Dapahelsun Tablet 10 mg (Dapagliflozin Anhydrous Mixture)

Adult dose

The recommended dosage for this drug is 10 mg once daily for monotherapy and as an additional combination therapy with insulin or other antihyperglycemic agents. If administered in combination with metformin for initial combination therapy, the initial recommended dosage is 5 mg once daily or 10 mg once daily. This drug can be taken orally at any time of the day regardless of meals, and the tablet should be swallowed whole.

Child dose

The efficacy and safety of dapagliflozin in children under 18 have not been established. There is no relevant data.

This drug should not be used in patients who have had an allergic reaction to the active ingredient or excipients. It should also not be administered to patients with type 1 diabetes or diabetic ketoacidosis. Moreover, patients with issues related to lactose breakdown, certain genetic disorders, and those on dialysis should not use this drug. It should be administered cautiously to patients with reduced fluid volume or impaired kidney function, as hypotension or changes in kidney function may occur. Patients allergic to the dyes Yellow No. 4 and Yellow No. 5 should also be careful. This drug may increase the risk of genital infections and urinary tract infections, and immediate treatment should be sought if symptoms of infection appear. Because of the risk of hypoglycemia, dosage adjustments may be necessary when used in combination with medications that cause hypoglycemia, such as insulin or sulfonylureas. Symptoms of dehydration or hypotension may occur due to reduced fluid volume, so caution is necessary, particularly for older adults or patients on diuretics. This drug may cause a serious metabolic condition called diabetic ketoacidosis; consult healthcare professionals immediately if related symptoms occur. It is recommended that pregnant or breastfeeding women do not use this drug. The safety and effectiveness of this drug in children or adolescents have not been established, so caution is advised. There is no specific antidote in case of overdose, and appropriate treatment should be provided based on symptoms. This drug does not significantly affect driving or machine operation, but caution should be exercised due to the possibility of hypoglycemic symptoms. This drug must be kept out of the reach of children, and it is safest to store it in its original container.

Serious side effects

Hives, severe swelling (edema), severe allergic reactions, chest pain, severe skin reactions, severe rash with high fever, blisters, skin peeling, pain in mucous membranes of mouth/eyes, shortness of breath or difficulty breathing, asthma attacks, respiratory distress with cough and fever, yellowing of skin or eyes (jaundice), extreme lethargy, liver dysfunction (jaundice), sudden and severe headache, thunderclap headache, seizures, altered consciousness

Mild side effects

Vulvovaginitis, balanitis and related genital infections, urinary tract infection, hypoglycemia (when used with sulfonylureas or insulin), reduced fluid volume, thirst, dizziness, constipation, dry mouth, back pain, dysuria, polyuria, nocturia, interstitial nephritis, vulvar itching, genital itching, elevated hematocrit, decreased creatinine clearance in initial treatment, dyslipidemia, elevated blood creatinine, elevated blood urea,

This drug should be stored in a tightly closed container to avoid exposure to air or moisture, ideally at room temperature between 1 to 30 degrees Celsius. This way, the effectiveness of the drug can be maintained for a longer period.

Appearance

Yellow, convex diamond-shaped film-coated tablet

Package unit

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