Vimpat

Monotherapy or adjunctive therapy in the treatment of partial-onset seizures w/ or w/o secondary generalisation in adults, adolescents & childn ≥2 yr w/ epilepsy. Adjunctive therapy in the treatment of primary generalised tonic-clonic seizures in adults, adolescents & childn ≥4 yr w/ idiopathic generalised epilepsy.

Initiate therapy w/ either PO (FC tab or syr) or IV (soln for infusion) administration. Directly convert to or from PO & IV administration w/o titration. Calculate precise vol of syr or soln for infusion according to exact body wt of child. Round calculated vol of syr to the nearest graduated increment, & use larger graduated increment if equidistant between 2 graduated increments. 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) based on physician's assessment of required seizure reduction versus potential side effects. Maintenance dose: Can be further increased by 50 mg bd (100 mg/day) at wkly intervals depending on response & tolerability. 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 by 50 mg bd (100 mg/day) at wkly intervals depending on response & tolerability. 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 maintenance dose of 100 mg bd (200 mg/day). Subsequently adjust dose according to individual response & tolerability. May be initiated in situations when physician determines that it is warranted to rapidly attain therapeutic effect. Childn ≥2 yr & adolescent weighing <50 kg Determine dose 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 by 1 mg/kg bd (2 mg/kg/day) or 0.1 mL/kg bd every wk depending on response & tolerability. Gradually increase dose until optimum response is obtained, then use lowest effective dose. 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 by 1 mg/kg bd (2 mg/kg/day) or 0.1 mL/kg bd every wk depending on response & tolerability. Gradually adjust dose until optimum response is obtained, then use lowest effective dose. 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. Patient (paed weighing <50 kg) w/ severe renal impairment or ESRD, or mild to moderate hepatic impairment Reduction of 25% of max dose is recommended.

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 PR interval prolongations; atrial fibrillation or flutter; AV block (including 2nd degree or higher AV block); ventricular tachyarrhythmia. 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. Associated w/ dizziness. Potential for new onset or worsening of myoclonic seizures. Weigh observed benefit of control for 1 seizure type against any observed worsening in another seizure type in patients w/ >1 seizure type. 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 loading dose is administered. Administration of loading dose has not been studied in acute conditions eg, status epilepticus. Use of 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. Discuss family planning & contraception w/ women of childbearing potential taking lacosamide. Do not use during pregnancy unless clearly necessary. Discontinue breastfeeding during treatment. Not recommended in childn <4 yr in the treatment of primary generalized tonic-clonic seizures & in childn <2 yr in the treatment of partial-onset seizures. Syr: Contains Na methyl parahydroxybenzoate, which may cause allergic reactions (possibly delayed). 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, equiv to 0.07% of WHO recommended max daily intake of 2 g Na for an adult. Soln for infusion: Contains 59.8 mg Na per vial, equiv to 3% of WHO recommended max daily intake of 2 g Na for an adult.

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.

Increased systemic exposure w/ strong inhibitors of CYP2C9 (eg, fluconazole) & CYP3A4 (eg, itraconazole, ketoconazole, ritonavir, clarithromycin). Decreased systemic exposure w/ strong enzyme inducers (eg, rifampicin, St. John's wort, carbamazepine, phenytoin, phenobarb). Pharmacodynamic effect w/ alcohol cannot be excluded.

Anticonvulsants

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

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