Vimpro 200 mg (Lacosamide)

Adult dose

This medicine should be taken twice daily. The recommended initial dose is 50mg twice daily, increasing to 100mg twice daily after 1 week. Depending on clinical response and tolerability, the maintenance dose may be increased by 50mg per dose twice daily each week, up to the maximum recommended dose of 400mg daily (200mg twice daily). If treatment with this medicine must be discontinued, gradual dose reduction is recommended. (e.g., gradually reduce the daily dose by 200mg 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 300mg daily is recommended for patients with severe renal impairment (CLCR≤30mL/min) and end-stage renal disease. Since 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 metabolites (whose pharmacological activity is unknown) may accumulate. Dose adjustment should be undertaken carefully in all patients with renal impairment. 2. Patients with hepatic impairment The dose should be determined with caution 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. 3. Elderly patients Dose reduction is not necessary in elderly patients. Although experience with lacosamide use in elderly patients with epilepsy is limited, the reduction in renal clearance and increase in AUC associated with age should be taken into consideration in elderly patients. (See the “Patients with renal impairment” section)

Child dose

Use in children and adolescents under 16 years of age is not recommended because there are no data on the safety and efficacy of this medicine in children and adolescents under 16 years of age.

This medication may increase the risk of suicidal thoughts or behaviors, so mood changes or symptoms of depression should be carefully monitored during treatment. Do not take this medication if you are allergic to any of its components. Dizziness may occur frequently, which can lead to a risk of falling or injury, so caution is especially advised when starting treatment. Patients with heart disease or abnormalities in heart rhythm should undergo an ECG and follow a doctor's instruction when using this medication. If symptoms such as a slow or irregular heartbeat, dizziness, or palpitations occur, inform a physician immediately. Mental health issues, such as mood changes or suicidal thoughts, may arise, so patients and caregivers should inform healthcare professionals if these symptoms appear. This medication can cause serious allergic reactions known as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), so if a rash, fever, or unusual symptoms appear on various parts of the body, discontinue use immediately and consult a doctor. Side effects such as dizziness, headache, nausea, and diplopia may commonly occur. If symptoms are severe, consult a physician for dosage adjustment. When driving or operating dangerous machinery, attention may be impaired due to the effects of this medication, so extra caution is advised when starting treatment. Interactions may occur when taken with other medications; therefore, inform your doctor or pharmacist of all medications you are taking. Elderly individuals may take this medication without special dosage adjustments, but monitoring should be conducted based on individual health conditions. The safety and efficacy of this medication in children and adolescents under 16 years of age have not been established, so its use is not recommended in this age group. Women who are pregnant or planning to become pregnant should consult with a doctor as this medication may affect the fetus. During breastfeeding, this medication may be transmitted through breast milk and affect the baby, so discontinuation of breastfeeding is recommended while taking this medication. In cases of overdose, symptoms such as dizziness, nausea, and vomiting may occur, indicating central nervous system and gastrointestinal effects; seek immediate medical treatment as there is no specific antidote. This medication may cause psychological dependence, such as feelings of euphoria, so it should be taken exactly as prescribed by a doctor.

Suicidal thoughts, suicidal behavior, depression, abnormal changes in mood and behavior, dizziness, ataxia, prolonged PR interval, second-degree or higher atrioventricular block, atrial fibrillation, atrial flutter, lightheadedness, headache, nausea, diplopia, depression, confusional state, insomnia, mood changes, depressed mood, cognitive impairment, eye twitching, balance disorder, coordination disorder, memory impairment, tremors, drowsiness, speech disturbance, attention deficit, sensory loss, sensory abnormalities, cerebellar syndrome, double vision, blurred vision, vertigo, tinnitus, vomiting, constipation, gastric distention, dyspepsia, dry mouth, diarrhea, diminished oral perception, muscle cramps, itching, gait disturbance, asthenia, fatigue, hypersensitivity, feeling intoxicated, fever, falls, skin laceration, contusion, neutropenia, anemia, palpitations, atrioventricular block, syncope, bradycardia, abnormal liver function tests, agranulocytosis, drug hypersensitivity reaction, relief, suicide attempt, aggressiveness, anxiety, psychotic disorder, hallucinations, bradycardia, cardiac arrest, cardiac standstill, death, toxic epidermal necrolysis, Stevens-Johnson syndrome, rash, angioedema, urticaria, convulsions, psychogenic seizures, ataxia, sedation, hair loss, vesicles, early satiety, weight gain, reduced appetite, urinary incontinence, hiccups, tonic-clonic seizures, status epilepticus, cardiac arrest

This medication may be sensitive to air and moisture, so it should be stored in a tightly sealed container. It is recommended to maintain a storage temperature between 1°C and 30°C to preserve its efficacy and prevent degradation.

Appearance

Blue oval film-coated tablet

Package unit

30 tablets/bottle, 120 tablets/bottle, 56 tablets (14 tablets/PTP packaging x 4)