Pronunciation:

ox-kar-BAZ-e-peen

Brand Names:

• Trileptal

Dosage Forms:

• Tablet, Extended Release
• Suspension
• Tablet

Classifications:

Therapeutic—

Anticonvulsant

Chemical—

Dibenzazepine Carboxamide

Uses of This Medicine:

Oxcarbazepine is used alone or together with other medicines in the treatment of epilepsy to control partial seizures. It works in the brain to prevent seizures. However, this medicine will not cure epilepsy and will only control seizures for as long as you continue to take it.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

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.

Children—

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of oxcarbazepine suspension or tablets in children 2 years of age and older.

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of oxcarbazepine extended-release tablets in children 6 years of age and older. However, use of the extended-release tablets is not recommended in children younger than 6 years of age.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of oxcarbazepine in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require caution and an adjustment in the dose for patients receiving oxcarbazepine.

Breast-feeding—

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.

Other medicines—

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.

• Cabotegravir
• Doravirine
• Rilpivirine

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.

• Alfentanil
• Amiodarone
• Apixaban
• Atazanavir
• Atogepant
• Belzutifan
• Benzhydrocodone
• Buprenorphine
• Calcifediol
• Carbamazepine
• Cilostazol
• Citalopram
• Cobicistat
• Codeine
• Cyclosporine
• Daclatasvir
• Darunavir
• Desogestrel
• Dienogest
• Dihydrocodeine
• Dolutegravir
• Doxorubicin
• Doxorubicin Hydrochloride Liposome
• Dronedarone
• Drospirenone
• Elvitegravir
• Enzalutamide
• Estetrol
• Estradiol
• Ethinyl Estradiol
• Ethynodiol
• Etonogestrel
• Fentanyl
• Fexinidazole
• Fosphenytoin
• Gestodene
• Hemin
• Hydrocodone
• Ifosfamide
• Ledipasvir
• Lenacapavir
• Levonorgestrel
• Linagliptin
• Lumacaftor
• Lumateperone
• Lurasidone
• Medroxyprogesterone
• Meperidine
• Mestranol
• Methadone
• Mitotane
• Naloxegol
• Nifedipine
• Nomegestrol
• Norelgestromin
• Norethindrone
• Norgestimate
• Norgestrel
• Oliceridine
• Orlistat
• Oxycodone
• Paclitaxel
• Palbociclib
• Panobinostat
• Pentazocine
• Perampanel
• Phenobarbital
• Phenytoin
• Primidone
• Rifampin
• Rivaroxaban
• Segesterone
• Sertraline
• Simeprevir
• St John's Wort
• Sufentanil
• Tacrolimus
• Tenofovir Alafenamide
• Tolvaptan
• Tramadol
• Tranylcypromine
• Ubrogepant
• Ulipristal
• Voxilaprevir
• Zolpidem
• Zuranolone

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Felodipine
• Ginkgo
• Lamotrigine
• Ospemifene
• Simvastatin
• Valproic Acid
• Verapamil

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
• Hyponatremia (low sodium in the blood)—Use with caution. May make these conditions worse.

• Kidney disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

• Liver disease, severe—Use is not recommended in patients with this condition.

Proper Use of This Medicine:

Take this medicine only 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.

Take the oral liquid or regular tablet with or without food. Take the extended-release tablet on an empty stomach, at least 1 hour before or 2 hours after a meal.

Swallow the extended-release tablet whole. Do not crush, break, or chew it.

For the oral liquid:

• Shake the bottle well before measuring the dose.
• Use the oral dosing syringe supplied in the package to measure each dose accurately.
• The dose of medicine can be mixed in a small glass of water just before taking it or you may swallow it directly from the syringe.
• After each use, close the bottle and rinse the syringe with warm water and allow it to dry completely before the next use.

