Small Description (basic): 

Oxcarbazepine (ox-car-BAZ-eh-peen) is the generic name (non–brand name) of a widely used seizure medicine. The common brand name for this type of medicine is Trileptal (try-LEP-tal). An extended release version of the drug is sold under the Brand name of Oxtellar XR with the primary difference being that the drug can be taken as a single daily dose. Oxcarbazepine is available in many countries, including the United States, Canada, the UK, Australia, and the countries of the European Union.

Large Description (basic): 

Although oxcarbazepine has been used in the United States since 2000, it has been used in other countries since 1990 and has been studied in thousands of patients around the world.

Using generic medicines rather than brand-name ones is often suggested as a way to save money. Sometimes the savings are large, but with other medicines the price differences are pretty small. Investigate and shop around before deciding whether the savings are worth any possible problems.

While unlikely, it is not yet known if people who switch from brand-name Trileptal to generic oxcarbazepine risk having more seizures or side effects during the changeover due to differences in the way the body absorbs the different types medicines. Likewise, it is not known if switching from one company's generic oxcarbazepine to another company's or switching from generic oxcarbazepine to Trileptal may have similar risks.

What's important is that you and the doctor should know what you're getting from the pharmacy and be able to control what type of seizure medicine you get.

Used to treat: 

Forms (basic): 

The appearance, formulations and dosages of oxcarbazepine may vary from manufacturer to manufacturer. Check with your pharmacist to be sure you are taking the correct amount.  Trileptal is available in generic (non-brand name) form in the United States and some other countries, which is called oxcarbazepine.

How to take and store Oxcarbazepine?

Follow your doctor's directions. Call if you have any questions. Usually, your doctor will tell you to start by taking one tablet – either 150 or 300 milligrams – two times each day. After a while, the doctor may gradually increase the dosage to get better control of your seizures. Because oxcarbazepine is generally taken twice a day, many people help themselves to remember by taking it with breakfast and dinner. It's OK to take it either with food or without food. Ask the doctor what to do if you forget to take a dose.

Be careful if the doctor writes a new prescription using a different kind of pill. For example, if you've been using 150-mg tablets and the new prescription is for 300-mg tablets, be careful to use the correct number. Don't automatically continue to use the same number of pills as before. Make sure you know what size tablet has been prescribed.

Oxcarbazepine should be stored at room temperature, away from light and humidity. (Don't keep the pills in the bathroom if it's damp there.) Of course, keep all oxcarbazepine out of the reach of children.

Don't take more than the doctor prescribes. If you think you've taken one or two extra tablets, call your doctor for advice. For a larger overdose, call your local poison control center or emergency room right away, unless you have special directions from the doctor.

Don't stop taking oxcarbazepine or change the amount you take without talking to your doctor first. Stopping any seizure medicine all at once can cause serious problems.

What if I forget?

If you forget a dose, take it as soon as you remember. If it is almost time for the next dose, delay that dose for a few hours instead of taking two doses very close together. Then go back to the regular schedule. . If you're not sure about what to do, call the doctor's office for more advice.

Do your best to follow the doctor's directions. If you forget doses often, it may be a good idea to get a special pillbox or watch with an alarm to remind you.

Taking the right amount of seizure medicine on time every single day is the most important step in preventing seizures!

How does Oxcarbazepine effect the brain?

Brain cells need to work (fire) at a certain rate to function normally. During a seizure, brain cells are forced to work much more rapidly than normal. Oxcarbazepine helps prevent brain cells from working as fast as a seizure requires them to. In this way, seizures can be stopped when they are just beginning.

How does the body digest Oxcarbazepine?

After medicine is swallowed, it must be absorbed into the blood so it can move throughout the body. The process of absorbing, digesting, and excreting a medicine or food is called metabolism. The way the body metabolizes a particular medicine affects how often it must be taken. It also determines whether it will interact with other medicines or be affected by liver disease or kidney disease.

Oxcarbazepine is metabolized by the liver but it doesn't change the way the liver metabolizes other seizure medicines, except for phenytoin (Dilantin, Phenytek).

The body eliminates oxcarbazepine through the kidneys. People with poor kidney function usually need to take less oxcarbazepine and they may take it less often, because it stays in their body longer.

How well does the Oxcarbazepine work?

Doctors have studied large numbers of patients with partial seizures to find out how well oxcarbazepine works. In studies where patients took either oxcarbazepine by itself, or phenytoin (Dilantin, Phenytek), valproate (Depakote), or carbamazepine (Tegretol, Carbatrol) alone, oxcarbazepine controlled seizures as well as the other medications.

