Lacosamide 50 mg (Lacosamide) Tablet

Adult dose

This medicine should be taken 2 times daily. The recommended initial dose is 50mg per dose, 2 times daily, and should be increased to 100mg per dose, 2 times daily, after 1 week. Depending on clinical response and tolerability, the maintenance dose may be increased by 50mg per dose, 2 times daily, each week. The maximum recommended dose is 400mg daily (200mg per dose, 2 times daily). If treatment with this medicine needs to be discontinued, gradual dose reduction is recommended. (e.g., gradually reducing the daily dose by 200mg each week) This medicine may be taken with or without food. No dose adjustment is required in patients with mild or moderate renal impairment (CLCR>30mL/min). A maximum dose of 300mg 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, patients on hemodialysis 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 a metabolite (with unknown pharmacological activity) may accumulate. Dose adjustment should be performed cautiously in all patients with renal impairment. The dose should be determined cautiously in patients with hepatic impairment. A maximum dose of 300mg daily is recommended for patients with mild or moderate hepatic impairment. Use is not recommended in patients with severe hepatic impairment. Dose reduction is not necessary in elderly patients. Experience with lacosamide in elderly patients with epilepsy is limited; however, the age-related decrease in renal clearance and increase in AUC should be taken into consideration in elderly patients. (See the section ‘Patients with renal impairment’)

Child dose

Use is not recommended in children and adolescents under 16 years of age because data on safety and efficacy in these age groups are unavailable.

This medication may increase the risk of suicidal thoughts or behaviors; therefore, if depression or mood changes occur during treatment, it is essential to consult a healthcare professional immediately. It should not be used if there is an allergy to any of the ingredients in this medication. Dizziness or balance disturbances may occur; caution should be taken to reduce the risk of falls when starting this medication or adjusting the dosage. Because there may be cardiac rhythm or conduction abnormalities, patients with heart disease should undergo an electrocardiogram before taking this medication and follow their doctor's instructions. Depression, suicidal thoughts, and abnormal mood changes may occur, so patients and guardians should carefully observe for these symptoms and report any abnormalities immediately. Multisystem hypersensitivity reactions such as skin rashes, fever, and eosinophilia may occur, so if these symptoms are suspected, stop taking the medication and inform a healthcare professional immediately. This medication may cause dizziness and blurred vision; it is advisable to avoid driving or operating hazardous machinery after taking it. There may be interactions with other medications, especially those affecting the heart or antiepileptic drugs; consult a doctor if taken concurrently. Elderly patients may experience metabolic changes with this medication, but dose adjustment is generally not necessary. Safety and efficacy have not been established in children under 16 years of age, so use is not recommended. During pregnancy, there is a potential risk to the fetus, so it should only be taken if necessary and discussed with a healthcare professional if planning to become pregnant. During breastfeeding, this medication may pass into breast milk and affect the baby; therefore, it is recommended to discontinue breastfeeding while taking this medication. In case of overdose, symptoms such as dizziness, nausea, and vomiting may occur, and since there is no specific antidote, seek appropriate medical treatment immediately. This medication can cause mental dependence, such as a feeling of euphoria; therefore, do not stop or increase the dosage without a doctor's instructions. Keep out of reach of children and do not transfer to other containers for safety.

suicidal thoughts, suicidal behavior, depression, dizziness, ataxia, prolonged PR interval, second-degree or higher atrioventricular block, atrial fibrillation, atrial flutter, multi-organ hypersensitivity reaction, headache, nausea, diplopia, confusion, insomnia, mood changes, depressed mood, cognitive impairment, eye twitching, balance disorder, coordination disorder, memory impairment, tremors, drowsiness, dysarthria, attention deficit, sensory loss, sensory abnormalities, cerebellar syndrome, blurred vision, vertigo, tinnitus, vomiting, constipation, abdominal distension, indigestion, dry mouth, diarrhea, oral sensation decrease, muscle cramps, itching, gait disturbance, weakness, fatigue, hypersensitivity, feeling drunk, fever, falls, skin laceration, contusion, neutropenia, anemia, palpitations, heart block, syncope, bradycardia, abnormal liver function tests, agranulocytosis, drug hypersensitivity reaction, relief, suicide attempt, aggression, anxiety, psychotic disorders, hallucinations, cardiac asystole, cardiac arrest, death, toxic epidermal necrolysis, Stevens-Johnson syndrome, rash, angioedema, urticaria, seizures, psychogenic seizures, ataxia, sedation, hair loss, blisters, early satiety, weight gain, decreased appetite, urinary incontinence, hiccups

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture. It is also safe to store it at room temperature between 1 degrees and 30 degrees Celsius, avoiding extremely hot or cold conditions.

Appearance

Pink oval film-coated tablet with 'KDC' on one side and '50' engraved on the other side.

Package unit

56 tablets (14 tablets/PTP x 4)