Rosi 10 mg (Dapagliflozin)

Adult dose

For type 2 diabetes as monotherapy or in combination therapy, the recommended dose is 10 mg orally once a day. In initial combination therapy, it can be administered at 5 mg or 10 mg orally once a day when combined with metformin. It can be taken at any time of the day regardless of meal intake, and the tablet should be swallowed whole.

Child dose

The efficacy and safety of dapagliflozin in children under the age of 18 years have not been established; thus, it is not recommended for use.

This medication should not be used by patients with allergies to the active ingredients or excipients. Patients with type 1 diabetes or diabetic ketoacidosis should not take this medication either. Patients with hereditary lactose intolerance or certain deficiencies in lactose-decomposing enzymes should not be treated with this drug. Moreover, patients undergoing dialysis should not use this medication. Patients with low fluid volume or impaired kidney function should use this medication cautiously. This drug can lower blood pressure or affect kidney function, thus monitoring the patient's fluid status and kidney function is essential before and during administration. Especially, elderly patients or those on diuretics are at higher risk for hypotension and need careful observation. During treatment with this medication, genital infections and urinary tract infections may occur frequently. If any infection symptoms arise, immediate treatment should be sought, and discontinuation of the medication may be considered if the infection is severe. Hypoglycemic symptoms may appear, so dosage adjustments are necessary when used with insulin or sulfonylureas, which pose a hypoglycemic risk. Dehydration or hypotensive symptoms due to decreased fluid volume may occur, so patients at risk for dehydration should be vigilant about their hydration status. Diabetic ketoacidosis may develop, so if symptoms such as nausea, vomiting, abdominal pain, or difficulty in breathing appear, immediate consultation with a physician is required. This medication may impact kidney function; hence regular kidney function tests are necessary. Serious infections such as perineal necrosis may rarely occur, so if there is pain or redness around the genitals, medical advice should be sought immediately. Use of this medication during pregnancy is not recommended, and it should be discontinued upon confirmation of pregnancy. Lactating women are also recommended not to use this medication. The safety and efficacy of this medication in children have not been established, so it is not recommended for pediatric use. In cases of overdose, immediate medical attention should be obtained, and there is no information on whether this drug can be removed by dialysis. Caution is advised regarding hypoglycemic symptoms while driving or operating machinery during treatment with this medication. This medication should be stored in its original container, out of reach of children.

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, paleness, severe rash with high fever, blisters, peeling skin, pain in the mucous membranes of the mouth/eyes, shortness of breath or difficulty breathing, asthma attacks, pulmonary issues accompanied by cough + fever, yellowing of the skin or eyes (jaundice), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urination changes

Mild side effects

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

This medication may be sensitive to air and humidity; therefore, it must be stored in a tightly sealed container. The optimal storage temperature is at room temperature between 1°C and 30°C.

Appearance

Yellow, bilaterally convex, diamond-shaped film-coated tablet

Package unit

100 tablets/bottle, 8 tablets/box [(8 tablets/Alu-Alu)]