Felbamate (oral)

Felbamate is used to control partial seizures in patients with epilepsy or Lennox-Gastaut syndrome.

Overview

Felbamate can be used alone or in combination with other medications for the control of partial seizures. It is used in the treatment of epilepsy when other treatments have failed or have not worked for the patient in question. The treatment is also used to control these seizures occurring in children as a result of Lennox-Gastaut syndrome.

Felbamate is a member of the medicine group called anticonvulsants. It acts within the brain of the patient to prevent convulsions from working.

This treatment is not a cure for epilepsy or other seizures. Instead it is a temporary treatment that will only continue to work for as long as the patient continues to use it regularly.

This is prescribed medication that is administered as a tablet or in suspension under the brand name Felbatol.

Condition treated

  • Epilepsy, seizures caused by
  • Lennox-Gastaut syndrome, seizures caused by

Type Of Medicine

  • Anticonvulsant

Side Effects

As well as the occurrence of the desired effects from the use of Felbamate, other unwanted side effects can occur. While not all side effects may occur, some cases may require the patient to seek medical attention.

Patients should consult their doctor immediately if they experience any of the following side effects from the use of Felbamate:

Occurring more commonly:

  • Black stools with at tarry appearance
  • Chest pains
  • Chills
  • Confusion
  • Coughing
  • Delusions
  • Dementia
  • Depression or extreme sadness
  • Feverishness
  • Loss of control of the bladder
  • Pain or difficulty experienced during urination
  • Red or purple spots appearing on the skin
  • Shakiness of the legs, arms, hands or feet
  • Shaking of the hands or feet
  • Shortness of breath without exertion
  • Soreness of the throat
  • Sores or ulcers around the mouth
  • Swelling of glands
  • Trembling of the hands or feet
  • Unusual bleeding
  • Unusual bruising
  • Unusual tiredness
  • Unusual weakness
  • White spots on the lips or mouth

Occurring less commonly:

  • Aggression
  • Agitation
  • Bladder pain
  • Bloody urine
  • Bone pains
  • Cloudy urine
  • Clumsiness
  • Crawling, itching, prickling or tingling feelings on the skin
  • Frequent urge to urinate
  • Lack of coordination
  • Loss of appetite
  • Lower back
  • Mental changes
  • Mood changes
  • Problems with muscle control
  • Side pain
  • Skin rash
  • Swollen or puffy face
  • Trouble with breathing
  • Unsteadiness
  • Unsteadiness or trembling

Occurring only rarely:

  • Continued vomiting
  • Continuing headache
  • Continuing stomach pain
  • Darkened coloration of urine
  • General feeling of tiredness
  • General feeling of weakness
  • Hives
  • Increased sensitivity of the skin to sunlight
  • Itching
  • Lightened coloration of stools
  • Muscle cramping
  • Nasal congestion
  • Nosebleeds
  • Pains
  • Swollen or painful glands
  • Tightness across the chest
  • Unusual bleeding
  • Unusual bruising
  • Yellowing of the eyes
  • Yellowing of the skin

Other side effect can also occur that are less serious, mild or will abate over time. If these side effects are ongoing or bothersome then you can consult your doctor for advice, but in most cases the following side effects would not necessitate that the patient seeks medical attention:

Occurring more commonly:

  • Acid stomach
  • Belching or burping
  • Body aches
  • Body pain
  • Changed gait and/or balance
  • Changed taste
  • Congestion of the ear
  • Constriction of the pupils in one or both eyes
  • Crying without cause
  • Depersonalization
  • Diarrhea
  • Difficulty in passing a bowel movement (stool)
  • Difficulty with sleeping
  • Dizziness
  • Doubling of vision
  • Dysphoria
  • Euphoria
  • Headaches
  • Heartburn
  • Hiccup
  • Inability to sleep
  • Indigestion
  • Lack of appetite
  • Loss of voice
  • Nausea
  • Paranoia
  • Quickness to react or to overreact emotionally
  • Rapidly changed moods
  • Runny nose
  • Seeing double
  • Sleepiness
  • Sleeplessness
  • Sneezing
  • Sour stomach
  • Stomach discomfort
  • Stomach upset or pain
  • Troubled sleep
  • Unusual drowsiness
  • Unusual or unpleasant aftertaste
  • Weight loss

Occurring less commonly:

  • Blemishing of the skin
  • Blurring of the vision
  • Decrease in weight
  • Decreased awareness
  • Decreased responsiveness
  • Difficulty experienced when moving
  • Difficulty in swallowing
  • Earaches
  • Hoarseness
  • Joint pains
  • Muscle aching
  • Muscle cramping
  • Muscle pains
  • Muscle stiffness
  • Pain or tenderness around the eyes
  • Pimples
  • Redness of ears
  • Severe sleepiness
  • Swelling inside the ear
  • Swelling of joints
  • Tender or swollen glands in the neck
  • Voice changes

Other side effects can also occur that are not listed herein. If you experience other side effects then you should report them to your doctor as soon as possible.

