Yongjin Dapagliflozin 5mg (Dapagliflozin Monohydrate Mixture)

Adult dose

The recommended dose of this medication for monotherapy and for combination with other glucose-lowering medications, such as insulin, is 10mg once daily. This medication can be taken orally at any time during the day, regardless of meals. The tablet should be swallowed whole. For initial combination therapy with metformin, the recommended starting dose is 5mg or 10mg once daily. In patients with renal impairment, liver impairment, and elderly patients (≥65 years).

This medication should not be used in certain patients. It should not be administered to patients who are allergic to the main component or additives of this medication, patients with type 1 diabetes, patients with diabetic ketoacidosis, and patients with genetic lactose intolerance issues. Additionally, it should not be used in patients with severely impaired kidney function, end-stage kidney disease, or those undergoing dialysis. Patients with kidney function problems or suspected acute kidney injury should use this medication with caution. Especially patients with reduced blood volume, chronic kidney failure, heart failure, or those taking diuretics or specific antihypertensive medications are at higher risk of acute kidney injury and should have their condition checked carefully before administration. If fluid loss occurs, drug administration should be temporarily suspended and kidney function should be closely monitored. In patients with severe symptoms of heart failure, the use of this medication is not recommended, and caution is required for patients allergic to the colorants included in the medication. Using this medication may result in hypoglycemia, decreased fluid volume, infections (particularly genital and urinary tract infections), abnormal kidney function, changes in specific hormone levels in the blood, etc. Hypoglycemia is especially more likely to occur when taken together with insulin or sulfonylureas, so caution should be exercised. Pregnant or breastfeeding women should not use this medication, and the safety for children has not been established. This medication should be used with caution in patients at risk of dehydration or hypotension, as serious metabolic disturbances such as ketoacidosis may occur, and immediate consultation with medical personnel is necessary if symptoms arise. This medication may interact with other drugs, so especially when taken with diuretics, insulin, or insulin secretagogues, the doctor's instructions should be closely followed. In case of overdose, appropriate treatment is required based on symptoms, and while this medication has minimal effects on driving or machine operation capabilities, caution is needed due to the risk of hypoglycemia. This medication may be restricted or not recommended for specific patient groups such as children, pregnant women, and patients with severely impaired kidney or liver function, so medical consultation is required.

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, skin peeling, oral/ocular mucosal pain, shortness of breath or difficulty breathing, asthma attacks, breathing abnormalities accompanied by cough+fever, jaundice (yellowing of the skin or eyes), profound fatigue, sudden and very severe headaches, thunderclap headaches, seizures, confusion of consciousness, visual disturbances, paralysis, urination

Mild side effects

• Hypoglycemia
• decreased fluid volume
• thirst
• dizziness
• constipation
• dry mouth
• low back pain
• painful urination
• polyuria
• nocturia

This medication may be sensitive to air or moisture; therefore, it should be stored in a sealed container. Storage temperature should be suitable at room temperature between 1 to 30 degrees Celsius, avoiding very hot or cold places.

Appearance

Yellow, biconvex, round film-coated tablet

Package unit

28 tablets/box [(7 tablets/PTP x 4)]