Lacosamide Tablets 100 mg

Adult dose

This medicine should be taken twice daily. The recommended initial dose is 50 mg twice daily, which should be increased after 1 week to 100 mg twice daily. Depending on clinical response and tolerability, the maintenance dose may be increased each week by 50 mg twice daily, up to the maximum recommended dose of 400 mg daily (200 mg twice daily). If treatment with this medicine must be discontinued, gradual dose reduction is recommended (e.g., gradually reduce the daily dose 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 daily is recommended for patients with severe renal impairment (CLCR≤30mL/min) and patients with end-stage renal disease. Since this medicine is removed from plasma by hemodialysis, an additional dose of up to 50% of the single dose is recommended immediately after hemodialysis for patients receiving hemodialysis. Treatment of patients with end-stage renal disease should be undertaken with caution because clinical experience is limited and a metabolite (with unknown pharmacological activity) may accumulate. Dose adjustment should be made cautiously in all patients with renal impairment. 2. Patients with hepatic impairment The dose should be used cautiously in patients with hepatic impairment. A maximum dose of 300 mg daily is recommended for patients with mild or moderate hepatic impairment. Use is not recommended in patients with severe hepatic impairment. 3. Elderly patients No dose reduction is necessary in elderly patients. Although experience with lacosamide in elderly patients with epilepsy is limited, reduced renal clearance and increased AUC associated with age should be considered in elderly patients (see section ‘Patients with renal impairment’).

Child dose

Children and adolescents under 16 years of age: Use in these age groups is not recommended because data on the safety and efficacy of this medicine are unavailable.

This medication is an antiepileptic drug and careful observation for suicidal thoughts or behaviors, depression, and unusual changes in mood or behavior should be made during treatment. Patients with allergies to any components of this medication should not take it. Dizziness may occur, so caution is required to prevent falls or accidents until the effects of this medication are well understood. Patients with heart diseases or conduction abnormalities should undergo an electrocardiogram before taking this medication and monitor their heart condition closely. This medication may exacerbate mental health issues such as suicidal thoughts; therefore, patients and caregivers should immediately inform healthcare professionals if such symptoms arise. Severe allergic reactions, such as multiorgan hypersensitivity, can occur rarely, and any abnormal symptoms such as fever or rash should lead to immediate discontinuation and a visit to the hospital. Common side effects include dizziness, headache, nausea, and double vision; if these symptoms are severe, consultation with a doctor is advised. It is advisable to avoid driving or operating dangerous machinery if there is dizziness or blurred vision after taking this medication. Caution is necessary when taking this medication with others due to potential interactions, especially with drugs affecting the heart. Elderly patients can take this medication without specific dose adjustments, but they should follow medical advice based on their physical condition. The safety and efficacy of this medication have not been established for children and adolescents under 16, hence its use is not recommended for this age group. Women who are pregnant or planning to become pregnant must consult a doctor before taking this medication, and caution is needed since it may be excreted in breast milk, potentially affecting the infant. In case of overdose, dizziness, nausea, vomiting may occur, and specific antidotes are not available, so immediate appropriate treatment at a medical facility is required. This medication may lead to psychological dependence, such as a sense of euphoria, so do not stop or change the dosage without medical guidance. When storing, keep it out of reach of children and do not transfer it to other containers.

suicidal ideation, suicidal behavior, depression, dizziness, ataxia, prolonged PR interval, second-degree or higher atrioventricular block, atrial fibrillation, atrial flutter, fever, rash, eosinophilia, hepatitis, nephritis, lymphadenopathy, myocarditis, headache, nausea, diplopia, depressed mood, confusion, insomnia, mood changes, cognitive impairment, eye twitching, balance disorder, coordination disorder, memory impairment, tremor, drowsiness, dysarthria, attention deficit, sensory loss, sensory abnormalities, cerebellar syndrome, blurred vision, vertigo, tinnitus, vomiting, constipation, abdominal distension, dyspepsia, dry mouth, diarrhea, oral hypoesthesia, muscle cramps, itching, gait disturbance, asthenia, fatigue, irritability, feeling drunk, fever, falls, skin laceration, contusion, neutropenia, anemia, palpitations, atrioventricular block, syncope, bradycardia, seizures, euphoria, suicide attempt, aggression, anxiety, psychotic disorder, hallucinations, bradycardia, heart asystole, cardiac arrest, death, abnormal liver function tests, toxic epidermal necrolysis, Stevens-Johnson syndrome, angioedema, urticaria, hair loss, vesicles, early satiety, weight gain, decreased appetite, urinary incontinence, hiccups

Store this medication in a tightly closed container to protect it from air and moisture. It is important to maintain a storage temperature between 1°C and 30°C. This way, the effectiveness and safety of the medication can be preserved for a long time.

Appearance

Yellow oval film-coated tablets

Package unit

60 tablets/PTP (10 tablets/PTP × 6), 100 tablets/bottle, 30 tablets/bottle