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 (extended-release tablets):
  • For seizures:
    • For patients taking oxcarbazepine alone or together with other medicines:
      • Adults—At first, 600 milligrams (mg) once a day for 1 week. Your doctor may adjust your dose in the following weeks as needed. However, the dose is usually not more than 2400 mg per day.
      • Older adults—At first, 300 or 450 mg once a day. Your doctor may adjust your dose as needed.
      • Children 6 to 16 years of age—Dose is based on body weight and must be determined by your doctor. The starting dose is 8 to 10 milligrams (mg) per kilogram (kg) of body weight per day as a single dose. Your doctor may adjust your dose as needed. However, the dose is usually not more than 1800 mg per day.
      • Children younger than 6 years of age—Use is not recommended.
• For oral dosage forms (suspension and tablets):
  • For seizures:
    • For patients taking oxcarbazepine together with other medicines:
      • Adults and children 17 years of age and older—At first, 300 milligrams (mg) 2 times a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 1200 mg per day.
      • Children 4 to 16 years of age—Dose is based on body weight and must be determined by your doctor. The starting dose is 8 to 10 milligrams (mg) per kilogram (kg) of body weight per day, divided into 2 doses. Your doctor may adjust your dose as needed. However, the dose is usually not more than 600 mg per day, divided into 2 equal doses.
      • Children 2 to 4 years of age—Dose is based on body weight and must be determined by your doctor. The starting dose is 8 to 10 mg per kg of body weight per day, divided into 2 doses. For patients weighing less than 20 kg, the starting dose is 16 to 20 mg per kg of body weight per day, divided in 2 doses. Your doctor may adjust your dose as needed. However, the dose is usually not more than 600 mg per day, divided into 2 equal doses.
      • Children younger than 2 years of age—Use and dose must be determined by your doctor.
    • For patients switching from another medicine to oxcarbazepine:
      • Adults and children 17 years of age and older—At first, 300 milligrams (mg) 2 times a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 2400 mg per day.
      • Children 4 to 16 years of age—Dose is based on body weight and must be determined by your doctor. The starting dose is 8 to 10 milligrams (mg) per kilogram (kg) of body weight per day, divided into 2 doses. Your doctor may adjust your dose as needed.
      • Children younger than 4 years of age—Use and dose must be determined by your doctor.
    • For patients who are not taking any seizure medicine:
      • Adults and children 17 years of age and older—At first, 300 milligrams (mg) 2 times a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 1200 mg per day.
      • Children 4 to 16 years of age—Dose is based on body weight and must be determined by your doctor. The starting dose is 8 to 10 milligrams (mg) per kilogram (kg) of body weight per day, divided into 2 doses. Your doctor may adjust your dose as needed.
      • Children younger than 4 years of age—Use and dose must be determined by your doctor.

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.

Store the oral liquid in the original container. Use the liquid within 7 weeks after opening the bottle for the first time. Throw away any unused liquid.

Precautions While Using This Medicine:

It is very important that your doctor check you or your child's progress at regular visits. This is to make sure the medicine is working properly and to allow for changes in your dose. Blood tests will also be needed to check for unwanted effects.

Tell your doctor if you become pregnant while using this medicine. Your doctor may need you to be monitored carefully during your pregnancy and after giving birth.

Hyponatremia (low sodium in the blood) may occur while you are using this medicine. Check with your doctor right away if you or your child develop confusion, decreased urine output, dizziness, fast or irregular heartbeat, headache, muscle pain or cramps, nausea or vomiting, weakness, or swelling of the face, ankles, or hands while using this medicine.

This medicine may cause serious types of allergic reactions, including anaphylaxis and angioedema, which can be life-threatening and require immediate medical attention. Call your doctor right away if you or your child have itching, hives, hoarseness, trouble breathing or swallowing, or any swelling of your face, eyes, lips, tongue, arms, or legs while you are using this medicine.

This medicine may cause drug reaction with eosinophilia and systemic symptoms (DRESS). It is a serious allergic reaction that may affect several parts of the body (eg, liver, kidneys, muscle, joints). Check with your doctor right away if you or your child have more than one of the following symptoms: dark urine, extra fluid around the face, fever, headache, itching, joint swelling, muscle aches, rash, stomach pain, swollen glands, unusual tiredness, or yellow eyes or skin.

Serious skin reactions can occur with this medicine. Check with your doctor right away if you or your child have blistering, peeling, or loosening of the skin, red skin lesions, severe acne or skin rash, sores or ulcers on the skin, or fever or chills while you are using this medicine.

