Dongkuk Dapagliflozin Anhydrous Sugars Mixture Tablet 5 mg

Adult dose

The recommended dosage of this medication for monotherapy and additional combination therapy with insulin or other hypoglycemic agents is 10 mg once daily. In the initial combination therapy with metformin, the initial recommended dosage is either 5 mg once daily or 10 mg once daily. This medication can be taken orally at any time of the day, regardless of meals. 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 is available.

This medication should not be used in patients who have had allergic reactions to active ingredients or excipients. It may be dangerous to administer to patients with type 1 diabetes or diabetic ketoacidosis. This medication contains anhydrous lactose, so it should not be taken by patients with lactose intolerance or certain genetic metabolic disorders. It is also not to be used in patients undergoing dialysis. Caution should be exercised when administering to patients with insufficient fluid volume or reduced kidney function, as there is a risk of blood pressure reduction and kidney damage. Elderly patients or those taking diuretics are at higher risk of hypotension with this medication and require careful monitoring. If there is an allergy to the coloring agents included in this medication, it should be used with caution. The risk of genital infections and urinary tract infections may increase while taking this medication, so immediate treatment is necessary if symptoms occur. There is a risk of hypoglycemia; therefore, dose adjustments may be required when taken with insulin or sulfonylureas. If symptoms of reduced fluid volume occur, immediate consultation with a healthcare professional is advised, and medication should be temporarily discontinued if necessary. Serious metabolic anomalies such as diabetic ketoacidosis may occur, so if symptoms like vomiting, abdominal pain, or difficulty breathing arise, immediate hospital visit is necessary. Elderly patients or those with reduced kidney function should carefully monitor kidney function and blood pressure before and after taking this medication. It is safest to avoid taking this medication during pregnancy or while breastfeeding. In case of overdose, as there are no specific antidotes, appropriate treatment should be administered according to symptoms. This medication does not significantly affect driving or operating machinery, but precautions for the risk of hypoglycemia should be taken. When storing, keep it out of reach of children and store in its original container.

Serious side effects

Diabetic ketoacidosis, acute kidney injury, kidney dysfunction, necrotizing fasciitis (Fournier's gangrene), urosepsis and pyelonephritis, angioedema, anaphylaxis, urticaria, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash accompanied by high fever, blisters, skin peeling, oral/ocular mucosal pain, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities with cough and fever, skin etc.

Mild side effects

Vulvovaginitis, glans inflammation and related genital infections, urinary tract infections, fungal infections, hypoglycemia, reduced fluid volume, dizziness, constipation, dry mouth, lower back pain, dysuria, polyuria, nocturia, elevated serum creatinine, increased blood urea, weight loss, itching, cold sweat, urticaria, gastrointestinal disturbances (indigestion, nausea, diarrhea, vomiting, etc.), urinary retention, edema, headache, cough, dyspnea, palpitations, insomnia, etc.

This medication is sensitive to air and moisture, so it must be stored in a tightly sealed container. The appropriate storage temperature is room temperature between 1 to 30 degrees Celsius, avoiding excessively hot or cold places.

Appearance

Yellow, round, biconvex, film-coated tablets

Package unit

28 tablets/box [(7 tablets/PTP x 4)]