Ilyang Dapagliflozin Tablets 10 mg (Dapagliflozin Monohydrate)

Adult dose

The recommended dose of this medication is 10 mg once a day for monotherapy or additional combination therapy with other blood glucose-lowering agents, including insulin. When using this medication in combination with insulin or insulin secretagogues such as sulfonylureas, lower doses of insulin or insulin secretagogues may be considered to reduce the risk of hypoglycemia. In initial combination therapy, if there is no prior experience with diabetes medication treatment, the initial recommended dose of this medication is 5 mg once a day or 10 mg once a day.

Child dose

The efficacy and safety of dapagliflozin in children under 18 years have not been established. No relevant data are available.

This medication should not be used in patients who have allergies to the active ingredient or excipients, or in patients with type 1 diabetes or diabetic ketoacidosis. Moreover, it is also not safe to administer to patients with lactose intolerance or certain genetic issues, and to those undergoing dialysis. Caution is necessary for patients with reduced fluid volume or renal dysfunction due to the possibility of decreased blood pressure or renal function deterioration. Elderly patients or those taking diuretics should carefully monitor their blood pressure and fluid status, and renal function evaluation is also required. This medication contains specific colorants, so caution should be exercised in patients with allergic reactions to these colorants. During use, there is a risk of increased genital infections or urinary tract infections, so immediate medical attention is required if symptoms occur. Hypoglycemic symptoms may occur; therefore, dosage adjustments may be necessary when used with medications such as insulin or sulfonylureas. If there are signs of dehydration or hypotension due to reduced fluid volume, medication administration should be temporarily stopped and the situation should be restored. Additionally, this medication may increase the risk of diabetic ketoacidosis, so immediate tests and treatment are necessary if related symptoms appear. Elderly patients or those with impaired renal function require special attention and should have regular renal function tests. Use of this medication is not recommended for women who are pregnant or breastfeeding, and if pregnancy is confirmed, drug administration should be discontinued. There is no specific antidote for overdose; therefore, appropriate treatment based on symptoms should be administered, and it is not removed by dialysis. This medication does not significantly affect driving or operating machinery, but caution is needed due to hypoglycemia risks. Finally, safety and efficacy have not been established in children, so it is advisable not to use this medication.

Serious side effects

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

Mild side effects

Vulvovaginitis, balanitis and related genital infections, urinary tract infections, fungal infections, hypoglycemia, reduced fluid volume, dizziness, constipation, dry mouth, low back pain, dysuria, polyuria, nocturia, interstitial nephritis, vulvar itching, genital itching, increased hematocrit, decreased initial renal creatinine clearance, dyslipidemia, rash, angioedema, chest pain, weakness, pain, itching, cold sweat, urticaria, swelling,

This medication is sensitive to air and moisture, so it must be stored in a tightly sealed container. It is advisable to maintain storage temperatures between 1°C and 30°C to preserve the drug's effectiveness and safety.

Appearance

Yellow, double-sided, convex, diamond-shaped film-coated tablets

Package unit

28 tablets/box [14 tablets/PTP×2, 7 tablets/PTP×4]