Dosage

This medication is not a first resort. Felbamate should be used only after other treatments have been tried and have failed or have caused the occurrence of unwanted side effects.

You should take this treatment only as you have been directed to by your doctor. This will ensure that you get the best possible results from the treatment. You should not take a greater dose of it than prescribed, take it more frequently than prescribed, nor use it for longer than your doctor has ordered.

Before using this treatment you should understand the risks of use. A medication guide will be provided with the treatment and you may also be asked to sign an acknowledgment that you understand and accept the risks of use. You should discuss anything that you do not understand or are unsure of with your doctor before use.

When taking the oral liquid treatment of Felbamate you must follow these steps for use:

  • Ensure that the bottle of medication is well shaken before use.
  • Use an appropriate device with clear markings to measure the treatment. You should not use a normal spoon as this may not give you an accurate measurement.

Felbamate can be taken at the same time as food or just after food unless you have been instructed to do otherwise. Your doctor may instruct you to take it on an empty stomach.

This medication can be used in conjunction with other seizure medications. Do not stop taking other treatments unless you are instructed to do so by your doctor.

The following information is a guideline only. The dose of this treatment will differ for each patient and you should only ever follow the directions for the use of this treatment as given by the prescribing doctor. The amount of medication will depend on a range of factors including your own personal circumstances and the strength of the medication that you are given.

When using either suspension or tablets for treatment:

In the use of patients with epilepsy:

  • Teenagers aged 14+ and adults¬†' The initial dose is usually 1200mg taken daily. The total dose is usually taken as 3-4 smaller doses throughout the day.
  • Children 'The doctor will determine the use and dose in each case.

In the use of patients with Lennox-Gastaut syndrome:

  • Teenagers aged 14+ and adults' The initial dose will usually be 1200mg in total taken daily across 3-4 smaller doses. This may be increased over a period of weeks to a maximum dose of 3600mg taken daily.
  • Children aged 2-14¬†' The dose will be based on the weight of the child and will be calculated by the doctor. The initial dose will normally be 15mg/kg and will be divided into 3-4 doses to take during the day. The maximum dose is 45mg/kg taken daily.
  • Children aged below 2 'The doctor will determine the use and the dose to be given in each individual case.

If a dose is missed the patient should take it as soon as it is possible to do so. If, however, the next dose is soon to be due then the missed dose should be skipped completely and the patient should return to the normal dosing schedule.

Interactions

Certain medications should not be used in conjunction with one another. This is because they can react in the body with unwanted results. In some cases this can cause serious medical complications. In other cases medications may stop one another form working or may increase the risk of the occurrence of certain unwanted side effects.

To ensure that you are not put at risk from medication interactions you should inform your doctor of all substances that you are taking whether they are prescribed or not.

The use of the following medications in conjunction with Felbamate is not recommended and your doctor may choose to change one or more of your treatments:

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

The use of Felbamate with the following medications would not normally be recommended, but in some cases the use of both may still be the best treatment available for you. In these cases the doctor may adjust the dose of the medication or change the frequency of use of the medication:

  • Zuclopenthixol
  • Vinflunine
  • Vemurafenib
  • Vandetanib
  • Triptorelin
  • Tacrolimus
  • Sulpiride
  • Sotalol
  • Sevoflurane
  • Quetiapine
  • Pitolisant
  • Pimavanserin
  • Pazopanib
  • Pasireotide
  • Panobinostat
  • Orlistat
  • Ondansetron
  • Nafarelin
  • Moxifloxacin
  • Metronidazole
  • Levofloxacin
  • Leuprolide
  • Ketoconazole
  • Ivabradine
  • Hydroxyzine
  • Hydroxychloroquine
  • Histrelin
  • Goserelin
  • Gonadorelin
  • Gestodene
  • Fluoxetine
  • Escitalopram
  • Efavirenz
  • Donepezil
  • Domperidone
  • Deslorelin
  • Delamanid
  • Degarelix
  • Dabrafenib
  • Crizotinib
  • Clopidogrel
  • Clarithromycin
  • Citalopram
  • Calcifediol
  • Buserelin
  • Arsenic Trioxide
  • Aripiprazole
  • Anagrelide
  • Amiodarone

Using the following medications in conjunction with Felbamate may increase the risk of certain side effects occurring, but the use of both may still be the best treatment for you. Your doctor may prescribe both and adjust the dose or frequency of use of these medications:

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

Other medication interactions may also occur. You should ensure your doctor is aware of everything that you take so that they can ensure there will be no medication interactions occurring.

