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|Felbatol

FELBAMATE (Systemic)†

Some commonly used brand names are:

In the U.S.—

• Felbatol

Another commonly used name is FBM .

† Not commercially available in Canada.

Category

• Anticonvulsant

Description

Felbamate (FEL-ba-mate) is used to control some types of seizures in the treatment of epilepsy. Felbamate acts on the central nervous system (CNS) to make it more difficult for seizures to start or to continue. This medicine cannot cure epilepsy and will only work to control seizures for as long as you continue to use it.

Felbamate is available only with your doctor"s prescription, in the following dosage forms:

• 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 felbamate, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to felbamate or to medicines like felbamate such as carbromal, carisoprodol (Soma, Rela), mebutamate, meprobamate (Equanil, Miltown), or tybamate (Tybatran). Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Felbamate has not been studied in pregnant women. However, studies in pregnant animals have shown that felbamate may cause lowered birth weight and lowered survival of offspring when given to the mother in doses more than one and one-half times the usual human dose. Before taking this medicine, make sure your doctor knows if you are pregnant or if you may become pregnant.

Breast-feeding—Felbamate passes into breast milk. However, it is not known whether this medicine causes problems in nursing babies.

Children—This medicine has some very serious unwanted effects. Children may not be able to tell their parent or guardian or their doctor if they have symptoms of these effects, such as chills or stomach pain. Felbamate should be used in children only if other medicines have not controlled their seizures.

Older adults—Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of felbamate in the elderly with use in other age groups. However, older people are more likely to have other illnesses and to use other medicines that may affect the way felbamate works. Your doctor may start with a lower felbamate dose or may increase the dose more slowly.

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 felbamate, it is especially important that your health care professional know if you are taking any of the following:

• Carbamazepine (e.g., Tegretol) or
• Phenytoin (e.g., Dilantin) or
• Valproic acid (e.g., Depakene)—Higher or lower blood levels of these medicines or felbamate may occur, which may increase the chance of unwanted effects; your doctor may need to change the dose of either these medicines or felbamate

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

• Anemia or other blood problems (or history of) or
• Liver problems (or history of)—Felbamate may make the condition worse

Proper Use of This Medicine

Take this medicine only as directed by your doctor , to benefit your condition as much as possible. 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.

For patients taking the oral liquid form of this medicine:

• Shake the bottle well before measuring the dose.
• Use a specially marked measuring spoon, a plastic syringe, or a small marked measuring cup to measure each dose accurately. The average household teaspoon may not hold the right amount of liquid.

To lessen stomach upset, felbamate may be taken with food, unless your doctor has told you to take it on an empty stomach.

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

The number of tablets or teaspoonfuls of suspension that you take depends on the strength of the medicine.

• For oral dosage forms (suspension or tablets):
  • For epilepsy:
    • Adults and teenagers 14 years of age and older—At first, usually 1200 milligrams (mg) a day, divided into three or four smaller doses. Your doctor may increase the dose gradually over several weeks if needed. However, the dose is usually not more than 3600 mg a day.
    • Children 2 to 14 years of age—At first, usually 15 mg per kilogram (kg) [6.8 mg per pound] of body weight per day, divided into smaller doses that are given three or four times during the day. Your doctor may increase the dose gradually over a few weeks if needed. However, the dose is usually not more than 45 mg per kg [20.5 mg per pound] or 3600 mg per day, whichever is less.

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. Do not double doses.

Storage—To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct sunlight.
• 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. Be sure that any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

It is important that your doctor check your progress at regular visits . This is necessary to allow dose adjustments and to test for serious unwanted effects.

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

Felbamate may cause blurred vision, double vision, or other changes in vision. It may also cause some people to become dizzy or drowsy. 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 not alert or able to see well . If these reactions are especially bothersome, check with your doctor.

Side Effects of This Medicine

Felbamate may cause some serious side effects, including blood problems and liver problems. You and your doctor should discuss the good this medicine will do as well as the risks of receiving it .

Along with its needed effects, a medicine may cause some unwanted effects. Some side effects will have signs or symptoms that you can see or feel. Your doctor may watch for others by doing certain tests. Although not all of these side effects may occur, if they do occur they may need medical attention.

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:

This medicine may also cause the following side effects that your doctor will watch for:

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

Revised: 03/28/1995

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