Dapagliflozin Propanediol Monohydrate 10 mg Tablet

Adult dose

The recommended dosage of this medication is 10 mg once a day for monotherapy and adjunctive therapy. In initial combination therapy, 5 mg or 10 mg once daily is administered. For patients with chronic heart failure and chronic kidney disease, the recommended dosage is also 10 mg once daily. In patients with liver impairment, starting with 5 mg in severe cases is recommended, and if tolerated well, it may be increased to 10 mg. The administration can occur once daily, regardless of food intake.

Child dose

The safety and efficacy of dapagliflozin have not been established in children under 18 years of age, and there are no dosing data available.

This medication should not be administered to specific patients. For example, patients with allergies to any ingredients or excipients of this medication, patients with type 1 diabetes, diabetic ketoacidosis, lactose intolerance, and those undergoing dialysis should not take this medication. Use this medication with caution in patients with decreased fluid volume or poor kidney function. Since this medication can lower blood pressure or affect kidney function, the condition should be closely monitored before and after administration. While taking this medication, side effects such as genital infections, urinary tract infections, hypoglycemia, decreased fluid volume, and diabetic ketoacidosis may occur, and symptoms should be discussed with a healthcare professional immediately upon onset. Particularly, elderly patients or those with reduced kidney function are at higher risk of side effects and should be monitored more closely. Pregnant or breastfeeding women are advised not to use this medication, and usage should be discontinued upon confirmation of pregnancy. When used with insulin or sulfonylureas, the risk of hypoglycemia may increase, necessitating dosage adjustments of these medications. There are no specific antidotes for overdose, and treatment should be based on symptoms. It is unclear whether dialysis can remove this medication. This medication does not significantly affect driving or operation of machinery, but caution should be taken due to the risk of hypoglycemia. Finally, safety and efficacy have not been established in children, and the medication should be kept out of reach of children.

Serious side effects

Hives, angioedema, severe swelling (edema), severe allergic reactions, ketoacidosis, diabetic ketoacidosis, urinary sepsis, pyelonephritis, acute kidney injury, kidney function impairment, perineal necrosis (Fournier's gangrene), severe skin reactions, rash, severe rash with high fever, blisters, skin shedding, pain in oral/ocular mucosa, shortness of breath, difficulty breathing, asthma attacks, respiratory abnormalities accompanying cough and fever, skin or eye

Mild side effects

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

This medication should be stored in a tightly closed container to protect it from air and moisture, preferably at room temperature between 1 and 30 degrees Celsius. Storing it this way will safely maintain the effectiveness of the medication.

Appearance

Yellow, biconvex diamond-shaped film-coated tablet

Package unit

PTP - 28 tablets/box [(28 tablets (7 tablets/PTP x 4))], bottle - 30 tablets/bottle