Oxcarbazepine

WHY is this medicine prescribed?

Oxcarbazepine (Trileptal) is used alone or in combination with other medications to control certain types of seizures in adults and children. Oxcarbazepine extended-release tablets (Oxtellar XR) are used in combination with other medications to control certain types of seizures in adults and children 6 years of age and older. Oxcarbazepine is in a class of medications called anticonvulsants. It works by decreasing abnormal electrical activity in the brain.

Are there OTHER USES for this medicine?

Oxcarbazepine is also sometimes used to treat bipolar disorder (manic-depressive disorder; a disease that causes episodes of depression, episodes of frenzied abnormal excitement, and other abnormal moods). Talk to your doctor about the possible risks of using this medication for your condition.

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

HOW should this medicine be used?

Oxcarbazepine comes as a tablet, an extended-release tablet, and a suspension (liquid) to take by mouth. The tablet and suspension are usually taken every 12 hours (twice a day) with or without food. The extended-release tablet is usually taken once a day on an empty stomach, 1 hour before or 2 hours after a meal. Take oxcarbazepine at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take oxcarbazepine exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Shake the suspension well right before each use to mix the medication evenly. Use the oral dosing syringe that came with the medication to withdraw the right amount of suspension from the bottle. You can swallow the suspension straight from the syringe or you can mix it with a small glass of water and swallow the mixture. Wash the syringe with warm water and allow it to dry thoroughly after use.

Swallow the extended-release tablets whole with water or another liquid; do not split, chew, or crush them.

Your doctor will probably start you on a low dose of oxcarbazepine and gradually increase your dose, not more often than once every 3 days. If you were taking another medication to treat your seizures and are switching to oxcarbazepine, your doctor may gradually decrease your dose of the other medication while increasing your dose of oxcarbazepine. Follow these directions carefully and ask your doctor if you are not sure how much medication you should take.

Oxcarbazepine may help control your seizures but will not cure your condition. Continue to take oxcarbazepine even if you feel well. Do not stop taking oxcarbazepine without talking to your doctor, even if you experience side effects such as unusual changes in behavior or mood. If you suddenly stop taking oxcarbazepine, your seizures may get worse. Your doctor will probably decrease your dose gradually.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with oxcarbazepine and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (https://www.fda.gov/Drugs) or the manufacturer's website to obtain the Medication Guide.

What SPECIAL PRECAUTIONS should I follow?

Before taking oxcarbazepine:

• tell your doctor and pharmacist if you are allergic to oxcarbazepine, carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), any other medications, or any of the inactive ingredients in oxcarbazepine tablets, extended release tablets, or suspension. Ask your pharmacist for a list of the inactive ingredients in oxcarbazepine tablets or suspension.

• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take while taking oxcarbazepine. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• you should know that oxcarbazepine may decrease the effectiveness of hormonal contraceptives (birth control pills, patches, rings, and injections). You will need to use another method of contraception to prevent pregnancy while taking oxcarbazepine. Talk to your doctor about other ways to prevent pregnancy while you are taking this medication.

• tell your doctor if you have or have ever had kidney or liver disease.

• tell your doctor if you are of Chinese, Thai, Malaysian, Korean, Indian, or Filipino descent. The risk of life-threatening allergic reactions called Stevens-Johnson syndrome (SJS) or toxic epidermal necrolysis (TEN) is increased in people of Asian ancestry who have a genetic (inherited) risk factor. If you are Asian, your doctor may order a test to see if you have the genetic risk factor before prescribing oxcarbazepine.

• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you are using hormonal contraceptives, you should know that this type of birth control may not work well when used with oxcarbazepine. Hormonal contraceptives should not be used as your only method of birth control while you are taking this medication. Talk to your doctor about birth control methods that will work for you. Call your doctor if you miss a period or think you may be pregnant while you are taking oxcarbazepine.

• you should know that this medication may make you drowsy or dizzy, affect the way you move, or may cause double vision or other vision changes. Do not drive a car or operate machinery until you know how this medication affects you.

• remember that alcohol can add to the drowsiness caused by this medication.

• you should know that your mental health may change in unexpected ways and you may become suicidal (thinking about harming or killing yourself or planning or trying to do so) while you are taking oxcarbazepine for the treatment of epilepsy, mental illness, or other conditions. A small number of adults and children 5 years of age and older (about 1 in 500 people) who took anticonvulsants such as oxcarbazepine to treat various conditions during clinical studies became suicidal during their treatment. Some of these people developed suicidal thoughts and behavior as early as 1 week after they started taking the medication. There is a risk that you may experience changes in your mental health if you take an anticonvulsant medication such as oxcarbazepine, but there may also be a risk that you will experience changes in your mental health if your condition is not treated. You and your doctor will decide whether the risks of taking an anticonvulsant medication are greater than the risks of not taking the medication. You, your family, or your caregiver should call your doctor right away if you experience any of the following symptoms: panic attacks; agitation or restlessness; new or worsening irritability, anxiety, or depression; acting on dangerous impulses; difficulty falling or staying asleep; aggressive, angry, or violent behavior; mania (frenzied, abnormally excited mood); talking or thinking about wanting to hurt yourself or end your life; withdrawing from friends and family; preoccupation with death and dying; giving away prized possessions; or any other unusual changes in behavior or mood. Be sure that your family or caregiver knows which symptoms may be serious so they can call the doctor if you are unable to seek treatment on your own.

What SPECIAL DIETARY instructions should I follow?

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

What should I do IF I FORGET to take a dose?

Before you begin your treatment, talk to your doctor about what you should do if you accidentally miss a dose. Be sure to ask your doctor how long you should wait between taking a missed dose and taking your next scheduled dose of oxcarbazepine. Do not take a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

Oxcarbazepine may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• fast, repeating eye movements that you cannot control
• diarrhea
• constipation
• heartburn
• stomach pain
• nausea
• vomiting
• loss of appetite
• changes in the way food tastes
• dry mouth
• thirst
• weight gain
• headache
• shaking of a part of the body that you cannot control; difficulty coordinating movements; falling down
• slowed movements or thoughts; forgetfulness, difficulty concentrating, and speech problems
• back, arm, or leg pain
• muscle weakness or sudden tightness
• increased sweating
• swelling, redness, irritation, burning, or itching of the vagina, white vaginal discharge

Some side effects can be serious. If you experience any of the following symptoms, call your doctor immediately:

• rash; hives; swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs: or difficulty swallowing or breathing
• nausea, headache, lack of energy, confusion, or seizures that last longer or happen more often than in the past
• peeling, blistering, or shedding skin
• rash; hives; sores in mouth or around eyes; fever; extreme tiredness; chest pain; muscle weakness or pain; swelling of the face, neck, groin, or underarm area; yellowing of the skin or eyes; unusual bleeding or bruising; bloody, cloudy, increased, decreased, or painful urination
• sore throat, cough, chills, and other signs of infection

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach and sight of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Store the extended-release tablets away from light. Dispose of any unused suspension 7 weeks after the bottle is first opened.

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 (https://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

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. https://www.upandaway.org

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your response to oxcarbazepine.

Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking oxcarbazepine.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

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.