Qingruitan Brivaracetam Tablets

1. Indications and Usage
Brivaracetam tablets are indicated as adjunctive therapy in patients 16 years of age and older with partial-onset seizures.
2. Dosage and Administration
Recommended Dosage: The recommended starting dose is 50 mg twice daily. Based on individual tolerability and clinical response, the dose can be titrated to 25 mg twice daily or 100 mg twice daily. The maximum recommended daily dose is 200 mg.
Administration: Tablets can be taken with or without food.
Hepatic Impairment: For patients with mild to severe hepatic impairment, the recommended starting dose is 25 mg twice daily, with a maximum recommended dose of 75 mg twice daily.
Renal Impairment: No dosage adjustment is required for mild to moderate renal impairment. For patients with severe renal impairment, caution is advised.
Discontinuation: The drug should be tapered gradually to minimize the risk of increased seizure frequency; abrupt discontinuation is not recommended.
3. Mechanism of Action
Brivaracetam is a high-affinity binder to synaptic vesicle protein 2A (SV2A). By binding to SV2A in the brain, it modulates neurotransmitter release, which helps stabilize neuronal membranes and suppresses the propagation of epileptic discharges.
4. Safety and Warnings
Suicidal Behavior and Ideation: Like other antiepileptic drugs, brivaracetam may increase the risk of suicidal thoughts or behavior. Patients and caregivers should monitor for new or worsening symptoms of depression or anxiety.
Neuropsychiatric Reactions: Adverse reactions such as aggression, agitation, anger, anxiety, depression, psychosis, and other psychiatric disorders have been reported.
Central Nervous System Depression: Brivaracetam may cause somnolence, dizziness, and fatigue, which can impair the ability to drive or operate machinery.
Withdrawal Seizures: As with any antiepileptic drug, abrupt discontinuation may precipitate increased seizure frequency or status epilepticus.
5. Adverse Reactions and Clinical Research
Adverse Reactions: The most common adverse reactions (occurring in ≥10% of patients) include somnolence, dizziness, fatigue, nausea, and vomiting. Other frequently reported reactions include headache, anxiety, and coordination abnormalities.
Clinical Research: Phase III clinical trials demonstrated that brivaracetam, as an add-on therapy, significantly reduced the frequency of partial-onset seizures compared to placebo, with a generally favorable safety profile.
6. Drug Interactions
CYP2C19 Inhibitors: Concomitant use with strong CYP2C19 inhibitors (e.g., omeprazole, fluoxetine) may increase brivaracetam exposure.
CYP3A4 Inducers: Strong CYP3A4 inducers (e.g., rifampin) may decrease brivaracetam plasma concentrations.
Other CNS Depressants: Caution is advised when used with alcohol, benzodiazepines, or opioids due to the potential for additive CNS depressant effects.
Other Antiepileptics: Brivaracetam does not significantly affect the plasma concentrations of common antiepileptic drugs.
7. Pharmaceutical Information
Composition: The active ingredient is brivaracetam. Excipients may include lactose, microcrystalline cellulose, povidone, magnesium stearate, and others depending on the formulation.
Appearance: Available as oral tablets in strengths of 10 mg, 25 mg, 50 mg, 75 mg, and 100 mg.
Storage: Store at controlled room temperature, protected from moisture and light.