Dapael Tablet 10 mg (Dapagliflozin)

Adult dose

The recommended dosage for this medication is 10 mg once daily for monotherapy and additional combination therapy, and 5 mg or 10 mg once daily for initial combination therapy. It can be taken orally once daily at any time during the day, regardless of food intake. The tablet should be swallowed whole.

Child dose

Safety and efficacy in children under 18 years have not been established, so it is not used in this population.

This medication should not be given to certain patients. First, it should not be used by patients who are allergic to the active ingredient or excipients, those with type 1 diabetes, or those with diabetic ketoacidosis. Additionally, patients with genetic issues such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption should avoid this medication due to the presence of anhydrous lactose. It should also not be used in patients undergoing dialysis. Caution should be exercised when administering to patients with reduced fluid volume or kidney dysfunction. This medication can cause a decrease in blood pressure or temporary changes in kidney function, and the risk may be greater in elderly patients with impaired kidney function or those taking diuretics. Therefore, fluid volume status and kidney function should be assessed before administration, and after administration, symptoms of hypotension and kidney function should be monitored carefully. The blood sugar control effect of this drug may vary depending on kidney function. In patients with moderate renal impairment, its blood sugar control effect may be diminished, and in type 2 diabetes patients with an eGFR below 45 mL/min/1.73 m2, it is not recommended for blood sugar control purposes. Common adverse reactions that may occur while taking this medication include genital infections. These occur more frequently in women, and appropriate treatment is necessary if an infection develops. Other possible symptoms include urinary tract infections, hypoglycemia, reduction in fluid volume, dizziness, constipation, dry mouth, lower back pain, dysuria, polyuria, and nocturia. Diabetic ketoacidosis may occur, so if symptoms of ketoacidosis appear even when blood sugar levels are in the normal range, immediate treatment is required. Symptoms of ketoacidosis include nausea, vomiting, abdominal pain, fatigue, and difficulty breathing, which should be heeded. This medication can cause a decrease in fluid volume, so patients with dehydration symptoms or at risk of hypotension should be cautious. If reduced fluid volume is suspected, administration should be temporarily suspended and status restored. Elderly patients are at higher risk of hypotension due to decreased kidney function or use of antihypertensive agents, so additional caution is necessary. This medication can increase the risk of hypoglycemia when used with Insulin or Sulfonylureas, so dose adjustments may be necessary when used in combination with these medications. Pregnant women should not use this medication, and treatment should be discontinued immediately if pregnancy is confirmed. Additionally, nursing mothers should not take this medication. This medication does not significantly affect driving or machine operation, but caution is required due to the risk of hypoglycemia. Finally, the safety and efficacy of this drug in children have not been established, so it is not used in pediatric patients.

Serious side effects

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

Mild side effects

Vulvovaginitis, balanitis and related genital infections, urinary tract infections, fungal infections, hypoglycemia (when used with sulfonylureas or insulin), reduction in fluid volume, thirst, dizziness, constipation, dry mouth, lower back pain, dysuria, polyuria, nocturia, interstitial nephritis, vulvar itching, genital itching, increased hematocrit, decreased serum creatinine clearance early in treatment, dyslipidemia, increased serum creatinine early in treatment,

This medication can be sensitive to air or moisture, so it must be stored in a tightly closed container. It is best to store it at room temperature between 1 and 30 degrees Celsius. This will help maintain the medication's efficacy over time.

Appearance

Yellow, biconvex, rhomboid film-coated tablet

Package unit

100 tablets/bottle, 8 tablets/box [8 tablets/Alu-Alu x 1]