Ilyang Dapagliflozin 5 mg (Dapagliflozin Propanediol Monohydrate)

Adult dose

The recommended dose of this drug for monotherapy and additional combination therapy with insulin or other antihyperglycemic agents is 10 mg once daily. As an initial combination therapy with metformin, the initial recommended dose is 5 mg or 10 mg once daily. This drug can be taken orally at any time of the day, irrespective of food intake, and the tablet should be swallowed whole.

Child dose

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

This drug should not be used in certain patients. In particular, it is contraindicated in patients who are allergic to the active ingredient or excipients, patients with type 1 diabetes, patients with diabetic ketoacidosis, and patients undergoing dialysis. Caution should be exercised when administering this drug to patients with low fluid volume or impaired kidney function. This drug may lower blood pressure or affect kidney function, so fluid status and kidney function should be carefully monitored before and during administration. The blood sugar control effect of this drug varies depending on kidney function. For patients with moderate to severe kidney impairment, the blood sugar control effect may decrease, and it is not recommended for patients with severely reduced kidney function. When using this drug, symptoms of genital infections, urinary tract infections, hypoglycemia, reduced fluid volume, and diabetic ketoacidosis may occur, so symptoms should be carefully monitored. In particular, women or patients with a history of infections may experience genital infections more frequently. Ketoacidosis can occur even when blood sugar is not high, so if symptoms such as vomiting, abdominal pain, fatigue, or difficulty breathing occur, immediate consultation with a healthcare professional is necessary. This drug may interact with other medications; therefore, careful dose adjustments may be needed, especially when used in combination with diuretics, insulin, or sulfonylureas, to reduce the risk of hypoglycemia or dehydration. Pregnant or breastfeeding women should avoid using this drug, and treatment should be discontinued upon confirmation of pregnancy. For children, the safety and efficacy of dapagliflozin have not been established, and therefore it should not be used. In cases of overdose, there is no specific antidote, so it is important to receive appropriate treatment based on symptoms. Patients taking this drug should be aware of the risk of hypoglycemia and symptoms of infection, and consult a doctor immediately if abnormal symptoms occur. Additionally, this drug should be stored out of reach of children and preserved in its original container to maintain quality.

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, paleness, severe rash with high fever, blisters, peeling skin, oral/ocular mucosal pain, difficulty breathing or shortness of breath, asthma attacks, cough with fever-related breathing abnormalities, yellowing of skin or eyes (jaundice), extreme lethargy, sudden and severe headaches, thunderclap headache, seizures, altered consciousness, vision abnormalities, 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 drug is susceptible to air and moisture; therefore, it should be stored in a tightly closed container. Maintaining the storage temperature between 1 to 30 degrees Celsius at room temperature is important.

Appearance

Yellow circular film-coated tablet

Package unit

28 tablets/box [7 tablets/Alu-Alu*4], 28 tablets/bottle