Vosamide

Monotherapy in partial-onset seizures in patients w/ epilepsy ≥16 yr. Adjunctive therapy in partial-onset seizures w/ or w/o secondary generalization in patients w/ epilepsy ≥16 yr.

Initial treatment w/ loading dose: 200 mg single dose followed by 100 mg bid for 1 wk after approx 12 hr. May be increased by 50 mg bid at wkly intervals. Monotherapy Initially 100 mg bid, may be increased to 150 mg bid after 1 wk. May be further increased up to max maintenance dose of 200 mg bid. Adjunctive therapy Initially 50 mg bid, may be increased to 100 mg bid after 1 wk. May be further increased by 50 mg bid every wk to max maintenance dose of 200 mg bid. Severe renal impairment (CrCl ≤30 mL/min) or ESRD Max: 250 mg daily. Patient requiring hemodialysis Administer supplement dose of up to 50% of divided daily dose after end of hemodialysis. Mild to moderate hepatic impairment Max: 300 mg daily.

May be taken with or without food: Swallow whole, do not divide.

Hypersensitivity. Current or history of 2nd- or 3rd-degree AV block.

Discontinue treatment if alternative etiology other than DRESS (ie, multi-organ hypersensitivity) cannot be established; gradually over min of 1 wk. W/draw therapy gradually over few wk to several mth to minimize potential of seizures or other w/drawal symptoms in patients in long-term treatment. Dose-dependent PR interval prolongation & possible further PR prolongation w/ other PR-prolonging agents; cardiac arrhythmias including bradycardia, AV block & ventricular tachyarrhythmia; atrial fibrillation & flutter; dose-related dizziness & ataxia. May predispose to atrial arrhythmias, especially in patients w/ diabetic neuropathy &/or CV disease. May cause hematologic disorders. Patient w/ underlying proarrhythmic conditions (eg, marked 1st- & 2nd-degree or higher AV block, sick sinus syndrome w/o pacemaker), severe cardiac disease (eg, myocardial ischemia or heart failure or structural heart disease) & cardiac Na channelopathies (eg, Brugada syndrome). Monitor patients for suicidal ideation & behavior. Concomitant use w/ medications affecting cardiac conduction including Na, Ca & K channel blockers, β-blockers & PR-prolonging medications; strong CYP3A4 or CYP2C9 inhibitors. Not to drive, operate machinery or drink alcohol containing products during medication. Liver & kidney disease. Not recommended in severe hepatic impairment. Not to be used during pregnancy due to risk of teratogenicity. Lactation. Increased risk of congenital malformations in newborns of women taking antiepileptic medications. Childn <16 yr. Decreased renal clearance w/ increased AUC levels in elderly >65 yr.

Nausea; dizziness, headache; diplopia. Atrial fibrillation & flutter, asymptomatic 1st degree AV block, prolonged PR interval; DRESS; suicidal behavior & thoughts.

Increased levels/effects w/ class III antiarrhythmics, antiepileptic agents (Na channel blockers), bradycardia-causing agents, strong CYP3A4 inhibitors, systemic lidocaine, mexiletine, QT-prolonging class IA (highest risk) & IC (moderate risk) antiarrhythmics. Decreased levels/effects w/ mefloquine, mianserin, orlistat.

Anticonvulsants

N03AX18 - lacosamide ; Belongs to the class of other antiepileptics.

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