Epastat 50-MG Tablet

Epastat tablet is indicated for the improvement of subjective symptoms (numbness and pain), abnormality of vibration sense and abnormal change in heartbeat associated with diabetic peripheral neuropathy (when high glycohemoglobin value is noted).

Epalrestat specifically inhibits aldose reductase and accumulation of sorbitol in the nerve; thereby improves subjective symptoms and nerve dysfunction in patients with diabetic peripheral neuropathy.

The usual adult dose is 1 tablet (50 mg) three times daily before each meal. The dosage may be adjusted according to the patient’s age and symptoms.

There are no known drug interactions and none well documented.

The drug is contraindicated for patients with known hypersensitivity to epalrestat.

Major adverse reactions are hepatic function abnormalities and thrombocytopenia. In cases of hepatic abnormalities drug should be discontinued immediately and appropriate measures should be taken. Other reactions may be malaise, headache, abdominal pain, nausea, hypersensitivity reaction etc.

The safety of epalrestat in pregnant women has not been established. The drug may be used in pregnant women or in women who may possibly be pregnant only if expected therapeutic benefits outweigh the possible risks associated with the treatment. Breast-feeding should be avoided during administration of epalrestat.

The administration of Epastat should be considered to patients showing high glycohemoglobin values even after fundamental therapies for diabetes mellitus such as diet therapy, exercise therapy and treatment with an oral hypoglycemic agent, insulin etc. The efficacy of Epastat has not been established in patients with diabetic peripheral neuropathy with irreversible organic changes. The patient should be carefully monitored during the administration of Epastat. When the efficacy of Epastat is not observed even after 12 weeks of administration, other appropriate therapies should be taken.

Aldose reductase inhibitor

Do not store above 30°C temperature. Keep away from light and wet place. Keep out of reach of children.