Dapagliflozin 10 mg (Dapagliflozin Propanediol Hydrate)

Adult dose

The recommended dose of this medication is 10 mg once daily for monotherapy and as an add-on to other blood sugar-lowering agents such as insulin. In the case of initial combination therapy, if there is no prior experience with diabetes medications, the recommended starting dose when co-administered with metformin is either 5 mg or 10 mg once daily. For patients with severe liver impairment, a starting dose of 5 mg is recommended, which may be increased to 10 mg if tolerated well.

Child dose

The safety and efficacy of dapagliflozin in children under 18 years of age have not been established.

This medication should not be used in certain patients. For example, it should not be administered to individuals allergic to the active ingredients or excipients, patients with type 1 diabetes or diabetic ketoacidosis, and those undergoing dialysis. Caution is required when using this medication in patients with reduced fluid volume or renal function issues. This medication can lead to lowered blood pressure or sudden worsening of renal function, so it is essential to assess fluid status and renal function prior to administration, and closely monitor symptoms of hypotension and changes in renal function after administration. The blood sugar control effect of this medication varies according to renal function. In patients with moderately reduced or worse renal function, the blood sugar control effect is diminished, hence it is not recommended for patients with severe renal impairment. During treatment with this medication, genital infections and urinary tract infections may occur, particularly more frequently in women or patients with a history of previous infections. If any signs of infection appear, immediate treatment is necessary. There is a risk of hypoglycemia, so caution is required when taking it together with blood sugar-lowering agents such as insulin or sulfonylureas, and in some cases, the dosages of these medications may need to be adjusted. Dehydration or hypotension symptoms may appear due to reduced fluid volume, so elderly patients or those taking diuretics should carefully check their blood pressure and fluid status. This medication can lead to serious metabolic disturbances called diabetic ketoacidosis. Ketoacidosis can occur even if blood sugar levels are not high, so if symptoms like nausea, vomiting, abdominal pain, or difficulty breathing occur, immediate consultation with healthcare professionals is necessary. There have been rare reports of a serious infection called necrotizing fasciitis of the perineum, so if there is pain, redness, swelling, etc. around the reproductive area, immediate treatment is required. Pregnant or breastfeeding women are advised not to use this medication, and if pregnancy is confirmed, use should be discontinued. In cases of overdose, there is no specific antidote, and appropriate treatment should be administered according to symptoms, as dialysis does not remove this medication. This medication does not significantly affect the ability to drive or operate machinery, but caution is needed due to the risk of hypoglycemia. Finally, the safety and efficacy of this medication have not been established in children, so it is not used among this population.

Serious side effects

Hives, severe swelling (edema), cold sweat, chest tightness, difficulty breathing, diabetic ketoacidosis, necrotizing fasciitis (Fournier's gangrene), acute kidney injury, renal dysfunction, severe rash with fever, blistering, skin peeling, pain in mucous membranes of mouth/eyes, sudden and severe headache, seizures, confusion, vision changes, paralysis, significantly reduced urine output, severe swelling and increased blood pressure, anaphylactic reaction

Mild side effects

Vulvovaginitis, balanitis and related genital infections, urinary tract infections, fungal infections, hypoglycemia, decreased fluid volume, thirst, dizziness, constipation, dry mouth, back pain, dysuria, polyuria, nocturia, interstitial nephritis, vulvar itching, genital itching, increased hematocrit, decreased creatinine clearance at the beginning of treatment, dyslipidemia, increased blood creatinine at the start of treatment, elevated blood urea, weight loss, elevated blood lactate

This medication must be stored in a tightly sealed container to prevent exposure to air or moisture. It is best stored at room temperature, between 1 degree and 30 degrees.

Appearance

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

Package unit

Box - 28 tablets/box [7 tablets/Alu-Alu x 4], bottle - 28 tablets/bottle, bottle - 30 tablets/bottle