What is Oxtellar XR?

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.

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.

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 together with other medicines:
      • Adults—At first, 600 milligrams (mg) once a day. Your doctor may adjust your dose 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 17 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.

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.

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.

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:

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.

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.

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.

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.

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.

• 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
• Benzhydrocodone
• Buprenorphine
• Calcifediol
• Cilostazol
• Citalopram
• Clarithromycin
• Cobicistat
• Codeine
• Daclatasvir
• Darunavir
• Desogestrel
• Dienogest
• Dihydrocodeine
• Dolutegravir
• Doxorubicin
• Doxorubicin Hydrochloride Liposome
• Drospirenone
• Elvitegravir
• Enzalutamide
• Estradiol
• Ethinyl Estradiol
• Ethynodiol
• Etonogestrel
• Fentanyl
• Gestodene
• Hemin
• Hydrocodone
• Ifosfamide
• Ledipasvir
• Levonorgestrel
• Linagliptin
• Meperidine
• Mestranol
• Methadone
• Naloxegol
• Nifedipine
• Norethindrone
• Norgestimate
• Norgestrel
• Orlistat
• Oxycodone
• Palbociclib
• Panobinostat
• Pentazocine
• Perampanel
• Rivaroxaban
• Sertraline
• Simeprevir
• Sufentanil
• Tacrolimus
• Tenofovir Alafenamide
• Tolvaptan
• Tramadol
• Tranylcypromine
• Velpatasvir
• Vilazodone
• Voxilaprevir

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.

• Carbamazepine
• Felodipine
• Fosphenytoin
• Ginkgo
• Lamotrigine
• Ospemifene
• Phenobarbital
• Phenytoin
• Rifampin
• Simvastatin
• Valproic Acid
• Verapamil

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.

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.

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 taking 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 taking 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 taking this medicine.

This medicine may cause serious types of allergic reactions, including anaphylaxis and angioedema. These 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, trouble 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-colored 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.

If you or your child develop any unusual or strange thoughts and behavior while taking this medicine, be sure to discuss it with your doctor. Other changes might be confusion, worsening of depression, hallucinations (seeing, hearing, or feeling things that are not there), suicidal thoughts, and unusual excitement, nervousness, or irritability.

Do not stop using this medicine suddenly without talking 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. Make sure you know how you react to this medicine before you drive, use machines, 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.

Do not take other medicines unless they have been discussed with your doctor. 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 medicines for hay fever, allergies or colds, sedatives, tranquilizers, or sleeping medicine, prescription pain medicine or narcotics, and other medicines for seizures.

Oral contraceptives (birth control pills) containing estrogen 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.