Vimpat

Vimpat

lacosamide

Manufacturer:

UCB

Distributor:

Zuellig Pharma

Marketer:

Abbott
Concise Prescribing Info
Contents
Lacosamide
Indications/Uses
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.
Dosage/Direction for Use
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 & end-stage renal disease 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) & end-stage renal disease 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.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Known 2nd or 3rd degree AV block.
Special Precautions
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.
Adverse Reactions
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.
Drug Interactions
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.
MIMS Class
ATC Classification
N03AX18 - lacosamide ; Belongs to the class of other antiepileptics.
Presentation/Packing
Form
Vimpat soln for infusion 10 mg/mL
Packing/Price
20 mL x 5 × 1's
Form
Vimpat FC tab 100 mg
Packing/Price
56's
Form
Vimpat FC tab 50 mg
Packing/Price
56's
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