Dongkuk Dapagliflozin Anhydrous Mixture Tablet 10 mg

Adult dose

The recommended dose of this medication is 10 mg once daily, and it can be taken orally at any time of the day regardless of food intake. The tablet should be swallowed whole. For initial combination therapy, 5 mg or 10 mg is administered once daily. Patients with renal impairment may not be recommended for administration or may have restrictions, and for patients with severe liver impairment, a starting dose of 5 mg is recommended.

Child dose

Efficacy and safety in children under 18 years have not been established, thus it should not be administered.

This medication should not be used in patients with allergies to the active ingredient or excipients, or in patients with type 1 diabetes or diabetic ketoacidosis. Additionally, it contains lactose anhydrous and should not be administered to patients with genetic issues such as galactose intolerance, lactose deficiency, or glucose-galactose malabsorption. Patients undergoing dialysis should also avoid this medication. Patients with reduced fluid volume or impaired renal function must have their fluid volume and renal function evaluated prior to administration, and should be carefully monitored for symptoms of hypotension and changes in renal function after administration. In particular, caution is needed in patients with moderate to severe renal impairment, as the effect of blood glucose control may decrease. This medication contains Yellow No. 4 and Yellow No. 5, and caution should be exercised in patients with allergies to these components. During treatment with this medication, genital infections and urinary tract infections may occur, so immediate consultation with medical personnel is advised if symptoms of infection arise. There is a risk of hypoglycemia, so dosage adjustments may be necessary when used in combination with insulin or sulfonylurea medications. Care should be taken to avoid dehydration or hypotension symptoms due to reduced fluid volume, and if symptoms are severe, medication administration may be temporarily stopped. There is a risk of diabetic ketoacidosis, so immediate medical attention is required if symptoms such as nausea, vomiting, abdominal pain, or fatigue occur. This medication is not recommended for use during pregnancy, and it should be discontinued if pregnancy is confirmed. It is advisable for nursing mothers to avoid this medication as well. Safety and efficacy in children under 18 years have not been established, so caution is needed when using this medication. There is no specific antidote for overdose, so appropriate treatment should be given based on symptoms, following medical personnel's instructions if necessary. This medication does not greatly affect driving or machine operation; however, caution should be exercised as hypoglycemic symptoms may occur. Medications should be kept out of reach of children and stored in the original container.

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, paleness, severe rash with high fever, blisters, skin peeling, pain in mouth/eyes mucosa, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities with coughing and fever, yellowing of skin or eyes (jaundice), extreme fatigue, sudden and severe headache, thunderclap headache, seizures, altered consciousness, visual disturbances, paralysis, urinary

Mild side effects

Vulvitis, balanitis and related genital infections, urinary tract infections, fungal infections, hypoglycemia, reduced fluid volume, thirst, dizziness, constipation, dry mouth, back pain, painful urination, polyuria, nocturia, vulvar itching, genital itching, increased hematocrit, decreased serum creatinine clearance at the start of treatment, dyslipidemia, elevated serum creatinine, elevated blood urea, weight loss, rash, angioedema, chest pain, weakness, pain,

This medication should be stored in a tightly sealed container to prevent exposure to air and moisture. It should be kept at room temperature, between 1 to 30 degrees Celsius, for optimal safety.

Appearance

Yellow, biconvex, diamond-shaped film-coated tablets

Package unit

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