DapaRose Tablets 10/100 Milligrams (Dapagliflozin Citric Acid, Sitagliptin Hydrochloride Hydrate)

Adult dosage

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

This medication should not be used in patients with hypersensitivity to certain components. Special attention should be paid as allergic reactions or severe skin diseases may occur. During the use of this medication, inflammation of the pancreas called pancreatitis may occur, so if symptoms like abdominal pain or vomiting appear, immediate medical attention should be sought. Patients with poor kidney function or dehydration, elderly patients, and patients on diuretics should thoroughly check kidney function and fluid status before starting this medication, and regularly monitor kidney status and blood pressure during treatment. This medication is not to be used in patients with severe type 1 diabetes, diabetic ketoacidosis, specific genetic lactose intolerance disorders, and patients undergoing dialysis. While this medication helps control blood sugar, the risk of hypoglycemia may increase if taken with insulin or sulfonylureas, so dosage adjustments may be necessary in such cases. During use, genital infections or urinary tract infections may occur, and if symptoms of infection arise, immediate treatment should be sought, particularly for those with a history of infections. This medication may cause dehydration or hypotension, hence it is advisable to temporarily stop taking it and consult with healthcare professionals when there are circumstances or symptoms indicative of fluid loss. It is recommended that pregnant or breastfeeding women do not use this medication, and if pregnancy is confirmed, discontinuation should occur immediately. The safety and efficacy in children and adolescents under 18 years have not yet been established, thus it should not be used in this population. This medication does not significantly impact driving or machinery operation; however, caution is required due to the risk of hypoglycemia. There are no specific antidotes for overdose, so appropriate treatment should be administered according to symptoms, following healthcare provider directions.

Serious side effects

Severe hypersensitivity reactions (anaphylaxis, angioedema), Stevens-Johnson syndrome, acute pancreatitis (including hemorrhagic or necrotizing), symptomatic hypotension due to decreased fluid volume, acute kidney injury, diabetic ketoacidosis, urosepsis and pyelonephritis, severe urinary tract infections, perineal necrosis (Fournier's gangrene), severe skin adverse reactions (severe rash with fever, blistering, skin peeling, pain in oral/ocular mucosa), liver abnormalities (skin

Mild side effects

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

This medication should be stored in a tightly closed container to prevent exposure to air or moisture, and it is recommended to keep it at room temperature between 1 degree and 30 degrees Celsius. Proper storage can prolong the effectiveness of the medication.

Appearance

Yellow rectangular film-coated tablet

Package unit

28 tablets/box - 28 tablets/box [7 tablets/ptp x 4], 30 tablets/box - 30 tablets/box [10 tablets/ptp x 3]