Xianbixin Edaravone and Dexborneol Concentrated Solution for Injection

1. Indications and Usage
Acute Cerebral Infarction: Treatment of acute cerebral infarction to improve neurological symptoms, activities of daily living (ADL), and functional disability.
2. Dosage and Administration
Route of Administration: For Intravenous (IV) Infusion ONLY.
Recommended Dosage:
Adults: 60 mg (2 vials) administered twice daily.
Duration: 14 days per course. Treatment should ideally be initiated within 24 hours of stroke onset.
Critical Administration Instructions:
Dilution: Must be diluted in an appropriate volume of normal saline before infusion.
Infusion Rate: The infusion must be completed within 30 minutes.
Incompatibility: Do not mix with antiepileptic drugs (e.g., diazepam, phenytoin sodium) or spironolactone, as turbidity may occur. Do not mix with high-energy infusions or amino acid preparations, which may decrease edaravone concentration.
3. Mechanism of Action
Edaravone: A free radical scavenger that inhibits lipid peroxidation and suppresses oxidative damage to vascular endothelial and nerve cells.
Dexborneol: Exerts anti-inflammatory effects by inhibiting the activation of glial cells (astrocytes and microglia) in the brain.
Synergy: The combination provides dual neuroprotection by simultaneously reducing oxidative stress and neuroinflammation, offering superior efficacy compared to edaravone monotherapy.
4. Safety and Warnings
Hypersensitivity: Contraindicated in patients with known hypersensitivity to edaravone, dexborneol, or any excipients.
Renal and Hepatic Impairment: Use with caution in patients with mild-to-moderate renal or hepatic impairment due to the risk of exacerbating organ dysfunction.
Cardiac and Elderly Patients: Use with caution in patients with cardiac disease and the elderly (especially those over 80 years old).
5. Adverse Reactions and Clinical Research
Most Common Adverse Reactions: Liver function abnormalities (elevated AST, ALT, LDH), increased serum creatinine, and increased blood urea nitrogen (BUN).
Other Common Adverse Reactions: Anorexia, polyuria, and hypersensitivity reactions (rash, itching, erythema).
Clinical Research Highlights: Phase 3 clinical trials demonstrated that the combination therapy was more effective than edaravone monotherapy in improving neurological deficits and daily living function in acute cerebral infarction patients.
6. Drug Interactions
Antiepileptic Drugs and Spironolactone: Concomitant use may cause turbidity and is prohibited.
High-Energy Infusions and Amino Acids: Concomitant use may decrease edaravone concentration and is prohibited.
Other Nephrotoxic Drugs: Concomitant use may increase the risk of renal impairment; renal function should be monitored closely.
7. Pharmaceutical Information
Chemical Composition: Active Ingredients: Edaravone and Dexborneol. Excipients: Sodium metabisulfite, hydrochloric acid, sodium hydroxide, water for injection.
Appearance: Clear, colorless to slightly yellowish liquid.
Packaging: 10 mL/20 mg vials.
Storage: Store in a cool, dark place, protected from light.