Vimpat

Lacosamide

Monotherapy & adjunctive therapy for partial-onset seizures w/ or w/o secondary generalisation in adults, adolescents, & childn ≥4 yr w/ epilepsy. Adjunctive therapy for primary generalised tonic-clonic seizures in adults, adolescents, & childn ≥4 yr w/ idiopathic generalised epilepsy.

Therapy can be initiated w/ either PO (tab or syr) or IV (soln for infusion) administration. Conversion to or from PO & IV administration can be done directly w/o titration. Administer soln for infusion over a period of 15-60 min bd (at least 30 min is preferred for >200 mg per infusion). Adult; adolescent & childn weighing ≥50 kg Monotherapy Starting dose: 50 mg bd (100 mg/day), increased to initial therapeutic dose of 100 mg bd (200 mg/day) after 1 wk. Can also be initiated at 100 mg bd (200 mg/day). Maintenance dose: Can be further increased at wkly intervals by 50 mg bd (100 mg/day). Max dose: 300 mg bd (600 mg/day). Adjunctive therapy Starting dose: 50 mg bd (100 mg/day), increased to initial therapeutic dose of 100 mg bd (200 mg/day) after 1 wk. Maintenance dose: Can be further increased at wkly intervals by 50 mg bd (100 mg/day). Max dose: 200 mg bd (400 mg/day). Monotherapy & adjunctive therapy Loading dose: May also initiate treatment w/ single loading dose of 200 mg, followed approx 12 hr later by 100 mg bd (200 mg/day) maintenance dose. Childn ≥4 yr & adolescent weighing <50 kg Dose is determined based on body wt. Initiate treatment w/ syr & switch to tab, if desired. Monotherapy Starting dose: 1 mg/kg bd (2 mg/kg/day) or 0.1 mL/kg bd, increased to initial therapeutic dose of 2 mg/kg bd (4 mg/kg/day) or 0.2 mL/kg bd after 1 wk. Maintenance dose: Can be further increased at wkly intervals by 1 mg/kg bd (2 mg/kg/day) or 0.1 mL/kg bd. Max dose in childn weighing ≥40 to <50 kg: 5 mg/kg bd (10 mg/kg/day) or 0.5 mL/kg bd. Max dose in childn weighing ≥10 to <40 kg: 6 mg/kg bd (12 mg/kg/day) or 0.6 mL/kg bd. Adjunctive therapy Starting dose: 1 mg/kg bd (2 mg/kg/day) or 0.1 mL/kg bd, increased to initial therapeutic dose of 2 mg/kg bd (4 mg/kg/day) or 0.2 mL/kg bd after 1 wk. Maintenance dose: Can be further increased at wkly intervals by 1 mg/kg bd (2 mg/kg/day) or 0.1 mL/kg bd. Max dose in childn weighing ≥30 to <50 kg: 4 mg/kg bd (8 mg/kg/day) or 0.4 mL/kg bd. Max dose in childn weighing ≥20 to <30 kg: 5 mg/kg bd (10 mg/kg/day) or 0.5 mL/kg bd. Max dose in childn weighing ≥10 to <20 kg: 6 mg/kg bd (12 mg/kg/day) or 0.6 mL/kg bd. Patient (paed weighing ≥50 kg & adult) w/ mild or moderate renal impairment Loading dose of 200 mg may be considered, but further dose titration (>200 mg daily) should be performed w/ caution. Patient (paed weighing ≥50 kg & adult) w/ severe renal impairment or ESRD Max dose of 250 mg/day is recommended & dose titration should be performed w/ caution. If loading dose is indicated, initial dose of 100 mg followed by 50 mg bd for the 1st wk should be used. Patient (paed weighing ≥50 kg & adult) w/ mild to moderate hepatic impairment Max dose of 300 mg/day is recommended. Loading dose of 200 mg may be considered, but further dose titration (>200 mg daily) should be performed w/ caution.

FC tab: May be taken with or without food.. Syr: May be taken with or without food: Shake well before use.

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

Monitor for signs of suicidal ideation & behaviours. Risk of dose-related PR interval prolongations. Caution in patients w/ underlying proarrhythmic conditions (eg, cardiac conduction problems or severe cardiac disease) or patients treated w/ medicinal products affecting cardiac conduction (including antiarrhythmics & Na channel blocking antiepileptics), as well as in the elderly. Reports of AV block (including 2nd degree or higher AV block) in post-marketing experience. Associated w/ dizziness. Reports of new onset or worsening of myoclonic seizures in adult & paed patients w/ primary generalised tonic-clonic seizures, in particular during titration. Safety & efficacy have not been determined in paed patients w/ epilepsy syndromes in which focal & generalised seizures may coexist. Consider potential for increased incidence of serious cardiac arrhythmia & CNS adverse reactions if administering a loading dose. Administration of a loading dose has not been studied in acute conditions eg, status epilepticus. Use of a loading dose is not recommended in adolescents & childn weighing <50 kg. Minor to moderate influence on the ability to drive & use machines. Caution in treating patients w/ ESRD. Administer to adult & paed patients w/ severe hepatic impairment only when expected therapeutic benefits are anticipated to outweigh possible risks. Do not use during pregnancy unless clearly necessary. Discontinue breast-feeding during treatment. Not recommended for use in childn <4 yr. Syr: Contains Na methyl parahydroxybenzoate, which may cause allergic reactions. Contains sorbitol, which may cause GI discomfort & mild laxative effect. Should not be taken by patients w/ rare hereditary problems of fructose intolerance. Contains aspartame, which may be harmful for people w/ phenylketonuria. Contains propylene glycol. Contains 1.42 mg Na per mL. Soln for infusion: Contains 59.8 mg Na per vial.

Dizziness, headache; diplopia; nausea. Depression, confusional state, insomnia; myoclonic seizures, ataxia, balance disorder, 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. Soln for infusion: Inj site pain or discomfort, irritation.

Caution if co-administered w/ medicinal products known to be associated w/ PR prolongation (including Na channel blocking antiepileptics) & antiarrhythmics. Possible increase in systemic exposure w/ strong inhibitors of CYP2C9 (eg, fluconazole) & CYP3A4 (eg, itraconazole, ketoconazole, ritonavir, clarithromycin). Possible moderate reduction in systemic exposure w/ strong enzyme inducers (eg, rifampicin or St. John's wort). Pharmacodynamic effect w/ alcohol cannot be excluded.

Anticonvulsants

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

P₁S₁S₃