Lacosamide intravenous

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 VIMPAT 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 ] .

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. VIMPAT 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 ] .

Administration Instructions for VIMPAT Tablets and Oral Solution VIMPAT tablets and oral solution may be taken with or without food. VIMPAT Tablets VIMPAT tablets should be swallowed whole with liquid. Do not divide VIMPAT tablets. VIMPAT Oral Solution 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. VIMPAT oral solution may also be administered using a nasogastric tube or gastrostomy tube. Discard any unused VIMPAT oral solution remaining after 6 months of first opening the bottle.

Preparation and Administration Information for VIMPAT Injection Preparation VIMPAT injection can be administered intravenously without further dilution or may be mixed with diluents listed below. The diluted solution should not be stored for more than 4 hours at room temperature. Diluents: Sodium Chloride Injection 0.9% (w/v) Dextrose Injection 5% (w/v) Lactated Ringer's Injection Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Product with particulate matter or discoloration should not be used. VIMPAT injection is for single-dose only. Any unused portion of VIMPAT injection should be discarded. Administration The recommended infusion duration is 30 to 60 minutes; however, infusions as rapid as 15 minutes can be administered in adults if required [see Adverse Reactions and Clinical Pharmacology ].

Infusion durations less than 30 minutes are generally not recommended in pediatric patients [see Adverse Reactions ]. Intravenous infusion of VIMPAT may cause bradycardia, AV blocks, and ventricular tachyarrhythmia [see Warnings and Precautions ] . Obtaining an ECG before beginning VIMPAT and after VIMPAT is titrated to steady-state maintenance dose is recommended in patients with underlying proarrhythmic conditions or on concomitant medications that affect cardiac conduction [see Drug Interactions ] .

Storage and Stability The diluted solution should not be stored for more than 4 hours at room temperature. Any unused portion of VIMPAT injection should be discarded.