Rufinamide


Concise Prescribing Info
Indications/Uses
Adjunct for seizures associated with the Lennox-gastaut syndrome.
Dosage/Direction for Use
Adult : PO <30 kg: Initial: 200 mg/day in 2 divided doses, increased in increments of 200 mg/day every 2 days according to response. Max: 1,000 mg/day (without valproate); 600 mg/day (with valproate); ≥30 kg: Initial: 400 mg/day in 2 divided doses, gradually increased by increments of 400/day every 2 days. Max: 30-50 kg: 1,800 mg/day; >50-70 kg: 2,400 mg/day; >70 kg: 3,200 mg/day.
Dosage Details
Oral
Adjunct for seizures associated with the Lennox-gastaut syndrome
Adult: <30 kg: Initially, 200 mg daily in 2 equally divided doses, increased in increments of 200 mg daily every 2 days according to response. Max: 1,000 mg daily (without valproate); 600 mg daily (with valproate); ≥30 kg: Initially, 400 mg daily in 2 equally divided doses, gradually increased by increments of 400 mg daily every 2 days. Max: 30-50 kg: 1,800 mg daily; >50-70 kg: 2,400 mg daily; >70 kg: 3,200 mg daily.
Child: 4-17 years Same as adult dose.
Hepatic Impairment
Severe: Contraindicated.
Contraindications
Familial short QT syndrome. Severe hepatic impairment.
Special Precautions
Avoid abrupt withdrawal. Mild to moderate hepatic impairment. Children. Pregnancy and lactation.
Adverse Reactions
Significant: Shortened QT interval, leucopenia, status epilepticus, ataxia, dizziness, gait disturbance, somnolence, fatigue, suicidal ideation and behaviour.
Blood and lymphatic system disorders: Anaemia.
Ear and labyrinth disorders: Ear infection.
Eye disorders: Nystagmus, diplopia, blurred vision.
Gastrointestinal disorders: Nausea, vomiting, constipation, dyspepsia, upper abdominal pain.
Metabolism and nutrition disorders: Decreased appetite.
Musculoskeletal and connective tissue disorders: Back pain.
Nervous system disorders: Headache, dizziness, vertigo, tremor.
Psychiatric disorders: Aggression (children), psychomotor hyperactivity (children), anxiety.
Respiratory, thoracic and mediastinal disorders: Influenza, nasopharyngitis, rhinitis, sinusitis, bronchitis.
Skin and subcutaneous tissue disorders: Pruritus, rash.
Potentially Fatal: Drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome.
Patient Counseling Information
This drug may cause blurred vision, dizziness, and somnolence, if affected, do not drive or operate machinery.
MonitoringParameters
Monitor for signs and symptoms of suicide ideation; rash; frequency and duration of seizures.
Drug Interactions
Increased plasma concentrations with valproate. May decrease the effect of oral contraceptives. May increase plasma levels of phenytoin and phenobarbital. May decrease plasma levels of carbamazepine and lamotrigine.
Food Interaction
Food increases absorption.
Action
Description: Rufinamide modulates the activity of sodium channels through prolongation of their inactive state, thereby limiting the repetitive firing of sodium-dependent action potentials mediating anticonvulsant effects.
Pharmacokinetics:
Absorption: Slowly and extensively absorbed from the GI tract. Bioavailability: ≥85%; increased with food. Time to peak plasma concentration: 4-6 hours.
Distribution: Evenly distributed between erythrocytes and plasma. Volume of distribution: Approx 50 L. Plasma protein binding: 34%, mainly to albumin.
Metabolism: Extensively metabolised via carboxylesterase-mediated hydrolysis of the carboxylamide group to inactive acid derivative CGP 47292.
Excretion: Via urine (85%, approx 66% as CGP 47292, 2% as unchanged drug). Elimination half-life: Approx 6-10 hours.
Chemical Structure

Click on icon to see table/diagram/image
Storage
Store at 25°C. Protect from moisture.
MIMS Class
ATC Classification
N03AF03 - rufinamide ; Belongs to the class of carboximide derivatives antiepileptic. Used in the management of epilepsy.
Disclaimer: This information is independently developed by MIMS based on Rufinamide 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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