Medication info
Vimpat 200 mg (Lacosamide)

Vimpat 200 mg (Lacosamide)

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

MFDS item code 201605342 · Approved 2016.08.31 · Insurance code 644704440

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. 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. 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. 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
Children and adolescents under 16 years of age: Use in these age groups is not recommended because data on the safety and efficacy of this medicine in children and adolescents under 16 years of age are unavailable.

Ingredients

Manufacturer
SK Chemical 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 as an adjunctive treatment for partial seizures in patients with epilepsy aged 16 and older. It is effective for both types of seizures, whether or not secondary generalized seizures are present. Therefore, this medication helps to reduce the frequency of seizures and alleviate symptoms in patients with epilepsy.

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. 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. 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. 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

Children and adolescents under 16 years of age: Use in these age groups is not recommended because data on the safety and efficacy of this medicine in children and adolescents under 16 years of age are unavailable.

Precautions

This medication is used to control seizures associated with epilepsy. During treatment, mood changes such as suicidal thoughts or behaviors, and depression may occur; if these symptoms appear, it is critical to inform healthcare professionals immediately. Patients should not take this medication if they are allergic to any of its ingredients. Dizziness or balance disorders may occur, so care should be taken against falls or accidents when starting treatment, and it is advisable to take the medication under medical supervision if necessary. If there is a history of heart disease or conduction abnormalities, it is important to have an ECG prior to taking this medication, as it may affect heart rhythm. During treatment, symptoms of depression or unusual behavior changes may appear; therefore, both the patient and the caregiver should closely monitor for these changes. In rare cases, a severe allergic reaction may occur with systemic rashes and fever; if such symptoms appear, discontinue use immediately and consult a healthcare professional. Side effects such as dizziness, headache, nausea, double vision (seeing overlapping images) may be common, and these symptoms may improve over time. This medication may affect the ability to drive or operate dangerous machinery, so caution is advised during the initial period of treatment. Drug interactions may occur when taking other medications, so it is essential to inform healthcare professionals of any other medications being taken. In elderly patients, special dosage adjustments are not usually necessary, but caution may be required depending on their physical condition. Use in children and adolescents under 16 years of age is not recommended as safety and efficacy have not been adequately established. During pregnancy, there is a risk of effects on the fetus; therefore, it should only be taken when absolutely necessary, and women planning to become pregnant or who are pregnant should consult their doctors. In nursing mothers, this medication is excreted in breast milk, which may affect the infant; therefore, whether to take it should be discussed with healthcare professionals. In case of overdose, symptoms such as dizziness, nausea, and vomiting may appear; as there is no specific antidote, it is essential to visit a medical institution immediately for appropriate treatment. This medication may lead to psychological dependence; therefore, do not discontinue use suddenly without a doctor's guidance. Keep out of reach of children, and do not transfer to different containers, which is crucial for maintaining quality.

Side effects

suicidal thoughts, suicidal behavior, depression, abnormal changes in mood and behavior, dizziness, ataxia, prolonged PR interval, atrioventricular block of degree 2 or greater, atrial fibrillation, atrial flutter, multicentric hypersensitivity reaction, headache, nausea, diplopia, confusion, insomnia, mood changes, depressed mood, cognitive impairment, eye twitching, balance disorder, coordination disorder, memory impairment, tremor, drowsiness, speech disturbance, attention deficit, sensory reduction, sensory abnormality, cerebellar syndrome, blurred vision, vertigo, tinnitus, vomiting, constipation, gastric distension, dyspepsia, dry mouth, diarrhea, oral sensory decline, muscle cramps, itching, gait disturbance, weakness, fatigue, hypersensitivity, feeling intoxicated, fever, falls, skin laceration, contusion, neutropenia, anemia, palpitations, heart block, syncope, bradycardia, abnormal liver function tests, agranulocytosis, drug hypersensitivity reaction, euphoria, suicide attempt, aggression, restlessness, psychotic disorder, hallucinations, bradycardia, cardiac asystole, cardiac arrest, death, toxic epidermal necrolysis, Stevens-Johnson syndrome, rash, angioedema, urticaria, convulsions, psychogenic seizure, ataxia, sedation, hair loss, vesicles, early satiety, weight gain, decreased appetite, urinary incontinence, hiccups, tonic-clonic seizures, status epilepticus, electrocardiogram abnormalities, cardiac arrest

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

Storage

This medication should be stored in a tightly closed container to protect it from air and moisture. Additionally, it is best to store it at room temperature between 1 degree Celsius and 30 degrees Celsius.

Appearance and packaging

Appearance

Blue oval film-coated tablet

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.