Eslicarbazepine acetate

eMC §4.2 (Eslicarbazepine Amarox 200 mg tablets). Eslicarbazepine acetate may be taken as monotherapy or added to existing anticonvulsant therapy for partial-onset seizures. ELDERLY (over 65 years): no dose adjustment is needed provided renal function is not disturbed, but the 1,600 mg monotherapy dose is not recommended. HEPATIC IMPAIRMENT: no dose adjustment is needed in mild to moderate impairment; pharmacokinetics have not been evaluated in severe hepatic impairment and use in these patients is not recommended. SWITCHING PREPARATIONS: based on comparative bioavailability data for the tablet and suspension formulations, patients can be switched from one formulation to the other. PAEDIATRIC (UK SPC): children above 6 years of age start at 10 mg/kg/day once daily, increased in weekly or bi-weekly increments of 10 mg/kg/day up to 30 mg/kg/day based on individual response, maximum 1,200 mg once daily; children weighing 60 kg or more should be given the adult dose; safety and efficacy in children aged 6 years and below have not been established and no posology recommendation can be made. US LABELLING DIFFERENCES (cross-check only): adults start at 400 mg once daily, or 800 mg once daily if the need for seizure reduction outweighs the increased risk of adverse reactions, increased in weekly increments of 400 mg to 600 mg to a maintenance dosage of 800 mg to 1,600 mg once daily; US paediatric dosing (4 to 17 years) is by fixed weight band rather than mg/kg (11-21 kg: initial/titration increment 200 mg/day, maintenance 400-600 mg/day; 22-31 kg: 300, maintenance 500-800; 32-38 kg: 300, maintenance 600-900; more than 38 kg: 400, maintenance 800-1,200); US renal adjustment is a 50% reduction of initial, titration and maintenance dosages when creatinine clearance is below 50 mL/min. The US label also states eslicarbazepine acetate should not be taken as adjunctive therapy with oxcarbazepine, that dose adjustment of eslicarbazepine or carbamazepine may be needed when taken together, that higher doses may be needed with other enzyme-inducing AEDs (phenobarbital, phenytoin, primidone), and that on discontinuation the dosage should be reduced gradually to minimise the risk of increased seizure frequency and status epilepticus.

UK SPC §4.2, children ABOVE 6 YEARS of age only. Recommended starting dose 10 mg/kg/day once daily; increase in weekly or bi-weekly increments of 10 mg/kg/day up to 30 mg/kg/day based on individual response; maximum 1,200 mg once daily. Children with a body weight of 60 kg or more should be given the same dose as adults. Safety and efficacy in children aged 6 years and below have not been established and no posology recommendation can be made. RENAL IMPAIRMENT in children above 6 years: CLCR above 60 mL/min — no adjustment; CLCR 30-60 mL/min — initial 5 mg/kg once daily or 10 mg/kg every other day for 2 weeks, followed by 10 mg/kg once daily, which may then be increased based on individual response; CLCR below 30 mL/min — use is not recommended. Note the US labelling instead uses fixed weight-band dosing for ages 4 to 17 years. DRAFT ONLY — verify every paediatric figure against a children's formulary before prescribing.