Medication info
Neopat Tablet 200 mg (Lacosamide)

Neopat Tablet 200 mg (Lacosamide)

Prescription medicationTabletOral
Ingredient · strength
Lacosamide›200mg / 1 tablet
Manufacturer / importer
Hanmi Pharmaceutical Co., Ltd.
Appearance
Blue oval film-coated tablet
Packaging
100 tablets (10 tablets/PTP x 10), 30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201700526 · Approved 2017.01.31 · Insurance code 657202990

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 drug should be taken twice daily. The recommended initial dose is 50mg twice daily; after 1 week, increase 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 per day (200mg twice daily). If treatment with this drug is to be discontinued, gradual dose reduction is recommended. (e.g., gradually reduce the daily dose by 200mg each week) This drug may be taken with or without food. 1. Patients with renal impairment No dosage adjustment is necessary in patients with mild or moderate renal impairment (CLCR>30mL/min). A maximum dose of 300mg per day is recommended for patients with severe renal impairment (CLCR≤30mL/min) and patients with end-stage renal disease. Since this drug is removed from plasma by hemodialysis, an additional 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 should be undertaken with caution because clinical experience is limited and accumulation of a metabolite (with unknown pharmacological activity) may occur. Dosage adjustment should be performed carefully in all patients with renal impairment. 2. Patients with hepatic impairment The dose should be selected with caution 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. 3. Elderly patients Dose reduction is not necessary in elderly patients. Experience with lacosamide in elderly patients with epilepsy is limited; however, the decrease in renal clearance and increase in AUC associated with age should be taken into consideration in elderly patients. (See section on patients with renal impairment.)
Child dose
Use of this drug is not recommended in children and adolescents under 16 years of age because data on safety and efficacy in these age groups are not available.

Ingredients

Manufacturer
Hanmi Pharmaceutical 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 and secondary generalized seizures in patients with epilepsy aged 16 years and older. It is prescribed to help control seizures in epilepsy.

How to take

Adult dose

This drug should be taken twice daily. The recommended initial dose is 50mg twice daily; after 1 week, increase 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 per day (200mg twice daily). If treatment with this drug is to be discontinued, gradual dose reduction is recommended. (e.g., gradually reduce the daily dose by 200mg each week) This drug may be taken with or without food. 1. Patients with renal impairment No dosage adjustment is necessary in patients with mild or moderate renal impairment (CLCR>30mL/min). A maximum dose of 300mg per day is recommended for patients with severe renal impairment (CLCR≤30mL/min) and patients with end-stage renal disease. Since this drug is removed from plasma by hemodialysis, an additional 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 should be undertaken with caution because clinical experience is limited and accumulation of a metabolite (with unknown pharmacological activity) may occur. Dosage adjustment should be performed carefully in all patients with renal impairment. 2. Patients with hepatic impairment The dose should be selected with caution 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. 3. Elderly patients Dose reduction is not necessary in elderly patients. Experience with lacosamide in elderly patients with epilepsy is limited; however, the decrease in renal clearance and increase in AUC associated with age should be taken into consideration in elderly patients. (See section on patients with renal impairment.)

Child dose

Use of this drug is not recommended in children and adolescents under 16 years of age because data on safety and efficacy in these age groups are not available.

Precautions

This medication may increase the risk of suicidal thoughts or actions, so mood changes or unusual behavior should be closely monitored during treatment. Do not use if you are allergic to any ingredient in this medication. Dizziness may occur when taking this medication, which could increase the risk of falling or injury; therefore, extra caution is advised when initially taking it. Patients with heart disease or abnormal heart rhythms should undergo an ECG before taking this medication, and their condition should be monitored periodically during treatment. This medication can affect mental health, including depression, suicidal thoughts, and mood changes; if any abnormal symptoms occur, inform your healthcare provider immediately. Rarely, hypersensitivity reactions affecting multiple organs may occur, so discontinue use and consult a doctor if you experience symptoms such as fever or rash. Driving or operating machinery requires caution due to symptoms like dizziness or blurred vision. Since interactions with other medications can occur, inform your healthcare provider of any other medications you are taking. Elderly patients can use this medication without special dosage adjustments, but careful monitoring is advised based on their physical condition. Safety and efficacy in children or adolescents under 16 years of age have not been established, so it is not recommended for these age groups. Pregnant women or women planning to become pregnant should discuss the use of this medication with their doctor, and breastfeeding mothers should avoid it due to the possibility of drug transfer through breast milk. In the case of overdose, symptoms such as dizziness, nausea, and vomiting may occur, and as no specific antidote exists, immediate medical attention is required. This medication may rarely cause psychological dependence, so caution is advised with long-term use. Store this medication in a place out of reach of children, and do not transfer it to another container for safety.

Side effects

suicidal thoughts, suicidal behavior, depression, dizziness, ataxia, prolonged PR interval, second-degree or greater atrioventricular block, atrial fibrillation, atrial flutter, multicentric hypersensitivity reaction, headache, nausea, double vision, confusion, insomnia, mood changes, depressed mood, cognitive impairment, eye twitching, balance disorder, cooperation disorder, memory impairment, tremor, drowsiness, speech disorder, attention deficit, sensory loss, paresthesia, cerebellar syndrome, blurred vision, vertigo, tinnitus, vomiting, constipation, gastric distension, dyspepsia, dry mouth, diarrhea, diminished oral perception, muscle cramps, itching, gait disturbance, asthenia, fatigue, hypersensitivity, feeling drunk, fever, falls, skin lacerations, contusions, neutropenia, anemia, palpitations, atrioventricular block, syncope, bradycardia, atrial fibrillation, atrial flutter, abnormal liver function tests, agranulocytosis, drug hypersensitivity reaction, euphoria, suicide attempt, aggression, anxiety, psychotic disorder, hallucinations, bradycardia, cardiac arrest, cardiac standstill, death, toxic epidermal necrolysis, Stevens-Johnson syndrome, rash, angioedema, hives, seizures, psychogenic seizures, ataxia, sedation, alopecia, blisters, early satiety, weight gain, appetite loss, urinary incontinence, hiccups

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

Storage

This medication can be sensitive to air and moisture, so it should be stored in a tightly sealed container. Additionally, avoid storing in very hot or very cold places, and it is best to keep it at room temperature between 1 to 30 degrees Celsius.

Appearance and packaging

Appearance

Blue oval film-coated tablet

Package unit

100 tablets (10 tablets/PTP x 10), 30 tablets/bottle, 100 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.