Other studies have shown that oxcarbazepine works well when added to other seizure medications. Oxcarbazepine is not a perfect add-on seizure medicine for everyone, however. Sometimes people must try a series of combinations before finding what is best for them. But because oxcarbazepine doesn't interact much with other medicines, it can be used as an add-on without the need for complicated changes in dosage. The one exception is that adding oxcarbazepine to phenytoin (Dilantin, Phenytek) can cause the amount of phenytoin in the blood to rise.

What are the most common side effects of Oxcarbazepine?

Oxcarbazepine has now been in use since 1990, and it appears to be very safe. In the earliest tests, people who took it as their only medication or as an add-on to another seizure medicine were only slightly more likely to quit because of side effects than people who took a placebo (a pill with no active medicine) instead.

Some side effects of oxcarbazepine that have been reported include:

  • dizziness
  • headache
  • tiredness
  • drowsiness
  • double vision
  • stomach upset
  • loss of coordination

If you notice any of these problems, call the doctor's office. Sometimes the doctor can help by changing the amount of oxcarbazepine you take or how you take it. Don't stop taking oxcarbazepine or change the amount you take without the doctor's guidance.

If you have just started taking oxcarbazepine (or have just started taking a larger amount), be careful doing anything that might be dangerous until you know whether you are feeling sleepy, dizzy, or uncoordinated. You should also be very cautious about drinking alcohol, because with oxcarbazepine the effects of alcohol on the brain (such as tiredness, slurred speech, or unsteadiness) may be increased.

Allergic reactions
A small percentage of people taking oxcarbazepine develop a rash within the first few weeks of taking it. If this happens, tell the doctor or nurse right away, to be sure that it's not the beginning of a serious problem. It's rare for the rash to be serious, but don't ignore it. It's often necessary to switch to a different seizure medicine.

Tell your doctor if you have ever had an allergic reaction to Tegretol or Carbatrol (carbamazepine), other seizure medicines that are chemically related to oxcarbazepine. About 25% to 30% of patients who have had allergic reactions to carbamazepine will have the same type of reaction to oxcarbazepine.

Long-term side effects
In some patients, especially those taking higher doses of oxcarbazepine, the level of sodium (salt) in the blood may become low (a condition called hyponatremia). Usually this is not serious, but occasionally it may increase the number of seizures that you have or cause other problems such as tiredness or dizziness. Your doctor may want to check the amount of sodium in your blood to see if this is happening to you, especially if you are having nausea, a vaguely "unwell" feeling, headache, listlessness, or confusion.

What are the most serious side effects of Oxcarbazepine?

Very few people have serious reactions to oxcarbazepine. If you take it, you should be aware of them, however, so you and your family can recognize them.

Here's a list of warning signs that may possibly be the start of a serious problem. If you notice any of these things, call your doctor right away:

  • Severe Skin reactions (see below)
  • Rash (possible allergic reaction)
  • Other severe allergic reactions
  • Swelling of the throat, lips and eyelids, which could occur after the first or later doses. These reactions can be life-threatening, and people who have had these reactions should not take the drug again.
  • Vomiting
  • Increased seizures
  • Frequent headaches or a headache that doesn't go away
  • Sluggishness
  • Confusion


Severe Skin Reactions
As of April 19, 2005 the FDA and Novartis pharmaceuticals (the manufacturer of the brand name version of oxcarbazepine called Trileptal) issued a new warning regarding oxcarbazepine. Serious dermatological reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), have been reported in both children and adults in association with oxcarbazepine use. SJS and TEN may start with fever and flu-like symptoms. Then, a rash develops, with or without ulcers of the mucous membranes, that quickly progresses to blisters that burn and are painful.

The most common time of onset after first dosage of oxcarbazepine was 19 days. Such serious skin reactions may be life-threatening, and some patients have required hospitalization with very rare reports of fatal outcome. Therefore, if you have any skin reactions upon taking oxcarbazepine, you should seek immediate medical attention.

Hyponatremia
If you have a low level of sodium (salt) in your blood, a condition called hyponatremia, you may have symptoms such as dizziness, vomiting, increased seizures, headaches, sluggishness, or confusion.

  • This condition has been reported in about 1 in every 40 patients taking oxcarbazepine.
  • It occurs most often during the first 3 months of treatment, but it can also be found much later.
  • Usually it is not serious. You might even have it without noticing anything wrong. But now and then it does cause major problems, so your doctor may want to check the sodium level in your blood to see if this is happening to you.
  • It is important to remember that only a tiny number of people who take oxcarbazepine have any serious problems.


