Vimpat/Vimpat Injection

Monotherapy in partial-onset seizures w/ epilepsy ≥16 yr. Adjunctive therapy in partial-onset seizures w/ or w/o secondary generalisation in patients ≥16 yr (Vimpat)/patients w/ epilepsy ≥16 yr (Vimpat Injection). Adjunctive therapy in primary generalised tonic-clonic seizures in patients ≥16 yr w/ idiopathic generalised epilepsy (Vimpat)/patients w/ epilepsy ≥16 yr (Vimpat Injection).

To be taken bid (approx 12 hr apart). Adult >16 yr Monotherapy in partial-onset seizures Initially 50 mg bid, increased to 100 mg bid after 1 wk. May be initiated at 100 mg bid based on assessment of required seizure reduction versus potential side effects. May be further increased at wkly intervals by 50 mg bid (100 mg daily), up to max of 300 mg bid (600 mg daily) depending on response & tolerability. Adjunctive therapy in partial-onset seizures or primary generalised tonic-clonic seizures Initially 50 mg bid, increased to initial therapeutic dose of 100 mg bid after 1 wk. May be further increased at wkly intervals by 50 mg bid (100 mg daily), up to max of 400 mg daily (200 mg bid) depending on response & tolerability. Initiation w/ loading dose (initial monotherapy or conversion to monotherapy in partial-onset seizures, or adjunctive therapy in partial-onset seizures or primary generalised tonic-clonic seizures) Initiate w/ single loading dose of 200 mg, followed approx 12 hr later by 100 mg bid (200 mg daily) maintenance dose. Perform subsequent dose adjustments according to individual response & tolerability. Discontinuation Discontinue gradually (eg, taper daily dose by 200 mg/wk). Mild or moderate renal impairment Consider loading dose of 200 mg but perform further dose titration (>200 mg daily) w/ caution. Severe renal impairment (CrCl ≤30 mL/min) or w/ ESRD Max: 250 mg daily & perform dose titration w/ caution. If loading dose is indicated, initially use 100 mg followed by 50 mg bid regimen for 1st wk. Patient requiring haemodialysis Supplement of up to 50% of divided daily dose directly after end of haemodialysis. Mild to moderate hepatic impairment Max: 300 mg daily. Perform dose titration w/ caution considering co-existing renal impairment. Consider loading dose of 200 mg but perform further dose titration (>200 mg daily) w/ caution.

Vimpat May be taken with or without food.

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

Monitor patients for signs of suicidal ideation & behaviours. Dose-related prolongations in PR interval. Perform ECG before dose increase >400 mg daily & after titration to steady-state in patients w/ underlying proarrhythmic conditions eg, w/ cardiac conduction problems or severe cardiac disease (eg, myocardial ischaemia/MI, heart failure, structural heart disease or cardiac Na channelopathies) or treated w/ medicinal products affecting cardiac conduction, including antiarrhythmics & Na channel blocking antiepileptic medicinal products. Patients w/ proarrhythmic conditions, ventricular tachyarrhythmia. Dizziness. Potential for new onset or worsening of myoclonic seizures in patients w/ primary generalised tonic-clonic seizures, in particular during titration. Minor to moderate influence on ability to drive & use machines. ESRD. Severe hepatic impairment. Discuss family planning & contraception w/ women of childbearing potential. Re-evaluate use carefully if woman decides to become pregnant. Not to be used during pregnancy unless clearly necessary. Discontinue lactation during treatment. Elderly.

Dizziness, headache; diplopia; nausea. Depression, confusional state, insomnia; myoclonic seizures, ataxia, balance & cognitive disorder, memory impairment, somnolence, tremor, nystagmus, hypoesthesia, dysarthria, attention disturbance, 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. Vimpat Injection Inj site pain or discomfort, irritation.

Concomitant use w/ medicinal products associated w/ PR prolongation (including Na channel blocking antiepileptics) & antiarrhythmics. Slightly increased C_max of midazolam. Increased systemic exposure w/ strong inhibitors of CYP2C9 (eg, fluconazole) & CYP3A4 (eg, itraconazole, ketoconazole, ritonavir, clarithromycin). Moderately reduced systemic exposure w/ strong enzyme inducers eg, rifampicin or St. John's wort (Hypericum perforatum). Decreased overall systemic exposure w/ other antiepileptics known to be enzyme inducers (carbamazepine, phenytoin, phenobarb, in various doses). Pharmacodynamic effect cannot be excluded w/ alcohol.

Anticonvulsants

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

Rx