Dapa Tablet 10mg (Dapagliflozin Citrate)

Adult dose

The recommended dose of this medication is 10 mg once daily for monotherapy and additional combination therapy with insulin or other blood glucose-lowering agents. When used in conjunction with insulin or insulin secretagogues such as sulfonylureas, lower doses of insulin or insulin secretagogues may need to be considered to reduce the risk of hypoglycemia. This medication can be taken orally at any time of the day regardless of food intake.

Child dose

The efficacy and safety of dapagliflozin in children under 18 years have not been established. There is no related data.

This medication should not be used in patients with allergies to the active ingredient or additives, Type 1 diabetes, or diabetic ketoacidosis. It should also not be administered to individuals with genetic issues such as lactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption, and to patients undergoing dialysis. Caution is required for patients with depleted body fluids or poor kidney function, and careful monitoring is necessary before and after administration due to the risk of hypotension and kidney damage. Especially in the elderly or patients on diuretics, blood pressure and fluid status should be closely monitored. The blood sugar control effectiveness of this medication varies with kidney function, therefore it is not recommended for patients with severe kidney impairment. The most commonly reported side effect in clinical trials is genital infections, which may occur more frequently in women and those with a history of infections. Hypoglycemia may occur when taken with medications such as insulin or sulfonylureas, so caution is needed. Symptoms of dehydration or hypotension due to body fluid depletion may also occur, so if these symptoms arise, consult medical professionals immediately. A serious metabolic disturbance known as diabetic ketoacidosis may rarely occur, so if symptoms such as nausea, vomiting, abdominal pain, or difficulty breathing occur, immediate treatment is necessary. The incidence of urinary tract infections, including pyelonephritis, can increase, so prompt treatment is required for any signs of infection. This medication may affect kidney function, causing a temporary rise in creatinine levels, hence kidney function tests are needed during treatment. Rarely, severe infections such as perineal necrosis may occur, so if there is pain, swelling, or fever, immediately visit a hospital. It is safest for pregnant or breastfeeding women to avoid using this medication, and it should be discontinued if pregnancy is confirmed. The safety and effectiveness of this medication in children have not been established, so its use is not recommended. There is no specific antidote in case of overdose, and appropriate treatment is necessary according to symptoms. This medication does not have a significant effect on driving or operating machinery, but caution is required due to the risk of hypoglycemia. Finally, this medication should be kept out of reach of children and stored in its original container.

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, sweating, pallor, severe rash with high fever, blisters, skin peeling, oral/ocular mucosal pain, shortness of breath or difficulty breathing, asthma attack, respiratory distress with cough and fever, skin or eye jaundice, extreme lethargy, sudden severe headache, thunderclap headache, seizures, altered consciousness, visual disturbances, paralysis, urinary issues

Mild side effects

• Genital infection
• urinary tract infection
• hypoglycemia
• thirst
• dizziness
• constipation
• dry mouth
• back pain
• dysuria
• polyuria

This medication should be stored in a tightly closed container to prevent exposure to air or moisture, ideally at room temperature between 1°C and 30°C. Proper storage maintains the effectiveness of the medication.

Appearance

Yellow, double-sided convex diamond-shaped film-coated tablet

Package unit

28 tablets/box [(14 tablets/PTPX 2)]