Dapasita Tablets 10/100 mg (Dapagliflozin Propanediol Monohydrate, Sitagliptin Phosphate Monohydrate)

Adult dosage

This medication can be administered as 1 tablet once daily irrespective of meals to patients receiving sitagliptin 100 mg and dapagliflozin 10 mg. The tablet should be swallowed whole.

This medication may cause severe allergic reactions due to the sitagliptin component; therefore, if skin rash or difficulty breathing occurs within three months of administration, it must be stopped immediately and a doctor consulted. This medication can cause serious pancreatic diseases known as pancreatitis; therefore, symptoms such as abdominal pain, nausea, or vomiting should immediately be reported to a healthcare professional. Patients with allergies to the active ingredients or excipients, type 1 diabetes, diabetic ketoacidosis, or those on dialysis should not use this medication. Patients with decreased blood volume or renal impairment must have their condition assessed before administration and should regularly monitor blood pressure and kidney function during treatment. Especially elderly patients or those on diuretics are at a higher risk of dehydration or hypotension and should be observed carefully. This medication can increase the risk of genital and urinary tract infections; if infectious symptoms develop, immediate treatment should be sought, and patients with a history of infections should be more cautious. There is a risk of hypoglycemia, so careful attention should be paid to hypoglycemic symptoms when used in combination with insulin or sulfonylureas, and dosage adjustments may be necessary if needed. Pregnant or breastfeeding women should avoid using this medication, and it should be discontinued immediately if pregnancy is confirmed. Safety and efficacy have not been established in pediatric patients, so use is not recommended. In case of overdose, there are no specific antidotes, and appropriate treatment should be administered according to the symptoms, and necessary action should be taken per healthcare professionals' directions. Care should be taken when driving or operating machinery due to the risk of hypoglycemia, especially when taken in conjunction with insulin or sulfonylureas.

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe allergic reactions, severe rash with high fever, blisters, peeling skin, oral/ocular mucosal pain, severe dermatological reactions, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by cough and fever, jaundice (yellowing of the skin or eyes), extreme lethargy, liver abnormalities (jaundice), sudden and severe

Mild side effects

• Genital infections
• urinary tract infections
• hypoglycemia
• dizziness
• constipation
• dry mouth
• back pain
• polyuria
• nocturia
• vulvar pruritus

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

Appearance

Beige oval film-coated tablet

Package unit

30 tablets/PTP [(10 tablets/PTP x 3)]