Briviac, 25 mg 56 pcs.

Epilepsy Briviac is indicated as adjunctive therapy in the treatment of partial seizures with or without secondary generalization in adults and adolescents from 16 years of age with epilepsy.

Active ingredient

Brivaracetam

Composition

Active ingredient:

Brivaracetam 25.00 mg;

Associates:

croscarmellose sodium 5.00 mg,

lactose monohydrate 48.50 mg,

Betadex 6.75 mg,

Lactose anhydrous 48.25 mg,

Magnesium stearate 1.50 mg,

film jacket Opadray II 85F275014 gray 6.75 mg (polyvinyl alcohol, talc, polyethylene glycol 3350 / macrogol 3350, titanium dioxide, iron oxide yellow dye, iron oxide black dye).

How to take, the dosage

Overly, without chewing, with water, regardless of meals (see section “Pharmacological properties”).

The recommended starting dose is 50 mg/day or YuOmg/day, at the discretion of the treating physician, based on the desired anticonvulsant effect and potential and side effects. The daily dose is divided equally into two doses, morning and evening. Depending on the patient’s individual response and tolerability, the dose can be varied from 50 mg/day to 200 mg/day, in which brivaracetam is effective as a concomitant therapy for PSP. Initial titration of the dose to an effective dose does not require consideration of the tolerability of brivaracetam therapy.

If one or more doses are missed, it is recommended that the missed dose be taken as soon as possible; the next dose is taken at the usual time in the morning or evening. Making up for the missed dose will prevent the plasma concentration of brivaracetam from dropping below the effective level and prevent a recurrence of a seizure.

Stopping the drug

If it is necessary to stop treatment with brivaracetam, it is recommended that the drug be withdrawn gradually, reducing the dose by 50 mg/day per week. After one week of the 50 mg/day dose, it is recommended that the last week of treatment be taken at a dose of 20 mg/day of Brivaracetam.

Peculiarities of use in selected groups of patients

Elderly (65 years and older)

Dose adjustment in elderly patients is not required (see section “Pharmacokinetics”). There is limited experience with use in patients 65 years of age and older.

Dose adjustment in patients with impaired renal function is not required (see section “Pharmacokinetics”). Brivaracetam is not recommended in patients with terminal renal failure requiring hemodialysis due to lack of clinical data.

Hepatic impairment

In patients with chronic liver disease, brivaracetam exposure is increased. A dose of 50 mg/day should be started. The recommended maximum daily dose for all stages of liver failure is 150 mg divided into two doses (see Pharmacokinetics).

Children

The safety and efficacy of brivaracetam in infants and children under 16 years of age have not been established. The data obtained to date are listed under “Side effects” and “Pharmacological properties”.

Interaction

Studies of drug-drug interactions have only been conducted in adults.

Contraindications

• High sensitivity to the active ingredient or other pyrrolidone derivatives or any of the excipients listed under “Composition”
• Children under 16 years of age (due to lack of clinical data).
• Rare hereditary galactose intolerance, lactase deficiency or glucose-galactose malabsorption.
• Terminal renal failure requiring hemodialysis (due to lack of clinical data).