【藥品性質提示】 根據 2019 AGS Beers Criteria，本藥品為【潛在不適當用藥 (PIM)】，不建議用於有骨折風險之老年人(除非用於癲癇、調節情緒)。

Monotherapy or adjunctive therapy in the treatment of focal (partial) onset seizures in children 4 years or older and adults

lacosamide stabilizes hyperexcitable neuronal membranes and inhibits repetitive neuronal firing by enhancing the slow inactivation of sodium channels (with no effects on fast inactivation of sodium channels)

Renal function impairment: AUC is increased ~25% in patients with mild or moderate renal impairment (CrCl >30 to 80 mL/minute) and 60% in patients with severe renal impairment (CrCl ?30 mL/minute). Following a 4-hour hemodialysis treatment, AUC is reduced by ~50%.
Hepatic function impairment: AUC is increased by ~50% to 60% in patients with moderate hepatic impairment (Child-Pugh class B).
Geriatric: In patients >65 years of age, AUC and Cmax are increased ~20% compared with younger subjects.

Hypersensitivity to lacosamide or any component of the formulation; current or history of second- or third-degree atrioventricular (AV) block

Lacosamide crosses the placenta. In general, maternal polytherapy with antiepileptic drugs may increase the risk of congenital malformations; monotherapy with the lowest effective dose is recommended.

Lacosamide is present in breast milk. According to the manufacturer, the decision to continue or discontinue breastfeeding during therapy should take into account the risk of exposure to the infant and the benefits of treatment to the mother.<20230320>

Central nervous system: Dizziness, headache, drowsiness, fatigue, ataxia, vertigo, equilibrium disturbance, abnormal gait, depression
Dermatologic: Pruritus
Gastrointestinal: Vomiting, diarrhea, nausea
Hematologic & oncologic: Bruise
Local: Pain at injection site, local irritation
Neuromuscular & skeletal: Tremor, asthenia
Ophthalmic: Diplopia, blurred vision, nystagmus
Miscellaneous: Laceration

Focal (partial) onset seizure:
1. Monotherapy:
Initial: 50 to 100 mg twice daily; may be increased at weekly intervals by 50 mg twice daily based on response and tolerability. Alternatively, may give 200 mg IV loading dose followed 12 hours later by 100 mg twice daily with same titration schedule. Administer loading doses under medical supervision due to increased incidence of CNS adverse reactions.
Maintenance: 150 to 200 mg twice daily. Doses up to 600 mg/day may provide additional benefit in some patients.
2. Adjunctive therapy:
Initial: 50 mg twice daily;其他同上
Maintenance dose: 100 to 200 mg twice daily. Doses up to 600 mg/day may provide additional benefit in some patients; however, risk of adverse effects may be greater when higher doses of lacosamide are used in combination with other agents.Status epilepticus (alternative agent) (off-label use):
Initial: 200 to 400 mg as a single dose followed by a maintenance dose of 200 to 400 mg/day in 2 divided doses; some patients may require up to 600 mg/day.Discontinuation of therapy: Avoid abrupt discontinuation. Lacosamide may be withdrawn in weekly intervals by 200 mg/day

Seizure, partial onset: For patients already on a single antiepileptic and converting to lacosamide monotherapy, maintain the maintenance dose for 3 days before beginning withdrawal of the concomitant antiepileptic drug. Gradually taper the concomitant antiepileptic drug over ?6 weeks.When switching from oral to IV formulations, the total daily dose and frequency should be the same; IV therapy should only be used temporarily.)
Monotherapy:
1. Initial: 100 mg twice daily; may be increased at weekly intervals by 50 mg twice daily based on response and tolerability.
2. Alternate initial dosage: Loading dose: 200 mg followed approximately 12 hours later by 100 mg twice daily for 1 week; may be increased at weekly intervals by 50 mg twice daily based on response and tolerability.
3. Maintenance: 150 to 200 mg twice daily. Note: In adjunctive clinical trials in adults, doses higher than 400 mg/day were not more effective and were associated with more adverse reactions.
Adjunctive therapy:
1. Initial: 50 mg twice daily; may be increased at weekly intervals by 50 mg twice daily based on response and tolerability.
2. Alternative initial dosage: 同monotherapy
3. Maintenance dose: 100 to 200 mg twice daily. Note: In adjunctive clinical trials in adults, doses higher than 400 mg/day were not more effective and were associated with more adverse reactions.

1. CrCl ≥30 mL/minute: No dosage adjustment necessary; for patients taking concomitant strong CYP3A4 and/or CYP2C9 inhibitors, dosage reduction may be necessary.
2. CrCl <30 mL/minute: Reduce dose to 75% of the maximum dose.
3. End-stage renal disease (ESRD) requiring hemodialysis: Reduce dose to 75% of the maximum dose. Removed by hemodialysis; after 4-hour hemodialysis treatment, a supplemental dose of up to 50% should be considered.

1. Mild to moderate hepatic impairment: Reduce dose to 75% of the maximum dose. Further dosage reduction/limitation may be necessary in patients taking concomitant strong CYP3A4 and/or CYP2C9 inhibitors.
2. Severe hepatic impairment: Use is not recommended.

仿單：與NS,D5W,RL稀釋混合後，存放在玻璃或PVC袋中，在溫度高達 25°C具 24 小時的化學和物理的安定性