Medication info
Brivaracetam 25mg (Brivaracetam)

Brivaracetam 25mg (Brivaracetam)

Prescription medicationTabletOral
Ingredient · strength
Brivaracetam›25mg / 1 tablet
Manufacturer / importer
Samjin Pharmaceutical Co., Ltd.
Appearance
Gray oval film-coated tablet
Packaging
60 tablets/box [10 tablets/PTP x 6]
Approval status
Active

MFDS item code 202502519 · Approved 2025.09.23

Summary

Main use
Adjunctive treatment of partial-onset seizures in patients with epilepsy aged 16 years and older
Who takes it
Adults
Adult dose
Take this medicine twice daily. The recommended initial dose is 25mg or 50mg per dose, based on the healthcare provider’s assessment of the potential side effects in relation to seizure reduction. Based on clinical response and tolerability, the dose may be increased or decreased from 50mg per day[25mg twice daily] to 200mg per day[100mg twice daily]. This medicine is a film-coated tablet. Swallow it whole with water. It may be taken with or without food. If you miss a dose If you miss one or more doses, take one dose as soon as you remember, and then take the next dose at the next morning or evening dose time. When discontinuing treatment If you wish to stop taking this medicine, gradually reduce the dose by 50mg per day at 1-week intervals. After taking 50mg per day for 1 week, a dose of 20mg per day is recommended for the final week (see section ‘1. Warnings’). Elderly patients (65 years and older) Dose adjustment is not required for elderly patients. Clinical experience in elderly patients aged 65 years and older is limited. Renal impairment Dose adjustment is not required in patients with renal impairment. This medicine is not recommended for patients with end-stage renal disease who are receiving hemodialysis. Hepatic impairment Exposure to this medicine is increased in patients with hepatic impairment. The recommended initial dose for patients with hepatic impairment is 50mg per day[25mg twice daily], and the recommended maximum dose is 150mg per day[75mg twice daily].

Ingredients

Manufacturer
Samjin Pharmaceutical Co., Ltd.

Efficacy & effects

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

  • Secondary generalized seizures
  • partial seizures
View approved original text

This medication is used as an adjunctive therapy for the treatment of partial seizures in patients aged 16 years and older with epilepsy. It is particularly effective for those who also experience secondary generalized seizures. Thus, it contributes to reducing the frequency and intensity of seizures in epilepsy.

How to take

Adult dose

Take this medicine twice daily. The recommended initial dose is 25mg or 50mg per dose, based on the healthcare provider’s assessment of the potential side effects in relation to seizure reduction. Based on clinical response and tolerability, the dose may be increased or decreased from 50mg per day[25mg twice daily] to 200mg per day[100mg twice daily]. This medicine is a film-coated tablet. Swallow it whole with water. It may be taken with or without food. If you miss a dose If you miss one or more doses, take one dose as soon as you remember, and then take the next dose at the next morning or evening dose time. When discontinuing treatment If you wish to stop taking this medicine, gradually reduce the dose by 50mg per day at 1-week intervals. After taking 50mg per day for 1 week, a dose of 20mg per day is recommended for the final week (see section ‘1. Warnings’). Elderly patients (65 years and older) Dose adjustment is not required for elderly patients. Clinical experience in elderly patients aged 65 years and older is limited. Renal impairment Dose adjustment is not required in patients with renal impairment. This medicine is not recommended for patients with end-stage renal disease who are receiving hemodialysis. Hepatic impairment Exposure to this medicine is increased in patients with hepatic impairment. The recommended initial dose for patients with hepatic impairment is 50mg per day[25mg twice daily], and the recommended maximum dose is 150mg per day[75mg twice daily].

Precautions

This medication is used for the treatment of epilepsy and may increase the risk of suicidal thoughts and behavior, so patients and guardians should closely monitor for such symptoms. When taking this medication, central nervous system side effects such as drowsiness, fatigue, dizziness, and coordination disorders may occur, and these symptoms can appear at the beginning of treatment or at any time during dosing. Suddenly stopping the medication may increase the frequency of seizures, so it should be discontinued gradually, following the doctor's instructions. Patients should not take this medication if they have allergic reactions to the main ingredient or other components, or if they have specific metabolic irregularities such as lactose intolerance. Patients with impaired liver function may need dosage adjustments, and as there is limited clinical data on patients with liver dysfunction, it should be used with caution. During treatment, psychiatric symptoms such as suicidal ideation, depression, anxiety, irritability, and insomnia may arise, so changes in condition should be closely monitored. Severe skin reactions such as Stevens-Johnson syndrome may occur, so if skin rashes or other abnormal symptoms appear, medical consultation is necessary. Taking this medication with alcohol may affect psychomotor skills and attention, so alcohol should be avoided during treatment. There may be interactions when used with other antiepileptic medications or specific drugs, so all medications being taken should be disclosed to healthcare providers. It is generally advised not to administer this medication during pregnancy, and if planning for pregnancy, it should be discussed with healthcare professionals before use. In breastfeeding cases, as this medication may be excreted in breast milk, the decision to continue breastfeeding should be made in consultation with a doctor. Safety and efficacy for children under 16 years have not yet been sufficiently established. Drowsiness or dizziness may occur during usage, so it is advisable to avoid driving or operating dangerous machinery until familiar with the symptoms. In case of overdose, symptoms such as drowsiness, dizziness, anxiety, aggression, and depression may occur, and as there is no specific antidote, symptomatic supportive treatment is necessary. This medication should be stored out of reach of children, and it is important not to transfer it to other containers to maintain the quality.

Side effects

  • suicidal ideation
  • suicidal behavior
  • drowsiness
  • fatigue
  • dizziness
  • coordination movement disorder
  • influenza
  • type 1 hypersensitivity reaction
  • neutropenia
  • decreased appetite
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  • depression
  • anxiety
  • irritability
  • insomnia
  • psychotic symptoms
  • aggressiveness
  • restlessness
  • convulsions
  • vertigo
  • upper respiratory infection
  • cough
  • nausea
  • vomiting
  • constipation
  • Stevens-Johnson syndrome (SJS)
  • dizziness
  • balance disorder
  • hypersensitivity
  • insomnia
  • suicidal thoughts

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 recommended to keep the storage temperature between 1 to 30 degrees Celsius at room temperature to safely maintain the medication's effectiveness.

Appearance and packaging

Appearance

Gray oval film-coated tablet

Package unit

60 tablets/box [10 tablets/PTP x 6]

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.