Epalrestat is an aldose reductase inhibitor that holds an important position in the treatment of diabetic complications. Since its first approval in Japan in 1992, it has become one of the key medications for the management of diabetic peripheral neuropathy, thanks to its unique mechanism of action and proven clinical efficacy.

What Are the Indications of Epalrestat?

Primary Therapeutic Indications

Epalrestat is specifically indicated for the treatment of diabetic peripheral neuropathy.

It works by selectively inhibiting aldose reductase, reducing the abnormal accumulation of sorbitol in nerve cells, thereby improving nerve conduction velocity and alleviating the symptoms of neuropathy.

Patient Eligibility Criteria

This medication is intended for patients with diabetic peripheral neuropathy whose glycated hemoglobin (HbA1c) levels remain persistently elevated (HbA1c ≥ 7.0%, JDS value ≥ 6.6%) despite systematic treatment, including dietary control, exercise therapy, oral hypoglycemic agents, or insulin therapy.

This strict eligibility standard ensures that the medication exerts its optimal efficacy in the most appropriate patient population.

Contraindications and Limitations

It is important to note that Epalrestat is not indicated for diabetic patients who have already developed irreversible organic lesions.

The therapeutic efficacy of the medication in such patients has not been established, and extreme caution is required when considering its clinical use.

Properties and Identification Features of Epalrestat

Appearance and Physical Properties

Epalrestat tablets are white film-coated tablets with standardized physical specifications: 6.7 mm in diameter, 3.9 mm in thickness, and approximately 120 mg in weight per tablet.

This uniform specification design facilitates patient identification and medication management.

Product Identification Marking

Each tablet is engraved with the identification code "NF611". This unique marking helps healthcare professionals and patients accurately identify the medication during administration, reducing the risk of accidental ingestion of incorrect drugs.

Storage Conditions for Epalrestat

Basic Storage Requirements

Epalrestat should be stored at room temperature, protected from high temperatures, moisture, and direct sunlight.

Appropriate storage conditions are crucial for maintaining the stability of the medication and ensuring its therapeutic efficacy.

Shelf Life Management

The shelf life of this medication is 36 months.

Before using the medication, patients should carefully check the production date and expiration date on the drug packaging to ensure use within the valid period.

Precautions for Packaging Use

The medication is packaged in PTP (Press-Through Package) aluminum foil. When administering, the tablets must be removed from the packaging before taking.

Swallowing the aluminum foil blister directly is strictly prohibited, as its rigid sharp edges may damage the esophageal mucosa. In severe cases, this could lead to serious consequences such as esophageal perforation and concurrent mediastinitis.