Dapagliflozin Tablets 10 mg

Adult dose

For monotherapy and additional combination therapy, take 10 mg once daily. In the case of initial combination therapy, when used with metformin, take either 5 mg once daily or 10 mg once daily. Dosage adjustment guidance is available for special population groups such as those with renal impairment, hepatic impairment, and the elderly, and the method of administration is oral, once daily at any time without regard to food, swallowing the tablet whole.

Child dose

The efficacy and safety of dapagliflozin in children under 18 years have not been established and there is no related data.

This medication is not to be administered to patients with allergies to the active ingredients or excipients of this medication, as well as type 1 diabetes patients or those with diabetic ketoacidosis. Additionally, it contains anhydrous lactose, so it should not be used in patients with genetic disorders such as galactose intolerance, lactase deficiency, or glucose-galactose malabsorption. This medication is also contraindicated in patients undergoing renal dialysis. Caution should be exercised when using this medication in patients with reduced fluid volume or impaired kidney function. This medication may lower blood pressure or cause transient changes in kidney function, increasing the risk of hypotension or acute kidney injury. Particularly, patients with decreased kidney function, the elderly, or those on diuretics require extra caution, and fluid status and kidney function should be closely monitored before and during treatment. During the use of this medication, genital and urinary tract infections may occur. These are more common in women, and patients with a history of previous infections are at higher risk of recurrence, so immediate treatment is necessary if symptoms of infection appear. The risk of hypoglycemia may increase when taken with insulin or sulfonylureas, so caution for hypoglycemic symptoms and dosage adjustments are necessary when combining with these medications. Symptoms of dehydration or hypotension due to decreased fluid volume may occur, so particularly elderly patients or those taking diuretics should closely monitor fluid status. There is a risk of a serious metabolic condition known as diabetic ketoacidosis, so if symptoms of ketoacidosis appear, immediate testing and treatment must be sought, even if blood sugar is not very high. There have been reports of a rare but serious infection known as perineal necrotizing fasciitis, so if symptoms such as pain, redness, swelling, or ulceration occur around the perineum or genital area, immediate consultation with healthcare professionals is necessary. Pregnant or breastfeeding women are advised against using this medication and should discontinue use if pregnancy is confirmed. This medication does not significantly affect driving or operation of machinery; however, caution is needed when combined with medications that pose a hypoglycemic risk. During the use of this medication, regular monitoring of blood pressure, kidney function, blood sugar, and signs of infection should be conducted to ensure safe treatment.

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, shortness of breath or difficulty breathing, asthma attack, respiratory abnormalities accompanied by cough + fever, yellowing of the skin or eyes (jaundice), severe systemic lethargy, sudden and severe headache, lightning headache, seizures, confusion of consciousness, vision changes, paralysis, urination

Mild side effects

Vulvovaginitis, balanitis, related genital infections, urinary tract infections, fungal infections, hypoglycemia, decreased fluid volume, dizziness, constipation, dry mouth, low back pain, dysuria, polyuria, nocturia, genital itching, increased hematocrit, decreased early treatment renal creatinine clearance, dyslipidemia, increased blood creatinine, increased blood urea, weight loss, urticaria, sweating, pruritus, dry mouth, allergic dermatitis, dry skin

This medication may be sensitive to air or moisture, so it must be stored in a tightly closed container. It is advisable to maintain a storage temperature between 1 degree and 30 degrees Celsius to preserve the efficacy of the medication for a longer period.

Appearance

Yellow, biconvex rhomboid film-coated tablets