Suicidal Thoughts
On July 10, 2008, an advisory panel was convened by the Food and Drug Administration (FDA) to review data that the FDA had previously collected from drug studies showing an association between many of the antiepileptic drugs (AEDs) and suicidal ideation and behavior, which together are called suicidality. According to the FDA's Alert, among the patients with epilepsy in these drug studies, 1 out of 1000 people taking the placebo (inactive substance) showed suicidality compared to approximately 3.5 out of 1000 people who took an AED. The FDA advisory panel voted to accept the FDA's data at its meeting on July 10. The FDA has provided the following information for patients, family members, and caregivers at http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm100192.htm.

  • Taking antiepileptic medicines may increase the risk of having suicidal thoughts or actions;
  • Do not make any changes to the medication regimen without first talking with the responsible healthcare professional;
  • Pay close attention to any day-to-day changes in mood, behavior and actions. These changes can happen very quickly so it is important to be mindful of any sudden differences.
  • Be aware of common warning signs that might be a signal for risk of suicide. Some of these are:
    • Talking or thinking about wanting to hurt yourself or end your life
    • Withdrawing from friends and family
    • Becoming depressed or having your depression get worse
    • Becoming preoccupied with death and dying
    • Giving away prized possessions


We again urge patients and families to contact their doctor before stopping an epilepsy medication because this may possibly lead to seizures and worsening of mood.

Multi-organ Hypersensitivity
This is a serious rare drug reaction that has been seen with oxcarbazepine.

  • Typically it starts with a fever, rash, and / or swollen lymph nodes.
  • Other body organs may become involved, for example inflammation or involvement of the liver, kidneys, blood, heart or muscles.
  • An increase in certain blood cells called eosinophils may be seen. Eosinophils are a type of white blood cells.
  • If any of these symptoms or signs occur, get immediate medical help. A rash does not need to occur to be a drug reaction.
  • Oxcarbazepine may need to be stopped if no other cause for the symptoms is found. Make sure the doctor treating your seizures is aware of the reaction and is involved in decisions about your seizure medication.


Skin reactions with HLA-B*1502 allele
(An allele is a form of a gene that is found on a chromosome. Alleles are involved in deciding whether certain traits passed on from a parent to a child will occur. The tendency to severe drug reactions can be one of these traits.)

  • People who have the HLS-B*1502 allele may be at higher risk of developing a serious drug reaction called Stevens-Johnson Syndrome (SJS) or toxic epidermal necrolysis (TEN) with oxcarbazepine.
  • This allele increases the risk of these drug reactions with carbamazepine (Tegretol, Tegretol XR, Carbatrol). Oxcarbazepine (Trielptal) is similar chemically to carbamazepine. Results of available clinical reports and other data shows a direct interaction between Trileptal and HLA-B*1502 protein. This suggests that a higher risk for developing SJS or TEN may also occur with Trileptal.
  • This allele occurs more frequently in certain groups of people, for example Han Chinese populations, the Philippines, some Malaysian groups, Korea and India.
  • People who may be from at risk for this allele may be tested before starting oxcarbazepine. People who test positive for HLA-B*1502 allele should avoid using Trileptal unless the benefits clearly outweigh the risks.
What else is Oxcarbazepine used for?

Often doctors find that medicines are useful for more than one purpose. It is legal to prescribe medicines for "off-label uses" even though the FDA has not formally approved such use.

Like Tegretol or Carbatrol, oxcarbazepine also can be used to treat a type of facial pain called trigeminal neuralgia (tic douloureux) and to stabilize mood in patients with the mental illness called bipolar (manic-depressive) disorder. Neither use is approved by the FDA.

Who should not take Oxcarbazepine?
  • People should not take oxcarbazepine if they are allergic to it or any of its inactive ingredients.

  • People who may be at risk for the HLA-B*1502 allele should be tested for this allele before starting oxcarbazepine. This allele occurs more frequently in certain groups of people, for example Han Chinese population, the Philippines, some Malaysian groups, Korea and India.

  • People who test positive for HLA-B*1502 allele should avoid using Trileptal unless the benefits clearly outweigh the risks.

  • If you have absence or myoclonic seizures, oxcarbazepine probably will not be helpful.

  • People with kidney disorders need to be extra careful. Oxcarbazepine may build up to a level that's too high unless they take lower doses under their doctor’s direction.

Can Oxcarbazepine be taken with other medicines?

Sometimes one kind of medicine changes the way another kind of medicine works in the body. If two kinds of medicine affect each other, the doctor may prescribe something else or change the amount to be taken.

