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Oxcarbazepine (Systemic)


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Oxcarbazepine (Systemic)

US Brand Names

• Trileptal

Another commonly used name is

GP 47680

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

    • Tablets (U.S.)

:

Special Considerations

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)

Administration

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.

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 (tablets):

      o 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

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.

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

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 as soon as possible if any of the following side effects occur:

More common

; Change in vision; change in walking or balance; clumsiness or unsteadiness; cough, fever, sneezing, or sore throat; crying; dizziness; double vision; false sense of well-being; feeling of constant movement of self or surroundings; mental depression; sensation of spinning; uncontrolled back-and-forth and/or rolling eye movements.

Less common

Agitation; awkwardness; bloody or cloudy urine; blurred vision; bruising; confusion; congestion; convulsions (seizures); decreased urination; difficulty in focusing eyes; disorientation; faintness or light-headedness when getting up from a lying or sitting position; fast or irregular heartbeat; frequent falls; frequent urge to urinate; general feeling of illness; headache; hoarseness; increased thirst; itching of the vagina, with or without white vaginal discharge; loss of consciousness; memory loss; muscle cramps; pain or burning while urinating; pain or tenderness around eyes or cheekbones; poor control in body movements-for example, when reaching or stepping; problems with coordination; shaking or trembling of arms, legs, hands, and feet; shortness of breath; skin rash; stuffy or runny nose; tightness in chest; trouble in walking; troubled breathing; unusual feelings; unusual tiredness or weakness; wheezing.

Rare

Anxiety; bleeding or crusting sores on lips; burning feeling in chest or stomach; chest pain; chills; decreased response to stimulation; hives or itching; irritability; joint pain; muscle pain or weakness; nervousness; purple spots on skin; rectal bleeding; redness, blistering, peeling, or loosening of skin; restlessness; sores, ulcers, or white spots in mouth or on lips; stomach upset; swelling of legs; swollen glands.

Other 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. However, check with your doctor if any of the following side effects continue or are bothersome.

More common

Abdominal pain; burning feeling in chest or stomach; nausea and vomiting; runny or stuffy nose; sleepiness or unusual drowsiness.

Less common

Acid or sour stomach; acne; back pain; belching; bloody nose; blurred vision; change in your sense of taste; constipation; diarrhea; difficulty in speaking; dryness of mouth; feeling of warmth and redness of face, neck, arms, and occasionally chest; heartburn; increased sweating; increased urination; nervousness; trouble in sleeping.

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

May 12, 2000

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