Bimskeuj (Lacosamide)

Adult administration

This medication should be administered twice daily. The recommended initial dose is 50mg twice daily; after 1 week, the dose should be increased to 100mg twice daily. Depending on clinical response and tolerability, the maintenance dose may be increased each week by 50mg per dose, twice daily; the maximum recommended dose is 400mg per day (200mg per dose, twice daily). If treatment with this medication is to be discontinued, gradual dose reduction is recommended (e.g., reduce the daily dose gradually by 200mg each week). Lacosamide treatment may be initiated orally or intravenously. The injection is administered by intravenous infusion over 30~60 minutes twice daily. The injection may be administered intravenously without dilution. When switching from oral to intravenous administration or vice versa, treatment may be continued directly without dose titration. The total daily dose and twice-daily administration should be maintained. Experience is available with twice-daily administration of the injection for up to 5 days. Patients with renal impairment No dose adjustment is required in patients with mild or moderate renal impairment (CLCR>30mL/min). A maximum dose of 300mg per day is recommended in patients with severe renal impairment (CLCR≤30mL/min) and in patients with end-stage renal disease. As this medication is removed from plasma by hemodialysis, a supplemental dose of up to 50% of the single dose is recommended immediately after hemodialysis in patients receiving hemodialysis. Treatment of patients with end-stage renal disease requires caution because clinical experience is limited and there may be accumulation of metabolites (whose pharmacological activity is unknown). Dose adjustment should be performed cautiously in all patients with renal impairment. Patients with hepatic impairment Dose titration should be performed cautiously in patients with hepatic impairment. A maximum dose of 300mg per day is recommended in patients with mild or moderate hepatic impairment. Use is not recommended in patients with severe hepatic impairment. Older adults Dose reduction is not required in older adults. Experience with lacosamide in older adults with epilepsy is limited; however, reduced renal clearance and increased AUC are associated with age and should be taken into consideration in older adults (see Patients with renal impairment).

Child administration

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

This drug is an antiepileptic used to treat neurological disorders such as epilepsy. Patients taking this medication should be aware of their mental health status, including suicidal thoughts or behavior, symptoms of depression, and mood changes. If these symptoms occur while taking the medication, they should inform a healthcare professional immediately. This medication should not be used if there is an allergy to its ingredients. Caution is required as central nervous system side effects such as dizziness or motor control difficulties may occur, especially when starting treatment. Care must be taken to prevent falls or injuries. As it may cause cardiac conduction abnormalities or heart rhythm problems, patients with heart disease should undergo an ECG examination before taking this medication and follow their doctor's instructions. This medication can interact with other drugs, so patients must inform their healthcare provider of any other medications they are taking. Extra caution is needed, especially when taken with drugs that affect the heart. Dizziness or blurred vision may occur while driving or operating machinery, so it is advisable to avoid these activities until accustomed to the medication. Women who are pregnant or planning to become pregnant should consult a doctor before taking this medication. It should be used cautiously as it may affect the fetus. Those who are breastfeeding should consider stopping to avoid potential effects on the baby, as this medication may pass into breast milk. In case of overdose, central nervous system and gastrointestinal symptoms may manifest, and in severe cases, cardiac issues can arise, requiring immediate medical attention. This medication has the potential for abuse, so it is important to strictly adhere to the prescribed dosage and regimen, avoiding sudden discontinuation. When storing, keep in a place out of reach of children, and use immediately after opening for safety. Any remaining medication should be disposed of and not mixed with other medications.

Suicidal ideation, suicidal behavior, depression, abnormal changes in mood and behavior, dizziness, ataxia, prolonged PR interval, second-degree or higher atrioventricular block, atrial fibrillation, atrial flutter, multiple organ hypersensitivity reaction, headache, nausea, diplopia, confusion state, insomnia, mood changes, depressive mood, cognitive impairment, tremor, balance disorder, coordination disorder, memory impairment, tremor, drowsiness, dysarthria, attention disorders, sensory reduction, sensory abnormalities, cerebellar syndrome, blurred vision, vertigo, tinnitus, vomiting, constipation, gastric distension, dyspepsia, dry mouth, diarrhea, reduced oral sensation, muscle spasms, itching, gait disturbance, asthenia, fatigue, hypersensitivity, feeling intoxicated, fever, falls, skin laceration, contusion, neutropenia, anemia, palpitations, injection site pain, injection site discomfort, injection site irritation, injection site erythema, atrioventricular block, syncope, bradycardia, cardiac arrest, severe bradycardia, liver function test abnormalities, agranulocytosis, drug hypersensitivity, relief, suicide attempt, aggression, anxiety, psychotic disorders, hallucinations, deep vein issues, toxic epidermal necrolysis, Stevens-Johnson syndrome, rash, angioedema, urticaria, seizures, ataxia, sedation, hair loss, vesicles, early satiety, weight gain, decreased appetite, urinary incontinence, hiccups, stiffening-automated seizure, status epilepticus, cardiac arrest

This medication should be kept in an airtight container to prevent exposure to air or moisture and should be stored at room temperature between 1 and 30 degrees Celsius. Proper storage will maintain the effectiveness of the medication.

Appearance

An injection solution in a colorless and transparent liquid contained in a colorless and transparent glass vial

Package unit

Vial - 10 vials/box [20 milliliters/vial]