Dapagliflozin 10 mg (Dapagliflozin Propanediol Hydrate)

Adult dose

The recommended dose for this medication is 10 mg once daily. Initially, in combination therapy, it may start at 5 mg or 10 mg once daily. For patients with chronic heart failure and chronic kidney disease, it is also 10 mg once daily. In patients with liver impairment, start at 5 mg in severe cases, increasing to 10 mg according to tolerance. Administration should be oral once daily, at any time during the day, regardless of food intake, and the tablet must be swallowed whole.

Child dose

Efficacy and safety in patients under 18 years of age have not been established, and therefore, administration is not recommended.

This medication should not be used in patients who have had allergic reactions to the active ingredient or excipients. It should not be administered to patients with type 1 diabetes, diabetic ketoacidosis, or those on dialysis. Caution is required for patients with reduced fluid volume or impaired kidney function, and blood pressure and kidney function should be closely monitored before and during administration. Special care is needed for the elderly or patients on diuretics due to a higher risk of hypotension or fluid depletion. This medication is not recommended for patients with severely impaired kidney function, and those with very low kidney function should be cautious as experience with this medication is limited. Infections of the genitals or urinary tract may occur while taking this medication, so if any symptoms of infection appear, consult a healthcare professional immediately. There is a risk of hypoglycemia, so dosage adjustments may be necessary when used alongside insulin or sulfonylureas. Dehydration or hypotension symptoms may occur due to reduced fluid volume, especially in cases of fluid loss from gastrointestinal diseases. Serious metabolic disturbances such as diabetic ketoacidosis can occur; seek immediate medical attention if symptoms such as vomiting, abdominal pain, or shortness of breath arise. It is advisable for women who are pregnant or nursing not to use this medication, and administration should be halted if pregnancy is confirmed. The safety and efficacy of this medication have not been established in children, thus it is not used in this population. In cases of overdose, there is no specific antidote, and symptomatic treatment is required; in severe cases, appropriate symptomatic treatment in a hospital is necessary. While taking this medication, it is generally safe to drive or operate machinery, but caution is needed if there is a risk of hypoglycemia.

Serious side effects

Diabetic ketoacidosis, acute kidney injury and renal impairment, necrotizing fasciitis (Fournier's gangrene), urosepsis and pyelonephritis, angioedema, anaphylactic reactions, hives, cold sweat, chest tightness, difficulty breathing, liver dysfunction (jaundice), severe edema, severe allergic reactions, severe neurological symptoms, severe skin adverse reactions, orthostatic hypotension, ketoacidosis, severe hypotension, rapid changes in creatinine levels in kidneys

Mild side effects

Vulvitis, balanitis and associated genital infections, urinary tract infections, fungal infection, hypoglycemia, dry mouth, dizziness, constipation, back pain, dysuria, polyuria, nocturia, interstitial nephritis, vulvar itching, genital itching, increased hematocrit, dyslipidemia, weight loss, dehydration, increased serum creatinine, elevated blood urea, headache, sensory impairment, abnormal sensations, indigestion, nausea, diarrhea, vomiting, hunger,

This medication should be stored in a tightly closed container to protect it from air and moisture. It is best to store the medication at room temperature between 1°C and 30°C, away from extreme heat or cold.

Appearance

Yellow, film-coated tablet with a convex diamond shape on both sides

Package unit

Bottle - 28 tablets/bottle, Bottle - 30 tablets/bottle, Box - 28 tablets/box [7 tablets/Alu-Alu x 4]