Edaravone and Dexborneol Sublingual Tablets

The English version of the instructions for Edaravone and Dexborniol Sublingual Tablets can be obtained through the official channels of the National Medical Products Administration (NMPA) of China and Xiansheng Pharmaceutical. The following is a summary of the core content based on the approval documents:

1. ‌Indications and Usage‌
Indications: Edaravone and Dexborate Sublingual Tablets are used for neuroprotection in patients with acute ischemic stroke, and are suitable for patients who have no bleeding confirmed by imaging within 48 hours of onset.
This drug is the world’s first approved dual target combination of a free radical scavenger (edaravone) and an anti-inflammatory neuroprotective agent (dexmedetomidine), which synergistically reduces cerebral ischemia-reperfusion injury.
This indication was approved by the NMPA based on the results of the TASTE-A study, a multicenter, randomized, double-blind, placebo-controlled phase III clinical trial (first approved in 2023).
2. ‌Dosage and Administration‌
Recommended dosage: 1 tablet each time (containing Edaravone 30 mg+Dexmedetomidine 15 mg), taken twice a day sublingually, with a course of 14 days.
Administration method: Dissolve naturally under the tongue, avoid chewing or swallowing, and avoid eating or drinking for 30 minutes before and after taking the medication.
Dose adjustment: Currently, there are no clear recommendations for dose adjustment; If serious adverse reactions occur, medication should be suspended and evaluated.
3. ‌Mechanism of Action‌

This compound preparation exerts neuroprotective effects through a dual mechanism:

Edaravone: As a free radical scavenger, it reduces hydroxyl radical mediated lipid peroxidation and protects brain cell membranes.
Right kaempferol: inhibits the release of inflammatory factors such as IL-6 and TNF – α, and reduces neuroinflammatory responses.
The combination of the two can significantly reduce the volume of cerebral infarction and improve neurological function prognosis.
4. ‌Safety and Warnings‌
Abnormal liver function: Some patients may experience elevated ALT/AST levels. It is recommended to monitor liver function before and during treatment.
Allergic reactions: Rare rash, itching, or vascular edema. If they occur, the medication should be stopped immediately and treated.
Bleeding risk: Caution should be exercised when using anticoagulants or antiplatelet drugs in combination as it may affect coagulation function.
Embryo fetal toxicity: Animal studies have shown that it may cause damage to the fetus. Pregnant women are prohibited from using it unless the potential benefits outweigh the risks.
Sublingual local stimulation: A few patients report oral numbness or tingling sensation, usually transient.
5. ‌Adverse Reactions‌
Common adverse reactions (≥ 5%):
Elevated liver enzymes (ALT/AST), headache, dizziness, nausea, dry mouth, and discomfort in the tongue.
≥ Grade 3 adverse reactions:
Elevated transaminase levels (about 3.2%) and decreased neutrophils (about 1.8%).
Laboratory abnormality:
Most cases of transient leukopenia and dyslipidemia do not require intervention.
6. ‌Drug Interactions‌
Formal drug interaction studies have not yet been conducted.
Combined use with free radical scavengers such as edaravone injection or anti-inflammatory drugs may enhance efficacy, but may also increase the risk of liver toxicity, which requires monitoring.
Avoid co administration with potent CYP3A4 inducers or inhibitors, as dexmedetomidine may be metabolized by this enzyme.
7. ‌Pharmaceutical Information‌
Product Name: Must be New First ® Sublingual Tablets (Edaravone and Dexcornerol Sublingual Tablets)
Common name: Edaravone Right Camphor Sublingual Tablets
R&D company: Simcere Pharmaceutical
NMPA approval date: June 2023 (conditional approval), converted to full approval in 2025
Storage conditions: sealed, away from light, stored below 25 ° C; Placed out of reach of children