Fosidi Tablet 10 mg (Dapagliflozin Anhydrous Mixed Preparation)

Adult dose

The recommended dose of this medication is 10 mg once daily for monotherapy and additional combination therapy with other antidiabetic agents such as insulin. In the case of initial combination therapy, if there is no prior experience of diabetes medication treatment, the initial recommended dosage of this medication when used alongside metformin is 5 mg or 10 mg once daily. Administration can be done orally at any time of the day, regardless of food intake.

Child dose

The efficacy and safety of dapagliflozin in children under 18 years have not been established. No relevant data is available.

This medication should not be administered to certain patients. For example, it must not be used in patients who are allergic to its components, individuals with Type 1 diabetes, those with diabetic ketoacidosis, genetically lactose intolerant patients, and patients undergoing dialysis. Caution should be exercised when administering to patients with low fluid volume or poor kidney function. This medication may lower blood pressure or affect kidney function, so blood pressure and kidney function must be carefully monitored before and after administration. The effect of this medication on blood sugar control varies based on kidney function; therefore, it is not recommended for patients with moderate or severely decreased kidney function for blood sugar control purposes. Moreover, this medication contains the colorants Yellow No. 4 and Yellow No. 5, necessitating caution for patients who are allergic or sensitive to these components. The most common side effect when taking this medication is genital infections, which may occur more frequently in female patients. Other side effects reported include urinary tract infections, hypoglycemia, decreased fluid volume, dizziness, constipation, dry mouth, and lower back pain. Especially, there is a rare occurrence of a serious metabolic disorder called diabetic ketoacidosis, so if symptoms like dehydration, vomiting, abdominal pain, or difficulty breathing occur, immediate medical consultation is necessary. The risk of hypoglycemia may increase when this medication is used in conjunction with other antidiabetic agents, so dosage adjustments may be necessary when used with insulin or sulfonylureas. It is advisable for pregnant or breastfeeding women to avoid using this medication, and if pregnancy is confirmed, immediate discontinuation of administration should take place. Elderly patients or those with decreased kidney function are at higher risk for decreased fluid volume and hypotension, so caution is needed. During use of this medication, glucose may be detected in urine tests, so this should be noted. There is no specific antidote for overdose; symptom-related treatment should be given according to a doctor's instructions. Finally, this medication does not significantly affect the ability to drive or operate machinery, but caution is required due to the risk of hypoglycemia.

Serious side effects

Necrotizing perineal fasciitis (Fournier's gangrene), diabetic ketoacidosis, urosepsis and pyelonephritis, acute kidney injury and renal dysfunction, anaphylactic reactions, urticaria, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, skin peeling, oral/ocular mucosal pain, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities with cough and fever, skin or eye issues

Mild side effects

• Vulvar vaginitis
• balanitis and related genital infections
• urinary tract infections
• fungal infections
• hypoglycemia
• decreased fluid volume
• thirst
• dizziness
• constipation
• dry mouth

This medication should be kept in a tightly closed container to prevent air or moisture exposure and stored at room temperature between 1 and 30 degrees Celsius. This helps maintain the medication's efficacy and ensures safe use.

Appearance

Yellow, biconvex, diamond-shaped film-coated tablet

Package unit

28 tablets/box [14 tablets/PTP × 2]