Medication info

Briviact 50 mg (Brivaracetam)

Prescription medicationTabletOral
Ingredient · strength
Brivaracetam›50mg / 1 tablet
Manufacturer / importer
UCB Korea
Appearance
Yellow oval film-coated tablet
Packaging
56 tablets/box [14 tablets/PTP * 4]
Approval status
Active

MFDS item code 201901309 · 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
Take this medicine twice daily. The recommended initial dose is 25 mg or 50 mg per dose, based on the healthcare provider's assessment of potential adverse effects versus seizure reduction. Based on clinical response and tolerability, the dose may be increased or decreased from 50 mg/day [25 mg twice daily] to 200 mg/day [100 mg twice daily]. (Tablets) This medicine is a film-coated tablet. Swallow it whole with water. It may be taken with or without food. (Oral solution) This medicine may be diluted with water immediately before taking. It may be taken with or without food. It may also be administered through a nasogastric tube or gastrostomy tube. If you miss a dose If you miss one or more doses, take one dose as soon as you remember, then take the next dose at the next scheduled morning or evening time. When discontinuing treatment When discontinuing this medicine, gradually reduce the dose by 50 mg/day at 1-week intervals. After 1 week at 50 mg/day, a dose of 20 mg/day is recommended during the final week (see section ‘2. Warnings’). Elderly patients (65 years and older) Dose adjustment is not required in elderly patients. Clinical experience in elderly patients aged 65 years and older is limited (see section ‘12. Information for healthcare professionals’).. Renal impairment Dose adjustment is not required 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 50 mg/day [25 mg twice daily], and a maximum dose of 150 mg/day [75 mg twice daily] is recommended.

Ingredients

Importer
UCB Korea

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 treatment for partial seizures in patients with epilepsy aged 16 and older, effective regardless of whether secondary generalized seizures are present or not. It helps in the prevention and control of complex generalized seizures.

How to take

Adult dose

Take this medicine twice daily. The recommended initial dose is 25 mg or 50 mg per dose, based on the healthcare provider's assessment of potential adverse effects versus seizure reduction. Based on clinical response and tolerability, the dose may be increased or decreased from 50 mg/day [25 mg twice daily] to 200 mg/day [100 mg twice daily]. (Tablets) This medicine is a film-coated tablet. Swallow it whole with water. It may be taken with or without food. (Oral solution) This medicine may be diluted with water immediately before taking. It may be taken with or without food. It may also be administered through a nasogastric tube or gastrostomy tube. If you miss a dose If you miss one or more doses, take one dose as soon as you remember, then take the next dose at the next scheduled morning or evening time. When discontinuing treatment When discontinuing this medicine, gradually reduce the dose by 50 mg/day at 1-week intervals. After 1 week at 50 mg/day, a dose of 20 mg/day is recommended during the final week (see section ‘2. Warnings’). Elderly patients (65 years and older) Dose adjustment is not required in elderly patients. Clinical experience in elderly patients aged 65 years and older is limited (see section ‘12. Information for healthcare professionals’).. Renal impairment Dose adjustment is not required 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 50 mg/day [25 mg twice daily], and a maximum dose of 150 mg/day [75 mg twice daily] is recommended.

Precautions

This medication is used as an antiepileptic drug and helps control seizures in patients with epilepsy. However, mental health issues such as suicidal thoughts or behaviors may occur during treatment, thus both the patient and caregiver should closely observe for these symptoms. This medication may cause central nervous system side effects such as drowsiness, fatigue, and dizziness, which can occur at the beginning of treatment or at any time during the therapy. Abrupt discontinuation of this medication may result in more frequent seizures; therefore, the dosage should be gradually reduced. Those allergic to any of the active ingredients or components of this medication should not take it, and patients with certain genetic conditions like lactose intolerance should also avoid it. Patients with liver dysfunction require caution when using this medication, and dosage adjustments are recommended. This medication can cause various adverse reactions, with the most common side effects being drowsiness and dizziness. Rarely, serious skin reactions or blood abnormalities may occur; consult medical personnel immediately if symptoms such as a rash, fever, or difficulty breathing develop. The effect of this medication on the fetus is unclear, so women planning to become pregnant or who are pregnant should consult a doctor before use. If nursing, as this medication is excreted in breast milk, a decision to continue breastfeeding should be made after consulting with a doctor. The safety and efficacy of this medication in children under 16 have not been adequately established. During treatment, it is advisable to avoid activities requiring alertness, such as driving or operating machinery, until drowsiness and dizziness completely subside. In case of overdose, symptoms may include drowsiness, dizziness, anxiety, aggression, and insomnia; since there are no specific antidotes, supportive treatment appropriate to the symptoms is needed. This medication may interact with other drugs; inform medical personnel if you are taking other medications. Lastly, keep this medicine out of reach of children and complete the use within five months after opening.

Side effects

  • suicidal impulses
  • suicidal behaviors
  • drowsiness
  • fatigue
  • dizziness
  • coordination disorders
  • influenza
  • Type 1 hypersensitivity reactions
  • neutropenia
  • decreased appetite
Show 22 more
  • depression
  • anxiety
  • irritability
  • insomnia
  • psychotic symptoms
  • aggression
  • restlessness
  • seizures
  • vertigo
  • upper respiratory tract infections
  • cough
  • nausea
  • vomiting
  • constipation
  • fatigue
  • Stevens-Johnson syndrome (SJS)
  • anxiety
  • hypersensitivity
  • insomnia
  • suicidal thoughts
  • dizziness
  • balance disorders

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. It is important to maintain storage temperatures at room temperature between 1 to 30 degrees Celsius.

Appearance and packaging

Appearance

Yellow oval film-coated tablet

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.

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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.