SAMDAPADUO Tablets 10/100 mg (Dapagliflozin Propanediol Hydrate, Sitagliptin Phosphate Hydrate)

Adult dosage

This medication can be administered to patients receiving 100 mg of sitagliptin and 10 mg of dapagliflozin as one tablet once daily, regardless of meals. The tablet must be swallowed whole.

This medication contains sitagliptin and dapagliflozin and is used for the treatment of diabetes. Firstly, sitagliptin may cause severe allergic reactions such as anaphylaxis, angioedema, and serious skin conditions in some patients, so if these symptoms occur, the medication should be discontinued immediately and a doctor should be consulted. Additionally, acute pancreatitis may occur, so if symptoms like abdominal pain or vomiting appear, medical personnel should be informed immediately. Next, this medication should not be used in patients with type 1 diabetes, diabetic ketoacidosis, or those on dialysis. Caution is required when administering dapagliflozin to patients with decreases in fluid volume or impaired kidney function. In particular, elderly patients or those taking diuretics are at risk of low blood pressure or worsening kidney function, so regular monitoring of kidney function and blood pressure should be conducted before and during treatment. During the use of this medication, the risk of genital and urinary tract infections may increase, so if symptoms of infection appear, immediate treatment should be sought. Furthermore, symptoms of hypoglycemia may occur, so blood sugar levels should be closely monitored, especially when taken with insulin or sulfonylureas. There is a risk of serious metabolic derangement known as ketoacidosis; if symptoms such as nausea, vomiting, abdominal pain, or respiratory distress develop, go to the hospital immediately. Pregnant or breastfeeding women are advised against using this medication, and if pregnancy is planned or confirmed, the medication should be discontinued. Elderly patients may have reduced kidney function, so dose adjustments and regular kidney function tests are necessary. In the case of overdose, there are no specific antidotes, so appropriate treatment should be given according to symptoms, and dialysis treatment may be considered if necessary. Finally, while this medication does not significantly affect driving or operating machinery, caution is advised due to the risk of hypoglycemia. It is important to consult a doctor or pharmacist immediately if any suspicious symptoms arise during the use of this medication.

Serious side effects

Hives, severe swelling (edema), anaphylaxis, angioedema, chest tightness, difficulty breathing, cold sweat, pallor, Stevens-Johnson syndrome and exfoliative skin conditions, severe rashes with high fever, vesicular rash, skin peeling, oral/ocular mucosal pain, acute pancreatitis, hemorrhagic or necrotizing pancreatitis, acute kidney injury, renal impairment, jaundice, severe lethargy, headaches, thunderclap headaches, seizures, confusion, visual disturbances

Mild side effects

• Vulvovaginitis
• balanitis and related genital infections
• urinary tract infections
• dry mouth
• dizziness
• constipation
• dry mouth
• back pain
• dysuria
• polyuria

This medication may be sensitive to air or moisture, so it must be stored in a sealed container. It is advisable to maintain a storage temperature between 1°C and 30°C to preserve the medication's efficacy for a long time.

Appearance

Beige oval film-coated tablet

Package unit

30 tablets/box [10 tablets/PTP*3]