Medication info
Brivaracetam 10 mg Tablet

Brivaracetam 10 mg Tablet

Prescription medicationTabletOral
Ingredient · strength
Brivaracetam›10mg / 1 tablet
Manufacturer / importer
Hanmi Pharmaceutical Co., Ltd.
Appearance
White or off-white round film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 202502491 · 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
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 for patients with epilepsy aged 16 and older, as an adjunctive therapy in the treatment of partial seizures, with or without secondary generalized 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 may increase the risk of suicidal thoughts or behaviors, so any mood changes or abnormal behavior during treatment should be reported to a healthcare provider immediately. Additionally, central nervous system side effects such as drowsiness, fatigue, dizziness, and coordination disorders may occur, so caution is advised when engaging in activities that require alertness, such as driving or operating machinery. Abrupt discontinuation of this medication may result in more frequent seizures, so it should be gradually reduced under the guidance of a physician. Patients with known allergies to the active ingredient or any other components should not take this medication, nor should those with lactose intolerance. Patients with impaired liver function should consult a healthcare provider for dose adjustment. If a rash or severe skin reaction occurs during treatment, the patient should discontinue use and visit a hospital immediately. This medication may interact with other anti-epileptic drugs, so it is important to inform the healthcare provider of any other medications being taken. Women who are pregnant or planning to become pregnant should consult their doctor before taking this medication, and breastfeeding mothers should also be cautious as the drug may be excreted in breast milk. For children's safety, this medication is not recommended for children under the age of 16. In case of overdose, symptoms such as drowsiness, dizziness, anxiety, and depression may occur, and since there is no specific antidote, supportive treatment specific to symptoms will be necessary. Lastly, this medication should be kept in a safe place out of reach of children, and it should not be transferred to other containers.

Side effects

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

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 air and moisture from entering. It is important to maintain a storage temperature between 1 to 30 degrees Celsius.

Appearance and packaging

Appearance

White or off-white round film-coated tablet

Package unit

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.

Questions about this medicine

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For anything that needs medical judgment, consult a doctor or pharmacist.

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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.