Dapagliflozin Tablets 10 mg (Dapagliflozin)

Adult dose

The recommended dose of this medication for both monotherapy and additional combination therapy with insulin or other blood sugar-lowering agents is 10 mg once daily. For initial combination therapy, it may start at 5 mg or 10 mg once daily. It can be taken orally once daily at any time of the day regardless of food intake, and the tablet should be swallowed whole.

Child dose

Efficacy and safety of dapagliflozin in pediatric patients under 18 years of age have not been established. No relevant data is available.

This medication should not be used in certain patients. First, patients who are allergic to or have experienced hypersensitivity to the active ingredient or excipients of this medication should not use it. Additionally, it should not be administered to patients with type 1 diabetes or diabetic ketoacidosis. As this medication includes anhydrous lactose, it should not be used in patients with genetic disorders such as galactose intolerance, lactase deficiency, or glucose-galactose malabsorption. Patients on dialysis should also avoid using this medication. Use with caution in patients with reduced fluid volume or renal function issues. This medication can lower blood pressure or reduce blood volume, leading to symptomatic hypotension or worsening renal function. Patients with impaired renal function, the elderly, and those taking diuretics are at higher risk and should have their fluid status and renal function evaluated before administration, along with continuous monitoring during treatment. In patients with significantly impaired renal function, the effect on blood sugar control may diminish, so it is not recommended for blood sugar control purposes. This medication may cause infections such as genital infections or urinary tract infections, especially in women and patients with a history of prior infections. Additionally, hypoglycemic symptoms may occur, particularly when taken with blood sugar-lowering agents such as insulin or sulfonylureas. Symptoms of dehydration or hypotension due to reduced fluid volume may also manifest, so attention is required for symptoms such as dizziness or dry mouth. Rarely, a serious metabolic disturbance known as diabetic ketoacidosis can occur, and if symptoms arise, immediate consultation with a healthcare provider is necessary. This medication is not recommended for patients with severely impaired liver function, and elderly patients should be monitored more closely for reduced fluid volume and changes in renal function. Additionally, it may be noted that glucose can be detected in urine tests while taking this medication. When taken with insulin or sulfonylureas, adjustments in dosage of these medications may be necessary to reduce the risk of hypoglycemia. Moreover, this medication increases lithium excretion in the kidneys, which may lower serum lithium levels, so patients taking lithium should have their blood levels checked frequently. Pregnant women are advised not to use this medication, and it should be discontinued if pregnancy is confirmed. Nursing mothers should also avoid taking this medication. In case of overdose, no specific antidote is available, but appropriate treatment should be given based on the patient's condition, and attention should be paid to symptoms of dehydration or hypotension. This medication does not significantly affect driving or operating machinery, but caution is needed due to the risk of hypoglycemia when taken with insulin or sulfonylureas. Finally, the safety and efficacy of this medication in children have not been established, so it is not used in this population.

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, skin peeling, pain in mouth/eyes mucosa, shortness of breath or difficulty breathing, asthma attacks, breathing abnormalities accompanied by cough and fever, yellowing of the skin or eyes (jaundice), profound lethargy, sudden and very severe headache, lightning headache, seizures, disorientation, visual disturbances, paralysis, urination

Mild side effects

• Vulvovaginitis
• balanitis and related genital infections
• urinary tract infections
• fungal infections
• hypoglycemia
• decreased fluid volume
• dizziness
• constipation
• dry mouth
• back pain

This medication should be stored in a tightly sealed container to prevent exposure to air and moisture, and it is important to keep it at room temperature between 1 and 30 degrees Celsius. Storing it this way helps maintain the efficacy of the medication and prevents degradation.

Appearance

Yellow, double-convex rhomboid film-coated tablet

Package unit

100 tablets/bottle, 8 tablets/PTP