Dapasel Tablets 10 mg (Dapagliflozin Anhydrous Mixture)

Adult dose

The recommended dosage of this medication for monotherapy and additional combination therapy with insulin or other blood glucose-lowering agents is 10 mg once daily. Initial combination therapy with metformin, if no previous experience with other diabetes medications, is 5 mg once daily or 10 mg once daily. Dose adjustment is needed for patients with renal impairment and liver impairment. This medication can be taken orally at any time of the day, regardless of food intake. The tablet should be swallowed whole.

Child dose

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

This medication should not be used in patients who are allergic to the active ingredients or excipients. It should not be taken by patients with type 1 diabetes or diabetic ketoacidosis. As it contains anhydrous lactose, it should not be administered to patients with lactose intolerance or related genetic disorders. Patients undergoing renal dialysis should also not use this medication. Patients with reduced fluid volume or impaired renal function should use this medication cautiously, and fluid status and kidney function should be carefully monitored before and during administration. As this medication can lower blood pressure, elderly patients with a history of hypotension or those taking diuretics should be cautious. Caution is also needed in patients allergic to Tartrazine (Yellow No. 4) and Yellow No. 5. During treatment, genital infections and urinary tract infections may occur; if symptoms of infection arise, immediate consultation with healthcare providers is necessary. Hyposensitivity symptoms may occur, so dosage adjustment may be necessary when used in combination with insulin or sulfonylureas. Monitor for dehydration or hypotension symptoms due to fluid loss; if symptoms are severe, consider stopping the medication. There is a risk of developing diabetic ketoacidosis, so immediate testing and treatment are needed if related symptoms (nausea, vomiting, abdominal pain, difficulty breathing, etc.) appear. Reduced kidney function may diminish the effectiveness of this medication and pose a risk of worsening renal function, so caution is required. This medication is not recommended for patients with severe liver dysfunction. Pregnant or breastfeeding women should avoid using this medication. There is no specific antidote for overdose, so appropriate treatment should be provided based on symptoms. This medication does not significantly affect the ability to drive or operate machinery; however, caution should be exercised due to the risk of hypoglycemia. The safety and efficacy of this medication in children have not been established. When taken with antihypertensive agents or diuretics, the risk of dehydration or hypotension may increase; consult with healthcare providers. It may affect blood lithium levels, so patients on lithium should regularly check their blood levels. Weight loss may occur during treatment with this medication. Diabetic patients should be vigilant about foot care, as there may be an increased risk of lower limb amputation. Immediately inform healthcare providers if there is pain, swelling, or fever around the perineum.

Serious side effects

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

Mild side effects

Vulvovaginitis, balanitis and related genital infections, urinary tract infections, hypoglycemia, reduced fluid volume, dizziness, constipation, dry mouth, low back pain, dysuria, polyuria, nocturia, interstitial nephritis, vulvar pruritus, genital pruritus, elevated hematocrit, decreased creatinine clearance at the beginning of treatment, dyslipidemia, increased serum creatinine at the beginning of treatment, elevated blood urea, weight loss, rash, angioedema

This medication should be stored in a tightly closed container to protect it from air and moisture. Additionally, it is best to store the medication at a temperature between 1 and 30 degrees Celsius, which is typical room temperature, and not in excessively hot or cold places.

Appearance

Yellow-brown, biconvex, rhomboid film-coated tablets

Package unit

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