Drugs A - Z

Felbamate Oral suspension

It is used to control seizures in certain types of epilepsy

Generic Name: felbamate  |  Brand Name: Felbatol

Brand Names: Felbatol

There is an FDA Alert for this drug. Click here to view it.

    Aplastic Anemia
  • Risk of aplastic anemia in patients receiving felbamate appears to be at least 40–100 times higher than that in general population (about 2–5 cases per million untreated individuals per year).
  • Potentially fatal; current estimated overall case fatality rate for untreated individuals with aplastic anemia ranges from 20–30%, but rates as high as 70% have been reported in the past.
  • Limit use to patients whose seizure disorder is so severe that the benefits of therapy outweigh the substantial risk of aplastic anemia. (See Seizure Disorders under Uses.)
  • Clinical manifestation of aplastic anemia (e.g., bleeding, infection) usually develops without premonitory clinical or laboratory signs after several months of therapy (range: 5–30 weeks). Routine blood tests are unreliable but may, nevertheless, result in early detection of the syndrome in some patients. (See Hematologic Effects under Cautions.)

    Hepatic Failure
  • Risk of acute hepatic failure resulting in death or hepatic transplantation reported at an estimated rate of about 6 cases per 75,000 patient years of use. Actual rate believed to be considerably higher.
  • Severe hepatic dysfunction followed by hepatic failure reported as early as 3 weeks after initiation of felbamate; has resulted in death or hepatic transplantation in about 67% of reported cases, usually within 5 weeks of the onset of signs and symptoms of hepatic failure. Prodromal symptoms (e.g., anorexia, malaise, other GI symptoms) and/or dark urine may or may not precede onset of jaundice.
  • Do not initiate therapy in patients with active liver disease, abnormal baseline serum transaminase concentrations, or a history of hepatic dysfunction.
  • Periodic serum transaminase testing has not been proven to prevent serious injury but may, nevertheless, result in early detection of the syndrome in some patients. (See Hepatic Effects under Cautions.)

What is this medicine?

FELBAMATE (fel BAM ate) is used to control seizures in certain types of epilepsy. This medicine is only for people who have not responded to other therapy.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:
  • blood disorders or disease
  • liver disease
  • suicidal thoughts, plans, or attempt; a previous suicide attempt by you or a family member
  • an unusual or allergic reaction to felbamate, carbamates, other medicines, foods, dyes, or preservatives
  • pregnant or trying to get pregnant
  • breast-feeding

How should I use this medicine?

Take this medicine by mouth. Follow the directions on the prescription label. Shake well before using. Use a specially marked spoon or container to measure your medicine. Ask your pharmacist if you do not have one. Household spoons are not accurate. This medicine may be taken with or without food. Take your medicien at regular intervals. Do not take it more often than directed.

Talk to your pediatrician regarding the use of this medicine in children. While this medicine may be prescribed for children as young as 2 years for selected conditions, precautions do apply.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medicine?

  • carbamazepine
  • female hormones, like estrogens or progestins and birth control pills
  • phenobarbital
  • phenytoin
  • sevelamer
  • valproic acid

What should I watch for while using this medicine?

Visit your doctor or health care professional for regular checks on your progress.

Wear a medical ID bracelet or chain, and carry a card that describes your disease and details of your medicine and dosage times.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol may interfere with the effect of this medicine. Avoid alcoholic drinks.

This medicine can make you more sensitive to the sun. Keep out of the sun. If you cannot avoid being in the sun, wear protective clothing and use sunscreen. Do not use sun lamps or tanning beds/booths.

The use of this medicine may increase the chance of suicidal thoughts or actions. Pay special attention to how you are responding while on this medicine. Any worsening of mood, or thoughts of suicide or dying should be reported to your health care professional right away.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:
  • allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
  • blood in urine
  • breathing problems
  • confusion
  • fever, chills, sore throat
  • unusual bleeding or bruising, pinpoint red spots on skin
  • unusually weak or tired
  • weight loss
  • worsening of mood, thoughts or actions of suicide or dying
  • yellowing of the eyes or skin

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

  • changes in taste
  • changes in vision
  • diarrhea or constipation
  • headache
  • nausea/vomiting
  • tremors
  • trouble sleeping

Last Updated: April 27, 2009
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