Epalrestat is a drug specifically used to improve neuropathy caused by diabetes. It works through a unique mechanism— inhibiting aldose reductase—to reduce the abnormal accumulation of sorbitol in nerve tissue, thereby helping to alleviate symptoms related to diabetic peripheral neuropathy. Since its launch in Japan in 1992, it has become one of the important drugs in the management of diabetic complications.
What Are the Indications of Epalrestat?
Main Indications
The main application field of Epalrestat is very clear, focusing on the improvement of diabetic peripheral neuropathy.
This drug is intended to improve the following problems caused by diabetic neuropathy:
Subjective symptoms: Including numbness and pain in the extremities.
Neurological dysfunction: Such as abnormal vibration sensation.
Autonomic nerve dysfunction: Manifested as abnormal heart rate variability.
Key Prerequisites for Eligible Patients
It is worth noting that the use of Epalrestat has clear screening criteria, and not all patients with diabetic neuropathy are eligible for it.
It should only be considered for patients whose glycated hemoglobin (HbA1c) remains poorly controlled after strict implementation of dietary control, exercise therapy, and basic treatments such as oral hypoglycemic drugs or insulin.
Specifically, the target population for administration usually refers to patients with a glycated hemoglobin level (NGSP value) of ≥7.0% (or JDS value of ≥6.6%).
Its efficacy has not been established in patients with irreversible organic neurological damage.
Specifications and Characteristics of Epalrestat
Preparation Specifications
Drug name: Kinedak Tablets 50mg.
Active ingredient: Each tablet contains 50mg of Epalrestat.
Added excipients: Including D-mannitol, hydroxypropyl cellulose, croscarmellose calcium, magnesium stearate, etc., to ensure the tablet’s formation, stability, and disintegration.
Preparation Characteristics
Dosage form and color: This product is a white film-coated tablet; after removing the coating, it appears yellow to orange.
Size and weight: The tablet has a diameter of approximately 6.7mm, a thickness of approximately 3.9mm, and a weight of approximately 120mg per tablet.
Identification code: The tablet is engraved with the identification code "NF611", which is an important feature for identifying this drug.
Storage Methods for Epalrestat
Storage Conditions
This product should be stored at room temperature.
It is necessary to avoid moisture, high temperatures, and direct sunlight; for example, it should not be placed in a bathroom or car.
Expiration Period
The expiration period of this drug is 3 years from the date of manufacture.
Be sure to check the expiration date on the packaging before use; do not use it after expiration.
Special Warning (Attention During Drug Delivery)
This product is usually packaged in PTP (Press-Through Package) aluminum-plastic blisters.
To ensure medication safety, patients must be instructed to press the tablets out of the PTP aluminum foil sheet before taking them; swallowing the entire PTP sheet directly is strictly prohibited.
Accidental ingestion of the hard PTP sheet may cause its sharp edges to pierce the esophageal mucosa, and even lead to serious complications such as perforation and mediastinitis.
