Dapagliflozin Propanediol Hydrate 10 mg

Adult dose

The recommended dose of this medication is 10 mg once daily. In initial combination therapy, the dose is 5 mg or 10 mg once daily. For patients with chronic heart failure or chronic kidney disease, it is also 10 mg once daily. For patients with severe liver impairment, the starting dose is 5 mg and may be increased to 10 mg based on tolerability. This medication is taken orally once daily regardless of food intake, and the tablets should be swallowed whole.

Child dose

The efficacy and safety of this medication in children under 18 years of age have not been established. Therefore, there is no dosage for pediatric use.

This medication should not be used in patients with allergies to the active ingredient or additives, those with type 1 diabetes or diabetic ketoacidosis, and those undergoing dialysis. It should be used cautiously in patients with reduced fluid volume or impaired kidney function, as there is a risk of hypotension or acute kidney injury, thus blood pressure and kidney function should be carefully monitored before and during administration. The blood sugar control effect of this medication varies according to kidney function and is not recommended for patients with significantly impaired kidney function. The most common side effect observed in clinical trials is genital infections, which may occur more frequently in women or patients with a history of infections. Symptoms of hypoglycemia may occur more frequently when this medication is used with insulin or sulfonylureas, so caution is warranted. Dehydration and hypotension symptoms have also been reported, so fluid status should be carefully monitored and medication may need to be temporarily halted if necessary. This drug can cause severe metabolic disturbances known as diabetic ketoacidosis, so if related symptoms arise, inform healthcare providers immediately. There is also an increased risk of urinary tract infections and pyelonephritis, so prompt treatment is needed if infection symptoms occur. Elderly patients or those with impaired kidney function should be used with particular caution due to the higher risk of reduced fluid volume and hypotension. Pregnant or breastfeeding women are advised not to use this medication, and it should be discontinued upon confirmation of pregnancy. Adjustment of insulin or sulfonylurea doses may be required when using this drug, so consultation with the treating physician is necessary. This drug increases urination which can lower blood pressure, so patients with a history of hypotension or those taking diuretics should be monitored closely. During the use of this medication, testing for 1,5-anhydroglucitol for blood sugar control is not recommended, and other methods should be used to manage blood sugar. In case of overdose, there is no specific antidote, so appropriate treatment based on symptoms should be sought, and it has not been confirmed whether this medication can be removed through dialysis. This medication does not significantly affect driving or machine operating abilities, but caution is needed in the event of a risk of hypoglycemia. Store the product out of reach of children and maintain its quality by keeping it in the original container.

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, peeling skin, pain of oral/ocular mucosa, shortness of breath or difficulty breathing, asthma attack, respiratory abnormalities accompanying cough and fever, yellowing of skin or eyes (jaundice), general lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urination.

Mild side effects

Vulvitis, glansitis and related genital infections, urinary tract infections, fungal infections, hypoglycemia, thirst, dizziness, constipation, dry mouth, back pain, dysuria, polyuria, nocturia, increased hematocrit, initial treatment-related decrease in kidney creatinine clearance rate, dyslipidemia, elevated blood creatinine levels, increased blood urea levels, weight loss, gastrointestinal disorders (e.g., gastroesophageal reflux disease, epigastric pain, diverticulitis, etc.), sensory disturbances, cerebral infarction, nerve compression.

This medication must be stored in a tightly sealed container to protect it from air and moisture. Additionally, avoid storing the medication in excessively hot or cold places; it is recommended to store it at room temperature between 1°C and 30°C.

Appearance

Yellow, bilaterally convex, diamond-shaped film-coated tablet

Package unit

30 tablets/bottle, 30 tablets (10 tablets/AluAlu) x 3