Dapagliflozin Propanediol Hydrate 5 mg Tablet

Adult dose

The recommended dose of this medication for monotherapy and additional combination therapy is 10 mg once daily. For initial combination therapy, 5 mg or 10 mg once daily is recommended. This medication can be taken orally once daily at any time regardless of meals, and the tablet should be swallowed whole.

Child dose

The safety and efficacy of dapagliflozin in children under 18 years have not been established.

This medication should not be used in patients who have had allergic reactions to the active ingredient or any excipients. Patients with type 1 diabetes or diabetic ketoacidosis may also be at risk when taking this medication. It contains anhydrous lactose, so it should not be administered to individuals with genetic issues such as galactose intolerance, lactase deficiency, or glucose-galactose malabsorption. This medication is also not recommended for patients on dialysis. Patients with low fluid volume or impaired kidney function should use this medication with caution. This medication can lower blood pressure and cause rapid changes in serum creatinine levels, affecting kidney function. Therefore, the patient's fluid status and kidney function should be evaluated before administration. During treatment, it is important to check for symptoms of hypotension and changes in kidney function regularly. In patients with moderate to severe renal impairment, the blood sugar control effect of this medication may be reduced, and it is not recommended for use in patients with severe renal dysfunction for blood sugar control. Taking this medication may increase the risk of genital infections and urinary tract infections; patients should consult a healthcare professional immediately if they exhibit symptoms of infection. Due to the risk of hypoglycemia, dose adjustments may be necessary when taking this medication alongside insulin or sulfonylureas, which can induce hypoglycemia. If signs of decreased fluid volume or dehydration occur, temporary cessation of this medication should be considered, and focus should be placed on fluid replenishment and recovery of the patient's condition. This medication can induce diabetic ketoacidosis, which may occur even if blood sugar levels are within normal ranges; therefore, immediate testing and treatment are necessary upon the onset of related symptoms. It is safe to avoid using this medication in patients with severe hepatic impairment, pregnant women, or nursing mothers. In elderly patients, careful monitoring of kidney function and fluid status is required. This medication does not have a major impact on the ability to drive or operate machinery, but caution is needed if there is a risk of hypoglycemia. There are no specific antidotes for overdose, so appropriate treatment should be administered according to symptoms, and dialysis will not remove the drug from the system. This medication should be stored in its original container, out of reach of children.

Serious side effects

Decreased fluid volume (including dehydration, hypovolemia, and hypotension), diabetic ketoacidosis, acute kidney injury and dysfunction, perineal necrosis (Fournier's gangrene), urinary sepsis and pyelonephritis, urticaria, severe swelling (angioedema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, skin peeling, oral/ocular mucosal pain, sudden and very severe headache, thunderclap headache, seizures,

Mild side effects

Vulvovaginitis, balanitis and related genital infections, urinary tract infections, hypoglycemia (when used with sulfonylureas or insulin), dry mouth, dizziness, constipation, back pain, dysuria, polyuria, nocturia, increased hematocrit, elevated serum creatinine at the beginning of treatment, dyslipidemia, weight loss, chest pain, weakness, pain, itching, cold sweat, headache, cough, difficulty breathing, palpitations, insomnia, etc.

This medication should be stored in a tightly sealed container to protect it from air and moisture. It is recommended to keep the medication at room temperature between 1°C and 30°C, avoiding extremes of heat or cold.

Appearance

Yellow, round film-coated tablet with convex sides

Package unit

PTP - 28 tablets/box [7 tablets/PTP x 4]