Medication info
BuKwang Brivaracetam 50 mg Tablet (Brivaracetam)

BuKwang Brivaracetam 50 mg Tablet (Brivaracetam)

Prescription medicationTabletOral
Ingredient · strength
Brivaracetam›50mg / 1 tablet
Manufacturer / importer
BuKwang Pharmaceutical Co., Ltd.
Appearance
Yellow oval film-coated tablet
Packaging
30 tablets/bottle, 120 tablets/bottle
Approval status
Active

MFDS item code 202502487 · Approved 2025.09.19

Summary

Main use
Adjunctive treatment of partial-onset seizures in patients with epilepsy aged 16 years and older
Who takes it
Adults
Adult dose
This medicine is taken twice daily. The recommended initial dose is 25mg or 50mg per dose, based on the healthcare professional's assessment of potential adverse effects relative to seizure reduction. Based on clinical response and tolerability, the dose may be increased or decreased from 50mg per day [25mg per dose, twice daily] to 200mg per day [100mg per dose, twice daily]. Swallow this film-coated tablet 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 scheduled morning or evening time. Discontinuation 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 2. Warnings). Older adults (65 years and older) No dosage adjustment is required in older adults. Clinical experience in patients aged 65 years or older is limited. Renal impairment No dosage adjustment is required in patients with renal impairment. This medicine is not recommended for patients with end-stage renal impairment 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 per dose, twice daily], and the recommended maximum dose is 150mg per day [75mg per dose, twice daily].

Ingredients

Manufacturer
BuKwang 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 therapy for the treatment of partial seizures in patients with epilepsy aged 16 years and older. It is particularly effective whether or not secondary generalized seizures are present, thus contributing to the reduction in the frequency and intensity of partial seizures and alleviating the patient's symptoms. It supports epilepsy patients in achieving a more stable daily life. To use it safely, the exact dosage regimen should be followed. This medication plays an important role in the management of epileptic seizures.

How to take

Adult dose

This medicine is taken twice daily. The recommended initial dose is 25mg or 50mg per dose, based on the healthcare professional's assessment of potential adverse effects relative to seizure reduction. Based on clinical response and tolerability, the dose may be increased or decreased from 50mg per day [25mg per dose, twice daily] to 200mg per day [100mg per dose, twice daily]. Swallow this film-coated tablet 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 scheduled morning or evening time. Discontinuation 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 2. Warnings). Older adults (65 years and older) No dosage adjustment is required in older adults. Clinical experience in patients aged 65 years or older is limited. Renal impairment No dosage adjustment is required in patients with renal impairment. This medicine is not recommended for patients with end-stage renal impairment 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 per dose, twice daily], and the recommended maximum dose is 150mg per day [75mg per dose, twice daily].

Precautions

This medication is used to treat epilepsy and may cause psychiatric side effects such as suicidal thoughts or behaviors, necessitating careful observation of these symptoms by the patient and guardian. Additionally, this medication can cause central nervous system-related side effects such as drowsiness, fatigue, and dizziness, which may occur frequently especially during the initial dosing period. Abrupt discontinuation of the drug can increase the frequency of seizures, so it must be tapered according to the physician's instructions. Patients with allergies to this medication's active ingredient or components, as well as those with lactose intolerance or certain genetic disorders, should not take it. Patients with liver function issues must have their dosage adjusted, and cautious use is required due to limited clinical data in liver impairment cases. This medication can cause various adverse reactions, with the most common side effects being drowsiness and dizziness, and rarely severe skin reactions like Stevens-Johnson syndrome. During treatment, if skin rashes or abnormal symptoms occur, immediate consultation with medical personnel is necessary. This medication may interact with other antiepileptic drugs, especially antibiotics, antifungals, and oral contraceptives, potentially affecting drug concentrations; therefore, it is essential to inform the physician about all medications being taken. Generally, this medication should not be used during pregnancy, and women planning a pregnancy should consult a physician before use. In the case of breastfeeding, since this medication may be excreted in breast milk, the decision to continue breastfeeding should be discussed with a physician. Use in children under 16 years is not recommended as the safety and effectiveness of this medication have not been established. This medication can cause drowsiness or dizziness, so it is advisable to avoid hazardous activities such as driving or operating machinery, particularly during the initial treatment period. In case of overdose, there is no specific antidote, and immediate visit to a medical institution for appropriate treatment is necessary, as blood dialysis is not effective in eliminating this medication. Finally, this medication should be stored out of the reach of children, and it is safer and better for quality maintenance not to transfer it to another container.

Side effects

  • suicidal thoughts
  • suicidal behavior
  • drowsiness
  • fatigue
  • dizziness
  • coordination disorders
  • influenza
  • type I hypersensitivity
  • neutropenia
  • decreased appetite
Show 20 more
  • depression
  • anxiety
  • irritability
  • insomnia
  • psychotic symptoms
  • aggression
  • restlessness
  • seizures
  • vertigo
  • upper respiratory tract infections
  • cough
  • nausea
  • vomiting
  • constipation
  • Stevens-Johnson syndrome (SJS)
  • tinnitus
  • balance disorders
  • hypersensitivity
  • insomnia
  • suicidal ideation

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

Storage

This medication should be stored in a tightly sealed container to prevent exposure to air and moisture. It is best kept at room temperature between 1 and 30 degrees Celsius.

Appearance and packaging

Appearance

Yellow oval film-coated tablet

Package unit

30 tablets/bottle, 120 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.