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Authoritative Clinical Reference
Schedule H
Oral
Formulation Strengths Available
Film-coated Tablet 200 mg, 400 mg
(Note: Oral suspension is NOT AVAILABLE in India)
INDICATIONS + DOSING — FOR CLINICIAN USE ONLY
Primary Indications (Approved / Standard in India):
Lennox-Gastaut Syndrome (Adjunctive Therapy)
Adults and Adolescents (≥18 years):
Parameter Recommendation
Starting Dose 400–800 mg/day in two divided doses
Titration Increase by 400 mg/day every 2 days based on tolerability
Usual Maintenance Dose 1800–3200 mg/day in two divided doses
Maximum Dose 3200 mg/day
Key Notes Administer with food to enhance absorption; always use as adjunctive therapy
Children (4 to <18 years): Refer to Paediatric Dosing Section
Secondary Indications – Adults Only (Off-label):
Indication Dose Duration Notes
Refractory Focal (Partial) Seizures Starting: 400–800 mg/day in two divided doses; titrate up to 3200 mg/day Long-term as per neurologist discretion OFF-LABEL — Specialist only. Evidence: Limited RCTs; considered when conventional AEDs have failed
PAEDIATRIC DOSING (Specialist Only)
Primary Indications (Approved / Standard in India):
Lennox-Gastaut Syndrome (Adjunctive Therapy in Children ≥4 years)
Parameter Recommendation
Age Group 4–17 years
Starting Dose 10 mg/kg/day in two divided doses
Titration Increase by approximately 10 mg/kg/day every 2 days
Usual Maintenance Dose 45 mg/kg/day in two divided doses
Maximum Dose 45 mg/kg/day OR 3200 mg/day (whichever is lower)
Administration With food to improve bioavailability
Weight-Based Dosing Guide:
Body Weight Starting Dose Target Maintenance Dose Maximum Dose
15–20 kg 200 mg/day 600–800 mg/day 800 mg/day
20–30 kg 200–400 mg/day 900–1200 mg/day 1200 mg/day
30–50 kg 400–600 mg/day 1400–2000 mg/day 2000 mg/day
50–70 kg 600–800 mg/day 2000–2800 mg/day 2800 mg/day
70 kg 800 mg/day 3200 mg/day 3200 mg/day
Safety Monitoring:
Secondary Indications – Paediatrics (Off-label):
Not applicable.
⚠️ Not recommended in children <4 years except under expert paediatric neurologist supervision in highly refractory cases.
⚠️ Oral suspension NOT AVAILABLE in India — For children unable to swallow tablets, careful tablet splitting may be necessary under pharmacist/specialist guidance.
| eGFR (ml/min/1.73m²) | Recommendation |
|---|---|
| eGFR (ml/min/1.73m²) | Recommendation |
| eGFR (ml/min/1.73m²) | Recommendation |
| Haemodialysis | Not significantly dialyzable; no supplemental dosing required |
| Peritoneal dialysis | No specific data; use with caution |
| Hepatic Impairment | Recommendation |
|---|---|
| Mild Impairment (Child-Pugh A) | Use with caution; initiate at lower dose range |
| Moderate Impairment (Child-Pugh B) | Reduce starting dose; titrate slowly under close monitoring |
| Severe Impairment (Child-Pugh C) | Avoid use; significantly altered pharmacokinetics with unpredictable drug levels |
Parameter Recommendation
Safety Category Limited human data; animal studies demonstrate teratogenic potential
Recommendation Use only if clearly indicated and benefits outweigh fetal risks; requires specialist (neurologist + obstetrician) input
Preferred Alternatives Lamotrigine or Levetiracetam (preferred in Indian obstetric neurology practice for women of childbearing potential)
Monitoring Serum AED levels (if available), detailed fetal anomaly scan, fetal growth monitoring
Counselling Women of childbearing age should receive pre-conception counselling; folic acid supplementation recommended
Parameter Recommendation
Compatibility Limited data; likely excreted in breast milk
Expected Milk Levels Low (based on physicochemical properties)
Recommendation May be used with caution if clinically necessary; monitor infant closely
