Duo-Sustained Release Tablet 10/1000 mg

Adult dose

This medication is generally administered once daily with the evening meal. The maximum dosage is 10 mg of dapagliflozin/2000 mg of sustained-release metformin once daily, given as 2 tablets of 5 mg/1000 mg. For initial therapy, the recommended starting dose is 5 mg/500 mg or 10 mg/500 mg once daily. To reduce gastrointestinal side effects of metformin, the dosage should be adjusted gradually.

This medication is a combination product used to help control blood glucose in patients with type 2 diabetes. While this medication is taken, it is necessary to be cautious as there is a very rare but serious risk of lactic acidosis, a dangerous condition that can occur. Lactic acidosis is a state where lactic acid is excessively accumulated in the body and leads to acidification, with symptoms such as shortness of breath, muscle pain, weakness, abdominal pain, requiring immediate treatment. Additionally, when taken with insulin or sulfonylureas, there is a risk of hypoglycemia, and blood sugar changes should be closely monitored. Patients with decreased renal function, especially those with moderate to severe renal dysfunction, should not use this medication, and those with unstable renal function need renal function tests before and during taking this medication. In acute diseases that may affect renal function, such as dehydration, severe infection, cardiac function deterioration, and acute myocardial infarction, this medication should be avoided. Women who are pregnant or may become pregnant and those who are breastfeeding should not take this medication. This medication contains lactose, and patients with lactose intolerance or specific genetic metabolism disorders should not use it. During treatment, there may be an increased occurrence of genital infections and urinary tract infections, so cleanliness should be maintained, and if symptoms occur, immediate consultation with a physician is required. Hypotension or dehydration due to reduced fluid volume may occur, so especially elderly patients or those taking diuretics should periodically check blood pressure and fluid status. Vitamin B12 deficiency may occur, thus it is advisable to check serum vitamin B12 levels with long-term use. If there are plans for sudden surgery or tests using iodine contrast media during the period of taking this medication, temporarily discontinuing use and consulting healthcare professionals is recommended. Excessive alcohol consumption may increase the risk of side effects with this medication, so it should be avoided. Symptoms of hypoglycemia may appear, so if dizziness, cold sweat, or severe fatigue are felt, blood sugar should be checked immediately and necessary actions taken. The safety and efficacy of this medication in children have not been established, hence it should not be used in pediatric patients. During use, keep this medication out of reach of children and store it in its original container to maintain its quality.

Serious side effects

Lactic acidosis, diabetic ketoacidosis, necrotizing fasciitis, urosepsis and pyelonephritis, acute kidney injury and renal dysfunction, acute cholecystitis, Guillain-Barré syndrome, atrial fibrillation, chest pain, severe allergic reactions (hives, swelling, chest tightness, difficulty breathing, cold sweat, pallor), severe skin adverse reactions (severe rash accompanied by fever, blistering, skin peeling, pain in oral/eye mucosa), respiratory problems (shortness of breath or difficulty breathing)

Mild side effects

Vulvovaginitis, balanitis and related genital infections, urinary tract infections, fungal infections, hypoglycemia, dry mouth, dizziness, constipation, lumbar pain, dysuria, polyuria, nocturia, vulvar itching, genital itching, increased hematocrit, decreased creatinine clearance at the beginning of treatment, dyslipidemia, increased serum creatinine at the beginning of treatment, elevated blood urea, weight loss, diarrhea, nausea/vomiting, decreased/deficiency of vitamin B12

This medication should be stored in a tightly closed container to protect it from air and moisture. It is important to maintain a storage temperature between 1 degree and 30 degrees Celsius.

Appearance

Yellow to deep yellow, biconvex, oval, film-coated tablet

Package unit

30 tablets/box [(6 tablets/PTP)x5], 28 tablets/box [(7 tablets/PTP)x4]