Dong-A Dapagliflozin 10 mg (Dapagliflozin Propanediol Hydrate)

Adult dose

The recommended dosage for this medication is 10 mg once daily for monotherapy and additional combination therapy with other hypoglycemic agents, including insulin. In cases of initial combination therapy where the patient has not previously received diabetes medication, the recommended starting dose is 5 mg or 10 mg once daily when administered with metformin. Dosage should be taken orally once daily at any time of day, regardless of food intake, and the tablets should be swallowed whole.

Child dose

The efficacy and safety of dapagliflozin in pediatric patients under 18 years of age have not been established. There is no relevant data.

This medication should not be used by individuals who have had allergic reactions to the active ingredient or excipients. It should not be administered to patients with type 1 diabetes or diabetic ketoacidosis. Contains lactose hydrate; individuals with lactose intolerance or related genetic disorders should not take this medication. It is not recommended for patients undergoing dialysis. Patients with fluid volume deficits or diminished kidney function should have their condition thoroughly evaluated prior to use, and blood pressure and kidney function should be monitored periodically after administration. In patients with moderate to severe renal impairment, caution is necessary as the blood sugar control effect may be reduced. The most commonly reported side effect in clinical trials is genital infections, which may occur more frequently in women and in those with a history of past infections. Hypoglycemia may occur primarily when this medication is used in conjunction with insulin or sulfonylureas, so dosage adjustments may be necessary when used together with these medications. This medication may cause symptoms of fluid volume depletion such as dehydration, hypotension, and thirst; therefore, fluid status should be monitored closely. Diabetic ketoacidosis may rarely occur, so immediate medical attention is necessary upon symptom onset. The risk of urinary infections, such as urinary tract infections and pyelonephritis, may increase, so prompt treatment is required if infection symptoms appear. This medication may affect kidney function, so it is important to regularly check kidney function test results. Severe infections, such as perineal necrosis, have been reported rarely; immediately consult a physician if there is pain or swelling in the perineum. The use of this medication is not recommended during pregnancy, and it should be discontinued upon confirmation of pregnancy. It is also safest not to use this medication while breastfeeding. In children, the safety and efficacy of this medication have not been established, and it is not used in this population. There is no specific antidote in the event of overdose, so symptomatic treatment will be provided according to the symptoms. This medication does not significantly affect driving or machine operation, but caution is advised if there is a risk of hypoglycemia. Keep this medication out of reach of children and store it in its original container.

Serious side effects

Hives, severe swelling (edema), tightness in the chest, difficulty breathing, cold sweat, pallor, severe rash with fever, blistering, skin peeling, pain in mucous membranes of the mouth/eyes, shortness of breath, asthma attacks, respiratory distress with cough and fever, jaundice (yellowing of skin or eyes), profound lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urinary incontinence

Mild side effects

• Vulvovaginitis
• balanitis
• and related genital infections
• urinary tract infections
• fungal infections
• hypoglycemia
• thirst
• dizziness
• constipation
• dry mouth

This medication should be stored in a tightly sealed container to prevent air or moisture intrusion. It is recommended to maintain storage temperatures between 1 to 30 degrees Celsius.

Appearance

Yellow round film-coated tablets

Package unit

30 tablets/box [(10 tablets/PTP x 3)]