oxcarbazepine

Pronunciation

Generic Name: oxcarbazepine (ox kar BAY zeh peen)
Brand Name: Oxtellar XR, Trileptal

What is oxcarbazepine?

Oxcarbazepine is in a group of drugs called anticonvulsants, or antiepileptic drugs. It works by decreasing nerve impulses that cause seizures.

Oxcarbazepine is used to treat partial seizures in adults and children who are at least 2 years old.

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

What is the most important information I should know about oxcarbazepine?

Oxcarbazepine is used to treat partial seizures in adults and children who are at least 2 years old.

Oxcarbazepine can reduce the sodium in your body to dangerously low levels, which can cause a life-threatening electrolyte imbalance. Contact your doctor right away if you have headache, problems with thinking or memory, weakness, loss of appetite, feeling unsteady, confusion, hallucinations, fainting, shallow breathing, and/or increased or more severe seizures.

Slideshow: Flashback: FDA Drug Approvals 2013

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.

What should I discuss with my healthcare provider before taking oxcarbazepine?

You should not take this medication if you are allergic to oxcarbazepine.

To make sure you can safely take oxcarbazepine, tell your doctor if you have:

  • liver disease;

  • kidney disease; or

  • if you are allergic to a similar medicine called carbamazepine (Carbatrol, Tegretol).

Some young people have thoughts about suicide when first taking an antidepressant. Your doctor will need to check your progress at regular visits while you are using oxcarbazepine. Your family or other caregivers should also be alert to changes in your mood or symptoms.

FDA pregnancy category C. Do not start or stop taking oxcarbazepine 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 while taking oxcarbazepine for seizures.

If you are pregnant, your name may be listed on a pregnancy registry. This is to track the outcome of the pregnancy and to evaluate any effects of oxcarbazepine on the baby.

Oxcarbazepine can make birth control pills less effective. Ask your doctor about using a non hormone method of birth control (such as a condom, diaphragm, spermicide) to prevent pregnancy while taking oxcarbazepine.

Oxcarbazepine can pass into breast milk and may harm a nursing baby. You should not breast-feed while you are taking oxcarbazepine.

Do not give this medication to a child younger than 2 years old.

How should I take oxcarbazepine?

Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Take oxcarbazepine with a full glass of water.

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

Shake the oral suspension (liquid) well just before you measure a dose. To be sure you get the correct dose, use the oral dosing syringe provided with this medicine. If you did not receive an oral syringe with your medication, ask your pharmacist for one.

Give the oral liquid directly from the oral syringe, or mix the medicine with a small glass of water. After using the syringe, rinse it with water and allow it to air dry.

Use oxcarbazepine regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Do not stop using oxcarbazepine suddenly, even if you feel fine. Stopping suddenly may cause increased seizures.

While using oxcarbazepine, you may need blood tests at your doctor's office. Visit your doctor regularly.

Wear a medical alert tag or carry an ID card stating that you take oxcarbazepine. Any medical care provider who treats you should know that you are using oxcarbazepine.

Seizures are often treated with a combination of drugs. Use all medications as directed by your doctor. Read the medication guide or patient instructions provided with each medication. Do not change your doses or medication schedule without your doctor's advice.

Store at room temperature away from moisture and heat. Throw away any unused liquid 7 weeks after opening the bottle.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

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

What should I avoid while taking oxcarbazepine?

Avoid becoming overheated or dehydrated during exercise and in hot weather. Follow your doctor's instructions about the type and amount of liquids you should drink. In some cases, drinking too much liquid can be as unsafe as not drinking enough.

Oxcarbazepine may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Drinking alcohol can increase certain side effects of oxcarbazepine. Alcohol may also increase the risk of seizures.

Oxcarbazepine side effects

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

Oxcarbazepine can reduce the sodium in your body to dangerously low levels, which can cause a life-threatening electrolyte imbalance. Contact your doctor right away if you have headache, trouble concentrating, memory problems, weakness, loss of appetite, feeling unsteady, confusion, hallucinations, fainting, shallow breathing, and/or increased or more severe seizures.

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, depression, anxiety, or if you feel agitated, hostile, restless, hyperactive (mentally or physically), or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have:

  • increased seizures;

  • swollen glands, fever, chills, body aches, flu symptoms, sores in your mouth and throat;

  • easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;

  • severe tingling, numbness, pain, muscle weakness;

  • urinating less than usual or not at all;

  • chest pain, dry cough, wheezing, feeling short of breath;

  • upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or

  • severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common side effects may include:

  • headache, mental slowness, trouble concentrating;

  • problems with speech, balance, or walking;

  • dizziness, drowsiness, tired feeling;

  • mild nausea, vomiting, upset stomach, diarrhea;

  • blurred vision, double vision;

  • tremors or shaking; or

  • skin rash.

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.

See also: Side effects (in more detail)

Oxcarbazepine Dosing Information

Usual Adult Dose for Seizures:

For use as adjunctive treatment or monotherapy in the treatment of partial seizures:

Adjunctive Therapy:
Initial Dose: 600 mg/day, (given as 300 mg twice a day). If clinically indicated, the dose may be increased by a maximum of 600 mg/day at approximately weekly intervals. The recommended daily dose is 1200 mg/day. Daily doses above 1200 mg/day have shown somewhat greater effectiveness in controlled trials, but most patients were not able to tolerate the 2400 mg/day dose, primarily because of CNS effects. It is recommended that the patient be observed closely and plasma levels of the concomitant antiepileptic drugs be monitored during the period of oxcarbazepine titration, as these plasma levels may be altered, especially at oxcarbazepine doses greater than 1200 mg/day.

