FELBAMATE (Systemic)?
Some commonly used brand names are:
In the U.S.?
Another commonly used name is FBM.
? Not commercially available in Canada.
Category
Description
Felbamate (FEL-ba-mate) is used to control some types of seizures inthe treatment of epilepsy. Felbamate acts on the central nervous system (CNS)to make it more difficult for seizures to start or to continue. This medicinecannot cure epilepsy and will only work to control seizures for as long asyou continue to use it.
Felbamate is available only with your doctor's prescription, in the followingdosage 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 willdo. This is a decision you and your doctor will make. For felbamate, the followingshould be considered:
Allergies?Tell your doctor if you have ever had any unusual orallergic reaction to felbamate or to medicines like felbamate such as carbromal,carisoprodol (Soma, Rela), mebutamate, meprobamate (Equanil, Miltown), ortybamate (Tybatran). Also tell your health care professional if you are allergicto 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 loweredbirth weight and lowered survival of offspring when given to the mother indoses more than one and one-half times the usual human dose. Before takingthis medicine, make sure your doctor knows if you are pregnant or if you maybecome pregnant.
Breast-feeding?Felbamate passes into breast milk. However, itis 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 doctorif they have symptoms of these effects, such as chills or stomach pain. Felbamateshould be used in children only if other medicines have not controlled theirseizures.
Older adults?Many medicines have not been studied specificallyin older people. Therefore, it may not be known whether they work exactlythe same way they do in younger adults or if they cause different side effectsor problems in older people. There is no specific information comparing useof felbamate in the elderly with use in other age groups. However, older peopleare more likely to have other illnesses and to use other medicines that mayaffect the way felbamate works. Your doctor may start with a lower felbamatedose or may increase the dose more slowly.
Other medicines?Although certain medicines should not be usedtogether at all, in other cases two different medicines may be used togethereven if an interaction might occur. In these cases, your doctor may want tochange the dose, or other precautions may be necessary. When you are takingfelbamate, it is especially important that your health care professional knowif 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 levelsof these medicines or felbamate may occur, which may increase the chance ofunwanted effects; your doctor may need to change the dose of either thesemedicines or felbamate
Other medical problems?The presence of other medicalproblems may affect the use of felbamate. Make sure you tell your doctor ifyou have any other medical problems, especially:
- Anemia or other blood problems (or history of) or
- Liver problems (or history of)?Felbamate may make the conditionworse
Proper Use of This Medicine
Take this medicine only as directed by your doctor, to benefit yourcondition as much as possible. Do not take more of it, do not take it moreoften, and do not take it for a longer time than your doctor ordered.
For patients taking the oral liquid form ofthis medicine:
- Shake the bottle well before measuring the dose.
- Use a specially marked measuring spoon, a plastic syringe, or a smallmarked measuring cup to measure each dose accurately. The average householdteaspoon may not hold the right amount of liquid.
To lessen stomach upset, felbamate may be taken with food, unless yourdoctor has told you to take it on an empty stomach.
Dosing?The dose of felbamate will be different fordifferent patients. Follow your doctor's orders or thedirections on the label. The following information includes only theaverage 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 dependson the strength of the medicine.
- For oral dosage forms (suspension ortablets):
- For epilepsy:
- Adults and teenagers 14 years of age and older?At first, usually1200 milligrams (mg) a day, divided into three or four smaller doses. Yourdoctor 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 dosesthat are given three or four times during the day. Your doctor may increasethe dose gradually over a few weeks if needed. However, the dose is usuallynot more than 45 mg per kg [20.5 mg per pound] or 3600 mg per day, whicheveris less.
Missed dose?If you miss a dose of this medicine, take it assoon as possible. However, if it is almost time for your next dose, skip themissed 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 otherdamp places. Heat or moisture may cause the medicine to break down.
- Do not keep outdated medicine or medicine no longer needed. Be surethat 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 regularvisits. This is necessary to allow dose adjustments and to test forserious unwanted effects.
Do not stop taking felbamate without first checkingwith your doctor. Your doctor may want you to gradually reduce theamount you are taking before stopping completely. Stopping the medicine suddenlymay cause your seizures to return or to occur more often.
Felbamate may cause blurred vision, double vision, or other changes invision. 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 tosee well. If these reactions are especially bothersome, check withyour doctor.
Side Effects of This Medicine
Felbamate may cause someserious side effects, including blood problems and liver problems. You and your doctor should discuss the good this medicine willdo as well as the risks of receiving it.
Along with its needed effects, a medicinemay cause some unwanted effects. Some side effects will have signs or symptomsthat you can see or feel. Your doctor may watch for others by doing certaintests. Although not all of these side effects may occur, if they do occurthey may need medical attention.
Other sideeffects may occur that usually do not need medical attention. These side effectsmay 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 arebothersome:
This medicinemay also cause the following side effects that your doctor will watch for:
Other side effects not listed above may also occur in some patients. Ifyou notice any other effects, check with your doctor.
Revised: 03/28/1995
