Dafos 10 mg (Dapagliflozin Propanediol Monohydrate)

Adult dose

The recommended dose of this medication is 10 mg once daily. In initial combination therapy, the dose is 5 mg or 10 mg once daily. Regardless of food intake, it can be administered orally once a day at any time of the day, and 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.

This medication should not be used in specific patients. For example, patients allergic to the active ingredient or excipients, patients with type 1 diabetes, patients with diabetic ketoacidosis, patients with lactose intolerance or related genetic disorders, and patients undergoing dialysis should not receive this medication. This drug should be used cautiously in patients with reduced fluid volume or renal impairment. This medication can lower blood pressure or affect renal function, so fluid status and renal function must be evaluated before administration, and hypotensive symptoms and changes in renal function should be carefully monitored during treatment. In clinical trials, patients taking this medication reported side effects such as genital infections, urinary tract infections, hypoglycemia, fluid volume depletion, and diabetic ketoacidosis. Particularly, genital infections may occur more frequently in females and in patients with a history of past infections. The blood sugar control effect of this medication varies depending on renal function, and in patients with moderate or severe renal impairment, the effect on blood sugar control may be reduced. Additionally, upon initial administration, serum creatinine levels may temporarily increase, necessitating attention. During this medication period, there is a risk of diabetic ketoacidosis; if symptoms such as dehydration, vomiting, abdominal pain, and respiratory distress occur, the patient should immediately consult medical personnel. Moreover, this medication may increase the risk of serious urinary tract infections such as urinary tract infections and pyelonephritis, thus prompt treatment is necessary if infection symptoms are present. Elderly patients or those taking diuretics should be especially cautious due to a higher risk of fluid volume depletion and hypotension. When co-administering this medication with hypoglycemic agents such as insulin or sulfonylureas, the risk of hypoglycemia may increase, therefore attention to hypoglycemic symptoms is recommended, and dose adjustment of concomitant medications may be necessary. It is recommended that women who are pregnant or breastfeeding do not use this medication, and if pregnancy is confirmed, administration should be immediately discontinued. There is no specific antidote for overdose; appropriate symptomatic treatment should be conducted based on the patient's condition. This medication does not significantly affect the ability to drive or operate machinery, but caution is needed due to the risk of hypoglycemia.

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, paleness, severe rash with fever, blisters, skin peeling, oral/ocular mucosal pain, shortness of breath or difficulty breathing, asthmatic attack, respiratory abnormalities accompanied by cough + fever, yellowing of the skin or eyes (jaundice), extreme lethargy, sudden and very severe headache, lightning-like headache, seizures, altered consciousness, visual disturbances, paralysis, urination

Mild side effects

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

This medication must be stored in a tightly closed container to avoid exposure to air or moisture, and it is safe to store at room temperature between 1 to 30 degrees Celsius.

Appearance

Yellow, convex, diamond-shaped film-coated tablet

Package unit

28 tablets/bottle, 30 tablets/bottle, 30 tablets/box [10 tablets/PTP x 3]