Oxcarbazepine has very few problems of this kind. The way oxcarbazepine works is not affected by other medicines and oxcarbazepine does not affect most other medicines. (See below for some exceptions.) This means that oxcarbazepine can be taken with most other medicines without difficulty.

One exception is that oxcarbazepine can make oral contraceptives and Depo-Provera less effective. To prevent pregnancy, you may need to use a different type of birth control or raise the dosage of the contraceptive. Talk to your doctor about this problem. Oxcarbazepine does not affect barrier types of birth control, like condoms, IUDs, and diaphragms.

Oxcarbazepine can cause the level of the seizure medicines Dilantin or Phenytek (phenytoin) to go higher, so adjustments may be necessary if these medicines are used together.

What are the effects of Oxcarbazepine on Children?

In children, oxcarbazepine has been used primarily to treat partial seizures, ones that begin in a limited area of the brain.

Doctors figure out how much medicine to give to young children based mostly on their weight. To keep side effects at a minimum, the doctor probably will prescribe a low dose to start with and increase it slowly. Children usually start with a dose of 8 to 10 milligrams (mg) for each kilogram (kg, about 2.2 pounds) of their body weight per day in two divided doses.

After a gradual increase every two weeks or so, most children do best taking about 10 to 50 mg per kg per day, split into two doses, Adjusted for weight, this is a little higher than the adult dose because children's bodies eliminate oxcarbazepine more quickly.

If a woman takes Oxcarbazepine during pregnancy will it hurt the baby?

In the United States, the Food and Drug Administration (FDA) assigns each medication to a Pregnancy Category according to whether it has been proven to be harmful in pregnancy. Oxcarbazepine is listed in Pregnancy Category C. This indicates that caution is advised, but the benefits of the medicine may outweigh the potential risks. Studies in animals have shown some harm to the baby, but there haven't been any good studies of results in women.

Talk to your doctor or another health professional if you are pregnant or plan to become pregnant. We don't yet have enough information to be able to estimate the risk of various types of birth defects that might occur if oxcarbazepine is taken during pregnancy. We also don't know enough to compare the risk with oxcarbazepine to the risk with other seizure medicines.

All women who are capable of becoming pregnant should take at least 0.4 mg (400 mcg) of the vitamin called folic acid every day because it helps to prevent one type of birth defect. (The most well-known of these is spina bifida, in which the spinal cord is not completely enclosed.) Women at high risk, such as those with a history of this kind of defect in a previous pregnancy, should take 4000 mcg (4 mg) daily, beginning before they become pregnant. In general, the risk of defects is higher for women who take more than one type of seizure medicine and for women with a family history of birth defects.

How much oxcarbazepine is passed through breast milk is not known for certain, but the way the body uses it suggests that probably a large portion does enter the milk. If you want to breastfeed your baby, check with your doctor about what seizure medicine would be best for you.

What are the effects of Oxcarbazepine on Seniors

Oxcarbazepine is commonly prescribed for people over 65, but it's important for the doctor to be careful about how much oxcarbazepine these people take. When people are older than 65 or 70, their kidneys usually don't work as well as before. The kidneys are responsible for removing oxcarbazepine from the body, so it stays in the body longer.

Seniors need to start with a very low dose of oxcarbazepine at the beginning and then increase the amount more slowly than a younger person would.

Seniors also may be more sensitive to the side effects of oxcarbazepine. Some of the common side effects, like dizziness, drowsiness, or problems with coordination, may worsen problems they had before taking oxcarbazepine. Seniors also are at greater risk of injury from falls or other accidents resulting from these problems.

What are the dose ranges for Oxcarbazepine?

The best amount is the amount that completely controls seizures without causing troublesome side effects. It depends on many factors, which are different for every individual. Follow the doctor's directions. Call if you have any questions.

No one should stop taking oxcarbazepine or change the amount they take without talking to the doctor first. Stopping any seizure medicine all at once can cause a problem that may be life-threatening.

Don’t use more than the doctor prescribes. If a little extra (such as an extra tablet or two) is taken by accident, call the doctor for advice. For a larger overdose, call a poison control center or emergency room right away unless you have other specific directions from your doctor.

Adults usually are told to start by taking 300 to 600 milligrams (mg) per day, divided into two doses. After about a week, the doctor probably will suggest taking a higher dose. The recommended dosage for most adults is 600 to 1,200 mg per day when oxcarbazepine is used alone. Higher dosages may be necessary when it used in combination with other seizure medicines.

Patients with poor kidney function generally should take only half as much. This also applies to many seniors, too.

