Acode 50 Dosage/Direction for Use

Monotherapy: Initial Monotherapy: Patients not currently being treated with antiepileptic drugs may have monotherapy initiated with lacosamide. The recommended starting dose is 100 mg twice a day (200 mg/day) which should be increased to a therapeutic dose of 150 mg twice a day (300 mg/day) after one week. Depending on response and tolerability, the dose can be further increased at weekly interval by 50 mg twice a day (100 mg/day), to a maximum recommended maintenance daily dose of 200 mg twice a day (400 mg/day).
Conversion to monotherapy: For patients who will convert to lacosamide monotherapy, the recommended starting dose is 100 mg twice a day (200 mg/day) which should be increased to a therapeutic dose of 150 mg twice a day (300 mg/day) after one week. Depending on response and tolerability, the dose can be further increased at weekly interval by 50 mg twice a day (100 mg/day), to a maximum recommended maintenance daily dose of 200 mg twice a day (400 mg/day).
The recommended maintenance daily dose should be maintained for at least 3 days before initiating conversion to lacosamide monotherapy. A gradual withdrawal of the concomitant antiepileptic drug over at least 6-weeks is recommended. If the patient is on more than one antiepileptic drug, the antiepileptic drugs should be withdrawn sequentially. Safety and efficacy of Lacosamide have not been established for simultaneous conversion to monotherapy from two or more concomitant antiepileptic drugs.
Adjunctive Therapy: The recommended starting dose is 50 mg twice a day which should be increased to an initial therapeutic dose of 100 mg twice a day after one week.
Depending on response and tolerability, the maintenance dose can be further increased by 50 mg twice a day every week, to a maximum recommended daily dose of 400 mg (200 mg twice a day).
Initiation of lacosamide treatment with a loading dose: Lacosamide treatment (e.g., for adjunctive therapy, initial monotherapy and conversion to monotherapy) may also be initiated with a single loading dose of 200 mg, followed approximately 12 hours later by a 100 mg twice daily (200 mg/day) maintenance dose regimen. A loading dose should be administered under medical supervision with consideration of the lacosamide pharmacokinetics (see Pharmacology: Pharmacokinetics under Actions) and the potential for increased incidence of CNS adverse reactions (see Adverse Reactions). Administration of a loading dose has not been studied in acute conditions such as status epilepticus. Depending on response and tolerability, the maintenance dose can be further increased by 50 mg twice a day every week, to a maximum recommended daily dose of 400 mg (200 mg twice a day).
Discontinuation: In accordance with current clinical practice, if lacosamide has to be discontinued, it is recommended this be done gradually (e.g., taper the daily dose by 200 mg/week).
Special populations: Elderly Population: No dose reduction is necessary in elderly patients. The experience with lacosamide in elderly patients with epilepsy is limited. Age associated decreased renal clearance with an increase in AUC levels should be considered in elderly patients.
Renal impairment: No dose adjustment is necessary in mildly and moderately renally impaired patients (CLCR >30 mL/min).
A maximum dose of 300 mg/ day is recommended for patients with severe renal impairment (CLCR ≤30 mL/min) and in patients with end-stage renal disease.
For patients requiring haemodialysis a supplement of up to 50% of the divided daily dose directly after the end of haemodialysis should be considered.
Treatment of patients with end-stage renal disease should be made with caution as there is little clinical experience and accumulation of a metabolite (with no known pharmacological activity).
In all patients with renal impairment, the dose titration should be performed with caution (see Pharmacology: Pharmacokinetics under Actions).
Hepatic impairment: A maximum dose of 300 mg/day is recommended for patients with mild to moderate hepatic impairment.
The dose titration in these patients should be performed with caution considering co-existing renal impairment. The pharmacokinetics of lacosamide has not been evaluated in severely hepatic impaired patients (see Pharmacology: Pharmacokinetics under Actions). Lacosamide should be administered to patients with severe hepatic impairment only when the expected therapeutic benefits outweigh the possible risks, and the dosage and administration need to be adjusted while carefully observing the symptoms of patient.
Pediatric population: Lacosamide is not recommended for use in children and adolescents below the age of 16 as there is no data on safety and efficacy in these age groups.
Method of administration: Lacosamide film-coated tablets must be taken twice a day. Lacosamide may be taken with or without food.