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|Trileptal

OXCARBAZEPINE (Systemic)†

Some commonly used brand names are:

In the U.S.—

• Trileptal

Another commonly used name is

† Not commercially available in Canada.

Category

• Anticonvulsant

Description

Oxcarbazepine((oks-kar-BAZ-e-peen)) is used to control some types of seizures in the treatment of epilepsy. This medicine cannot cure epilepsy and will only work to control seizures for as long as you continue to take it.

This medicine is available only with your doctor"s prescription, in the following dosage form

• Oral
• Suspension (U.S.)
• Tablets (U.S.)

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 oxcarbazepine, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to oxcarbazepine or carbamazepine. Also tell your doctor and pharmacist if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Oxcarbazepine has not been studied in pregnant women. However, oxcarbazepine is closely related to carbamazepine, a drug known for causing birth defects in humans. Before taking this medicine, make sure that your doctor knows if you are pregnant or if you may become pregnant.

Breast-feeding—Oxcarbazepine is known to pass into breast milk and may cause unwanted effects in nursing infants. It may be necessary for you to take another medicine or to stop breast-feeding during treatment. Be sure you have discussed the risks and benefits of the medicine with your doctor.

Children—This medicine has been tested in children 4 years of age and older, and in effective doses, has not been shown to cause different side effects or problems than in adults.

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 oxcarbazepine, it is especially important that your doctor and pharmacist know if you are taking any of the following:

• Carbamazepine (e.g., Tegretol) or
• Phenobarbital or
• Phenytoin (e.g., Dilantin) or
• Valproic acid (e.g., Depakote)—Blood levels of oxcarbazepine may be decreased, causing a decrease in effectiveness and a possible increase in seizure frequency

• Felodipine (e.g., Plendil) or
• Verapamil (e.g., Calan)—The effect of these medicines may be decreased.
• Oral contraceptives (birth control pills containing estrogen)—The effectiveness of these medicines may be decreased

Other medical problems—The presence of other medical problems may affect the use of oxcarbazepine. Make sure you tell your doctor if you have any other medical problems, especially:

• Kidney disease or
• Prior hypersensitivity reaction to carbamazepine or
• Hyponatremia (condition in which your body has too little sodium)—May make these conditions worse

Proper Use of This Medicine

Take this medicine only as directed by your doctor. Do not take more or less of it, and do not take more or less often than your doctor ordered.

For patients taking the oral suspension form of this medicine:

• Shake the bottle well before measuring the dose.
• Use the oral dosing syringe supplied 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

Do not suddenly stop taking this medicine without first checking with your doctor. To keep your seizures under control, it is usually best to gradually reduce the amount of oxcarbazepine you are taking before stopping completely.

Dosing—The dose of oxcarbazepine 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 oxcarbazepine. If your dose is different, do not change it unless your doctor tells you to do so.

• For oral dosage form (oral suspension and tablets):
  • For epilepsy:
    • Adults and teenagers 17 years of age and older—At first, 300 milligrams (mg) two times a day. Your doctor may increase your dose as needed. However, the dose is usually not more than 2400 mg a day.
    • Children 4 to 16 years of age—Dose is based on body weight. The usual dose is 8 to 10 mg per kg (3.7 to 4.5 mg per pound) of body weight. The doctor may need to adjust the dose based on your response to the medicine.
    • Children up to 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. Check with your doctor if you miss two or more doses. Do not double doses.

Storage—To store this medicine:

• Keep out of the reach of children.
• Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Ask your health care professional how you should dispose of any medicine you do not use. Be sure that any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

Your doctor should check your progress at regular visits. This is to make sure the medicine is working for you and to allow the dosage to be changed if needed.

If your symptoms do not improve within a few days or if they become worse, check with your doctor.

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, other allergies or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; and other medicines for seizures.

Tell your doctor right away if a skin reaction occurs while you are taking this medicine. There have been serious skin reactions associated with oxcarbazepine.

If you develop a fever along with a rash or swollen glands, contact your doctor right away.

This medicine may cause some people to become drowsy, dizzy, 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 if you are dizzy or are not alert .

Oral contraceptives (birth control pills) containing estrogen or progestin, contraceptive progestin injections (e.g., Depo-Provera), and implant contraceptive forms of progestin (e.g., 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 health care professional.

Dizziness, lightheadedness, or fainting may occur, especially when you get up from a lying or sitting position. Getting up slowly may help. If the problem continues or gets worse, check with your doctor.

Do not stop taking this medicine without first checking with your doctor. Stopping the medicine suddenly may cause your seizures to return or to occur more often. Your doctor may want you to gradually reduce the amount of oxcarbazepine you are taking before stopping completely.

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.

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.

Developed: 05/12/2000
Revised: 06/07/2005

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