Dapagliflozin 5 mg (Dapagliflozin Bisl-Proline)

Adult dose

The recommended dose for this medication is 10 mg once daily for monotherapy and additional combination therapy with insulin and other glucose-lowering agents. In the case of initial combination therapy, the dose is 5 mg or 10 mg once daily. For chronic heart failure and chronic kidney disease, the dose is 10 mg once daily. In patients with severe liver impairment, a starting dose of 5 mg is recommended, which may be increased to 10 mg if well tolerated. This medication can be taken with or without food.

Child dose

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

This medication should not be administered to certain patients. For example, patients who are allergic to the active ingredient or excipients of this medication, patients with type 1 diabetes, diabetic ketoacidosis patients, patients with lactose intolerance or certain genetic conditions, and patients undergoing dialysis should not use it. Caution is advised when administering this medication to patients with reduced fluid volume or poor kidney function. It can lower blood pressure or affect kidney function, increasing the risk of hypotension, particularly in elderly patients or those taking diuretics. Therefore, careful assessment and monitoring of fluid status and kidney function should be conducted before and after administration. The most common side effects during treatment with this medication may include genital infections. Symptoms such as urinary tract infections, hypoglycemia, decreased fluid volume, dizziness, thirst, constipation, and back pain may also occur. Particularly, severe metabolic abnormalities such as diabetic ketoacidosis may occur; immediately consult healthcare professionals if symptoms such as dehydration, vomiting, abdominal pain, or difficulty breathing appear while taking this medication. This medication may interact with other drugs; caution is required particularly when taken with diuretics, insulin, or sulfonylureas, as the risk of hypoglycemia or dehydration may increase. Pregnant or breastfeeding women are advised not to use this medication, and its safety and efficacy in pediatric patients have not been established. There is no specific antidote for overdose; therefore, it is important to receive appropriate treatment based on the symptoms. While taking this medication, there are no impairments reported for driving or operating machinery, but caution is advised for hypoglycemic symptoms when taken in combination with insulin or sulfonylureas. Finally, this medication should be stored in its original container and kept out of reach of children.

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, skin peeling, pain in the oral/eye mucosa, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by cough+fever, yellowing of skin or eyes (jaundice), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urination

Mild side effects

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

This medication may be sensitive to air and moisture, so it should be stored in a tightly closed container. The storage temperature should be maintained at room temperature between 1 degree and 30 degrees.

Appearance

Yellow, round, biconvex film-coated tablets

Package unit

For domestic use - 30 tablets/bottle