Lacosamide
Dosing in kidney impairment
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 (CL CR ) less than 30 mL/min as estimated by the Cockcroft-Gault equation for adults; CL CR less than 30 mL/min/1.73m 2 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, dose initiation and titration should be based on clinical response and tolerability. Hemodialysis Lacosamide oral solution 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 [ see Drug Interactions, Use in Specific Populations, and Clinical Pharmacology ].
Dosing in liver impairment
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 initiation and titration should be based on clinical response and tolerability in patients with hepatic impairment. Lacosamide oral solution 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 [ see Drug Interactions, Use in Specific Populations, and Clinical Pharmacology ].
Preparation and administration
Administration Instructions for Lacosamide oral solution Lacosamide oral solution may be taken with or without food. A calibrated measuring device is recommended to measure and deliver the prescribed dose accurately. A household teaspoon or tablespoon is not an adequate measuring device. Lacosamide oral solution may also be administered using a nasogastric tube or gastrostomy tube.
Discard any unused Lacosamide oral solution remaining after 6 months of first opening the bottle.