Dapagena 10mg (Dapagliflozin Monohydrate and Lactose Mixture)

Adult dose

The recommended dosage for this medicine is 10mg once daily for both monotherapy and additional combination therapy with insulin or other hypoglycemic agents. During initial combination therapy, the recommended starting dose is either 5mg once daily or 10mg once daily when used with metformin. Dose adjustments are included for renal impairment, liver impairment, and elderly patients. This medicine can be taken regardless of food intake, once daily at any time of the day.

Child dose

The efficacy and safety of this medication in pediatric patients under 18 years of age have not been established.

This medicine should not be used in patients who have had allergic reactions to the active ingredient or excipients. It should not be given to patients with type 1 diabetes or diabetic ketoacidosis. Patients with genetic lactose intolerance, such as galactose intolerance or lactase deficiency, may be at risk when taking this medicine. Patients undergoing renal dialysis should also refrain from using this medicine. In patients with low fluid volume or impaired renal function, this medicine should be used with caution, As it can lead to lowering blood pressure or worsening kidney function, it is essential to thoroughly check fluid status and kidney function before and during administration. Especially elderly patients or patients on diuretics are at a higher risk of hypotension and require caution. This medicine contains Yellow No. 4 and Yellow No. 5 dyes, so patients with a history of allergy to these ingredients should be careful. Infection symptoms may occur, such as genital and urinary tract infections, so immediate consultation with medical personnel is recommended if any symptoms of infection emerge. Also, hypoglycemic symptoms may arise, thus dose adjustments may be necessary if taken alongside insulin or sulfonylureas to reduce the risk of hypoglycemia. Symptoms such as dehydration, hypotension, dry mouth may occur due to decreased fluid volume, thus adequate hydration and symptom monitoring are crucial. Diabetic ketoacidosis, a severe metabolic disturbance, may occur rarely, and this symptom can arise even when blood sugar levels are not elevated, Thus, immediate medical attention should be sought if experiencing symptoms like nausea, vomiting, abdominal pain, or difficulty breathing. This medicine's effectiveness can vary based on kidney function, hence patients with severely impaired kidney function may experience reduced blood sugar control effects. Women who are pregnant or planning to become pregnant should avoid using this medicine, And breastfeeding women should also avoid taking this medicine for safety reasons. There is no specific antidote for overdosing, so appropriate treatment should be provided according to symptoms, And if an overdose is suspected, immediate consultation with medical personnel is necessary. While taking this medicine, caution should be exercised when driving or operating machinery due to the potential for hypoglycemic side effects, Especially when combined with insulin or sulfonylureas, more caution is needed. Finally, the safety and efficacy in children have not been established, so it is not used in pediatric patients.

Serious side effects

Hives, severe swelling (edema), angioedema, chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blistering, skin peeling, pain in oral/eye mucosa, yellowing of skin or eyes (jaundice), severe lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, significantly reduced urine output, severe edema with increased blood pressure

Mild side effects

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

This medicine should be stored in a tightly sealed container to prevent exposure to air or moisture, and it is important to maintain a storage temperature between 1°C and 30°C room temperature. By storing this way, the effectiveness of the medicine can be safely preserved.

Appearance

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

Package unit

28 tablets/PTP [(7 tablets/PTP x 4, 14 tablets/PTP x 2)]