Lacosamide 100 mg (Lacosamide)

Adult dose

This medicine should be taken twice daily. The recommended initial dose is 50 mg twice daily, and should be increased to 100 mg twice daily after 1 week. Depending on clinical response and tolerability, the maintenance dose may be increased each week by 50 mg twice daily; the maximum recommended dose is 400 mg per day (200 mg twice daily). If treatment with this medicine is to be discontinued, gradual dose reduction is recommended (e.g., reduce the daily dose gradually 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 per day is recommended in patients with severe renal impairment (CLCR≤30mL/min) and in patients with end-stage renal disease. Because 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 the metabolite (whose pharmacological activity is unknown) may accumulate. Dose adjustments should be made cautiously in all patients with renal impairment. 2. Patients with hepatic impairment Dosing should be undertaken cautiously in patients with hepatic impairment. A maximum dose of 300 mg per day is recommended in 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. Experience with lacosamide in elderly patients with epilepsy is limited; however, the reduced renal clearance and increased AUC associated with age should be taken into consideration in elderly patients (see section ‘Patients with renal impairment’).

Child dose

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

This medication may cause mood changes such as suicidal thoughts or behavior and depression during treatment, so patients and caregivers should closely monitor for these symptoms. Patients with allergies to any of the ingredients in this medication should not take it. Dizziness may occur at the beginning of treatment, so caution should be taken to prevent falls or accidents until the patient becomes accustomed to the medication. Patients with heart disease or conduction abnormalities should undergo an ECG before using this medication and take it under medical supervision. This medication can exacerbate symptoms of depression or suicidal thoughts, so it’s important to immediately inform healthcare professionals of any abnormal changes in mood or behavior. Rarely, serious allergic reactions, such as multi-organ hypersensitivity reactions, may occur; thus, if symptoms like fever or rash develop, medication should be discontinued immediately and medical attention sought. This medication may cause dizziness, headache, nausea, diplopia, and if these symptoms are severe, consulting a doctor is advised. It is safest to avoid driving or operating dangerous machinery until the patient is familiar with the medication. When taking this medication with other drugs, interactions may occur, so it is essential to inform healthcare professionals about all medications being taken. Elderly patients can take this medication without specific dosage adjustments; however, caution is advised based on physical condition. It is not recommended for children or adolescents under 16 years old due to insufficient safety and efficacy data. Women who are pregnant or planning to become pregnant should consult with a doctor regarding the use of this medication, and breastfeeding should be discontinued if the mother is using this medication. In case of overdose, symptoms such as dizziness, nausea, and vomiting may occur, necessitating immediate medical treatment. This medication may cause a sense of euphoria and should not be abused, and sudden cessation of use is not recommended. Keep medicine out of reach of children and do not transfer to other containers.

suicidal ideation, 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, depressed mood, confusion, insomnia, mood swings, cognitive impairment, eye twitching, balance disorder, collaboration disorder, memory impairment, tremor, drowsiness, speech difficulty, attention deficit, sensory loss, sensory abnormality, cerebellar syndrome, blurred vision, vertigo, tinnitus, vomiting, constipation, abdominal distension, dyspepsia, dry mouth, diarrhea, oral hypersensitivity, muscle cramps, itching, gait disturbance, weakness, fatigue, hypersensitivity, feeling drunk, fever, falls, skin laceration, contusion, neutropenia, anemia, palpitations, atrioventricular block, syncope, bradycardia, abnormal liver function test, agranulocytosis, drug hypersensitivity reaction, euphoria, suicide attempt, aggression, anxiety, psychotic disorder, hallucination, bradycardia, cardiac asystole, cardiac arrest, death, toxic epidermal necrolysis, Stevens-Johnson syndrome, rash, angioedema, urticaria, seizures, psychogenic seizures, ataxia, sedation, hair loss, vesicles, early satiety, weight gain, decreased appetite, urinary incontinence, hiccups, rigidity-tonic seizures, status epilepticus, cardiac arrest

This medication should be stored in a tightly closed container to prevent air or moisture from entering. It is recommended to maintain a storage temperature between 1 degree and 30 degrees Celsius at room temperature. This will help preserve the effectiveness and safety of the medication.

Appearance

Yellow oval film-coated tablet

Package unit

30 tablets/bottle, 200 tablets/bottle