Vimpat

Lacosamide

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

FC tab Monotherapy Initially 100 mg bid (200 mg/day), increased to a therapeutic dose of 150 mg bid (300 mg/day) after 1 wk. May be increased further by 50 mg bid (100 mg/day) wkly. Max maintenance daily dose: 200 mg bid (400 mg/day). Adjunctive therapy Initially 50 mg bid, increased to 100 mg bid after 1 wk. May be increased further by 50 mg bid every wk. Max: 200 mg bid daily (400 mg/day). Conversion to monotherapy Initially 100 mg bid. May be increased to 150 mg bid after 1 wk. May be further increased at wkly interval by 50 mg bid. Max maintenance daily dose: 200 mg bid. Recommended maintenance daily dose should be maintained for at least 3 days prior to initiating conversion. Initiation w/ a loading dose Initially w/ single loading dose of 200 mg, followed approx 12 hr later by 100 mg bid maintenance dose regimen. Severe renal impairment & ESRD Max maintenance dose: 250 mg/day. If loading dose is indicated, initial dose of 100 mg followed by a 50 mg bid regimen for the 1st wk. Mild to moderate hepatic impairment Max dose: 300 mg/day. Soln for infusion Infused over a period of 15-60 min bid. Monotherapy Initially 100 mg bid (200 mg/day), increased to 150 mg bid (300 mg/day) after 1 wk. May be further increased at wkly interval by 50 mg bid (100 mg/day). Max recommended maintenance dose: 200 mg bid (400 mg/day). Conversion to monotherapy Maintain maintenance daily dose for at least 3 days before conversion. Gradual w/drawal of concomitant antiepileptic drug over at least 6 wk. Recommended starting dose: 100 mg bid (200 mg/day), increased to 150 mg bid (300 mg/day) after 1 wk. May be increased further by 50 mg bid (100 mg/day) wkly to max: 200 mg bid (400 mg/day). Adjunctive therapy Initially 50 mg bid, increased to an initial therapeutic dose of 100 mg bid after 1 wk. May be further increased by 50 mg bid every wk. Max dose: 400 mg daily (200 mg bid). Initiation w/ a loading dose Initiated w/ a single loading dose of 200 mg, followed approx 12 hr later by a 100 mg bid (200 mg/day) maintenance dose. Severe renal impairment (CrCl ≤30 mL/min) & ESRD Max maintenance dose: 250 mg/day. If a loading dose is indicated, an initial dose of 100 mg followed by 50 mg bid regimen for the 1st wk. Mild, moderate renal & hepatic impairment Loading dose of 200 mg, titrated further to >200 mg daily. Max (mild, moderate hepatic impairment): 300 mg/day. Haemodialysis 50% of divided daily dose after end of haemodialysis.

May be taken with or without food.

Hypersensitivity. Known 2nd or 3rd degree AV block.

Dizziness. 2nd degree or higher AV block. Patients w/ known conduction problems & severe cardiac disease eg, history of MI or heart failure; elderly (increased risk of cardiac disorders). Monitor for signs of suicidal ideation & behavior. Concomitant use w/ drugs known to be associated w/ PR prolongation. May have minor to moderate influence on ability to drive & use machines. Pregnancy & lactation. Childn <16 yr.

Dizziness, headache; diplopia; nausea. Depression, confusional state, insomnia; balance disorder, abnormal coordination, memory impairment, cognitive disorder, somnolence, tremor, nystagmus, hypoesthesia, dysarthria, disturbance in attention, paraesthesia; blurred vision; vertigo, tinnitus; vomiting, constipation, flatulence, dyspepsia, dry mouth, diarrhoea; pruritus, rash; muscle spasms; gait disturbance, asthenia, fatigue, irritability, feeling drunk; fall, skin laceration; contusion.

Drugs known to be associated w/ PR prolongation (eg, carbamazepine, lamotrigine & pregabalin) & class I antiarrhythmics. May lead to increased systemic exposure w/ strong inhibitors of CYP2C9 (eg, fluconazole) & CYP3A4 (eg, itraconazole, ketoconazole, ritonavir, clarithromycin). Moderately reduced systemic exposure w/ rifampicin or St. John's wort (Hypericum perforatum). Decreased overall systemic exposure w/ carbamazepine, phenytoin, phenobarb.

Anticonvulsants

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

D