Medication info

Briviact (Brivaracetam)

Prescription medicationSolutionOral
Ingredient · strength
Brivaracetam›1g / 100mL
Manufacturer / importer
UCB Korea
Appearance
A slightly viscous, colorless to yellowish liquid contained in a brown glass bottle.
Packaging
300 milliliters/bottle
Approval status
Active

MFDS item code 201901306 · Approved 2019.03.04

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 drug is taken twice daily. The recommended initial dose is 25 mg or 50 mg per dose, based on the healthcare professional's assessment of potential adverse effects relative to seizure reduction. Based on clinical response and tolerability, the dosage may be increased or decreased from 50 mg daily [25 mg per dose, twice daily] to 200 mg daily [100 mg per dose, twice daily]. (Tablets) This drug is a film-coated tablet. Swallow it whole with water. It may be taken with or without food. (Oral solution) This drug may be diluted in water immediately before administration and may be taken with or without food. It may also be administered through a nasogastric tube or gastrostomy tube. If you forget 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 When discontinuing this drug, gradually reduce the dosage by 50 mg daily at 1-week intervals. After taking 50 mg daily for 1 week, a dosage of 20 mg daily is recommended during the final week (see section ‘2. Warnings’). Older adults (65 years and older) Dosage adjustment is not required in older adults. Clinical experience in older patients aged 65 years and older is limited (see section ‘12. Information for healthcare professionals’).. Renal impairment Dosage adjustment is not required in patients with renal impairment. This drug is not recommended for patients with end-stage renal disease receiving hemodialysis. Hepatic impairment Exposure to this drug is increased in patients with hepatic impairment. The recommended initial dosage for patients with hepatic impairment is 50 mg daily [25 mg per dose, twice daily], and the recommended maximum dosage is 150 mg daily [75 mg per dose, twice daily].

Ingredients

Importer
UCB Korea

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 for the treatment of partial seizures in patients with epilepsy aged 16 years and older. It helps effectively improve symptoms, whether or not secondary generalized seizures are present. Therefore, it contributes to reducing the frequency of seizures in epilepsy and enhancing the quality of life for patients.

How to take

Adult dose

This drug is taken twice daily. The recommended initial dose is 25 mg or 50 mg per dose, based on the healthcare professional's assessment of potential adverse effects relative to seizure reduction. Based on clinical response and tolerability, the dosage may be increased or decreased from 50 mg daily [25 mg per dose, twice daily] to 200 mg daily [100 mg per dose, twice daily]. (Tablets) This drug is a film-coated tablet. Swallow it whole with water. It may be taken with or without food. (Oral solution) This drug may be diluted in water immediately before administration and may be taken with or without food. It may also be administered through a nasogastric tube or gastrostomy tube. If you forget 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 When discontinuing this drug, gradually reduce the dosage by 50 mg daily at 1-week intervals. After taking 50 mg daily for 1 week, a dosage of 20 mg daily is recommended during the final week (see section ‘2. Warnings’). Older adults (65 years and older) Dosage adjustment is not required in older adults. Clinical experience in older patients aged 65 years and older is limited (see section ‘12. Information for healthcare professionals’).. Renal impairment Dosage adjustment is not required in patients with renal impairment. This drug is not recommended for patients with end-stage renal disease receiving hemodialysis. Hepatic impairment Exposure to this drug is increased in patients with hepatic impairment. The recommended initial dosage for patients with hepatic impairment is 50 mg daily [25 mg per dose, twice daily], and the recommended maximum dosage is 150 mg daily [75 mg per dose, twice daily].

Precautions

This medication is used to treat epilepsy and may increase the risk of suicidal thoughts or behaviors, so it is important to closely monitor for these symptoms during treatment. Additionally, central nervous system adverse reactions such as drowsiness, fatigue, and dizziness may occur frequently, especially during the early stages of treatment. Abruptly stopping this medication may lead to more frequent seizures, so the dosage should be gradually reduced under a doctor's supervision. Patients with known allergies to this medicine's active ingredients or other components should not take it, and caution is also advised for patients with specific genetic disorders such as lactose intolerance. Dose adjustments may be necessary for patients with impaired liver function, so consultation with a doctor is recommended. Serious skin reactions may occur, so patients should notify their doctor immediately if they experience skin rashes or any other unusual symptoms. Taking this medication with alcohol may exacerbate drowsiness and impair attention, so alcohol consumption should be avoided. The safety for the fetus during pregnancy has not been established, and it should only be used when absolutely necessary. If breastfeeding, consultation with an expert is advised as the drug may be excreted into breast milk. It is recommended that this medication not be used in children under 16 years of age due to insufficient confirmation of safety and effectiveness. Activities that require concentration, such as driving or operating machinery, should be approached with caution during the early stages of taking this medication, as symptoms of drowsiness or dizziness may appear. In the case of overdose, symptoms such as drowsiness, dizziness, anxiety, and depression may occur, and there is no specific antidote, so immediate medical attention should be sought.

Side effects

  • suicidal thoughts
  • suicidal behavior
  • drowsiness
  • fatigue
  • dizziness
  • coordination disorder
  • influenza
  • Type 1 hypersensitivity reaction
  • 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
  • lightheadedness
  • balance disorder
  • anxiety
  • 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 exposure to air or moisture, and it is best to keep it at room temperature between 1°C and 30°C. Storing it this way helps maintain the effectiveness of the medication for a longer time.

Appearance and packaging

Appearance

A slightly viscous, colorless to yellowish liquid contained in a brown glass bottle.

Package unit

300 milliliters/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.