Enbipu Butylphthalide and Sodium Chloride Injection

1. Indications and Usage
Butylphthalide and Sodium Chloride Injection is indicated for the improvement of neurological deficits in patients with acute ischemic stroke.
2. Dosage and Administration
Recommended Dosage: The recommended dosage is 25 mg (100 mL) administered intravenously twice daily.
Administration: Each infusion should be administered over not less than 50 minutes. The interval between two consecutive infusions should be at least 6 hours.
Duration: The recommended course of treatment is 14 days.
Timing: Treatment should ideally be initiated within 48 hours after stroke onset.
Administration Equipment: Polyvinyl chloride (PVC) infusion sets have a significant adsorption effect on butylphthalide. Therefore, only polyethylene (PE) or polypropylene infusion sets should be used for administration.
3. Mechanism of Action
Butylphthalide acts through multiple pathways to protect the brain. It improves cerebral microcirculation and blood flow, inhibits platelet aggregation, and protects against ischemic injury. Additionally, it preserves mitochondrial function and reduces oxidative stress and neuronal apoptosis.
4. Safety and Warnings
Hypersensitivity: Patients with a known hypersensitivity to butylphthalide or any components of the formulation should not use this product.
Cardiac and Liver Function: Caution is advised during infusion, as transient bradycardia or mild elevation of liver enzymes (such as ALT and AST) has been observed in clinical trials.
Timing Limitations: The efficacy and safety of initiating treatment more than 48 hours after stroke onset have not been established.
5. Adverse Reactions and Clinical Research
Common Adverse Reactions: Uncommon adverse reactions include dizziness, headache, diarrhea, and fatigue.
Laboratory Abnormalities: Mild elevations in aspartate aminotransferase (AST) and alanine aminotransferase (ALT) have been observed, typically resolving after discontinuation.
Dermatological Reactions: Erythema multiforme drug eruptions have been reported and may be related to the drug.
Clinical Research: Clinical trials have demonstrated that butylphthalide significantly improves neurological function without causing serious adverse events.
6. Drug Interactions
Other Medications: There are no well-documented drug-drug interaction studies for butylphthalide.
Precautions: When used concurrently with other medications, appropriate monitoring is recommended.
7. Pharmaceutical Information
Composition: The active ingredient is butylphthalide. The excipients include sodium chloride, hydroxypropyl-β-cyclodextrin, and water for injection.
Appearance: It is a colorless, clear liquid.
Storage: The product should be stored protected from light.