Those who have been taking another seizure medicine may be told to continue to take it in the same way as before, or the amount of the other medicine may gradually be reduced over several weeks to months. If the plan is to continue taking another medicine along with oxcarbazepine, blood tests may be needed to check the level of the other medication. Oxcarbazepine sometimes causes it to change.

The dose for children is calculated based on the child's body weight. Usually the doctor will prescribe 8 to 10 mg per kilogram (2.2 pounds) of weight to start, divided into two doses per day. This dose will be increased over a period of about 2 weeks. Because of the way their bodies process the medication, children who are 8 or younger may need a higher dose than older children.

Read the package insert of Oxcarbazepine

In the United States, companies that manufacture medicines are required to publish certain kinds of information about each product. This document is commonly known as a “package insert” because it is usually included with each package of the medicine.

You can also read these documents (also called "prescribing information") online. The U.S. package insert for Trileptal (oxcarbazepine) is found at:

Some of the information may differ in other countries.

To learn how to read and understand a package insert, see How to read a package insert.

Small Description (adv): 

Oxcarbazepine is the generic name for Trileptal.  There is also an extended release version of the drug sold by the brand name Oxtellar XR. Oxcarbazepine is available in many countries, including the United States, Canada, the UK, Australia, and the countries of the European Union.

Large Description (adv): 

Although oxcarbazepine has been used in the United States just since 2000, it has been used in some other countries since 1990 and has been tested in thousands of patients in many clinical trials around the world.

Indications (adv): 

In 2000, oxcarbazepine was approved by the U.S. Food and Drug Administration (FDA) for the treatment of partial seizures. It is approved for use as either monotherapy or adjunctive therapy for adults and children as young as 4 years of age.

As the name suggests, oxcarbazepine is related to carbamazepine (Tegretol, Carbatrol) and appears to be similarly effective for controlling complex partial seizures and primary and secondarily generalized tonic-clonic seizures. It seems to cause fewer unwanted side effects in many (but not all) patients.

Oxcarbazepine is not effective against absence or myoclonic seizures.

Forms (adv): 

The appearance, formulations and dosages of oxcarbazepine may vary from manufacturer to manufacturer.

How to take and store Oxcarbazepine?

Oxcarbazepine is generally taken twice a day. It can be taken either with food or without food. (Food does not appear to affect the rate or extent of absorption.)

The Oxtellar XR version of the drug is generally taken once daily.

All forms of oxcarbazepine should be stored at room temperature.

Missed Doses

In general, tell patients that if they forget a dose, they should take it as soon as they remember. If it is almost time for the next dose, they should delay that dose for a few hours instead of taking two doses very close together.

Patients who often forget doses may benefit from using a special pillbox or watch with an alarm.

Mechanisms of actions of Oxcarbazepine

The mechanism of action of oxcarbazepine is similar to that of carbamazepine.

Oxcarbazepine and its active metabolite, monohydroxy derivative (MHD), have effects on sodium channels and possibly potassium and calcium channels. Neither oxcarbazepine nor MHD has an effect at binding sites for GABA or other neurotransmitter receptors.

Clinical Pharmacology of Oxcarbazepine

Absorption peak plasma levels are reached approximately 4-5 hours after an oral dose. Nearly the entire administered dose is absorbed. Food appears to have almost no effect on the absorption of oxcarbazepine.

Distribution and metabolism
Oxcarbazepine is chemically and structurally similar to carbamazepine, but undergoes a different metabolic process. Carbamazepine is oxidized to the 10,11 epoxide and then hydrolyzed. Oxcarbazepine undergoes reduction of the carbonyl group to form MHD by a cytosolic, non-microsomal, non-inducible keto-reductase. MHD is the active metabolite of oxcarbazepine and accounts for its antiseizure activity. The half-life of MHD averages 8 to 10 hours and is stable during chronic oxcarbazepine therapy in co-medicated patients. MHD is approximately 40% protein-bound.

Because unchanged oxcarbazepine and its metabolites are nearly entirely excreted in the urine, hepatic impairment has no apparent affect on the pharmacokinetics of oxcarbazepine or MHD. However, because oxcarbazepine metabolites are cleared renally, MHD levels are significantly increased in patients with reduced creatinine clearances. Oxcarbazepine dosages in patients with renal impairment should be reduced by 50% and the titration phase should be prolonged.

Steady state
Steady state is achieved after 3 to 4 oxcarbazepine doses in a twice-daily regimen. The dose that a patient takes should not be increased until steady state has been reached (or some time later), so that the effects of the previous dosage can be assessed.