Conversion to Monotherapy
Patients receiving concomitant antiepileptic drugs may be converted to monotherapy by initiating treatment with oxcarbazepine at 600 mg/day (given as 300 mg twice a day) while simultaneously reducing the dose of the concomitant antiepileptic drugs. The concomitant antiepileptic drugs should be completely withdrawn over 3 to 6 weeks, while the maximum dose of oxcarbazepine should be reached in about 2 to 4 weeks. Oxcarbazepine may be increased as clinically indicated by a maximum increment of 600 mg/day at approximately weekly intervals to achieve the recommended daily dose of 2400 mg/day. Patients should be observed closely during this transition phase.

Initiation of Monotherapy
Patients not currently being treated with antiepileptic drugs may have monotherapy initiated with oxcarbazepine. In these patients, oxcarbazepine should be initiated at a dose of 600 mg/day (given as 300 mg twice a day); the dose should be increased by 300 mg/day every third day to a dose of 1200 mg/day. A daily dose of 1200 mg/day has been shown in one study to be effective in patients in whom monotherapy has been initiated with oxcarbazepine.

Usual Pediatric Dose for Seizures:

For use as adjunctive treatment for partial seizures in children ages 2 to 16:

Initial Dose: 8-10 mg/kg generally not to exceed 600 mg/day, (given as 300 mg twice a day). The target maintenance dose of oxcarbazepine should be achieved over 2 weeks, and is dependent upon patient weight, according to the following:

20-29 kg: 900 mg/day

29.1-39 kg: 1200 mg/day

>39 kg: 1800 mg/day

2 to<4 years: Treatment should also be initiated at a daily dose of 8 to 10 mg/kg generally not to exceed 600 mg/day, given in a twice daily regimen.

For patients under 20 kg: A starting dose of 16 to 20 mg/kg may be considered. The
maximum maintenance dose of oxcarbazepine should be achieved over 2 to 4 weeks and should not exceed 60 mg/kg/day in a twice daily regimen.

In the clinical trial in pediatric patients (2 to 4 years of age) in which the intention was to
reach the target dose of 60 mg/kg/day, 50% of patients reached a final dose of at least 55 mg/kg/day.

When normalized by body weight, apparent clearance (L/hr/kg) decreased when age increased such that children 2 to <4 years of age may require up to twice the oxcarbazepine dose per body weight compared to adults; and children 4 to 12 years of age may require a 50% higher oxcarbazepine dose per body weight compared to adults.


For use as monotherapy for partial seizures in patients ages 4 to 16:

Conversion to Monotherapy
Patients receiving concomitant antiepileptic drugs may be converted to monotherapy by initiating treatment with oxcarbazepine at approximately 8 to 10 mg/kg/day given in a twice daily regimen, while simultaneously initiating the reduction of the dose of the concomitant antiepileptic drugs. The concomitant antiepileptic drugs can be completely withdrawn over 3 to 6 weeks
while oxcarbazepine may be increased as clinically indicated by a maximum increment of 10 mg/kg/day at approximately weekly intervals to achieve the recommended daily dose. Patients should be observed closely during this transition phase. The recommended total daily dose of oxcarbazepine is shown below.

Initiation of Monotherapy
Patients not currently being treated with antiepileptic drugs may have monotherapy initiated with oxcarbazepine. In these patients, oxcarbazepine should be initiated at a dose of 8 to 10 mg/kg/day given in a twice daily regimen. The dose should be increased by 5 mg/kg/day every third day to the recommended daily dose shown below.

Range of Maintenance Doses of oxcarbazepine for Children by Weight During Monotherapy:
If the patient's weight is 20 kg, then dose from 600 to 900 mg/day.
If the patient's weight is 25 kg, then dose from 900 to 1200 mg/day.
If the patient's weight is 30 kg, then dose from 900 to 1200 mg/day.
If the patient's weight is 35 kg, then dose from 900 to 1500 mg/day.
If the patient's weight is 40 kg, then dose from 900 to 1500 mg/day.
If the patient's weight is 45 kg, then dose from 1200 to 1500 mg/day.
If the patient's weight is 50 kg, then dose from 1200 to 1800 mg/day.
If the patient's weight is 55 kg, then dose from 1200 to 1800 mg/day.
If the patient's weight is 60 kg, then dose from 1200 to 2100 mg/day.
If the patient's weight is 65 kg, then dose from 1200 to 2100 mg/day.
If the patient's weight is 70 kg, then dose from 1500 to 2100 mg/day.

What other drugs will affect oxcarbazepine?

Tell your doctor about all medicines you use, and those you start or stop using during your treatment with oxcarbazepine, especially:

  • carbamazepine;

  • cyclosporine;

  • felodipine;

  • phenobarbital;

  • phenytoin;

  • valproic acid; or

  • verapamil.

This list is not complete and there are many other drugs that can interact with oxcarbazepine. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor. Keep a list of all your medicines and show it to any healthcare provider who treats you.

This list is not complete and many other drugs can interact with oxcarbazepine. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you.

Where can I get more information?

  • Your pharmacist has information about oxcarbazepine.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 10.03. Revision Date: 2013-03-05, 11:52:14 AM.

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