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. Make sure the doctor knows if you have trouble sleeping, get upset easily, have a big increase in energy, or start to act reckless. Also tell the doctor if you have sudden or strong feelings, such as feeling nervous, angry, restless, violent, or scared. If you or your caregiver notice any of these side effects, tell your doctor right away.

Do not stop using this medicine suddenly without talking first to your doctor. You may need to slowly decrease your dose before stopping it completely.

This medicine may cause some people to become dizzy, drowsy, lightheaded, clumsy, unsteady, or less alert than they are normally. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

This medicine can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. If you can, avoid people with infections. Check with your doctor immediately if you think you or your child have a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.

Check with your doctor before using this medicine with other medicines that affect the central nervous system (CNS). The use of other medicines that affect the CNS with oxcarbazepine may worsen the side effects of this medicine, such as dizziness, poor concentration, drowsiness, unusual dreams, and trouble with sleeping. Some examples of medicines that affect the CNS are antihistamines or medicine for allergies or colds, sedatives, tranquilizers, or sleeping medicines, medicine for depression, medicine for anxiety, prescription pain medicine or narcotics, medicine for attention deficit and hyperactivity disorder, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics.

Oral contraceptives (birth control pills) containing estrogen, ethinyl estradiol, levonorgestrel, or progestin, contraceptive progestin injections (eg, Depo-Provera®), and contraceptive implant forms of progestin (eg, Norplant®) may not work properly if you take them while you are taking oxcarbazepine. Unplanned pregnancies may occur. You should use a different or additional means of birth control while you are taking oxcarbazepine. If you have any questions about this, check with your doctor.

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 of This Medicine:

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:

More common

Change in vision

change in walking or balance

clumsiness or unsteadiness

cough

crying

dizziness

double vision

false sense of well-being

feeling of constant movement of self or surroundings

fever

mental depression

sensation of spinning

sneezing

sore throat

uncontrolled back-and-forth or rolling eye movements

Less common

Agitation

awkwardness

bloody or cloudy urine

blurred vision

bruising

confusion about identity, place, and time

decreased urination

difficulty with focusing the eyes

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

fast or irregular heartbeat

frequent falls

frequent urge to urinate

headache

hoarseness

increased thirst

loss of consciousness

memory loss

muscle cramps

pain or burning while urinating

pain or tenderness around the eyes or cheekbones

problems with coordination

shaking or trembling of the arms, legs, hands, and feet

seizures

skin rash

stuffy or runny nose

tightness in the chest

trouble with walking

troubled breathing

unusual feelings

unusual tiredness or weakness

Rare

Anxiety

bleeding or crusting sores on the lips

burning feeling in the chest or stomach

chest pain

chills

hives or welts, itching

irritability

joint pain

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals

muscle pain or weakness

purple spots on the skin

rectal bleeding

redness, blistering, peeling, or loosening of the skin

restlessness

sores, ulcers, or white spots in the mouth or on the lips

stomach upset

swelling of the legs

swollen glands

Incidence not known

Black, tarry stools

bloating

constipation

dark urine

decrease in height

decreased awareness or responsiveness

difficulty swallowing

dry skin and hair

fainting

feeling cold

hair loss

hostility

indigestion

loss of appetite

loss of consciousness

muscle stiffness or twitching

nausea

pain in the back, ribs, arms, or legs

pains in the stomach, side, or abdomen, possibly radiating to the back

pounding, slow heartbeat

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

rapid weight gain

severe sleepiness

swelling of the face, ankles, or hands

swollen, painful, or tender lymph glands in the neck, armpit, or groin

unusual bleeding or bruising

unusual drowsiness, dullness, or feeling of sluggishness

vomiting

weight gain

yellow eyes or 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

Burning feeling in the chest or stomach

sleepiness or unusual drowsiness

stomach pain

Less common

Acne

back pain

belching

bloody nose

change in your sense of taste

diarrhea

difficulty with speaking

dryness of the mouth

feeling of warmth and redness of the face, neck, arms, and occasionally chest

heartburn

increased sweating

increased urination

itching of the vagina

trouble sleeping

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.