Dapagliflozin 10mg (Dapagliflozin)

Adult dose

The recommended dosage of this drug is 10 mg once a day for monotherapy and additional combination therapy with other antihyperglycemic agents such as insulin. For the initial combination therapy with Metformin, the dosage is 5 mg or 10 mg once daily. Dosage adjustment guidelines are recommended for patients with renal impairment, liver impairment, and elderly patients, while a starting dose of 5 mg is recommended for patients with severe liver impairment. This drug can be taken regardless of food intake.

Child dose

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

This drug should not be used in patients who are allergic to the active ingredient or excipients. It should not be administered to patients with type 1 diabetes or diabetic ketoacidosis. It contains anhydrous lactose, so patients with genetic conditions such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption should not use it. This drug should not be administered to patients undergoing dialysis. Patients with decreased fluid volume or impaired kidney function should have their fluid status and kidney function thoroughly evaluated before administration, and after administration, symptoms of hypotension and changes in kidney function should be closely monitored. For patients with moderate to severe kidney function impairment, blood sugar control efficacy may decrease, and it is not recommended for patients with eGFR below 45 mL/min/1.73m² for blood sugar control purposes. This drug may increase the risk of genital infections and urinary tract infections, so treatment should be sought immediately if symptoms of infection occur. There is a risk of hypoglycemia, so dose adjustments may be necessary when taken with insulin or Sulfonylureas. Dehydration and hypotension due to decreased fluid volume may occur, so special caution should be taken, particularly for elderly patients or those on diuretics. Diabetic ketoacidosis may occur, so if metabolic acidosis symptoms arise regardless of blood sugar levels, immediate testing and treatment are required. Elderly patients have a higher risk of changes in kidney function and decreased fluid volume, so careful monitoring is essential. Pregnant or breastfeeding women should not use this drug, and treatment should be discontinued when pregnancy is confirmed. There is no specific antidote for overdose, but appropriate treatment should be received based on symptoms, and it is unknown whether the drug is removed by dialysis. This drug does not significantly affect the ability to drive or operate machinery, but awareness of hypoglycemia symptoms is necessary.

Serious side effects

Urticaria, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, pain in mucous membranes of the mouth/eyes, shortness of breath or difficulty in breathing, asthma attacks, cough with fever accompanied respiratory abnormalities, jaundice indicated by yellowing of the skin or eyes, severe fatigue throughout the body, sudden and severe headache, thunderclap headache, seizure, confusion, visual disturbances, paralysis, urination changes

Mild side effects

• Vulvovaginitis
• balanitis and related genital infections
• urinary tract infection
• fungal infection
• hypoglycemia
• dizziness
• constipation
• dry mouth
• back pain
• dysuria

This drug should be stored in a tightly sealed container to prevent exposure to air and moisture. The storage temperature should be maintained between 1 and 30 degrees Celsius. Proper storage will help maintain the drug's effectiveness for a longer duration.

Appearance

Yellow, double-convex, diamond-shaped film-coated tablet

Package unit

8 tablets/Blister, 100 tablets/Bottle