Medication info
Brivatop 25 mg Tablets (Brivaracetam)

Brivatop 25 mg Tablets (Brivaracetam)

Prescription medicationTabletOral
Ingredient · strength
Brivaracetam›25mg / 1 tablet
Manufacturer / importer
Daewoong Pharm. Co., Ltd.
Appearance
Pale gray oval film-coated tablets
Packaging
56 tablets/box [(14 tablets/PTP * 4)]
Approval status
Active

MFDS item code 202502406 · Approved 2025.09.11

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]. Take this film-coated tablet whole with water, 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 dosing time. Discontinuation If you wish to discontinue 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 during the final week (see section '1. Warnings'). Elderly patients (65 years and older) No dose adjustment is necessary in elderly patients. Clinical experience in elderly patients aged 65 years and older is limited. Renal impairment No dose adjustment is necessary in patients with renal impairment. This medicine is not recommended for patients with end-stage renal disease 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
Daewoong Pharm. Co., Ltd.

Efficacy & effects

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

  • Epilepsy
  • secondary generalized seizure
  • partial seizure
View approved original text

This medication is used to treat partial seizures in patients with epilepsy aged 16 and older. Partial seizures may occasionally progress to generalized seizures, and this medication is effective in such cases. It primarily helps to reduce the frequency and severity of seizures by being added to existing therapies. Therefore, it is used as an adjunctive therapy to improve seizure control in patients with epilepsy.

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]. Take this film-coated tablet whole with water, 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 dosing time. Discontinuation If you wish to discontinue 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 during the final week (see section '1. Warnings'). Elderly patients (65 years and older) No dose adjustment is necessary in elderly patients. Clinical experience in elderly patients aged 65 years and older is limited. Renal impairment No dose adjustment is necessary in patients with renal impairment. This medicine is not recommended for patients with end-stage renal disease 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 cause mental health issues such as suicidal thoughts or behaviors, so it is important to closely monitor for mood changes or unusual behavior during treatment. Also, central nervous system-related side effects such as drowsiness, fatigue, and dizziness may frequently occur. Activities requiring alertness, such as driving or operating machinery, should be avoided until you are accustomed to the medication. Abruptly stopping this medication may lead to an increase in seizure frequency, so the dosage should be gradually reduced following a doctor's instructions. Individuals with allergic reactions to any component of this medication or specific genetic problems like lactose intolerance should not take it. Patients with liver function issues may require dosage adjustments when using this medication, so it is advisable to consult with a doctor. If severe rashes, red spots, blisters, etc., occur on the skin while taking this medication, it is essential to stop taking it immediately and visit a hospital. There may be interactions with other medications, so if you are taking any other medicines or health supplements, be sure to inform your doctor or pharmacist. Women who are pregnant or planning to become pregnant should consult with their doctor, as taking this medication may affect the fetus. If breastfeeding, consider that this medication may be secreted in breast milk, and discuss whether to continue breastfeeding with your doctor. It is advisable not to use this medication in children under 16 years of age, as its safety and efficacy have not been adequately established. In cases of overdose, symptoms such as drowsiness, dizziness, anxiety, and aggression may appear. There is no specific antidote, so seek immediate medical attention for appropriate treatment. This medication must be kept out of reach of children, and care should be taken to avoid transferring it to another container, as this may cause accidents and degrade the product's quality.

Side effects

  • suicidal thoughts
  • suicidal behavior
  • drowsiness
  • fatigue
  • dizziness
  • coordination disorders
  • influenza
  • Type 1 hypersensitivity reaction
  • neutropenia
  • decreased appetite
Show 15 more
  • depression
  • anxiety
  • irritability
  • insomnia
  • psychotic symptoms
  • aggression
  • restlessness
  • seizures
  • vertigo
  • upper respiratory infection
  • cough
  • nausea
  • vomiting
  • constipation
  • Stevens-Johnson syndrome

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

Storage

This medication may be sensitive to air and moisture, so it should be stored in a tightly closed container. It is advisable to maintain a room temperature between 1 and 30 degrees Celsius to preserve the efficacy of the medication for a longer period.

Appearance and packaging

Appearance

Pale gray oval film-coated tablets

Package unit

56 tablets/box [(14 tablets/PTP * 4)]

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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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.