Xensiga 5 mg (Dapagliflozin Anhydrous Mixture)

Adult dose

The recommended dose of this medication is 10 mg once daily for monotherapy and as an additional combination therapy with insulin and other blood glucose-lowering agents. When used in conjunction with insulin or sulfonylureas, lower doses of insulin or insulin secretagogues may be considered to reduce the risk of hypoglycemia. In cases where prior diabetes drug therapy has not been experienced, metformin is suggested.

Child dose

The efficacy and safety of dapagliflozin in pediatric patients under 18 years of age have not been established. There is no relevant data.

This medication should not be used in certain patients. First, individuals who are allergic to the active ingredient or excipients of this medication should not take it. Second, patients with type 1 diabetes or diabetic ketoacidosis should not use this medication. Third, individuals with lactose intolerance, galactose intolerance, congenital lactose enzyme deficiency, or glucose-galactose malabsorption should also avoid taking it. Fourth, patients undergoing dialysis should not use this medication. Furthermore, this medication should be administered with caution to patients with reduced fluid volume or poor kidney function. This medication poses a risk of low blood pressure or sudden deterioration of kidney function, so such patients must check fluid status and kidney function carefully before administration. After administration, periodic observation of symptoms of low blood pressure or changes in kidney function is necessary. This medication contains Yellow No. 4 and Yellow No. 5 dyes, so persons allergic or hypersensitive to these dyes should use it with caution. Taking this medication may increase the risk of infections such as genital infections and urinary tract infections. Especially in women or individuals with a history of such infections, caution is needed as infections may occur more easily. Symptoms of low blood sugar may appear; however, this medication alone has a low risk of hypoglycemia, and the risk may increase when used with medications such as insulin or sulfonylureas. Therefore, dosage adjustments may be necessary if used in combination with such medications. Dehydration or low blood pressure symptoms due to decreased fluid volume may occur, so immediate consultation with healthcare professionals is necessary if dehydration symptoms appear. Diabetic ketoacidosis, a serious metabolic disorder, may rarely occur; thus, if symptoms such as vomiting, abdominal pain, shortness of breath, or fatigue appear, immediate medical attention is required. This medication is not recommended for women who are pregnant or breastfeeding. Elderly patients or those with impaired kidney function should be managed carefully as they are at higher risk of decreased fluid volume and low blood pressure. This medication does not significantly affect driving or machine operation, but caution is needed when used with medications that may cause low blood sugar.

Serious side effects

• Hives
• severe swelling (edema)
• chest tightness
• difficulty breathing
• sweating
• pallor
• severe rash with fever
• blisters
• skin peeling
• mucosal pain in mouth/eyes

Mild side effects

Vulvovaginitis, balanitis and related genital infections, urinary tract infections, fungal infections, hypoglycemia, decreased fluid volume, dizziness, constipation, dry mouth, back pain, dysuria, polyuria, nocturia, increased hematocrit, decreased renal creatinine clearance at the beginning of treatment, dyslipidemia, increased serum creatinine, increased blood urea, weight loss, itching, hives, sweating, thirst, indigestion, nausea, diarrhea, vomiting, urinary retention, weakness

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture, and it is recommended to store it at room temperature between 1°C and 30°C. Proper storage maintains the medication's efficacy and prevents deterioration.

Appearance

Yellow, double convex, round, film-coated tablet

Package unit

28 tablets/box [(7 tablets/PTP X 4)], 28 tablets/box [(14 tablets/PTP X 2)]