Preferred Alternatives Levetiracetam if initiating new AED therapy during lactation
Infant Monitoring Sedation, poor feeding, hypotonia, developmental milestones
Parameter Recommendation
Starting Dose 400 mg/day in two divided doses
Titration Slower titration recommended (every 3–4 days instead of every 2 days)
Special Considerations Increased risk of CNS depression, dizziness, falls
Additional Risks Polypharmacy interactions; reduced hepatic reserve; QT changes
Monitoring Frequent clinical review; ECG if on other cardiac medications
Interacting Drug/Class Mechanism Clinical Advice
Valproate Inhibits rufinamide metabolism; increases rufinamide plasma concentration by ~50–70% Reduce rufinamide dose; monitor for toxicity (somnolence, ataxia)
Carbamazepine Induces rufinamide metabolism; decreases rufinamide levels by ~20–30% May require higher rufinamide doses; monitor seizure control
Phenytoin Enzyme induction; reduces rufinamide efficacy Adjust rufinamide dose based on clinical response
Phenobarbital Enzyme induction; lowers rufinamide levels Monitor seizure control; dose adjustment may be needed
QT-shortening drugs Additive effect on QT interval shortening Avoid if possible; obtain ECG if combination unavoidable
Interacting Drug/Class Mechanism Clinical Advice
Hormonal Contraceptives Rufinamide may reduce efficacy of ethinylestradiol and norethindrone Counsel on additional barrier contraception or use higher-dose OCP formulations
Lamotrigine Potential additive CNS effects Monitor for excessive sedation; no major pharmacokinetic interaction
Benzodiazepines Additive CNS depression Use cautiously; monitor for excessive sedation
Primidone May induce rufinamide metabolism Monitor seizure control
Rifampicin Strong enzyme inducer; may reduce rufinamide levels Avoid combination if possible; monitor efficacy
Adverse Effect Clinical Notes
QT Interval Shortening Contraindicated in familial short QT syndrome; obtain baseline ECG in high-risk patients
Stevens-Johnson Syndrome / Toxic Epidermal Necrolysis Rare but life-threatening; discontinue immediately if mucocutaneous reaction develops
DRESS Syndrome (Drug Reaction with Eosinophilia and Systemic Symptoms) Multi-organ hypersensitivity; requires immediate discontinuation and hospitalisation
Suicidal Ideation / Behaviour Class effect of AEDs; requires close psychiatric monitoring especially in first few weeks
Status Epilepticus May occur with abrupt withdrawal; always taper gradually
Leukopenia Rare; monitor if unexplained infections occur
Phase Parameter Frequency
Baseline ECG (QT interval), LFTs, CBC, renal function Before initiation
Psychiatric assessment Especially in patients with history of mood disorders
During Titration Clinical assessment for rash, behavioural changes At each dose increase
ECG At 2 weeks (if QT concerns)
Long-term LFTs Every 6–12 months
Seizure frequency diary At each visit
Mood and behavioural assessment Periodically
Serum drug level Only in complex cases (not routinely available in India)
(Availability may vary by region; confirm with local suppliers)
Strength Approximate Price per Tablet
| 200 mg ₹55–₹90 |
|---|
| 400 mg ₹95–₹160 |
rufinamide; Lennox-Gastaut syndrome; antiepileptic; triazole anticonvulsant; paediatric epilepsy; QT-shortening; refractory seizures; adjunctive therapy; Schedule H; specialist-use
RxIndia v1.0 — 09 Jan 2025
This platform is designed strictly for healthcare professionals. Data provided is synthesized from authoritative pharmacological sources and clinical registries. Do not use for consumer medical decisions. Always verify critical dosing and contraindications with official institutional protocols and peer-reviewed journals.
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