Vimpro Tablet 50 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

Children and adolescents under 16 years of age: Use in this age group 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 is an antiepileptic drug used to treat epilepsy and other conditions. During the course of treatment with this medication, there is a risk of developing mental health problems such as suicidal thoughts or behaviors, and depression. Patients and caregivers should carefully observe for the emergence of such symptoms. This medication should not be taken if there is an allergy to the active ingredient or excipients. Dizziness or motor control disorders may occur upon administration; caution should be exercised to prevent falls or accidents until the patient is accustomed to these symptoms. Patients with heart disease or conduction abnormalities should undergo an ECG before taking this medication and should do so under medical supervision. This medication can cause serious allergic reactions known as multiorgan hypersensitivity. If there are symptoms of rash or fever, administration should be stopped immediately and a doctor should be consulted. Common side effects include dizziness, headache, nausea, double vision, confusion, insomnia, mood changes, depressed mood, cognitive impairment, eye tremors, balance issues, coordination difficulties, memory impairment, tremors, drowsiness, speech disorders, attention deficits, sensory loss, sensory abnormalities, cerebellar syndrome, blurred vision, vertigo, tinnitus, vomiting, constipation, abdominal distention, dyspepsia, dry mouth, diarrhea, muscle cramps, itching, gait disturbances, weakness, fatigue, irritability, feelings of drunkenness, and fever. This medication may affect the ability to drive or operate machinery; it is recommended to refrain from such activities in the early stages of treatment. Due to potential drug interactions, inform the physician or pharmacist about any other medications being taken. There is no specific dose adjustment required for the elderly, but caution may be necessary based on physical condition. Safety and efficacy have not been established for children and adolescents under 16, and use is not recommended. Women who are pregnant or planning to become pregnant should carefully consider the potential impact on the fetus before using this medication, and breastfeeding women are advised to discontinue breastfeeding due to the possibility of drug transfer through breast milk. In case of overdose, symptoms related to the central nervous system and heart may appear, and as there is no specific antidote, it is crucial to seek immediate medical care for appropriate treatment. This medication may potentially lead to psychological dependence; therefore, even when discontinuing, consult a physician for gradual reduction. Store this medication out of reach of children and do not transfer it to other containers for safety.

suicidal thoughts, suicidal behavior, depression, abnormal changes in mood and behavior, dizziness, vertigo, ataxia, PR interval prolongation, second-degree or higher atrioventricular block, atrial fibrillation, atrial flutter, palpitations, slow or irregular pulse, fainting, double vision, diplopia, blurred vision, lightheadedness, tinnitus, nausea, vomiting, constipation, abdominal distension, dyspepsia, dry mouth, diarrhea, oral paresthesia, muscle cramps, itching, gait disturbance, weakness, fatigue, irritability, feeling intoxicated, fever, falls, skin lacerations, contusions, neutropenia, anemia, atrioventricular block, syncope, bradycardia, liver function test abnormalities, agranulocytosis, drug hypersensitivity reaction, euphoria, suicide attempt, aggressiveness, anxiety, psychotic disorder, insomnia, hallucinations, bradycardia, deep vein thrombosis, 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, coma, tonic-clonic seizures, status epilepticus, electrocardiogram abnormalities

This medication may be sensitive to air or moisture and should be stored in a sealed container. Additionally, avoid storing the medication in excessively hot or cold environments, and keep it at room temperature between 1 and 30 degrees Celsius.

Appearance

Pink oval film-coated tablet

Package unit

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