Dapagaregn 10 mg (Dapagliflozin Propanediol Hydrate)

Adult dose

The recommended dosage for this medication is 10 mg once daily for monotherapy and add-on therapy. For initial combination therapy, 5 mg or 10 mg is administered once daily. Separate dosage adjustment guidelines are available for renal impairment, liver impairment, and elderly patients. This medication can be taken orally at any time of day, regardless of meals, and should be swallowed whole.

Child dose

Efficacy and safety for children under 18 years have not been established, and it is not recommended for use.

This medication should not be used by individuals allergic to the active ingredient or excipients. It should not be administered to patients with type 1 diabetes or diabetic ketoacidosis. Individuals with hereditary lactose intolerance or related diseases should also not take this medication. Patients undergoing dialysis treatment should not use this medication. Caution is needed when using this in patients with low fluid volume or impaired renal function, as there is a risk of hypotension or kidney damage, and the status should be closely monitored before and after administration. This medication is not recommended for patients with significantly decreased kidney function for blood sugar control purposes. When taking this medication, side effects such as genital infections, urinary tract infections, hypoglycemia, decreased fluid volume, and ketoacidosis may occur, and immediate consultation with a doctor is required if symptoms appear. Genital infections are more common in women, and those with a history of past infections are at a higher risk of recurrence. Hypoglycemia may occur more frequently when used together with medications like insulin or sulfonylureas, so caution is needed. If symptoms of decreased fluid volume or hypotension occur, temporary discontinuation of this medication may be considered. Diabetic ketoacidosis can occur even with normal blood sugar levels, so any symptoms like nausea, vomiting, abdominal pain, or difficulty breathing should lead to immediate testing. This medication is not recommended for patients with severely impaired liver function. Elderly patients or those on diuretics should be cautious due to a higher risk of decreased fluid volume and hypotension. While taking this medication, glucose may be detected in urine tests, so please be aware of this. If used with insulin or insulin secretagogues, dose adjustments may be necessary to minimize the risk of hypoglycemia. This medication is not recommended for pregnant or breastfeeding women and should be discontinued if pregnancy is confirmed. Safety and efficacy in children have not yet been established. There is no specific antidote in case of overdose, and appropriate treatment should be provided according to symptoms. This medication does not significantly affect driving or operating machinery, but caution should be exercised for hypoglycemic symptoms when taken with insulin or sulfonylurea.

Serious side effects

Perineal necrosis, diabetic ketoacidosis, acute kidney injury, urosepsis, pyelonephritis, severe swelling and blood pressure increase with urinary disturbances, anaphylaxis, rash, severe swelling, chest tightness, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, skin peeling, oral/ocular mucosal pain, shortness of breath or difficulty breathing, asthma attacks, respiratory difficulty accompanied by cough and fever, skin or

Mild side effects

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

This medication should be stored in a tightly closed container to protect it from air and moisture. It is best to keep the storage temperature between 1 degree and 30 degrees Celsius.

Appearance

Yellow, biconvex, diamond-shaped film-coated tablet

Package unit

28 tablets/box [(7 tablets/PTP X 4)], 90 tablets/bottle, 30 tablets/bottle, 100 tablets/bottle