Dong-A Dapagliflozin 5 mg (Dapagliflozin Propanediol Hydrate)

Adult dose

The recommended dose for this medication in type 2 diabetes as a monotherapy and as an adjunct therapy is 10mg once daily. For initial combination therapy, if no previous experience with diabetes medication is reported, the combined administration with metformin may be either 5mg once daily or 10mg once daily. In cases of renal impairment, it is not recommended for patients with an eGFR less than 45 mL/min/1.73m2, and this medication should not be administered to patients undergoing dialysis.

Child dose

Safety and efficacy in children under 18 years have not been established and are therefore not recommended.

This medication should not be used in certain patients. For example, it is contraindicated in individuals allergic to the active ingredient or excipients, patients with type 1 diabetes, diabetic ketoacidosis, those with lactose intolerance or associated genetic disorders, and patients undergoing dialysis. This medication should be used with caution in patients with inadequate fluid volume or impaired kidney function. This medication may cause hypotension or worsen kidney function, so it is essential to thoroughly check fluid status and kidney function before and during administration. During treatment with this medication, adverse effects such as genital infections, urinary tract infections, hypoglycemia, reduced fluid volume, and diabetic ketoacidosis may occur. Genital infections are reported to occur more frequently in women, and immediate treatment should be sought if symptoms arise. The blood sugar control effectiveness of this medication can vary depending on kidney function and is not recommended for patients with moderate to severe renal impairment. Pregnant or breastfeeding women should avoid using this medication, and it should be discontinued immediately if pregnancy is confirmed. This medication may interact with other drugs, particularly diuretics, insulin, and sulfonylureas, requiring dose adjustments to minimize the risk of hypoglycemia or dehydration. In the case of overdose, no specific antidote exists, so it is important to receive symptomatic care. Furthermore, while taking this medication, the 1,5-anhydroglucitol test for blood sugar monitoring may not be reliable; alternative methods should be used to determine blood glucose levels. This medication does not significantly affect driving or machine operation abilities; however, caution is advised due to the risk of hypoglycemia when taken with insulin or sulfonylureas. Finally, the safety and effectiveness of this medication have not been established in children, so it should not be administered to pediatric patients.

Serious side effects

Diabetic ketoacidosis, reduced fluid volume (including dehydration, hypovolemia, hypotension), acute kidney injury, renal dysfunction, urinary sepsis and pyelonephritis, perineal necrosis (Fournier's gangrene), anaphylactic reactions, urticaria, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, rash, skin peeling, oral/ocular mucosal pain, shortness of breath, or difficulty breathing, asthma attacks, accompanied by cough and fever

Mild side effects

Vulvovaginitis, balanitis and associated genital infections, urinary tract infections, fungal infections, hypoglycemia, dry mouth, dizziness, constipation, back pain, dysuria, polyuria, nocturia, interstitial nephritis, increased hematocrit, initial treatment-related increase in serum creatinine, dyslipidemia, weight loss, itching, urticaria, cold sweat, weakness, facial edema, chest pain, fatigue, fever, pain, rash, angioedema, orthostatic hypotension, palpitations

This medication may be sensitive to air or moisture, so it should be stored in a tightly sealed container. It is best to keep the storage temperature between 1 to 30 degrees Celsius to maintain the medication's effectiveness.

Appearance

Yellow round film-coated tablets

Package unit

30 tablets/box[(10 tablets/PTP x 3)]