Medication info
Epalle (Epalerastat)

Epalle (Epalerastat)

Prescription medicationTablet
Ingredient · strength
Epalrestat›50mg / 1 tablet
Manufacturer / importer
Jungheon Pharmaceutical Co., Ltd.
Appearance
White round film-coated tablet
Packaging
Bottle - 30 tablets/bottle, Bottle - 300 tablets/bottle
Approval status
Active

MFDS item code 202102055 · Notified 2021.03.05

Summary

Main use
Improvement of symptoms of diabetic neuropathy (such as numbness) and abnormalities in vibratory sensation and heart rate variability
Who uses it
Adults
Adult dosage
Adults: 1 tablet (epalrestat 50mg) per dose, 3 times daily before meals. Adjust the dose as appropriate according to age and symptoms.

Ingredients

Manufacturer
Jungheon Pharmaceutical Co., Ltd.

Efficacy & effects

Improvement of symptoms of diabetic neuropathy (such as numbness) and abnormalities in vibratory sensation and heart rate variability

  • Numbness
  • pain
  • abnormal vibration sense
  • abnormal heart rate variability
View approved original text

This medication alleviates subjective symptoms such as numbness and pain that occur due to diabetic peripheral neuropathy. It also helps in improving abnormal vibration sense and heart rate variability issues. It shows positive effects in patients who have difficulty controlling blood sugar, particularly those with high HbA1c levels. Overall, it is used to relieve neurological symptoms and contribute to stabilizing heart function, thereby enhancing the quality of life.

Dosage and Administration

Adult dosage

Adults: 1 tablet (epalrestat 50mg) per dose, 3 times daily before meals. Adjust the dose as appropriate according to age and symptoms.

Precautions

This medication may reduce platelet count, so if symptoms of thrombocytopenia appear, discontinue use immediately. There is a risk of liver abnormalities, so if symptoms such as acute hepatitis, liver dysfunction, jaundice, or liver failure occur, stop taking the drug and seek appropriate treatment. Hypersensitivity reactions such as skin rash, itching, red spots, and blisters may occur, and if these symptoms appear, the drug should be discontinued. Gastrointestinal symptoms such as abdominal pain, nausea, vomiting, diarrhea, loss of appetite, abdominal bloating, constipation, and heartburn may occur, so be attentive to symptoms. It may affect kidney function, potentially leading to decreased urine output, increased frequency of urination, and elevated blood levels of BUN and creatinine, so regular monitoring is necessary. Anemia or leukopenia may be noted in blood tests, so consult with a doctor in case of unusual symptoms. Other symptoms that may appear include fatigue, dizziness, headache, muscle stiffness, weakness, limb pain, chest discomfort, palpitations, edema, facial flushing, sensory abnormalities, hair loss, petechial skin bleeding, and fever, so observe the body's condition closely. When treating diabetes, it should be used alongside dietary control, exercise, other hypoglycemic agents, and insulin therapy, and it is recommended for patients with HbA1c levels above 7.0%. Its effectiveness in diabetic peripheral neuropathy patients is not clearly established, so caution is required. During medication, carefully monitor for changes in condition, and if no effects are observed after 12 weeks of use, consider changing to alternative treatment methods. Women who are pregnant or may become pregnant should take this medication only if the benefits outweigh the risks, as safety during pregnancy has not been established. Breastfeeding should be avoided during the use of this drug, as animal studies have confirmed transmission of the medication through breast milk. Safety in children has not been established, so use is not recommended.

Side effects

  • Thrombocytopenia
  • acute hepatitis
  • liver dysfunction
  • jaundice
  • liver failure
  • rash
  • pruritus
  • erythema
  • vesicles
  • elevated AST (GOT)
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  • elevated ALT (GPT)
  • elevated γ-GTP
  • elevated bilirubin
  • abdominal pain
  • nausea
  • vomiting
  • diarrhea
  • loss of appetite
  • abdominal distension
  • constipation
  • heartburn
  • elevated BUN
  • elevated creatinine
  • decreased urine output
  • frequency of urination
  • anemia
  • leukopenia
  • malaise
  • dizziness
  • headache
  • rigidity
  • weakness
  • limb pain
  • chest discomfort
  • palpitations
  • edema
  • flushing
  • tingling
  • hair loss
  • purpura
  • elevated creatine kinase
  • fever

Not everyone experiences these, and they can vary from person to person.

Storage

This medication should be stored in a tightly closed container to avoid exposure to air or moisture, and it is safe to store at room temperature between 1 to 30 degrees Celsius.

Appearance and packaging

Appearance

White round film-coated tablet

Package unit

Bottle - 30 tablets/bottle, Bottle - 300 tablets/bottle

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

Questions about this medicine

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.