowing of your skin or eyes, or any illness that does not get better.

Some people have thoughts about suicide while taking cenobamate. Stay alert to changes in your mood or symptoms. Report any new or worsening symptoms to your doctor.

Do not stop using cenobamate suddenly. Follow your doctor's instructions about tapering your dose.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

You may take cenobamate with or without food.

Swallow the tablet whole with liquid. Do not crush, chew, or break the tablet.

Do not stop using cenobamate suddenly, even if you feel fine. Stopping suddenly may cause increased seizures or unpleasant withdrawal symptoms. Follow your doctor's instructions about tapering your dose.

Store at room temperature away from moisture and heat.

Usual Adult Dose for Seizures:

Initial dose: 12.5 mg orally once a day for weeks 1 and 2
Titration: 25 mg orally once a day for weeks 3 and 4; 50 mg orally once a day for weeks 5 and 6; 100 mg orally once a day for weeks 7 and 8; 150 mg orally once a day for weeks 9 and 10
Maintenance Dose (starting at week 11): 200 mg orally once a day
Maximum Dose: 400 mg orally once a day

Comments:
-This drug may be used as monotherapy or as adjunctive therapy.
-Dosage and titration should not be exceeded because of the potential for serious adverse reactions.
-Titration to the maximum dose should be accomplished in increments of 50 mg/day every 2 weeks; the decision to increase the dose above the maintenance dose should be based on clinical response and tolerability.

Use: For the treatment of partial-onset seizures.

You should not use cenobamate if you are allergic to it, or if you have:

• a genetic heart rhythm disorder called short QT syndrome.

Tell your doctor if you have ever had:

• depression, or a mood disorder;

• suicidal thoughts or actions;

• liver or kidney disease;

• a blood cell disorder; or

• an allergic reaction to a medicine that caused a rash or affected your internal organs or blood cells.

Some people have thoughts about suicide while taking cenobamate. Your doctor will need to check your progress at regular visits. Your family or other caregivers should also be alert to changes in your mood or symptoms.

Do not start or stop taking seizure medication during pregnancy without your doctor's advice. Having a seizure during pregnancy could harm both mother and baby. Tell your doctor right away if you become pregnant.

Cenobamate can make birth control pills less effective. Ask your doctor about using a non-oral birth control to prevent pregnancy. This includes injections, implants, skin patches, vaginal rings, condom, diaphragm, cervical cap, or contraceptive sponge.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of cenobamate on the baby.

It may not be safe to breastfeed while using cenobamate. Ask your doctor about any risk.

Cenobamate is not approved for use by anyone younger than 18 years old.

Call your doctor for instructions if you miss a dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

Unless your doctor tells you otherwise, continue your normal diet.

cenobamate may cause blurred vision and may impair your reactions. Avoid driving or hazardous activity until you know how this medicine will affect you.

Drinking alcohol with this medicine can cause side effects.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include: skin rash, fever, swollen glands, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes.

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

Cenobamate can cause serious or life-threatening allergic reactions that can affect your liver, blood cells, or other parts of the body. Call your doctor or get emergency medical help if you have symptoms such as:

• fast or pounding heartbeats, fluttering in your chest, and sudden dizziness (like you might pass out);

• feeling very weak or tired;

• severe muscle pain;

• fever, swollen glands, sore throat; unusual bruising or bleeding;

• painful sores in your mouth or around your eyes;

• swelling in your face, mouth, or throat;

• trouble breathing or swallowing;

• hives or a rash;

• yellowing of your skin or eyes;

• any infection or illness that does not get better; or

• nervous system problems--dizziness, trouble walking, loss of coordination, vision problems, drowsiness, tiredness, problems with thinking or memory.

Common side effects of cenobamate may include:

• feeling tired;

• dizziness, drowsiness;

• double vision; or

• headache.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your doctor about all your other seizure medications.

Using cenobamate with other drugs that make you dizzy or drowsy can worsen this effect. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Other drugs may affect cenobamate, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Keep all appointments with your doctor.

Do not let anyone else take your medication. Cenobamate is a controlled substance. Prescriptions may be refilled only a limited number of times; ask your pharmacist if you have any questions.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.