Efficacy of Oxcarbazepine

Monotherapy studies
Three international, randomized, double-blind, monotherapy trials of oxcarbazepine in patients with newly diagnosed or previously untreated partial-onset or primary generalized seizures have been performed. One study (Christe et al. 1997) compared oxcarbazepine to valproate, and the other two (Guerreiro et al.1997; Bill et al. 1997) compared oxcarbazepine to phenytoin—one in adults and one in children and adolescents. Blinded treatment was administered three times daily and titrated over 8 weeks based on clinical response. In the study of oxcarbazepine versus valproate, randomized patients were titrated to between 900 and 2,400 mg daily for both AEDs. In the other two studies, oxcarbazepine dosages were 450 to 2,400 mg daily and phenytoin dosages were 150 to 800 mg daily. Efficacy and tolerability were recorded during a 48-week maintenance period.

In each of these studies, the primary efficacy variable was the proportion of seizure-free patients who had at least one seizure assessment during the maintenance period. In the study comparing oxcarbazepine to valproate, slightly more than half of the patients in each treatment group remained seizure-free during the maintenance period; there was no statistically significant treatment difference. Similarly, there was no treatment difference in the percentage of patients with partial-onset seizures who were seizure-free (46% for oxcarbazepine and 48% for valproate) or the proportion of patients with primary generalized seizures who were seizure-free (72% for oxcarbazepine and 62% for valproate).

In the study testing oxcarbazepine versus phenytoin in adults, nearly 60% of patients in each treatment group were seizure-free during the maintenance period; there was no statistically significant treatment difference. Similarly, there was no treatment difference in the percentage of patients with partial-onset seizures who were seizure-free (56% with oxcarbazepine and 53% for phenytoin) or the proportion with primary generalized seizures who were seizure-free (64% with oxcarbazepine and 68% with phenytoin).

In the pediatric study of oxcarbazepine versus phenytoin, nearly 60% of the children in each treatment group were seizure-free during the maintenance period; there was no statistically significant difference in seizure frequency. Similarly, there was no treatment difference in the percentage of patients with partial-onset seizures who were seizure-free (60% for oxcarbazepine and 62% for phenytoin) or the proportion of patients with primary generalized seizures who were seizure-free (59% for oxcarbazepine and 54% for phenytoin).

An outpatient, double-blind oxcarbazepine monotherapy study compared seizure frequencies in patients maintained at oxcarbazepine 2,400 mg/day to seizure frequencies in patients taking tapering dosages down to 300 mg/day (Sachdeo et al. 2001). The primary efficacy measure, a survival analysis of the time to meet one of the exit criteria, was significantly in favor of the high-dose oxcarbazepine group.

Comparisons of oxcarbazepine and Tegretol (carbamazepine) have generally found them to be equally effective.

Adjunctive therapy studies
A summary of studies in which oxcarbazepine was used adjunctively for partial seizures reported that 41% of adults who took oxcarbazepine had their seizures reduced in frequency by at least half, compared to 13% of those who added a placebo to their previous medications (Cramer et al. 2001).

A comparable study of oxcarbazepine as adjunctive therapy for children also found that 41% of those who took oxcarbazepine had at least a 50% decrease in seizure frequency (Glauser et al. 2000). Of those who took a placebo, 22% had a similar reduction.

Common side effects of Oxcarbazepine

Dose-related side effects
Common side effects of oxcarbazepine include:

  • sedation
  • dizziness
  • double vision
  • nausea
  • headache

If these problems do not diminish within several days, a reduction in the dose of oxcarbazepine often will solve the problem. Problems with sedation also may be helped by splitting the dose or giving the largest dose at bedtime. Patients taking oxcarbazepine and lamotrigine simultaneously may have fewer side effects if the pills are staggered by 1-2 hours.

Idiosyncratic reactions

Rash
Skin reactions occur less frequently with oxcarbazepine than with carbamazepine. In the Novartis safety database of Trileptal (oxcarbazepine), which includes data on 2,436 patients treated with Trileptal and 277 treated with carbamazepine, 2.8% of Trileptal-treated patients had hypersensitivity reactions compared with 6.5% of those on carbamazepine.

There is cross-sensitivity with skin reactions. In one study, 46 of 55 patients (84%) who were switched from carbamazepine to oxcarbazepine because of skin reactions did not experience a recurrence while taking oxcarbazepine. In another report, 37 of 51 patients (73%) with previous skin reactions to carbamazepine did not have a recurrence with oxcarbazepine.

Abnormal liver or bone marrow function
No clinically relevant fluctuations of white blood count have been observed in clinical studies and clinically relevant elevations of liver function tests appear to occur less often than with carbamazepine. In a large retrospective study, liver and bone marrow function tests became abnormal in no more than 2% of patients.

