Dapagliflozin Propanediol Monohydrate 10 mg

Adult dose

Take 10 mg once daily for monotherapy and additional combination therapy. For initial combination therapy, 5 mg or 10 mg once daily may be taken. Patients with chronic heart failure and chronic kidney disease also take 10 mg once daily. In patients with renal impairment, it is not recommended to administer this medication when eGFR is less than 45 mL/min/1.73m2; for severe liver impairment, a starting dose of 5 mg is recommended. Elderly

Child dose

Efficacy and safety of dapagliflozin in children under 18 years of age have not been established, and there is no relevant data.

This medication should not be used in patients who are allergic to its active ingredient or excipients, or in those with type 1 diabetes or diabetic ketoacidosis. Additionally, it should not be taken by patients with lactose intolerance, specific genetic disorders, or those undergoing dialysis. Use with caution in patients with dehydration or poor kidney function, and blood pressure and kidney function should be closely monitored before and after administration. In patients with moderate to severe reduction in kidney function, the blood sugar control effect may be diminished, so attempting to manage blood sugar with this medication alone is not recommended. During treatment, genital infections and urinary tract infections may occur; immediate treatment is required if symptoms appear. Hypoglycemic symptoms may occur; hence, careful monitoring of blood sugar is necessary, especially when taken with medications such as insulin or sulfonylureas. Symptoms of dehydration or hypotension could present due to decreased fluid volume, and medical consultation is advised if these symptoms occur. There is a risk of developing severe metabolic dysfunction known as diabetic ketoacidosis; if symptoms such as vomiting, abdominal pain, or difficulty breathing occur, immediate medical attention is advised. Caution is required for elderly patients and those on diuretics due to a higher risk of fluid volume depletion. Pregnant or breastfeeding women should avoid using this medication, and if pregnancy is confirmed, it should be discontinued immediately. There is no specific antidote in case of overdose, and treatment should be administered based on symptoms, following medical guidance. This medication does not significantly impact driving or machine operation, but caution is advised in case of hypoglycemia. Finally, this medication should be stored out of reach of children and kept in its original container for safety.

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, skin peeling, pain in oral/ocular mucosa, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by cough + fever, yellowing of the skin or eyes (jaundice), extreme 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
• dry mouth
• dizziness
• constipation
• back pain
• dysuria

This medication should be stored in a tightly closed container, protected from air and moisture. It is important to maintain the storage temperature between 1 and 30 degrees Celsius.

Appearance

Yellow, film-coated, diamond-shaped, biconvex tablets

Package unit

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