Felbamate


Concise Prescribing Info
Indications/Uses
Monotherapy or adjunct in severe refractory partial seizures unresponsive to other drugs.
Dosage/Direction for Use
Adult : PO Monotherapy: Initial: 1.2 g/day in 3-4 divided doses, may increase increase gradually by 0.6 g every 2 wk up to 2.4 g/day. May further increase if needed. Max: 3.6 g/day. Adjunct therapy: Initial: 1.2 g/day in 3-4 divided doses, may increase by 1.2 g at wkly intervals up to 3.6 g/day. Reduce the dose of concomitant anticonvulsants by 20-33% upon initiation of felbamate.
Dosage Details
Oral
Monotherapy or adjunct in refractory partial seizures with or without secondary generalisation
Adult: In severe cases unresponsive to other drugs: As monotherapy: Initially, 1.2 g daily in 3 or 4 divided doses, may increase gradually by 0.6 g every 2 wk up to 2.4 g daily. May further increase if needed. Max: 3.6 g daily. As adjunctive treatment: Initially, 1.2 g daily in 3 or 4 divided doses, may increase by 1.2 g at wkly intervals up to 3.6 g daily. Reduce the dose of concomitant anticonvulsants by 20-33% when initiating felbamate therapy.
Child: As adjunct in Lennox-Gastaut syndrome: 2-<14 yr Initially, 15 mg/kg daily in 3 or 4 divided doses, may increase gradually in increments of 15 mg/kg at wkly intervals. Max: 45 mg/kg daily. Reduce the dose of concomitant anticonvulsants by 20% when initiating felbamate therapy; ≥14 yr Same as adult dose.
Renal Impairment
Reduce initial and maintenance doses by 50%.
Hepatic Impairment
Contraindicated.
Contraindications
History of blood disorders. Active liver disease or history of hepatic impairment.
Special Precautions
Avoid abrupt withdrawal. Renal impairment. Childn. Pregnancy and lactation.
Adverse Reactions
Nervous: Headache, dizziness, anorexia, insomnia, somnolence, anxiety.
GI: Nausea, vomiting, dyspepsia, constipation or diarrhoea.
Resp: Upper resp tract infection, rhinitis.
Hepatic: Increased SGPT.
Genitourinary: UTI, intramenstrual bleeding.
Ophthalmologic: Diplopia.
Otic: Otitis media.
Dermatologic: Photosensitivity, acne, rash, facial oedema.
Others: Fatigue, decreased wt, hypophosphataemia.
Potentially Fatal: Acute hepatic failure, aplastic anaemia.
Patient Counseling Information
Avoid exposure to UV radiation.
MonitoringParameters
Perform CBC and LFT prior to and during treatment. Monitor for suicidality (e.g. depression, suicidal thoughts, mood/behavioural changes).
Drug Interactions
Enhanced metabolism w/ enzyme inducers (e.g. phenobarbital, carbamazepine, phenytoin). Prolonged half-life w/ gabapentin.
Action
Description: Felbamate is a carbamate w/ unknown mechanism of action, but has properties similar to other anticonvulsants. It has weak inhibitory effects on GABA-receptor binding, benzodiazepine receptor binding, and is devoid of activity at the MK-801 receptor binding site of the NMDA receptor-ionophore complex.
Pharmacokinetics:
Absorption: Well absorbed from the GI tract. Bioavailability: ≥80%. Time to peak plasma concentration: 1-6 hr.
Distribution: Enters breast milk. Volume of distribution: 0.76 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 inactive metabolites); faeces (<5%). Terminal elimination half-life: 16-23 hr.
Chemical Structure

Click on icon to see table/diagram/image
Storage
Store between 20-25°C.
MIMS Class
ATC Classification
N03AX10 - felbamate ; Belongs to the class of other antiepileptics.
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 © 2020 MIMS. All rights reserved. Powered by MIMS.com
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