Felbatol

DRUG DESCRIPTION

Felbatol® (felbamate) is an antiepileptic available as 400 mg and 600 mg tablets and as a 600 mg/5 mL suspension for oral administration. Its chemical name is 2-phenyl-1,3-propanediol dicarbamate.

Felbamate is a white to off-white crystalline powder with a characteristic odor. It is very slightly soluble in water, slightly soluble in ethanol, sparingly soluble in methanol, and freely soluble in dimethyl sulfoxide. The molecular weight is 238.24; felbamate's molecular formula is C11H14N2O4; its structural formula is:

FELBATOL® (felbamate) Structural Formula Illustration

The inactive ingredients for Felbatol® (felbamate) Tablets 400 mg and 600 mg are starch, microcrystalline cellulose, croscarmellose sodium, lactose, magnesium stearate, FD&C Yellow No. 6, D&C Yellow No. 10, and FD&C Red No. 40 (600 mg tablets only). The inactive ingredients for Felbatol® (felbamate) Oral Suspension 600 mg/5 mL are sorbitol, glycerin, microcrystalline cellulose, carboxymethylcellulose sodium, simethicone, polysorbate 80, methylparaben, saccharin sodium, propylparaben, FD&C Yellow No. 6, FD&C Red No. 40, flavorings, and purified water.

What are the possible side effects of felbamate (Felbatol)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; fever; swollen glands; painful sores in or around your eyes or mouth; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, depression, anxiety, or if you feel agitated, hostile, restless, hyperactive (mentally or physically), or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have any of these...

Read All Potential Side Effects and See Pictures of Felbatol »

What are the precautions when taking felbamate (Felbatol)?

Before taking felbamate, tell your doctor or pharmacist if you are allergic to it; or to meprobamate; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: blood problems (e.g., anemia), liver disease.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease.

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid...

Read All Potential Precautions of Felbatol »


Felbatol Consumer (continued)

SIDE EFFECTS: See also Warning section.

Drowsiness, dizziness, nausea, vomiting, diarrhea, trouble sleeping, headache, hiccups, and loss of appetite may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: ear pain, vision changes (e.g., blurred vision, double vision).

A small number of people who take anticonvulsants for any condition (such as seizure, bipolar disorder, pain) may experience depression, suicidal thoughts/attempts, or other mental/mood problems. Tell your doctor immediately if you or your family/caregiver notice any unusual/sudden changes in your mood, thoughts, or behavior including signs of depression, suicidal thoughts/attempts, thoughts about harming yourself.

Tell your doctor immediately if any of these rare but very serious side effects occur: fast/irregular/pounding heartbeat.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking felbamate, tell your doctor or pharmacist if you are allergic to it; or to meprobamate; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: blood problems (e.g., anemia), liver disease.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease.

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

This medication passes into breast milk. Consult your doctor before breast-feeding.


Felbatol Patient Information Including Side Effects

Brand Names: Felbatol

Generic Name: felbamate (Pronunciation: fel BAM ate)

  • What is felbamate (Felbatol)?
  • What are the possible side effects of felbamate (Felbatol)?
  • What is the most important information I should know about felbamate (Felbatol)?
  • What should I discuss with my healthcare provider before taking felbamate (Felbatol)?
  • How should I take felbamate (Felbatol)?
  • What happens if I miss a dose (Felbatol)?
  • What happens if I overdose (Felbatol)?
  • What should I avoid while taking felbamate (Felbatol)?
  • What other drugs will affect felbamate (Felbatol)?
  • Where can I get more information?

What is felbamate (Felbatol)?

Felbamate is an anti-epileptic medication, also called an anticonvulsant.

Felbamate is used alone or in combination with other medications to treat seizures in adults with epilepsy. Felbamate is also used to treat children with Lennox-Gastaut syndrome, a severe form of childhood epilepsy that also causes developmental and behavior problems.

Felbamate is usually given after other seizure medications have been tried without successful treatment of symptoms.

Felbamate may also be used for other purposes not listed in this medication guide.

What are the possible side effects of felbamate (Felbatol)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; fever; swollen glands; painful sores in or around your eyes or mouth; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, depression, anxiety, or if you feel agitated, hostile, restless, hyperactive (mentally or physically), or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have any of these serious side effects:

  • pale skin, weakness, easy bruising or bleeding (nosebleeds, bleeding gums);
  • fever, chills, body aches, flu symptoms;
  • fast or pounding heartbeats, feeling short of breath;
  • nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • pain or burning when you urinate;
  • loss of balance or coordination; or
  • worsening of seizures.

Less serious side effects may include:

  • dizziness, drowsiness, nervousness, tired feeling;
  • headache;
  • sleep problems (insomnia);
  • changes in weight or appetite;
  • acne, mild itching or skin rash;
  • diarrhea, constipation, vomiting;
  • runny or stuffy nose;
  • blurred vision; or
  • changes in your sense of taste.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about felbamate (Felbatol)?

Felbamate can cause a decrease in many types of blood cells (white cells, red cells, platelets). Call your doctor at once if you have any unusual bleeding, weakness, or any signs of infection, even if these symptoms first occur after you have been using the medication for several months.

Felbamate may also cause liver damage. Call your doctor if you have symptoms such as loss of appetite, stomach pain, or jaundice (yellowing of the skin or eyes).

You may have thoughts about suicide while taking this medication. Your doctor will need to check you at regular visits. Do not miss any scheduled appointments.

Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, depression, anxiety, or if you feel agitated, hostile, restless, hyperactive (mentally or physically), or have thoughts about suicide or hurting yourself.

Do not stop taking felbamate without first talking to your doctor, even if you feel better. You may have increased seizures if you stop taking felbamate suddenly. You will need to use less and less before you stop the medication completely.

Contact your doctor if your seizures get worse or you have them more often while taking felbamate.

Carry an ID card or wear a medical alert bracelet stating that you are taking felbamate, in case of emergency. Any doctor, dentist, or emergency medical care provider who treats you should know that you are taking a seizure medication.

Related Drug Centers
  • Felbatol


Related Drugs Index: