Lacasa 50/Lacasa 100/Lacasa 150 Dosage/Direction for Use

The recommended dosage for adults and pediatric patients 4 years to less than 17 years of age is included in Table 1. In pediatric patients 4 years to less than 17 years of age, the recommended dosing regimen is dependent upon body weight. Dosage should be increased based on clinical response and tolerability, no more frequently than once per week. Titration increments should not exceed those shown in Table 1. (See Table 1.)

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In adjunctive clinical trials in adult patients with partial-onset seizures, a dosage higher than 200 mg twice daily (400 mg per day) was not more effective and was associated with a substantially higher rate of adverse reactions.
Loading Dose in Adult Patients (17 Years and Older): Lacosamide may be initiated in adult patients with a single loading dose of 200 mg, followed approximately 12 hours later by 100 mg twice daily (200 mg per day). This maintenance dose regimen should be continued for one week. Lacosamide can then be titrated as recommended in Table 1. The adult loading dose should be administered with medical supervision because of the increased incidence of CNS adverse reactions.
The use of a loading dose in pediatric patients has not been studied.
Converting From a Single Antiepileptic (AED) to LACOSAMIDE Monotherapy for the Treatment of Partial-Onset Seizures: For patients who are already on a single AED and will convert to Lacosamide monotherapy, withdrawal of the concomitant AED should not occur until the therapeutic dosage of Lacosamide is achieved and has been administered for at least 3 days. A gradual withdrawal of the concomitant AED over at least 6 weeks is recommended.
Dosage Information for Patients with Renal Impairment: For patients with mild to moderate renal impairment, no dosage adjustment is necessary.
For patients with severe renal impairment [creatinine clearance (CLCR) less than 30 mL/min as estimated by the Cockcroft-Gault equation for adults; CLCR less than 30 mL/min/1.73 m² as estimated by the Schwartz equation for pediatric patients] or end-stage renal disease, a reduction of 25% of the maximum dosage is recommended.
In all patients with renal impairment, the dose titration should be performed with caution.
Hemodialysis: LACOSAMIDE is effectively removed from plasma by hemodialysis. Following a 4-hour hemodialysis treatment, dosage supplementation of up to 50% should be considered.
Concomitant Strong CYP3A4 or CYP2C9 Inhibitors: Dose reduction may be necessary in patients with renal impairment who are taking strong inhibitors of CYP3A4 and CYP2C9.
Dosage Information for Patients with Hepatic Impairment: For patients with mild or moderate hepatic impairment, a reduction of 25% of the maximum dosage is recommended. The dose titration should be performed with caution in patients with hepatic impairment.
Lacosamide use is not recommended in patients with severe hepatic impairment.
Concomitant Strong CYP3A4 and CYP2C9 Inhibitors: Dose reduction may be necessary in patients with hepatic impairment who are taking strong inhibitors of CYP3A4 and CYP2C9.
Discontinuation of Lacosamide: When discontinuing Lacosamide, a gradual withdrawal over at least 1 week is recommended.
Method of administration: Lacosamide film-coated tablets are for oral use. Lacosamide may be taken with or without food.