Formulary
Rufinamide: Indications, Dosing, Side Effects and Interactions
Rufinamide clinical drug profile including indications, dosing, side effects, cautions and interactions.
MedNext Academy | 6 min read
Rufinamide: Indications, Dosing, Side Effects and Interactions
Rufinamide clinical drug profile including indications, dosing, side effects, cautions and interactions.
Indications and dose
**Adjunctive treatment of seizures in Lennox-Gastaut syndrome without valproate (initiated by a specialist)**
- **Child** (By Mouth): 4-17 years (body-weight 70.1 kg and above) Initially 200 mg twice daily, then increased in steps of 200 mg twice daily (max. per dose 1.6 g twice daily), adjusted according to response, dose to be increased at intervals of not less than 2 days.
- **Adult** (By Mouth): (body-weight 70.1 kg and above) Initially 200 mg twice daily, then increased in steps of 200 mg twice daily (max. per dose 1.6 g twice daily), adjusted according to response, dose to be increased at intervals of not less than 2 days.
**Adjunctive treatment of seizures in Lennox-Gastaut syndrome with valproate (initiated by a specialist)**
- **Child** (By Mouth): 4-17 years (body-weight 70.1 kg and above) Initially 200 mg twice daily, then increased in steps of 200 mg twice daily (max. per dose 1.1 g twice daily), adjusted according to response, dose to be increased at intervals of not less than 2 days.
- **Adult** (By Mouth): (body-weight 70.1 kg and above) Initially 200 mg twice daily, then increased in steps of 200 mg twice daily (max. per dose 1.1 g twice daily), adjusted according to response, dose to be increased at intervals of not less than 2 days.
**Adjunctive treatment of seizures in Lennox-Gastaut syndrome without valproate (initiated by a specialist) for rufinamide**
- **Child 1-3 years** (By mouth): Initially 5 mg/kg twice daily, then increased in steps of up to 5 mg/kg twice daily (max. per dose 22.5 mg/kg twice daily), adjusted according to response, dose to be increased at intervals of not less than 3 days to the target dose (maximum dose), each dose should be given to the nearest 0.5 mL.
- **Child 4-17 years (body-weight up to 30 kg)** (By mouth): Initially 100 mg twice daily, then increased in steps of 100 mg twice daily (max. per dose 500 mg twice daily), adjusted according to response, dose to be increased at intervals of not less than 3 days.
- **Child 4-17 years (body-weight 30-50 kg)** (By mouth): Initially 200 mg twice daily, then increased in steps of 200 mg twice daily (max. per dose 900 mg twice daily), adjusted according to response, dose to be increased at intervals of not less than 2 days.
- **Child 4-17 years (body-weight 50.1-70 kg)** (By mouth): Initially 200 mg twice daily, then increased in steps of 200 mg twice daily (max. per dose 1.2 g twice daily), adjusted according to response, dose to be increased at intervals of not less than 2 days.
- **Child 4-17 years (body-weight 70.1 kg and above)** (By mouth): Initially 200 mg twice daily, then increased in steps of 200 mg twice daily (max. per dose 1.6 g twice daily), adjusted according to response, dose to be increased at intervals of not less than 2 days.
**Adjunctive treatment of seizures in Lennox-Gastaut syndrome with valproate (initiated by a specialist) for rufinamide**
- **Child 1-3 years** (By mouth): Initially 5 mg/kg twice daily, then increased in steps of up to 5 mg/kg twice daily (max. per dose 15 mg/kg twice daily), adjusted according to response, dose to be increased at intervals of not less than 3 days to the target dose (maximum dose), each dose should be given to the nearest 0.5 mL.
- **Child 4-17 years (body-weight up to 30 kg)** (By mouth): Initially 100 mg twice daily, then increased in steps of 100 mg twice daily (max. per dose 300 mg twice daily), adjusted according to response, dose to be increased at intervals of not less than 2 days.
- **Child 4-17 years (body-weight 30-50 kg)** (By mouth): Initially 200 mg twice daily, then increased in steps of 200 mg twice daily (max. per dose 600 mg twice daily), adjusted according to response, dose to be increased at intervals of not less than 2 days.
- **Child 4-17 years (body-weight 50.1-70 kg)** (By mouth): Initially 200 mg twice daily, then increased in steps of 200 mg twice daily (max. per dose 800 mg twice daily), adjusted according to response, dose to be increased at intervals of not less than 2 days.
- **Child 4-17 years (body-weight 70.1 kg and above)** (By mouth): Initially 200 mg twice daily, then increased in steps of 200 mg twice daily (max. per dose 1.1 g twice daily), adjusted according to response, dose to be increased at intervals of not less than 2 days.
Cautions
Patients at risk of further shortening of QTc interval
Side effects
Common or very common Anxiety; appetite decreased; back pain; constipation; diarrhoea; dizziness; drowsiness; eating disorder; epistaxis; fatigue; gait abnormal; gastrointestinal discomfort; headache; increased risk of infection; insomnia; movement disorders; nausea; nystagmus; oligomenorrhoea; seizures; skin reactions; tremor; vertigo; vision disorders; vomiting; weight decreased Uncommon Hypersensitivity Frequency not known Suicidal behaviours
Interactions
**Severe interactions:**
- For patients on rufinamide treatment who have administration of valproate initiated, significant increases in rufinamide plasma concentrations may occur.
- No significant changes in rufinamide concentration are observed following coadministration with lamotrigine, topiramate or benzodiazepines.
- Thus, clinically significant interactions mediated through inhibition of cytochrome P450 system by rufinamide are unlikely to occur.
**Other interactions (16):**
- Potential for other medicinal products to affect rufinamide Other antiepileptic medicinal products Rufinamide concentrations are not subject to clinically relevant changes on coadministration with...
- Therefore, consideration should be given to a dose reduction of rufinamide in patients who are initiated on valproate therapy (see section 4.2).
- The addition or withdrawal of these medicinal products or adjusting of the dose of these medicinal products during rufinamide therapy may require an adjustment in dosage of rufinamide (see section...
- Potential for rufinamide to affect other medicinal products Other antiepileptic medicinal products The pharmacokinetic interactions between rufinamide and other antiepileptic medicinal products have...
- Rufinamide appears not to have a clinically relevant effect on carbamazepine, lamotrigine, phenobarbital, topiramate, phenytoin or valproate steady state concentrations.
- Oral contraceptives Coadministration of rufinamide 800 mg twice daily and a combined oral contraceptive (ethinyloestradiol 35 g and norethindrone 1 mg) for 14 days resulted in a mean decrease in...
Pregnancy
Important safety information For rufinamide MHRA/CHM advice: Antiepileptics: risk of suicidal thoughts and behaviour (August 2008) See Epilepsy . MHRA/CHM advice: Antiepileptic drugs: updated advice on switching between different manufacturers' products (November 2017) See Epilepsy and see also Prescribing and dispensing information . MHRA/CHM advice: Antiepileptic drugs in pregnancy: updated advice following comprehensive safety review (January 2021) See Epilepsy .
Breast feeding
Manufacturer advises avoid-no information available.
Hepatic impairment
Manufacturer advises caution in mild to moderate impairment; avoid in severe impairment (no information available). Dose adjustments Manufacturer advises cautious dose titration in mild to moderate impairment.
Medicinal forms
Tablet,Suspension
Clinical governance
**Author:** MedNext Clinical Team. **Clinical reviewer:** Dr Shameer Deen, MBBS, MS, MRCS. **Sources:** BNF, Indian Pharmacopoeia, CIMS India. **Correction:** Report errors at support@mednext.academy.
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