Generic Medicine Info
Indications and Dosage
Partial seizures with or without secondary generalisation
Adult: In severe cases unresponsive to other drugs: As monotherapy: Initially, 1,200 mg daily in 3 or 4 divided doses, may increase in increments of 600 mg daily every 2 weeks for up to 2,400 mg daily depending on patient response and tolerability. Max: 3,600 mg daily. As adjunctive therapy: Initially, 1,200 mg daily in 3 or 4 divided doses, may increase in increments of 1,200 mg daily at weekly intervals depending on patient response and tolerability. Reduce the dose of concomitant antiepileptic drugs (AEDs) by 1/3 (20-33%) when initiating felbamate therapy.
Child: ≥14 years Same as adult dose.

Seizures associated with the Lennox-Gastaut syndrome
Child: 2-<14 years In severe cases unresponsive to other drugs: As adjunctive therapy: Initially, 15 mg/kg daily in 3 or 4 divided doses, may increase in increments of 15 mg/kg at weekly intervals. Max: 45 mg/kg daily. Reduce the dose of concomitant AEDs by 20% when initiating felbamate therapy.
Renal Impairment
Reduce initial and maintenance doses by 50%.
Hepatic Impairment
Hypersensitivity to carbamates. History of blood dyscrasia. Hepatic impairment.
Special Precautions
Avoid abrupt withdrawal. Renal impairment. Children. Pregnancy and lactation.
Adverse Reactions
Significant: Suicidal behaviour and ideation.
Blood and lymphatic system disorders: Leucopenia.
Cardiac disorders: Chest pain.
Ear and labyrinth disorders: Otitis media.
Eye disorders: Miosis, diplopia, visual disturbance.
Gastrointestinal disorders: Vomiting, nausea, dyspepsia, constipation, hiccups, dysgeusia, abdominal pain, diarrhoea, dry mouth.
General disorders and administration site conditions: Fatigue, fever.
Investigations: Increased liver enzymes, decreased weight.
Metabolism and nutrition disorders: Anorexia.
Musculoskeletal and connective tissue disorders: Myalgia.
Nervous system disorders: Drowsiness, headache, dizziness, insomnia, somnolence, tremor, gait disturbance, ataxia, paraesthesia, stupor.
Psychiatric disorders: Emotional lability, anxiety, depression.
Renal and urinary disorders: UTI.
Respiratory, thoracic and mediastinal disorders: Upper respiratory tract infection, pharyngitis, cough, rhinitis, sinusitis.
Skin and subcutaneous tissue disorders: Rash, acne, purpura.
Potentially Fatal: Aplastic anaemia, acute hepatic failure.
PO: Z (Insufficient data to conclude its safety and risk during pregnancy. Use only when benefits outweigh risks.)
Monitoring Parameters
Monitor therapeutic effectiveness and response (e.g. seizure activity, force, type, duration); serum levels of concomitant antiseizure therapy. Perform LFTs (at baseline, every 2 weeks after therapy initiation for the first 6-12 months of therapy, and periodically thereafter); CBC (at baseline, every 2 weeks for the first 6-12 months of therapy, periodically thereafter, and for a significant period after discontinuation). Monitor for suicidality (e.g. suicidal thoughts, depression, behavioural changes).
Symptoms: Mild gastric distress, resting heart rate. Management: Symptomatic and supportive treatment.
Drug Interactions
May increase serum concentration of phenobarbital, carbamazepine, phenytoin.
Mechanism of Action: Felbamate is a dicarbamate derivative with unknown mechanism. It has weak inhibitory effects on GABA-receptor binding, benzodiazepine receptor binding. It also exhibits NMDA antagonism, and Ca and Na channel inhibition.
Absorption: Well absorbed from the gastrointestinal tract. Bioavailability: >90%. Time to peak plasma concentration: 1-6 hours.
Distribution: Enters breast milk. Volume of distribution: 0.7-0.91 L/kg. Plasma protein binding: Approx 22-25%, mainly to albumin.
Metabolism: Partly metabolised in the liver via hydroxylation and conjugation to inactive metabolites.
Excretion: Mainly via urine (40-50% as unchanged drug, 40% as metabolites). Terminal elimination half-life: 20-23 hours.
Chemical Structure

Chemical Structure Image

Source: National Center for Biotechnology Information. PubChem Compound Summary for CID 3331, Felbamate. https://pubchem.ncbi.nlm.nih.gov/compound/Felbamate. Accessed Sept. 28, 2022.

Store between 20-25°C.
MIMS Class
ATC Classification
N03AX10 - felbamate ; Belongs to the class of other antiepileptics.
Anon. Felbamate. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 05/08/2022.

Anon. Felbamate. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 05/08/2022.

Buckingham R (ed). Felbamate. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 05/08/2022.

Felbatol Tablets, Oral Suspension (Meda Pharmaceuticals Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 05/08/2022.

Disclaimer: This information is independently developed by MIMS based on Felbamate from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2024 MIMS. All rights reserved. Powered by MIMS.com
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