Dapagliflozin 10 mg (Dapagliflozin Propanediol Hydrate)

Adult dose

The recommended dose for this drug is 10 mg once daily for monotherapy and additional combination therapy. For initial combination therapy, in cases where there is no previous experience with diabetes medications, it is used in conjunction with Metformin at a dose of either 5 mg or 10 mg once daily. Dosage adjustments should be based on renal impairment, liver impairment, and the elderly, and the method of administration requires oral intake at any time during the day regardless of food. The tablet should be swallowed whole.

Child dose

The efficacy and safety in children under 18 years have not been established, and hence it is not administered.

This medication should not be administered to certain patients. For example, it should not be used in patients with allergies to the active ingredient or excipients, type 1 diabetes patients, patients with diabetic ketoacidosis, individuals with genetic lactose intolerance issues, and patients on dialysis. Use this drug cautiously in patients with reduced fluid volume or impaired kidney function. This medication may lower blood pressure or cause temporary changes in kidney function; therefore, it is essential to assess fluid status and kidney function thoroughly before administration and to monitor for symptoms of hypotension or changes in kidney function after administration. This drug may cause various side effects, including genital infections, urinary tract infections, hypoglycemia, reduction in fluid volume, and diabetic ketoacidosis. Genital infections are particularly common in women, especially in those with a history of past infections, who may have a higher risk of recurrence. Pregnant or breastfeeding women are advised not to use this medication, and if pregnancy is confirmed, it should be discontinued immediately. This drug may interact with other medications, particularly diuretics or hypoglycemic agents such as insulin and sulfonylureas, requiring dose adjustments to reduce the risk of hypoglycemia. Elderly patients or those with decreased kidney function are at higher risk for fluid volume reduction and hypotension, necessitating more careful use. During treatment with this medication, keep track of fluid status and monitor blood sugar levels consistently, and consult healthcare professionals immediately if any unusual symptoms arise. Furthermore, this medication does not significantly affect driving or machinery operation but caution should be taken for hypoglycemia symptoms when used with insulin or similar medications. Lastly, the safety and efficacy of this drug have not been established in children, so it is not recommended for pediatric use.

Serious side effects

Hives, severe swelling, chest tightness, difficulty breathing, cold sweat, paleness, severe rash with fever, blisters, skin peeling, pain in oral/eye mucous membranes, shortness of breath or breathing difficulties, asthma attacks, respiratory abnormalities with cough and fever, jaundice, systemic lethargy, sudden and severe headache, lightning headache, seizures, confusion, visual disturbances, paralysis, significantly reduced urine output

Mild side effects

Vulvitis, balanitis and associated genital infections, urinary tract infections, fungal infections, hypoglycemia, dry mouth, dizziness, constipation, back pain, pain during urination, polyuria, nocturia, interstitial nephritis, increased hematocrit, decreased initial renal creatinine clearance, dyslipidemia, initial increase in blood creatinine, elevated blood urea, weight loss, abnormal platelet count, gastrointestinal disturbances, sensory disturbances, taste disturbances, headache

This medication should be stored in a tightly closed container to protect it from air and moisture, and it is best stored at room temperature between 1°C and 30°C. Maintaining proper temperature and airtight conditions ensures the effectiveness and safety of the medication over time.

Appearance

Yellow, rounded diamond-shaped film-coated tablet

Package unit

28 tablets (14 tablets/PTP×2)