Felbatol

1 What is Felbatol?

Brand: Felbatol

Generic: Felbamate

Felbatol is an anticonvulsant used alone or in combination with other drugs to control partial seizures in the treatment of epilepsy. Partial and generalized seizures secondary to Lennox-Gastaut syndrome can also be controlled by this drug. This drug inhibits the GABA receptor in the brain to prevent seizures. This drug cannot cure the causes of your seizure but it can only provide symptomatic relief against seizures.

This drug requires a prescription.

2 What to Know Before Using

Before using Felbatol, the risks and benefits for your body should be discussed with your healthcare provider.

Inform your healthcare provider for any allergic reactions to these drugs or any other drugs, foods, dyes, preservatives, or animals.

Carefully read the label of non-prescription drugs for any possible allergic reaction or contraindications.

  • Studies in children regarding the correlation of age to the effects of felbamate have not been performed while safety and efficacy have not been established.
  • Studies in the elderly have not demonstrated any geriatric-specific problems that would limit the utility of felbamate.
  • Adverse effects have been reported in animal studies but studies in pregnant women and animals are still inadequate.
  • Infant risk is still undetermined when using this drug during breastfeeding. Discuss with your healthcare professional about potential risks and benefits of taking this drug while breastfeeding.

Drugs should not be taken together to prevent any interactions but in necessary cases inquire your healthcare provider regarding the adjustments in dosage or any other necessary precautions to prevent any unwanted side effects.

Inform your healthcare professional if you are taking any other drugs such as:

  • Amifampridine
  • Bepridil
  • Cisapride
  • Dronedarone
  • Mesoridazine
  • Pimozide
  • Piperaquine
  • Saquinavir
  • Sparfloxacin
  • Terfenadine
  • Thioridazine
  • Ziprasidone
  • Amiodarone
  • Anagrelide
  • Aripiprazole
  • Arsenic Trioxide
  • Buserelin
  • Citalopram
  • Clarithromycin
  • Clopidogrel
  • Crizotinib
  • Dabrafenib
  • Degarelix
  • Delamanid
  • Deslorelin
  • Domperidone
  • Donepezil
  • Escitalopram
  • Fluoxetine
  • Gestodene
  • Gonadorelin
  • Goserelin
  • Histrelin
  • Hydroxychloroquine
  • Ivabradine
  • Ketoconazole
  • Leuprolide
  • Levofloxacin
  • Metronidazole
  • Moxifloxacin
  • Nafarelin
  • Ondansetron
  • Orlistat
  • Panobinostat
  • Pasireotide
  • Pazopanib
  • Quetiapine
  • Sevoflurane
  • Tacrolimus
  • Triptorelin
  • Vandetanib
  • Vemurafenib
  • Vinflunine
  • Carbamazepine
  • Clobazam
  • Fosphenytoin
  • Ginkgo
  • Methsuximide
  • Phenytoin
  • Valproic Acid
  • Warfarin

Intake of specific food or using alcohol or tobacco with this drug is associated with an increased risk of certain side effects. Your healthcare professional can give you special instructions about the use of food, alcohol, or tobacco.

Inform your healthcare provider for any other medical problems such as blood problems, liver problems, depression, mental illness, or kidney disease.

3 Proper Usage

Proper usage of Felbatol requires strict adherence to your doctor’s orders. To prevent any side effects, take this drug exactly as directed in the label or as prescribed by your healthcare professional.

Shake the bottle well before measuring the dose and use a specially marked measuring spoon, a plastic syringe, or a small marked measuring cup to measure each dose accurately. Take this drug with food to lessen the risk of an upset stomach.

This drug can be used with other seizure drugs. Keep using all of your seizure drugs unless your healthcare professional tells you to stop. The dose of this drug will be variable for different patients. The directions on the label or the prescription by your healthcare professional should be followed.

The dosage of this drug you take depends on the medical problem for which you are using this drug. 

  • Adults and teenagers 14 years of age and older with epilepsy are initially given 1200 milligrams per day, divided into three or four smaller doses. Your healthcare professional may gradually increase your dose over several weeks up to 3600 mg per day.
  • Use and dose in children must be determined by your healthcare professional.
  • Adults and teenagers 14 years of age and older with Lennox-Gastaut syndrome are initially given 1200 milligrams per day, divided into three or four smaller doses. Your healthcare professional may gradually increase your dose over several weeks up to 3600 mg per day.
  • The dose in children 2 to 14 years of age is based on body weight and must be determined by your healthcare professional. The starting dose is usually 15 mg per kilogram of body weight per day, divided into three or four smaller doses. Your healthcare professional may gradually increase the dose over a few weeks up to 45 mg per kg of body weight per day.
  • Use and dose in children younger than 2 years of age must be determined by your healthcare professional.

A missed dose should be taken as soon as possible. However, skip the missed dose and go back to your regular dosing schedule if it is almost time for your next dose.

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

Keep from freezing. Keep out of the reach of children.

Dispose any outdated or expired drugs and ask your healthcare professional for the proper disposal of the drugs.

4 Precautions to Take

In using Felbatol, you must be careful and take some precautions as advised by your doctor.

Regular visits should be made to your healthcare provider to track your progress and to monitor the effectiveness and unwanted effects of the drug. 

Inform your healthcare professional if you are pregnant as you may be advised to join the North American Antiepileptic Drug Pregnancy Registry. This drug has been reported to cause aplastic anemia and a few cases of liver failure.

Check with your healthcare professional immediately if you have symptoms of a liver problem such as:

  • pain or tenderness in the upper stomach
  • pale stools, dark urine
  • loss of appetite, nausea
  • unusual tiredness or weakness
  • or yellow eyes or skin

Inform your healthcare professional immediately if you have symptoms of aplastic anemia such as:

Consult with your healthcare professional before you stop taking Felbamate. Your healthcare professional may want slowly taper the amount you are taking before stopping completely to your seizures from returning or to occurring more often.

Inform your healthcare professional if you develop any unusual or strange thoughts and behavior, confusion, worsening of depression, hallucinations, suicidal thoughts, and unusual excitement, nervousness, or irritability while taking this drug.

This drug can cause blurred vision, double vision, other changes in vision, dizziness or drowsiness. Be careful in taking this drug before you drive, use machines, or do anything else that could be dangerous.

Consult with your healthcare professional before taking any other prescription or non-prescription drugs, and herbal or vitamin supplements.

5 Potential Side Effects

As with many medications, there are several potential side effects associated with Felbatol.

Side effects may vary for each individual and prompt medical attention should be given if they occur.

Seek advice from your healthcare professional immediately if you experience any unusual symptoms such as:

  • 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
  • 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
  • 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. As your body adjusts to the medicine, the side effects will slowly disappear.

Ask your healthcare professional about ways to prevent or reduce some of these side effects. If any of the following side effects persists, or are inconvenient, or if you notice any other effects, or if you have any questions about them, consult with your health care professional.

Report any side effects to the FDA hotline at 1-800-FDA-1088.

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