Pronunciation:

fel-BAM-ate

Brand Names:

• Felbatol

Dosage Forms:

• Tablet
• Suspension

Warnings:

Felbamate use is associated with a marked increase in the incidence of aplastic anemia, sometimes fatal. Discontinue if any evidence of bone marrow depression occurs. Liver failure resulting in death or transplant has been reported with therapy. Felbamate should not be prescribed for anyone with a history of hepatic dysfunction and should be discontinued in anyone showing signs of liver injury while on therapy. Monitor liver enzymes during therapy .

Classifications:

Therapeutic—

Anticonvulsant

Chemical—

Carbamate

Uses of This Medicine:

Felbamate is used alone or together with other medicines to control partial seizures (convulsions) in the treatment of epilepsy, after other therapies have failed or are not right for the patient. It is also used in children to control partial and generalized seizures caused by Lennox-Gastaut syndrome.

Felbamate belongs to a class of medicines called anticonvulsants. It acts in the brain to prevent seizures. However, 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.

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 this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of felbamate to treat seizures other than Lennox-Gastaut syndrome in children. Safety and efficacy have not been established.

Older adults—

Although appropriate studies on the relationship of age to the effects of felbamate have not been performed in the geriatric population, no geriatric-specific problems have been documented to date. However, elderly patients are more likely to have age-related heart, kidney, or liver problems, which may require caution and an adjustment in the dose for patients receiving felbamate.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

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 this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Bepridil
• Cisapride
• Dronedarone
• Levoketoconazole
• Mesoridazine
• Pimozide
• Piperaquine
• Saquinavir
• Sparfloxacin
• Terfenadine
• Thioridazine
• Ziprasidone

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Adagrasib
• Amiodarone
• Amisulpride
• Anagrelide
• Apomorphine
• Aripiprazole
• Aripiprazole Lauroxil
• Arsenic Trioxide
• Atazanavir
• Buprenorphine
• Buserelin
• Calcifediol
• Ceritinib
• Chloroquine
• Citalopram
• Clarithromycin
• Clofazimine
• Clopidogrel
• Clothiapine
• Clozapine
• Crizotinib
• Dabrafenib
• Dasatinib
• Degarelix
• Delamanid
• Deslorelin
• Deutetrabenazine
• Dexmedetomidine
• Domperidone
• Donepezil
• Drospirenone
• Efavirenz
• Encorafenib
• Entrectinib
• Escitalopram
• Ethinyl Estradiol
• Fexinidazole
• Fingolimod
• Fluconazole
• Fluoxetine
• Formoterol
• Foscarnet
• Fostemsavir
• Gepirone
• Gestodene
• Glasdegib
• Gonadorelin
• Goserelin
• Histrelin
• Hydroxychloroquine
• Hydroxyzine
• Inotuzumab Ozogamicin
• Ivabradine
• Ivosidenib
• Ketoconazole
• Lefamulin
• Lenvatinib
• Leuprolide
• Levofloxacin
• Lofexidine
• Macimorelin
• Methadone
• Methotrexate
• Metronidazole
• Mirtazapine
• Mobocertinib
• Moxifloxacin
• Nafarelin
• Nilotinib
• Norethindrone
• Norgestimate
• Olanzapine
• Ondansetron
• Orlistat
• Osilodrostat
• Osimertinib
• Oxaliplatin
• Ozanimod
• Pacritinib
• Panobinostat
• Paroxetine
• Pasireotide
• Pazopanib
• Pexidartinib
• Phenobarbital
• Pimavanserin
• Pitolisant
• Ponesimod
• Posaconazole
• Primidone
• Quetiapine
• Quizartinib
• Relugolix
• Ribociclib
• Selpercatinib
• Sertraline
• Sevoflurane
• Siponimod
• Solifenacin
• Sotalol
• Sulpiride
• Sunitinib
• Tacrolimus
• Trazodone
• Triclabendazole
• Triptorelin
• Ulipristal
• Valproic Acid
• Vandetanib
• Vardenafil
• Vemurafenib
• Vilanterol
• Vinflunine
• Voclosporin
• Zuclopenthixol

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Carbamazepine
• Clobazam
• Fosphenytoin
• Ginkgo
• Methsuximide
• Phenytoin
• Warfarin

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

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

• Blood problems (e.g., aplastic anemia), history of or
• Liver problems, history of—Should not be used in patients with these conditions.

• Depression or
• Mental illness—Use with caution. May make these conditions worse.

• Kidney disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of This Medicine:

This medicine should not be the first medicine you use to treat your condition. It is meant to be used only after you have tried other medicines that have not worked or have caused unwanted side effects.

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.

It is very important that you understand the risks and benefits of felbamate before using it. You may also be asked to sign a patient/physician acknowledgment form and read the Medication Guide to make sure you understand the information about this medicine. Be sure to ask your doctor about anything you do not understand.

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.

This medicine can be used with other seizure medicines. Keep using all of your seizure medicines unless your doctor tells you to stop.

Dosing—

The dose of this medicine 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 this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using 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) per day, divided into three or four smaller doses. Your doctor may gradually increase your dose over several weeks up to 3600 mg per day.
    • Children—Use and dose must be determined by your doctor.
  • For Lennox-Gastaut syndrome:
    • Adults and teenagers 14 years of age and older—At first, usually 1200 milligrams (mg) per day, divided into three or four smaller doses. Your doctor may gradually increase your dose over several weeks up to 3600 mg per day.
    • Children 2 to 14 years of age—Dose is based on body weight and must be determined by your doctor. The starting dose is usually 15 mg per kilogram (kg) of body weight per day, divided into three or four smaller doses. Your doctor may gradually increase the dose over a few weeks up to 45 mg per kg of body weight per day.
    • Children younger than 2 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. Do not double doses.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check the progress of you or your child at regular visits. This is necessary to allow dose adjustments and to check for serious unwanted effects.

It is important to tell your doctor if you become pregnant. Your doctor may want you to join the North American Antiepileptic Drug Pregnancy Registry, which is used by pregnant patients who are taking this medicine.

Felbamate has caused a few cases of a serious blood disorder called aplastic anemia and a few cases of liver failure. Talk to your doctor about these risks.

Stop using this medicine and check with your doctor right away if you or your child have pain or tenderness in the upper stomach; pale stools; dark urine; loss of appetite; nausea; unusual tiredness or weakness; or yellow eyes or skin. These could be symptoms of a serious liver problem.

Tell your doctor right away if you or your child has chest pain; chills; cough; fever; headache; shortness of breath; sores, ulcers, or white spots on lips or in mouth; swollen or painful glands; tightness in chest; unusual bleeding or bruising; unusual tiredness or weakness; or wheezing. These could be symptoms of aplastic anemia.

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

If you or your child develop any unusual or strange thoughts and behavior while taking this medicine, be sure to discuss it with your doctor. Other changes might be confusion, worsening of depression, hallucinations (seeing, hearing, or feeling things that are not there), suicidal thoughts, and unusual excitement, nervousness, or irritability.

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.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

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.

Check with your doctor immediately if any of the following side effects occur:

More common

Black, tarry stools

chest pain

chills

confusion

cough

delusions

dementia

depression

fever

loss of bladder control

painful or difficult urination

purple or red spots on the skin

shakiness in the legs, arms, hands, or feet

shortness of breath

sore throat

sores, ulcers, or white spots on the lips or in the mouth

swollen glands

trembling or shaking of the hands or feet

unusual bleeding or bruising

unusual tiredness or weakness

Less common

Agitation, aggression, or other mood or mental changes

bladder pain

bloody or cloudy urine

bone pain

burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

clumsiness or unsteadiness

frequent urge to urinate

loss of appetite

lower back or side pain

skin rash

swelling or puffiness of the face

trouble with breathing

unsteadiness, trembling, or other problems with muscle control or coordination

Rare

Continuing headache

continuing stomach pain

continuing vomiting

dark-colored urine

general feeling of tiredness or weakness

hives or itching

light-colored stools

muscle cramps

nasal congestion

nosebleeds or other unusual bruising or bleeding

pain

sensitivity of the skin to sunlight

swollen or painful glands

tightness in the chest

yellow eyes or skin

Some 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. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Acid or sour stomach

bad, unusual, or unpleasant (after) taste

belching

body aches or pain

change in taste

change in walking and balance

constricted, pinpoint, or small pupils (black part of the eye)

crying

depersonalization

diarrhea

difficulty having a bowel movement (stool)

difficulty with sleeping

dizziness

double vision

dysphoria

ear congestion

euphoria

headache

heartburn

hiccup

indigestion

loss of appetite

loss of voice

nausea

paranoia

quick to react or overreact emotionally

rapidly changing moods

runny nose

seeing double

sleepiness or unusual drowsiness

sleeplessness

sneezing

stomach discomfort, upset, or pain

trouble sleeping

unable to sleep

weight loss

Less common

Blemishes on the skin

blurred vision

decreased awareness or responsiveness

decreased weight

difficulty with moving

earache

hoarseness

joint pain

muscle aching or cramping

muscle pains or stiffness

pain or tenderness around the eyes and cheekbones

pimples

redness or swelling in the ear

severe sleepiness

swollen joints

tender, swollen glands in the neck

trouble with swallowing

voice changes

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

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.