Dapaflo 10 mg (Dapagliflozin Propanediol Hydrate)

Adult dose

The recommended dose for this medication is 10 mg once daily for monotherapy and for additional combination therapy with insulin and other blood glucose-lowering agents. For initial combination therapy with metformin, the recommended starting dose is 5 mg once daily or 10 mg once daily. This medication can be taken orally at any time of the day regardless of meals. The tablet should be swallowed whole.

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 drug should not be used in certain patients. It should not be administered to those allergic to the active ingredient or additives, patients with type 1 diabetes, diabetic ketoacidosis, or those with lactose intolerance or related genetic disorders. Additionally, patients on dialysis should not take this medication. Patients with decreased fluid volume or impaired kidney function should use this medication with caution. This drug can lower blood pressure and reduce fluid volume in the blood, potentially leading to hypotension or kidney damage, so fluid status and kidney function should be carefully monitored before and after administration. The efficacy of this drug in controlling blood sugar varies with kidney function, and it may be less effective in patients with moderate or severe renal impairment. During administration, side effects such as genital infections, urinary tract infections, hypoglycemia, decreased fluid volume, and diabetic ketoacidosis may occur. Particularly, genital infections may be more common in women and patients with a history of infections, so caution is advised. When used in conjunction with blood glucose-lowering agents, there may be an increased risk of hypoglycemia, and dosage adjustments of insulin or sulfonylureas may be necessary. If symptoms of dehydration or hypotension due to decreased fluid volume occur, it is essential to consult a physician immediately, and the medication may need to be temporarily discontinued. Use during pregnancy is not recommended, and the medication should be stopped if pregnancy is confirmed. Breastfeeding women are also advised not to use this medication. Elderly patients or those with impaired kidney function should use it with special caution, and frequent blood tests and health assessments are required. During the course of taking this medication, regular blood sugar monitoring is essential, and caution should be exercised as some testing methods may be affected. There is no specific antidote in case of overdose, and appropriate treatment based on symptoms is necessary, with symptomatic management as advised by a physician. Finally, this medication has not been established for safety and efficacy in children, so it should not be used by this population. During treatment, patients should be cautious of hypoglycemic symptoms when driving or operating machinery and should consult a professional immediately if any unusual symptoms occur.

Serious side effects

Decreased fluid volume, diabetic ketoacidosis, necrotizing fasciitis of the perineum (Fournier's gangrene), hyperglycemia, acute pyelonephritis, urosepsis, acute kidney injury, renal dysfunction, anaphylactic reactions, urticaria, severe swelling (edema), chest tightness, difficulty breathing, sweating, pallor, severe rash with fever, blisters, skin peeling, pain in mucous membranes of the mouth/eyes, shortness of breath or difficulty breathing, asthma attack, cough with fever accompanying respiratory symptoms.

Mild side effects

Vulvovaginitis, balanitis and related genital infections, urinary tract infection, fungal infection, hypoglycemia, thirst, dizziness, constipation, dry mouth, back pain, dysuria, polyuria, nocturia, interstitial nephritis, increased hematocrit, reduced renal creatinine clearance initially, dyslipidemia, increased serum creatinine initially, elevated blood urea, weight loss, urticaria, sweating, pruritus, chest pain, weakness, fatigue, pain.

This medication must be stored in a tightly closed container to prevent exposure to air or moisture. It is important to maintain storage temperatures between 1 and 30 degrees Celsius. Proper storage helps preserve the medication's effectiveness and safety.

Appearance

Yellow, biconvex, diamond-shaped film-coated tablets

Package unit

28 tablets (14 tablets/PTP×2)