Dapagliflozin Tablet 10 mg (Dapagliflozin Propanediol Hydrate)

Adult dose

The recommended dosage of this medication is 10 mg once daily for monotherapy and add-on therapy. For initial add-on therapy, it is 5 mg or 10 mg once daily. For patients with chronic heart failure and chronic kidney disease, the dose is 10 mg once daily. It can be taken orally at any time of the day without regard to meals and should be swallowed whole.

Child dose

The efficacy and safety of dapagliflozin in children under 18 years of age have not been established.

This medication should not be used in patients with allergies to the active ingredient or excipients. It is also not recommended for patients with type 1 diabetes or diabetic ketoacidosis. Containing lactose anhydrous, it should not be used in patients with lactose intolerance or certain genetic metabolic disorders. This medication should not be administered to patients undergoing dialysis. It should be administered with caution in patients who are dehydrated or have impaired kidney function due to the risk of blood pressure reduction or kidney damage; regular monitoring of their condition is necessary. Particularly in elderly patients or those on diuretics, special caution is needed due to a higher risk of fluid loss and hypotension. The glycemic control effect may vary according to renal function, and it is not recommended for patients with severely impaired kidney function. During the use of this medication, there may be an increased risk of genital infections and urinary tract infections, and immediate treatment should be sought if symptoms appear. There is a risk of hypoglycemia; thus, dose adjustments may be necessary when used in conjunction with insulin or sulfonylureas which can induce hypoglycemia. This medication can cause dehydration or hypotension due to reduced fluid volume, so it should be temporarily discontinued and consulted with a physician if dehydration symptoms occur. Diabetic ketoacidosis may rarely occur, so immediate medical attention should be sought if symptoms such as nausea, vomiting, abdominal pain, or difficulty breathing arise. Serious infections such as necrotizing fasciitis have been reported rarely, and immediate medical care should be sought if there is pain, redness, or swelling around the genital area. Pregnant women or those planning to become pregnant should not take this medication, and breastfeeding women should also avoid it. There are no specific antidotes for overdose, and appropriate treatment should be administered based on symptoms, following physician instructions. This medication does not significantly affect driving or machine operation abilities, but caution is required when taken with other medications that may induce hypoglycemia. The safety and efficacy in children have not been established, and it is recommended not to use it for this age group. When storing this medication, keep it out of reach of children and in its original container.

Serious side effects

• Urticaria, severe swelling (edema), cold sweat → severe allergic reaction
• Severe rash with high fever, blisters, skin peeling, pain in oral/ocular mucosa → severe skin adverse reactions
• Shortness of breath or difficulty breathing, asthma attacks, respiratory issues accompanied by cough + fever → respiratory problems
• Yellowing of the skin or eyes (jaundice), severe lethargy → liver issues (jaundice)
• Sudden and very severe headache, thunderclap headache, seizures,

Mild side effects

Vulvovaginitis, balanitis and related genital infections, urinary tract infections, hypoglycemia, thirst, dizziness, constipation, dry mouth, lumbago, dysuria, polyuria, nocturia, renal tubular inflammation, vulvar itching, genital itching, elevated hematocrit, initial decrease in renal creatinine clearance, dyslipidemia, initial increase in blood creatinine levels, increased blood urea, weight loss, urticaria, cold sweat, dermatitis, dry skin, excessive

This medication may be sensitive to air or moisture, so it must be stored in a tightly sealed container. It is also safe to store at room temperatures between 1 and 30 degrees Celsius, avoiding excessively hot or cold places.

Appearance

Yellow, film-coated tablet with a two-sided convex diamond shape

Package unit

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