Serious Side effects of Oxcarbazepine

SJS and TEN
As of April 19, 2005 the FDA and Novartis pharmaceuticals (the manufacturer of Trileptal) issued a new warning regarding oxcarbazepine. Serious dermatological reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), have been reported in both children and adults in association with oxcarbazepine use. The most common time of onset after first dosage of oxcarbazepine was 19 days. Such serious skin reactions may be life-threatening, and some patients have required hospitalization with very rare reports of fatal outcome.

The reporting rate of TEN and SJS associated with oxcarbazepine use, which is generally accepted to be an underestimate due to underreporting, exceeds the background incidence rate estimates by a factor of 3 to 10 fold. Estimates of the background incidence rate for these serious skin reactions in the general population range between 0.5 to 6 cases per million person years. Therefore, if a patient develops a skin reaction while taking oxcarbazepine, consideration should be given to discontinuing oxcarbazepine use and prescribing another anti-epileptic medication.

Hyponatremia
Hyponatremia occurs more commonly with oxcarbazepine than with carbamazepine. While isolated cases of hyponatremic coma have been reported, oxcarbazepine-induced hyponatremia is seldom clinically significant.

Anaphylaxis and angioedema
Rare cases of anaphylaxis and angioedema involving the larynx, glottis, lips and eyelids have been reported in patients after taking the first or subsequent doses of oxcarbazepine. Angioedema associated with laryngeal edema can be fatal. If a patient develops any of these reactions after treatment with oxcarbazepine, the drug should be discontinued and an alternative treatment started. These patients should not be rechallenged with the drug

On July 10, 2008, an advisory panel was convened by the Food and Drug Administration (FDA) to review data that the FDA had previously collected from drug studies showing an association between many of the antiepileptic drugs (AEDs) and suicidal ideation and behavior, which together are called suicidality. According to the FDA’s Alert, among the patients with epilepsy in these drug studies, 1 out of 1000 people taking the placebo (inactive substance) showed suicidality compared to approximately 3.5 out of 1000 people who took an AED. The FDA advisory panel voted to accept the FDA's data at its meeting on July 10. The FDA has provided the following information for patients, family members, and caregivers at http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm100192.htm.

  • Taking antiepileptic medicines may increase the risk of having suicidal thoughts or actions;
  • Do not make any changes to the medication regimen without first talking with the responsible healthcare professional;
  • Pay close attention to any day-to-day changes in mood, behavior and actions. These changes can happen very quickly so it is important to be mindful of any sudden differences.
  • Be aware of common warning signs that might be a signal for risk of suicide. Some of these are:
    • Talking or thinking about wanting to hurt yourself or end your life
    • Withdrawing from friends and family
    • Becoming depressed or having your depression get worse
    • Becoming preoccupied with death and dying
    • Giving away prized possessions

We again urge patients and families to contact their doctor before stopping an epilepsy medication because this may possibly lead to seizures and worsening of mood.

Other Uses of Oxcarbazepine

Open trials of oxcarbazepine in patients with carbamazepine-resistant trigeminal neuralgia have shown positive results. In one study, all cases responded within 24 hours.

A limited number of other studies evaluated oxcarbazepine in patients with affective disorders, especially bipolar disorder, with mixed results.

Oxcarbazepine Contraindications

The only contraindication is a history of allergy to oxcarbazepine.

Oxcarbazepine Interactions with other medications

Effects of other drugs on oxcarbazepine
The metabolism of oxcarbazepine and MHD is unaffected by induction or inhibition of the cytochrome P450 system. This reduces the potential for interactions with AEDs and other drugs that inhibit the metabolism of carbamazepine, such as erythromycin, cimetidine, and propoxyphene.

Effects of oxcarbazepine on other drugs
Studies in non-epileptic women taking oral contraceptives found that oxcarbazepine reduced ethinylestradiol and levonorgestrel concentrations. It may therefore reduce the potency of oral contraceptives and other hormonal forms of birth control.

Oxcarbazepine can inhibit the hepatic isoenzyme CYP 2C19 and thereby increase phenytoin concentrations by up to 40%.

AED Interaction Sheets:
Seizure drugs are often affected by drug-drug interactions. Print these informative sheets for practical help.

 

Oxcarbazepine effects on Children

The starting dose for children is usually 8 to 10 mg/kg per day, divided into two doses. Children under 8 may need a higher dose relative to weight than older children. Dosage increases should be done slowly to minimize side effects, with a target dose of 10-50 mg/kg per day.

