Medication info
Neopat 50 mg (Lacosamide)

Neopat 50 mg (Lacosamide)

Prescription medicationTabletOral
Ingredient · strength
Lacosamide›50mg / 1 tablet
Manufacturer / importer
Hanin Pharmaceutical Co., Ltd.
Appearance
Pink oval film-coated tablet
Packaging
100 tablets (10 tablets/PTP x 10), 30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201606651 · Approved 2016.11.17 · Insurance code 657202960

Summary

Main use
Adjunctive treatment of partial-onset seizures in patients 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, which should be increased after 1 week 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 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 per day is recommended for patients with severe renal impairment (CLCR≤30mL/min) and end-stage renal disease. As this medicine is removed from plasma by hemodialysis, patients receiving hemodialysis are recommended to receive an additional dose of up to 50% of a single dose immediately after 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 made cautiously in all patients with renal impairment. 2. Patients with hepatic impairment The dose should be determined cautiously in patients with hepatic impairment. A maximum dose of 300mg per day is recommended for 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. Although experience with lacosamide use in elderly patients with epilepsy is limited, reduced renal clearance and increased AUC are associated with age and should be taken into consideration in elderly patients. (See the section “Patients with renal impairment”)
Child dose
Children and adolescents under 16 years of age: Use of this medicine is not recommended in these age groups because data on its safety and efficacy in children and adolescents under 16 years of age are unavailable.

Ingredients

Manufacturer
Hanin Pharmaceutical Co., Ltd.

Efficacy & effects

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

  • Epilepsy
  • secondarily 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 and is also effective when secondary generalized seizures occur. In other words, it helps control seizures when monotherapy is difficult, thereby contributing to a reduction in the frequency and intensity of seizures. This medication aids in enhancing therapeutic effects while allowing for safe dosing. Therefore, it plays a critical role in controlling partial and generalized seizures.

How to take

Adult dose

This medicine should be taken twice daily. The recommended initial dose is 50mg twice daily, which should be increased after 1 week 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 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 per day is recommended for patients with severe renal impairment (CLCR≤30mL/min) and end-stage renal disease. As this medicine is removed from plasma by hemodialysis, patients receiving hemodialysis are recommended to receive an additional dose of up to 50% of a single dose immediately after 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 made cautiously in all patients with renal impairment. 2. Patients with hepatic impairment The dose should be determined cautiously in patients with hepatic impairment. A maximum dose of 300mg per day is recommended for 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. Although experience with lacosamide use in elderly patients with epilepsy is limited, reduced renal clearance and increased AUC are associated with age and should be taken into consideration in elderly patients. (See the section “Patients with renal impairment”)

Child dose

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

Precautions

This medication is used to treat epilepsy, and there may be an increased risk of mental health issues such as suicidal thoughts or behaviors and depression during treatment. Hence, if there are any changes in mood or behavior while taking this medication, it is essential to inform healthcare professionals immediately. Individuals with allergies to any of the components in this medication should not take it. Dizziness may occur with this medication, increasing the risk of falls or injury, so caution is necessary when starting it. Patients with heart conditions or irregular heartbeats should undergo an electrocardiogram before use and follow medical advice. This medication may affect driving or operation of dangerous machinery, so caution should be exercised until familiarity with the effects is achieved. It may interact with other medications, so if you are taking any other medications, you must inform healthcare professionals. Elderly patients may take this medication, but dosage adjustment may be necessary based on physical condition. The safety and efficacy of this medication for children under 16 years of age have not been confirmed and, therefore, its use is not recommended. Pregnant women should consult healthcare professionals before taking this medication due to potential risks to the fetus, and caution is needed during breastfeeding as the medication can pass into breast milk. Overdose may lead to symptoms such as dizziness, nausea, vomiting, and in severe cases, arrhythmias or altered consciousness, necessitating immediate medical attention. This medication may have the potential for psychological dependence, so dosage changes or discontinuation should be done according to medical advice. Finally, this medication should be stored out of reach of children and should not be transferred to other containers.

Side effects

suicidal thoughts, suicidal behavior, depression, dizziness, ataxia, prolonged PR interval, second-degree or higher atrioventricular block, slow or irregular heartbeat, fainting, palpitations, fast or irregular heartbeat, shortness of breath, multisystem hypersensitivity reaction, headache, nausea, diplopia, cognitive impairment, eye twitching, balance disorder, coordination disorder, memory impairment, tremors, drowsiness, dysarthria, attention deficit, sensory decrease, sensory abnormality, cerebellar syndrome, blurred vision, vertigo, tinnitus, vomiting, constipation, gastric distension, dyspepsia, dry mouth, diarrhea, decreased oral sensation, muscle cramps, itching, gait disturbance, asthenia, fatigue, hypersensitivity, euphoric feeling, fever, falls, skin lacerations, contusions, neutropenia, anemia, atrioventricular block, syncope, bradycardia, abnormal liver function tests, agranulocytosis, drug hypersensitivity reaction, euphoria, suicide attempt, aggression, anxiety, psychotic disorder, insomnia, hallucinations, bradycardia, atrial fibrillation, atrial flutter, 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

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

Storage

This medication must be stored in a tightly closed container to avoid exposure to air or moisture. Maintaining a storage temperature between 1°C and 30°C at room temperature is essential.

Appearance and packaging

Appearance

Pink 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.