Lacosamide 50 mg (Lacosamide)

Adult dose

This medicine should be taken twice daily. The recommended initial dose is 50 mg twice daily, and should be increased to 100 mg twice daily after 1 week. Depending on clinical response and tolerability, the maintenance dose may be increased each week by 50 mg twice daily; the maximum recommended dose is 400 mg per day (200 mg twice daily). If treatment with this medicine is to be discontinued, gradual dose reduction is recommended (e.g., reduce the daily dose gradually by 200 mg each week). This medicine may be taken with or without food. 1. Patients with renal impairment No dose adjustment is necessary in patients with mild or moderate renal impairment (CLCR>30mL/min). A maximum dose of 300 mg per day is recommended in patients with severe renal impairment (CLCR≤30mL/min) and in patients with end-stage renal disease. Because this medicine is removed from plasma by hemodialysis, hemodialysis patients are recommended to receive an additional dose of up to 50% of a single dose immediately after hemodialysis. Treatment of patients with end-stage renal disease should be undertaken with caution because clinical experience is limited and the metabolite (whose pharmacological activity is unknown) may accumulate. Dose adjustments should be made cautiously in all patients with renal impairment. 2. Patients with hepatic impairment Dosing should be undertaken cautiously in patients with hepatic impairment. A maximum dose of 300 mg per day is recommended in patients with mild or moderate hepatic impairment. Use is not recommended in patients with severe hepatic impairment. 3. Elderly patients Dose reduction is not necessary in elderly patients. Experience with lacosamide in elderly patients with epilepsy is limited; however, the reduced renal clearance and increased AUC associated with age should be taken into consideration in elderly patients (see section ‘Patients with renal impairment’).

Child dose

4. Children There are no data on the safety and efficacy of this medicine in children and adolescents under 16 years of age; therefore, its use is not recommended in these age groups.

This drug may increase the risk of suicidal thoughts or behaviors, so mood changes or symptoms of depression should be closely monitored during use. Do not take this medicine if you are allergic to any of its ingredients. Dizziness or motor control disorders may occur, so it is necessary to monitor your condition closely during the initial period of use, and take it under medical supervision if necessary. For patients with heart disease or cardiac conduction abnormalities, it should be used cautiously after confirming the condition through an electrocardiogram. This medication can exacerbate mental health issues such as depression, abnormal mood changes, and suicidal thoughts, so both patients and guardians must inform healthcare providers immediately if these symptoms occur. Rarely, severe allergic reactions such as multi-organ hypersensitivity reactions may occur, so if unusual symptoms such as fever or rash appear, stop taking it immediately and consult a doctor. Common side effects may include dizziness, headache, nausea, diplopia, depression, confusion, insomnia, mood changes, cognitive impairment, eyelid twitching, balance disorders, coordination disorders, memory impairment, tremors, drowsiness, speech disturbances, attention deficits, sensory loss, sensory abnormalities, cerebellar syndrome, blurred vision, vertigo, tinnitus, vomiting, constipation, abdominal distention, indigestion, dry mouth, diarrhea, muscle cramps, itching, gait disturbances, weakness, fatigue, hypersensitivity, feelings of drunkenness, fever, and falls. It is advisable to avoid hazardous activities such as driving or operating machinery until you are accustomed to the effects of this medication. As there may be interactions with other medications, inform healthcare providers of any other medications you are taking. Elderly patients can take this medication without special dosage adjustments, but caution is needed depending on the physical condition. This drug is not recommended for children or adolescents under 16 years of age. Women who are pregnant or planning to become pregnant should consult a doctor before taking this medication, and breastfeeding women are advised to discontinue breastfeeding. In case of overdose, symptoms such as dizziness, nausea, and vomiting may occur, and as there is no specific antidote, immediate medical attention is required. This drug can potentially cause psychological dependence similar to a feeling of euphoria, so it must be taken exactly as directed by a physician. Lastly, medications should be stored in a safe place out of the reach of children, and it is recommended not to transfer them to other containers.

suicidal thoughts, suicidal behavior, depression, dizziness, ataxia, prolonged PR interval, second-degree or higher atrioventricular block, atrial fibrillation, atrial flutter, multisystem hypersensitivity reaction, headache, nausea, diplopia, depressed mood, confusion, insomnia, mood changes, cognitive impairment, tremor, sleepiness, speech disorder, attention deficit, sensory loss, sensory abnormalities, cerebellar syndrome, blurred vision, vertigo, tinnitus, vomiting, constipation, gastric distension, dyspepsia, dry mouth, diarrhea, oral sensory impairment, muscle cramps, itching, walking difficulties, asthenia, fatigue, hypersensitivity, feeling drunk, fever, falls, skin lacerations, contusions, neutropenia, anemia, palpitations, atrioventricular block, syncope, bradycardia, abnormal liver function tests, agranulocytosis, drug hypersensitivity reaction, sense of well-being, suicide attempt, aggression, anxiety, psychotic disorders, hallucinations, bradycardia, cardiac asystole, cardiac arrest, death, toxic epidermal necrolysis, Stevens-Johnson syndrome, rash, angioedema, urticaria, convulsions, psychogenic seizures, ataxia, sedation, alopecia, blisters, early satiety, weight gain, loss of appetite, urinary incontinence, hiccups, rigidity-clonic seizures, status epilepticus, cardiac arrest

This medication may be sensitive to air or moisture, so it should be stored in a tightly sealed container. It is important to maintain a storage temperature between 1°C and 30°C at room temperature. This way, the effectiveness of the medication can be well maintained, and it can be used safely.

Appearance

Pink oval film-coated tablet

Package unit

30 tablets/bottle, 200 tablets/bottle