The concentrations of the active metabolite, MHD, in children aged 6 to 18 are similar to those observed in adults, but those reported in children aged 2 to 5 are lower due to faster clearance.

Oxcarbazepine and Pregnancy

The U.S. Food and Drug Administration (FDA) lists oxcarbazepine in Pregnancy Category C. This indicates that caution is advised, but the benefits of the medication may outweigh the potential risks. Studies in animals have shown some harm to the fetus.

Information about the safety of oxcarbazepine in pregnancy is limited. In one retrospective study, 3 of 12 women treated with oxcarbazepine as monotherapy or polytherapy during the first trimester had spontaneous abortions; the other 9 delivered normal babies.

Women who are capable of becoming pregnant should take at least 400 mcg (0.4 mg) of folic acid (folate) daily to help prevent neural tube defects. Women at high risk, such as those with a history of a neural tube defect in a previous pregnancy, should take 4000 mcg (4 mg) daily, beginning before they become pregnant.

The risk of defects is generally higher for women who take more than one AED and for women with a family history of birth defects.

About 20% to 35% of women have seizures more often during pregnancy because of changes in hormones or changes in how their AED is metabolized. It is not known if this is true for oxcarbazepine.

Oxcarbazepine and MHD cross the placenta and are excreted in breast milk, with a milk-to-plasma concentration ratio of 0.5.

Oxcarbazepine effects on Seniors

Lower initial doses and caution in titration are required. Maintenance doses should be reduced, dosing intervals increased, or both in seniors with reduced creatinine clearance.

Some common side effects of oxcarbazepine, such as sedation, may exacerbate pre-existing problems of seniors, and their greater risk of injury from falls or other accidents makes this an area of concern.

Oxcarbazepine Dosing and titration

Adults usually are started with 300 to 600 mg per day, divided into two doses. The dose can be increased after about a week. The recommended dosage as monotherapy in adults is 600 to 1,200 mg per day, in two doses. Higher dosages may be necessary when used as polytherapy in patients with refractory seizures. MHD levels of 10-30 mcg/mL are usually attained.

Doses should be reduced by half for patients with renal insufficiency.

 

 

Oxcarbazepine Package insert

In the United States, companies that manufacture medicines are required to publish certain kinds of information about each product. This document is commonly known as a “package insert” because it is usually included with each package of the medicine.

You can also read these documents (also called "prescribing information") online. The U.S. package insert for Trileptal (oxcarbazepine) is found at:

Some of the information may differ in other countries.

To learn how to read and understand a package insert, see How to read a package insert.

Oxcarbazepine References for Professionals

Abstracts of articles relevant to this topic are available through PubMed, a service of the National Library of Medicine:

Here are links to some articles relevant to this subject:

Bill PA, Vigonius U, Pohlmann H, et al. A double-blind controlled clinical trial of oxcarbazepine versus phenytoin in adults with previously untreated epilepsy. Epilepsy Res 1997 Jun;27(3):195-204. PMID: 9237054    

Christe W, Kramer G, Vigonius U, et al. A double-blind controlled clinical trial: Oxcarbazepine versus sodium valproate in adults with newly diagnosed epilepsy. Epilepsy Res 1997 Mar;26(3):451-60. PMID: 9127726.

Cramer JA, Ben Menachem E, French J. Review of treatment options for refractory epilepsy: new medications and vagal nerve stimulation. Epilepsy Res 2001 Nov;47(1-2):17-25. PMID: 11673017.

Friis ML, Kristensen O, Boas J, et al: Therapeutic experiences with 947 epileptic out-patients in oxcarbazepine treatment. Acta Neurol Scand 87: 224-7, 1993. PMID 8475694.

Glauser TA, Nigro M, Sachdeo R, et al. Adjunctive therapy with oxcarbazepine in children with partial seizures. The Oxcarbazepine Pediatric Study Group. Neurology 2000 Jun 27;54(12):2237-44. PMID: 10881246.

Guerreiro MM, Vigonius U, Pohlmann H, et al. A double-blind controlled clinical trial of oxcarbazepine versus phenytoin in children and adolescents with epilepsy. Epilepsy Res 1997 Jun;27(3):205-13. PMID: 9237055.

Sachdeo R, Beydoun A, Schachter S, et al: Oxcarbazepine (Trileptal) as monotherapy in patients with partial seizures. Neurology 2001 Sep 11;57(5):864-71.

Schachter SC, Vazquez B, Fisher RS, et al: Oxcarbazepine: double-blind, randomized, placebo-control, monotherapy trial for partial seizures. Neurology 52: 732-7, 1999. PMID 10078718.