Medication info
Vimsc Tablets 50mg (Lacosamide)

Vimsc Tablets 50mg (Lacosamide)

Prescription medicationTabletOral
Ingredient · strength
Lacosamide›50mg / 1 tablet
Manufacturer / importer
SK Chemicals Co., Ltd.
Appearance
Pink oval film-coated tablets
Packaging
Bottle packaging - 30 tablets/bottle, Bottle packaging - 200 tablets/bottle
Approval status
Active

MFDS item code 201605343 · Approved 2016.08.31 · Insurance code 644704450

Summary

Main use
Adjunctive treatment of partial-onset seizures in patients with epilepsy aged 16 years and older
Who takes it
Adults · Children
Adult dose
This medicine should be taken twice daily. The recommended initial dose is 50mg twice daily, and after 1 week it should be increased to 100mg twice daily. Depending on clinical response and tolerability, the maintenance dose may be increased by 50mg per dose twice daily each week. The maximum recommended dose is 400mg/day (200mg per dose, twice daily). If treatment with this medicine is to 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/day 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, an additional dose of up to 50% of the single dose is recommended immediately after hemodialysis for patients receiving hemodialysis. Use caution when treating patients with end-stage renal disease because clinical experience is limited and metabolites (whose pharmacological activity is unknown) may accumulate. Dose adjustment should be performed carefully in all patients with renal impairment. 2. Patients with hepatic impairment Use caution with dosing in patients with hepatic impairment. A maximum dose of 300mg/day is recommended in patients with mild or moderate hepatic impairment. Use is not recommended in patients with severe hepatic impairment. 3. Older adults No dose reduction is necessary in older adults. Although experience with lacosamide in older adults with epilepsy is limited, the age-related decrease in renal clearance and increase in AUC should be taken into consideration in older adults. (See the section on Patients with Renal Impairment.)
Child dose
There are no data on the safety and efficacy of this medicine in children and adolescents under 16 years of age; therefore, use in these age groups is not recommended.

Ingredients

Manufacturer
SK Chemicals Co., Ltd.

Efficacy & effects

Adjunctive treatment of partial-onset seizures in patients with epilepsy aged 16 years and older

  • Epilepsy
  • secondary generalized seizures
  • partial seizures
View approved original text

This medication is used for the treatment of partial-onset seizures in patients with epilepsy aged 16 years and older, which may or may not include secondary generalized seizures. It is used as adjunctive therapy for partial seizures to help reduce the frequency and intensity of seizures. Appropriately utilized within the patient's treatment plan, it contributes to effectively managing seizure symptoms.

How to take

Adult dose

This medicine should be taken twice daily. The recommended initial dose is 50mg twice daily, and after 1 week it should be increased to 100mg twice daily. Depending on clinical response and tolerability, the maintenance dose may be increased by 50mg per dose twice daily each week. The maximum recommended dose is 400mg/day (200mg per dose, twice daily). If treatment with this medicine is to 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/day 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, an additional dose of up to 50% of the single dose is recommended immediately after hemodialysis for patients receiving hemodialysis. Use caution when treating patients with end-stage renal disease because clinical experience is limited and metabolites (whose pharmacological activity is unknown) may accumulate. Dose adjustment should be performed carefully in all patients with renal impairment. 2. Patients with hepatic impairment Use caution with dosing in patients with hepatic impairment. A maximum dose of 300mg/day is recommended in patients with mild or moderate hepatic impairment. Use is not recommended in patients with severe hepatic impairment. 3. Older adults No dose reduction is necessary in older adults. Although experience with lacosamide in older adults with epilepsy is limited, the age-related decrease in renal clearance and increase in AUC should be taken into consideration in older adults. (See the section on Patients with Renal Impairment.)

Child dose

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

Precautions

This medication, as an antiepileptic agent, may increase the risk of suicidal thoughts or behaviors, so it is important to carefully monitor for any mood changes or depression symptoms during treatment. Patients with allergies to any component contained in this drug should not take it. Dizziness or balance disorders may occur, so caution is needed during the initial period of taking this medication to prevent falls or accidents. Patients with heart-related issues should undergo an electrocardiogram (ECG) before administration and should be closely monitored for symptoms of cardiac rhythm or conduction abnormalities. During treatment, both the patient and caregivers must recognize any changes in mental health status, including suicidal thoughts, depression, or mood changes, and report any abnormal symptoms to healthcare professionals immediately. Rarely, multiorgan hypersensitivity reactions may occur, so the medication should be stopped immediately and healthcare professionals consulted if there are symptoms such as rash, fever, or systemic abnormalities. Common side effects of this medication may include dizziness, headache, nausea, diplopia, and these symptoms may alleviate over time. It is advisable to avoid hazardous activities such as driving or operating machinery during the initial period of taking this medication or when symptoms are present. This medication may interact with other drugs, so patients must inform healthcare providers, especially if they are taking other medications affecting the heart or other antiepileptic drugs. Elderly patients can take it without special dosage adjustments; however, caution is warranted based on their physical condition. Safety and efficacy have not been established for children and adolescents under 16, so use in this age group is not recommended. Pregnant women must consult a physician before taking this medication as it may affect the fetus, and caution is also needed for nursing mothers as the drug can be transmitted through breast milk. In case of overdose, symptoms such as dizziness, nausea, and vomiting may occur, and since there is no specific antidote, treatment must be received immediately at a medical institution. This medication has the potential for psychological dependence, so administration and discontinuation should follow medical guidance. It is safest to store this medication out of reach of children and not to transfer it to another container.

Side effects

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, palpitations, rapid or irregular heartbeat, shortness of breath, confusion, insomnia, mood swings, depressed mood, headache, nausea, diplopia, cognitive impairment, eye twitching, balance disorders, coordination disorders, memory impairment, tremors, drowsiness, speech disorders, attention deficit, sensory impairment, sensory disturbances, cerebellar syndrome, blurred vision, vertigo, tinnitus, vomiting, constipation, gastric distension, dyspepsia, dry mouth, diarrhea, oral sensory reduction, muscle cramps, itching, gait disturbances, asthenia, fatigue, hypersensitivity, feeling intoxicated, fever, falls, skin laceration, bruising, neutropenia, anemia, atrioventricular block, syncope, bradycardia, abnormal liver function tests, agranulocytosis, drug hypersensitivity reaction, euphoria, suicide attempt, aggression, anxiety, psychotic disorders, hallucinations, bradycardia, asystole, cardiac arrest, death, toxic epidermal necrolysis, Stevens-Johnson syndrome, rash, angioedema, urticaria, convulsions, ataxia, sedation, hair loss, blisters, early satiety, psychogenic seizures, weight gain, decreased appetite, urinary incontinence, hiccups, tonic-clonic seizures, status epilepticus

Not everyone experiences these, and they can vary from person to person.

Storage

This medication may be sensitive to air or moisture, so it should be stored in a tightly sealed container. It is advisable to maintain a storage temperature between 1 to 30 degrees Celsius at room temperature. By storing it this way, the effectiveness of the medication can be preserved for a longer time.

Appearance and packaging

Appearance

Pink oval film-coated tablets

Package unit

Bottle packaging - 30 tablets/bottle, Bottle packaging - 200 tablets/bottle

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.