Dapasel Tablet 5mg (Dapagliflozin Anhydrous Mixture)

Adult dose

The recommended dose for adults is 10mg once daily, either as monotherapy or as an add-on therapy. In the case of initial combination therapy, it can be taken in a dose of either 5mg or 10mg once daily with metformin. This medication can be administered orally at any time of the day, regardless of food intake. The tablets should be swallowed whole.

Child dose

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

This medication should not be used in patients with allergies to its active ingredients or excipients. It should not be administered to patients with type 1 diabetes or diabetic ketoacidosis. Patients with lactose intolerance should not use this medication due to the presence of lactose anhydrous. Patients undergoing dialysis should not take this medication. Patients with reduced fluid volume or compromised kidney function should use this medication cautiously, and renal function and blood pressure should be closely monitored before and after administration. Caution is especially needed for elderly patients or those on diuretics, as they are at higher risk for hypotension or volume depletion. This medication contains certain dyes, so patients with allergies to these components should take it cautiously. This medication may cause genital infections or urinary tract infections; if symptoms occur, seek immediate treatment. There is a risk of hypoglycemia, so when used in conjunction with insulin or sulfonylurea medications, dosage adjustments may be necessary. Dehydration or hypotensive symptoms may arise due to reduced fluid volume, so adequate fluid intake and monitoring of condition are essential. Diabetic ketoacidosis may occur, so if symptoms such as nausea, vomiting, abdominal pain, or breathing difficulties arise, consult a healthcare professional immediately. This medication may affect kidney function; therefore, patients with reduced renal function require regular check-ups. Serious infections like perineal necrosis have been rarely reported, so if there is pain or abnormal symptoms in that area, seek immediate treatment. Pregnant women or those planning to become pregnant should avoid this medication, and breastfeeding women should also not take it. The safety of this medication has not been established in pediatric patients; thus, it should not be used in children. In case of overdose, there is no specific antidote, and appropriate treatment should be based on symptoms, with attention paid to dehydration or hypotensive symptoms. This medication does not significantly impact driving or operating machinery but caution is needed as hypoglycemic symptoms may occur. When storing, keep it out of reach of children and store in its original container to maintain quality.

Serious side effects

• Diabetic ketoacidosis
• acute kidney injury and renal impairment
• perineal necrosis (Fournier's gangrene)
• angioedema
• urosepsis and pyelonephritis

Mild side effects

Vulvovaginitis, balanitis and related genital infections, urinary tract infections, fungal infections, hypoglycemia (when used with sulfonylureas or insulin), volume depletion, thirst, dizziness, constipation, dry mouth, low back pain, dysuria, polyuria, nocturia, genital itching, increased blood creatinine, increased blood urea, weight loss, dyslipidemia

This medication should be stored in a tightly closed container to prevent exposure to air and moisture. It is recommended to store at room temperature between 1 degree and 30 degrees. This storage method will safely maintain the medication's efficacy.

Appearance

Yellow, biconvex, round film-coated tablet

Package unit

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