Tapagazine 5 mg (Dapaglifozen Propanediol Hydrate)

Adult dose

The recommended dose of this medication is 10 mg once daily for monotherapy and additional combination therapy with other hypoglycemic agents such as insulin. For initial combination therapy, the initial recommended dose of this medication is either 5 mg or 10 mg once daily. For patients with chronic heart failure and chronic kidney disease, the recommended dose is 10 mg once daily. For patients with severe liver impairment, a starting dose of 5 mg is recommended, and if tolerated well, this can be increased to 10 mg.

Child dose

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

This medication should not be used by patients with allergies to the active ingredient or additives, patients with type 1 diabetes, patients with diabetic ketoacidosis, patients with lactose intolerance or related genetic disorders, and patients undergoing dialysis. It should be administered cautiously to patients with decreased fluid volume or renal impairment, and blood pressure and renal function should be closely monitored before and after administration. This medication may cause side effects such as genital infections, urinary tract infections, hypoglycemia, decreased fluid volume, diabetic ketoacidosis, and renal function abnormalities, so if any unusual symptoms occur, one should immediately consult a healthcare professional. Particularly, elderly patients or those with impaired kidney function are at higher risk for side effects and require additional caution. Women who are pregnant or breastfeeding are advised not to use this medication, and treatment should be discontinued upon confirmation of pregnancy. This medication may increase the risk of hypoglycemia when used with drugs that can cause hypoglycemia, such as insulin or sulfonylureas, thus dosage adjustments may be necessary for these medications. Also, it should be noted that glucose may be detected in urine tests while taking this medication. In case of overdose, there is no specific antidote available, so symptomatic treatment is required, and it is known that it cannot be removed by dialysis. This medication does not significantly affect driving or machine operation ability; however, caution is necessary when used in combination with medications that pose a risk of hypoglycemia. Finally, its use is not recommended in children due to insufficient safety and efficacy data.

Serious side effects

Decreased fluid volume (dehydration, hypovolemia, hypotension), diabetic ketoacidosis, perineal necrosis (Fournier's gangrene), acute kidney injury, renal dysfunction, urosepsis, pyelonephritis, rash, angioedema, anaphylactic reactions, urticaria, severe swelling (edema), chest tightness, difficulty breathing, cold sweats, pallor, severe rash with fever, blisters, skin peeling, oral/ocular mucosal pain, breathlessness or difficulty breathing.

Mild side effects

Vulvitis, balanitis and related genital infections, urinary tract infections, fungal infections, hypoglycemia, dry mouth, dizziness, constipation, dry mouth, low back pain, dysuria, polyuria, nocturia, elevated hematocrit, decreased initial renal creatinine clearance, dyslipidemia, elevated serum creatinine, elevated blood urea, weight loss, chest pain, asthenia, pain, edema, foreign body sensation, facial edema, facial pain, warmth, flu-like symptoms, menstrual issues.

This medication should be stored in a tightly sealed container to protect it from air and moisture. Moreover, it is best to keep the medication at room temperature between 1 to 30 degrees Celsius. Avoid storing it in excessively hot or cold places.

Appearance

Yellow, round, biconvex film-coated tablets

Package unit

2 blisters/box [(14 tablets/blister) × 2]