Medical problems not linked to this treatment can also prohibit its use. You should inform your doctor of your full medical history before beginning use. It is especially important that your doctor is aware that you have any of the following conditions:

This treatment should not be used in patients who suffer from the following conditions:

  • Blood problems
  • Liver problems

The following medical conditions could be worsened by the use of Felbamate and caution should be taken:

  • Depression
  • Mental illness

Felbamate may take longer to be removed from the body if the patient suffers from the following condition. This may lead to increased effects from the treatment occurring.

  • Kidney disease

Other medical conditions can also limit or prohibit the use of this treatment. Ensure your doctor is aware of all conditions from which you are suffering.

Warnings

Before beginning use of this treatment you must understand the risks of doing so. Before it is prescribed you may be required to complete a form and sign to say that you understand the potential risks that may arise from the use of this medication. You should do so only having discussed the risks in relation to the benefits with your doctor and ensuring that the following factors have been taken into account:

Allergies ' Your doctor should be made aware of any allergic reactions that you have had in the past. Allergies to medication, dyes, preservatives or other substances may prohibit the use of this treatment in patients.

Pediatric'This medication has only been tested for safety and efficiency of use in children suffering from seizures are a result of Lennox-Gastaut syndrome. Felbamate should not be used for the treatment of children in cases other than this.

Geriatric 'No specific tests have been carried out on the use in the elderly but no limitations have been recorded to date. Elderly patients are more likely to have conditions such as kidney problems, however, which may in some cases mean that this treatment is inappropriate or needs to be adjusted. Caution should therefore be taken in the treatment of elderly patients.

Pregnancy 'You should inform your doctor if you are pregnant or believe that you may become pregnant during the use of this treatment. There is a risk to the use of this medication when pregnant. If you are pregnant during use then you may be required to register with the Antiepileptic Drug Pregnancy Registry to help to learn more about the use of this treatment through pregnancy.

Breastfeeding'No studies have been performed on the use of this treatment during the nursing of a child at the breast. You should discuss the risks and the benefits of doing so with your doctor before you begin use.

Your doctor will need to see you regularly when you are taking this medication to ensure that you are progressing well and to observe for unwanted side effects. Dose adjustments may be made and medical laboratory tests may be taken.

Liver problems can occur during the use of this treatment. You should stop taking the medication and contact your doctor immediately if you notice any of the following symptoms:

  • Tenderness of the stomach
  • Paleness of the stool
  • Darkened urine
  • Lost appetite
  • Nausea
  • Unusual tiredness
  • Unusual weakness
  • Yellowing of the eyes
  • Yellowing of the skin

Aplastic anemia can occur during the use of felbamate. You should inform your doctor straight away if you experience any of the following:

  • Chills
  • Pain
  • Coughing
  • Fever
  • White spots around the mouth
  • Unusual bleeding
  • Unusual bruising
  • Wheezing
  • Tightness across the chest

You should not cease use of this treatment without discussing doing so with your doctor first. Cessation may need to be carried out gradually to prevent the return of seizures and the onset of other serious conditions that could occur.

This medication can cause unusual changes in mood and behavior. If you start experiencing strange thoughts or behavior then you should inform your doctor. Changes may include the following:

  • Confusion
  • Depression
  • Worsened depression
  • Hallucination
  • Suicidal thought
  • Nervousness
  • Irritability
  • Unusual excitement

Felbamate may impair your ability to drive and operate machinery. This is because it can make you less attentive, drowsy, dizzy and can change your vision. Remember that it is your legal responsibility to ensure that you are safe to carry out tasks such as these and ensure that you are aware of how the medication affects you before doing so. You should not take action that puts yourself or others at risk. If these side effects are particularly bothersome and debilitating then you should consult your doctor for advice.

You should not take any other medications in conjunction with this treatment unless they have been approved by your doctor. This includes both prescription and nonprescription medications.

Inform any medical professionals that you have contact with that you are taking this medication before receiving any treatments or medications.

Storage

This medication can be stored at room temperature. Ensure that it is kept out of direct light, away from sources of heat and away from moisture.

Felbamate should always be kept out of the reach of children, even when the medication is for their use.

Ensure that this medication is properly disposed of as directed by a healthcare professional.

Summary

Felbamate is used in the treatment of seizures. It works on the brain to prevent the seizures from occurring.

Felbamate is used to treat epilepsy and Lennox-Gastaut syndrome.

Felbamate is a very serious medication that should not be used as a first option. It is for use where other medications have failed or where unwanted side effects have occurred from the use of other treatments. It can be used in conjunction with other seizure medications when approved by the prescribing doctor.

Before receiving this medication you may be required to sign an acknowledgment of the risks of use. You should ensure that you have read all of the information provided and have discussed anything that you do not understand with your doctor before doing so.

You should inform your doctor if you are pregnant or may become pregnant during use. Pregnant women may be asked to join the Antiepileptic Drug Pregnancy Registry so that more can be learned about the use of treatments during pregnancy.

Felbamate can interact with a wide range of medications if taken together so it is very important that your doctor is fully aware of all other substances and medications that you are taking before you begin use.