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| VIMPAT® (lacosamide) Tablet, Film Coated for Oral use, CV
VIMPAT® (lacosamide) Injection for Intravenous use, CV
VIMPAT® (lacosamide) Oral Solution, CV
Initial U.S. Approval: 2008
The chemical name of lacosamide, the single (R)-enantiomer, is (R)-2-acetamido-N-benzyl-3-methoxypropionamide (IUPAC). Lacosamide is a functionalized amino acid. Its molecular formula is C13H18N2O3 and its molecular weight is 250.30.
Lacosamide is a white to light yellow powder. It is sparingly soluble in water and slightly soluble in acetonitrile and ethanol.
VIMPAT tablets are supplied as debossed tablets and contain the following coloring agents:
50 mg tablets: red iron oxide, black iron oxide, FD&C Blue #2/indigo carmine aluminum lake
VIMPAT Oral Solution
| CLINICAL PHARMACOLOGY
Mechanism of Action
The precise mechanism by which VIMPAT exerts its antiepileptic effects in humans remains to be fully elucidated. In vitro electrophysiological studies have shown that lacosamide selectively enhances slow inactivation of voltage-gated sodium channels, resulting in stabilization of hyperexcitable neuronal membranes and inhibition of repetitive neuronal firing.
Lacosamide binds to collapsin response mediator protein-2 (CRMP-2), a phosphoprotein which is mainly expressed in the nervous system and is involved in neuronal differentiation and control of axonal outgrowth. The role of CRMP-2 binding in seizure control is unknown.
| INDICATIONS AND USAGE
VIMPAT (lacosamide) tablets and oral solution are indicated as adjunctive therapy in the treatment of partial-onset seizures in patients with epilepsy aged 17 years and older.
VIMPAT (lacosamide) injection for intravenous use is indicated as adjunctive therapy in the treatment of partial-onset seizures in patients with epilepsy aged 17 years and older when oral administration is temporarily not feasible.
USE IN SPECIFIC POPULATIONS
Renal impairment: Dose adjustment is recommended for patients with severe renal impairment (creatinine clearance ≤ 30 mL/min). Dose supplementation should be considered following hemodialysis.
Hepatic impairment: Dose adjustment is recommended for patients with mild or moderate hepatic impairment. Use in severe hepatic impairment patients is not recommended. Patients with co-existing hepatic and renal impairment should be monitored closely during dose titration.
| WARNINGS AND PRECAUTIONS
| ADVERSE REACTIONS
Most common adverse reactions (>/=10% and greater than placebo) are diplopia, headache, dizziness, nausea.
To report SUSPECTED ADVERSE REACTIONS, contact UCB, Inc. at 1-800-477-7877 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
| DOSAGE AND ADMINISTRATION
VIMPAT may be taken with or without food.
When using VIMPAT oral solution, it is recommended that a calibrated measuring device be obtained and used. A household teaspoon or tablespoon is not an adequate measuring device. Healthcare providers should recommend a device that can measure and deliver the prescribed dose accurately, and provide instructions for measuring the dosage.
Switching from Oral to Intravenous Dosing
Switching from Intravenous to Oral Dosing
Compatibility and Stability
The stability of VIMPAT injection in other infusion solutions has not been evaluated. Product with particulate matter or discoloration should not be used.
Patients with Renal Impairment
Patients with Hepatic Impairment
VIMPAT use is not recommended in patients with severe hepatic impairment.
| DOSAGE FORMS AND STRENGTHS
[ 1] 50 mg (pink), 100 mg (dark yellow), 150 mg (salmon), and 200 mg (blue) film-coated tablets
[ 2] 200 mg/20mL injection
[ 3] 10 mg/mL oral solution
Do not freeze Vimpat injection or oral solution. Discard any unused Vimpat oral solution remaining after seven (7) weeks of first opening the bottle.
National Institutes of Health, U.S. National Library of Medicine, DailyMed Database.
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