TruDa Tablet 5 mg (Dapagliflozin bis L-Proline)

Adult dose

The recommended dose for this medication is 10 mg once daily. This medication can be taken orally once daily at any time during the day, regardless of food intake. The tablet should be swallowed whole.

Child dose

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

This medication should not be used in patients with allergies to the active ingredient or excipients. It should not be administered to patients with type 1 diabetes or diabetic ketoacidosis. Because this drug contains anhydrous lactose, it should not be used in patients with lactose intolerance or certain genetic metabolic disorders. Patients undergoing dialysis should also not be given this medication. Patients with reduced fluid volume or kidney function issues should use this drug with caution, and fluid status and kidney function should be closely monitored before and after administration. In patients with moderate to severe renal impairment, the blood sugar control effect of this drug may be reduced, and it is not recommended for patients with severe renal impairment. During treatment with this medication, genital infections and urinary tract infections may occur, so immediate treatment should be sought if infection symptoms appear. There is a risk of hypoglycemia, so dose adjustments may be needed when used with medications that may induce hypoglycemia, such as insulin or sulfonylureas. Fluid volume reduction or symptoms of hypotension may occur, so caution is required, particularly in elderly patients or those on diuretics. This medication may increase the risk of diabetic ketoacidosis; therefore, immediate consultation with healthcare professionals should be sought if symptoms or signs of ketoacidosis appear. Pregnant or breastfeeding women are advised not to use this medication, and if pregnancy is confirmed, use should be discontinued. Safety and efficacy in children have not been established, and it should not be used in pediatric patients. In cases of overdose, there is no specific antidote; appropriate treatment should be given based on symptoms, and hospital management may be required as necessary. This medication does not significantly affect driving or machine operation, but caution is needed when there is a risk of hypoglycemia. The product should be kept out of the reach of children and stored in its original container to maintain quality.

Serious side effects

Decreased fluid volume (including dehydration, hypovolemia, hypotension), diabetic ketoacidosis, perineal necrosis (Fournier's gangrene), urosepsis and pyelonephritis, acute kidney injury and renal impairment, anaphylactic reactions, urticaria, angioedema, severe rashes with fever, blisters, skin peeling, pain in oral/ocular mucosa, chest tightness, difficulty breathing, cold sweat, pallor, severe allergic reactions, acute pancreatitis, severe liver abnormalities

Mild side effects

Vulvovaginitis, balanitis and related genital infections, urinary tract infection, hypoglycemia, dizziness, constipation, dry mouth, back pain, dysuria, polyuria, nocturia, increased hematocrit, initial treatment decrease in renal creatinine clearance, dyslipidemia, initial treatment increase in serum creatinine, elevated blood urea, weight loss, dyspepsia, nausea, diarrhea, vomiting, weakness, chest pain, fatigue, chest discomfort, pain, peripheral edema, generalized edema

This medication must be stored in a tightly closed container to prevent exposure to air or moisture. It is important to maintain a storage temperature between 1°C and 30°C at room temperature.

Appearance

A yellow, biconvex, round film-coated tablet

Package unit

30 tablets/bottle