Fosioled 10 mg Tablet (Dapagliflozin Propanediol Hydrate)

Adult dose

The recommended dosage of this drug is 10 mg once daily for monotherapy and additional combination therapy with other hypoglycemics such as insulin. For initial combination therapy, if the patient has no prior experience with diabetes medication, the recommended initial dosage when co-administered with metformin is 5 mg or 10 mg once daily. For special populations, in patients with severe liver impairment, a starting dose of 5 mg is recommended, which may be increased to 10 mg if tolerated well.

Child dose

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

This drug should not be used in patients who have allergies to the active ingredient or excipients, or in patients with type 1 diabetes or diabetic ketoacidosis. Patients with lactose intolerance or genetic lactose metabolism disorders, and patients undergoing dialysis should also not take this medication. Patients with low fluid volume or impaired kidney function should use this drug cautiously, and blood pressure and kidney function should be closely monitored before and during administration. This drug may have reduced blood sugar control efficacy in patients with severely impaired kidney function. When taking this medication, there is a possibility of infections such as genital infections or urinary tract infections, which require immediate treatment if symptoms appear. Due to the risk of hypoglycemia, caution should be exercised for those taking it in conjunction with insulin or sulfonylureas, and the dosage of such medications may need to be reduced if necessary. Dehydration or low blood pressure symptoms may occur due to decreased fluid volume, so adequate hydration and monitoring of symptoms is necessary. There is a risk of serious metabolic disorders such as diabetic ketoacidosis; thus, if symptoms like vomiting, abdominal pain, or difficulty breathing occur, immediate consultation with a healthcare provider is essential. Older adults or those taking diuretics are at higher risk for decreased fluid volume and low blood pressure, requiring additional caution. It is recommended that pregnant women and lactating women do not use this drug, and it should be discontinued once pregnancy is confirmed. The safety and efficacy of this drug in children have not been sufficiently established, so use is not advised. In cases of overdose, there are no specific antidotes, and appropriate treatment should be administered based on symptoms, with immediate visit to a medical institution if necessary. This drug does not significantly affect driving or machinery operation, but caution is needed in cases of hypoglycemia. Finally, this medication should be stored in its original container, safely out of reach of children.

Serious side effects

Hives, severe swelling, chest tightness, difficulty breathing, cold sweats, paleness, severe rash with high fever, blisters, skin peeling, pain in the mucous membranes of the mouth/eyes, shortness of breath or difficulty breathing, asthma attack, respiratory abnormalities along with cough and fever, yellowing of the skin or eyes, extreme lethargy, sudden and severe headache, lightning-type headache, seizures, confusion of consciousness, vision abnormalities, paralysis, significantly decreased urine output

Mild side effects

Vulvovaginitis, balanitis, and related infections, urinary tract infection, fungal infections, hypoglycemia, thirst, dizziness, constipation, dry mouth, back pain, dysuria, polyuria, nocturia, increased hematocrit, reduced renal creatinine clearance at treatment initiation, dyslipidemia, elevated blood creatinine, elevated blood urea, weight loss, chest pain, weakness, pain, swelling, foreign body sensation, facial swelling, facial pain, warmth, flu-like symptoms, menstruation

This drug may be sensitive to air or moisture, so it must be stored in a tightly sealed container. It is recommended to maintain storage temperatures between 1 to 30 degrees Celsius to preserve its efficacy and safety over time.

Appearance

Yellow, flat, diamond-shaped film-coated tablet

Package unit

28 tablets/box [7 tablets/PTP x 4], 30 tablets/bottle