Jeil Dapagline 10mg (Dapagliflozin bis L-Proline)

Adult dose

The recommended dosage for this medication is 10mg once daily for monotherapy and for additional combination therapy with insulin and other glucose-lowering agents. For initial combination therapy with metformin, the recommended dosage is either 5mg or 10mg once daily. The medication can be taken orally once daily at any time of the day regardless of meals, and the tablets should be swallowed whole.

Child dose

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

This medication should not be used in certain patients. Patients allergic to the main ingredient or excipients of this medication, patients with type 1 diabetes or diabetic ketoacidosis should not be administered this medication. Additionally, it contains anhydrous lactose, thus patients with lactose intolerance or specific genetic issues should also refrain from usage. This medication is not recommended for patients on dialysis. Caution should be exercised when administering this medication to patients with decreased fluid volume or poor kidney function. This medication may cause low blood pressure or changes in kidney function; therefore, fluid status and kidney function should be assessed prior to administration, and symptoms of hypotension and kidney function should be periodically checked after administration. In particular, for patients with moderate to severe impairment of kidney function, blood sugar control effectiveness may decrease, in which case administration is not recommended. Side effects such as genital infections, urinary tract infections, hypoglycemia, decreased fluid volume, and diabetic ketoacidosis may occur with this medication. Genital infections and urinary tract infections may be more common, especially in women, and patients with a past history of these infections are at higher risk of recurrence. Hypoglycemia may occur more frequently when used with medications such as insulin or sulfonylureas and should be monitored. Dehydration or hypotension symptoms may occur due to decreased fluid volume; in such cases, immediate consultation with healthcare professionals is necessary. It is advised that pregnant women should not use this medication, and if pregnancy is confirmed, administration should be stopped. Lactating women also should not use this medication as safety has not been established. Elderly individuals or patients with liver impairment may have increased serum concentrations of this medication and should be monitored closely. Additionally, glucose may be detected in urine tests while taking this medication, thus caution should be taken in interpreting test results. This medication may interact with other drugs, especially when combined with diuretics, insulin, and sulfonylureas, requiring dose adjustments. Patients taking other medications must inform their healthcare provider. In cases of overdose, as there is no specific antidote, appropriate symptomatic treatment is needed based on the symptoms, and the patient's condition should be closely monitored. This medication does not significantly affect driving or operating machinery; however, caution is necessary when combined with medications that pose a hypoglycemic risk. Lastly, the safety and effectiveness of this medication have not been confirmed in children under 18 years of age, thus it is not used in this population. To use this medication safely, regular check-ups and monitoring for side effects are important, and any unusual symptoms should be reported to healthcare professionals immediately.

Serious side effects

Urticaria, severe swelling, chest tightness, difficulty breathing, cold sweat, pallor, rash, blistering, peeling skin, pain in oral/eye mucosa, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by cough and fever, yellowing of skin or eyes (jaundice), extreme lethargy, sudden and very severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, markedly decreased urine output,

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 must be stored in a tightly sealed container to avoid exposure to air or moisture. Additionally, it should be stored at room temperature between 1 and 30 degrees Celsius, avoiding very hot or very cold places.

Appearance

Yellow, biconvex, diamond-shaped film-coated tablet

Package unit

7 tablets/PTP, 30 tablets/bottle