Enpidapa Tablet 10mg (Dapagliflozin Propanediol Hydrate)

Adult dose

The recommended dosage for this medication is 10mg once daily for monotherapy and as an adjunct to other hypoglycemic agents, including insulin. In the case of initial combination therapy with metformin when there is no prior experience with diabetes medications, the dosage is 5mg or 10mg once daily. Dosage adjustments may be necessary based on renal impairment, liver impairment, or elderly patients, but generally, the administration is 10mg once daily.

Child dose

The safety and efficacy of dapagliflozin in children under 18 years of age have not been established. There are no related data.

This medication should not be administered to certain patients. For example, individuals allergic to the main ingredient or excipients of this medication, patients with type 1 diabetes or diabetic ketoacidosis, and patients with lactose intolerance or related genetic disorders should not use this medication. Additionally, patients undergoing dialysis should not take this medication. Patients with reduced fluid volume or kidney function issues should use this medication cautiously. This medication may cause blood pressure reduction or worsen kidney function, so patients, especially the elderly or those taking diuretics, require assessment and continuous monitoring by a physician. For patients with significantly impaired kidney function, blood sugar control effects may be diminished, which is not recommended. While taking this medication, various side effects may occur. The most common side effect is genital infection, which may occur more frequently in women. Additionally, reports of hypoglycemia, fluid volume reduction, diabetic ketoacidosis, urinary tract infections, and changes in kidney function have been documented. If abnormal symptoms appear, immediate consultation with healthcare providers is necessary. In particular, ketoacidosis may occur even if blood sugar levels are not high, so if symptoms such as nausea, vomiting, abdominal pain, or difficulty breathing occur, rapid examination and treatment are required. Moreover, if pain, swelling, or redness occurs around the perineum, immediate treatment is necessary due to the possibility of serious perineal necrosis. This medication may increase the risk of hypoglycemia when used with hypoglycemic drugs such as insulin or sulfonylureas, so dose adjustments for these drugs may be necessary. Additionally, combining with diuretics may elevate the risk of dehydration or hypotension, necessitating caution. Pregnant or nursing women are advised not to use this medication, and if pregnancy is confirmed, the use should be discontinued immediately. The safety for children has not been established. There is no specific antidote for overdose; therefore, appropriate treatment should be given based on symptoms, and it is not known whether dialysis is effective in removing this medication from the body. Finally, this medication does not significantly affect driving or machine operation abilities, but caution is necessary when there is a risk of hypoglycemia. The medication should be kept out of the reach of children and stored in its original container.

Serious side effects

Rash, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, peeling skin, pain in oral/ocular mucosa, shortness of breath or difficulty breathing, asthma attack, respiratory issues accompanied by cough and fever, jaundice (yellowing of the skin or eyes), significant lethargy, sudden and severe headache, thunderclap headache, seizures, confusion of consciousness, visual disturbances, paralysis, urination

Mild side effects

Vulvovaginitis, balanitis and related genital infections, urinary tract infections, fungal infections, hypoglycemia (when used with sulfonylureas or insulin), dry mouth, dizziness, constipation, back pain, dysuria, polyuria, nocturia, increased hematocrit, elevated serum creatinine at the start of treatment, dyslipidemia, weight loss, rash, cold sweat, itching, chest pain, weakness, fatigue, pain, swelling, foreign body sensation, facial swelling,

This medication should be stored in a tightly closed container to protect it from air and moisture. Additionally, avoid storing it in too hot or too cold environments, ideally at room temperature between 1°C and 30°C.

Appearance

Yellow, biconvex, diamond-shaped film-coated tablet

Package unit

28 tablets/box [14 tablets/PTP×2]