Epalrestat is an aldose reductase inhibitor, primarily used to improve subjective symptoms, abnormal vibration sensation, and abnormal heart rate variation associated with diabetic peripheral neuropathy.

What Are the Precautions for Taking Epalrestat?

Target Population Characteristics

This medication is suitable for patients whose glycated hemoglobin (HbA1c) remains at a high level after receiving standardized diabetes treatment, including diet control, exercise therapy, oral hypoglycemic drugs, or insulin therapy.

It is recommended to use HbA1c (NGSP value) ≥ 7.0% or HbA1c (JDS value) ≥ 6.6% as the reference standard for medication use.

Medication Warnings for Special Populations

Pregnant women and women of childbearing potential: Use may be considered only when the clear therapeutic benefits outweigh the potential risks; in principle, its use should be avoided.

Lactating women: The necessity of treatment and the benefits of breastfeeding should be comprehensively considered to decide whether to continue medication or stop breastfeeding. Animal experiments have shown that the drug components can be excreted in breast milk.

Pediatric patients: Currently, there is a lack of clinical research data on patients under 18 years old, so its use in this population is not recommended.

Patients with hepatic or renal impairment: Patients with a history of liver disease should use this medication with caution; patients with severe renal impairment should consider dose reduction or discontinuation under close monitoring.

Standard Administration Regimen

The recommended adult dose is 50 mg each time, three times a day, taken orally before each meal.

Clinicians may appropriately adjust the dose based on factors such as the patient’s age and the severity of symptoms.

Identification of Severe Adverse Reactions

Thrombocytopenia (incidence frequency unknown).

Severe liver damage: Including fulminant hepatitis (incidence frequency unknown), significant increases in AST and ALT (incidence < 0.1%), jaundice (incidence frequency unknown), and liver failure (incidence frequency unknown).

Medication Monitoring for Epalrestat

Baseline Assessment Items

Before treatment, it is necessary to complete the assessment of blood glucose control level, determination of the degree of neuropathy, and baseline testing of liver and kidney function.

Regular Monitoring Plan

Neurological sign examination.

Nerve conduction velocity measurement.

Vibration perception threshold detection.

Autonomic nerve function assessment (e.g., heart rate variability analysis).

Key items for laboratory monitoring: Regular re-examination of liver function (focusing on ALT, AST, γ-GTP, and total bilirubin), blood routine (especially platelet count), and renal function indicators (creatinine, blood urea nitrogen).