Dafor Tablets 10 mg (Dapagliflozin bis L-proline)

Adult dose

For monotherapy and add-on therapy in type 2 diabetes, the dosage is 10 mg once daily. In initial combination therapy, for those with no prior experience of diabetes drug treatment, it is 5 mg or 10 mg once daily when combined with metformin. In special populations, for patients with severe liver impairment, a starting dose of 5 mg is recommended, and if well tolerated, it can be increased to 10 mg. For patients with renal impairment: eGFR 45 mL/min/1.

Child dose

Safety and effectiveness in children under 18 years of age have not been established; thus, it is not recommended.

This medication should not be used in patients with hypersensitivity to the active ingredients or excipients, type 1 diabetes, diabetic ketoacidosis, or genetic issues such as lactose intolerance. It should also not be administered to patients undergoing dialysis. Caution should be exercised when this medication is used in patients with reduced fluid volume or renal dysfunction. This medication can lower blood pressure or reduce intravascular volume, which may cause hypotension or changes in kidney function. Special attention is required for patients with impaired kidney function, the elderly, and those taking diuretics, and fluid status and kidney function should be closely monitored before and after administration. This medication may cause various side effects, including genital infections, urinary tract infections, hypoglycemia, dizziness, dry mouth, back pain, painful urination, polyuria, nocturia, increased hematocrit, elevated blood creatinine, elevated blood urea, weight loss, rash, chest pain, weakness, pain, fever, foreign body sensation, facial edema, facial pain, warmth, flu-like symptoms, itching, urticaria, cold sweats, abdominal pain, dyspepsia, and nausea. Genital infections and urinary tract infections are particularly commonly reported, and if such symptoms occur, prompt treatment is necessary. When used with medications that can cause hypoglycemia, such as insulin or sulfonylureas, there may be an increased risk of hypoglycemia, so adjustments to the doses of these medications may be necessary. It is advisable for pregnant or nursing women to avoid using this medication, and if pregnancy is confirmed, administration should be discontinued immediately. This medication does not significantly affect the ability to drive or operate machinery; however, caution is required due to the risk of hypoglycemia when combined with medications such as insulin. Finally, the safety and efficacy of this medication in children have not been sufficiently established, so it is recommended not to use it in pediatric patients. When using this medication, it is essential to follow the physician's guidance, and it is important to seek immediate consultation if any abnormal symptoms occur.

Serious side effects

Decreased fluid volume (dehydration, hypovolemia, hypotension), diabetic ketoacidosis, acute renal injury and renal dysfunction, perineal necrosis (Fournier's gangrene), anaphylaxis, urticaria, angioedema, severe swelling (edema), rash (severe skin adverse reactions), cold sweats, chest tightness, difficulty breathing, severe allergic reactions, severe skin adverse reactions, respiratory problems, liver abnormalities (jaundice), severe neurological symptoms, severe edema

Mild side effects

Vulvovaginitis, balanitis and associated genital infections, urinary tract infections, fungal infections, hypoglycemia, dry mouth, dizziness, constipation, back pain, painful urination, polyuria, nocturia, increased hematocrit, elevated blood creatinine, elevated blood urea, weight loss, rash, chest pain, weakness, pain, fever, foreign body sensation, facial edema, facial pain, warmth, flu-like symptoms, itching, urticaria, cold sweats, abdominal pain, dyspepsia, nausea

This medication is sensitive to air and moisture, so it should be stored in a tightly sealed container. Additionally, it is best to keep the medication at room temperature between 1 degree and 30 degrees Celsius, avoiding excessively hot or cold environments.

Appearance

Yellow, convex diamond-shaped film-coated tablet

Package unit

100 tablets/bottle, 30 tablets/bottle