Finished product reference
Brivaracetam
Tablet · Oral · 100 mg
- List code
- 53459
What it is and how it works
Mechanism of Action The precise mechanism by which brivaracetam exerts its anticonvulsant activity is not known. Brivaracetam displays a high and selective affinity for synaptic vesicle protein 2A (SV2A) in the brain, which may contribute to the anticonvulsant effect.
Mechanism class: Epoxide Hydrolase Inhibitors
Indications
Brivaracetam oral solution is indicated for the treatment of partial-onset seizures in patients 1 month of age and older. Brivaracetam oral solution is indicated for the treatment of partial-onset seizures in patients 1 month of age and older.
Dosage and administration (summary)
Adults (16 Years and Older): The recommended starting dosage for monotherapy or adjunctive therapy is 50 mg twice daily (100 mg per day). Based on individual patient tolerability and therapeutic response, the dosage may be adjusted down to 25 mg twice daily (50 mg per day) or up to 100 mg twice daily (200 mg per day). Pediatric Patients (1 Month to less than 16 Years): The recommended dosage is based on body weight and is administered orally twice daily Hepatic Impairment: Dose adjustment is recommended for all stages of hepatic impairment. Dosage Information Monotherapy or Adjunctive Therapy The recommended dosage for patients 1 month of age and older is included in Table 1.
Contraindications
Hypersensitivity to brivaracetam or any of the inactive ingredients in brivaracetam oral solution (bronchospasm and angioedema have occurred) . Hypersensitivity to brivaracetam or any of the inactive ingredients in brivaracetam oral solution.
Warnings and precautions
Suicidal Behavior and Ideation: Monitor patients for suicidal behavior and ideation. Neurological Adverse Reactions: Monitor for somnolence and fatigue, and advise patients not to drive or operate machinery until they have gained sufficient experience on brivaracetam. Psychiatric Adverse Reactions: Behavioral reactions including psychotic symptoms, irritability, depression, aggressive behavior, and anxiety; monitor patients for symptoms. Hypersensitivity: Bronchospasm and Angioedema: Advise patients to seek immediate medical care.
Pregnancy
Pregnancy Risk Summary Available data from the North American Antiepileptic Drug (NAAED) pregnancy registry, a prospective cohort study, case reports, and a case series are insufficient to identify a risk of major birth defects, miscarriage or other maternal or fetal outcomes associated with brivaracetam use during pregnancy.
Storage and supply
Storage and Handling Store at 25°C (77°F); excursions permitted between 15°C to 30°C (59°F to 86°F). See USP Controlled Room Temperature. Do not freeze brivaracetam oral solution. Discard any unused brivaracetam oral solution remaining after 5 months of first opening the bottle.
Source: Brivaracetam (Brivaracetam) — US FDA prescribing information, 2026-02-28, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.
Other presentations of the same active ingredient
Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.
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