Floga 10 mg (Dapagliflozin Propanediol Monohydrate)

Adult dose

The recommended dosage of this medication is 10 mg once daily for monotherapy and additional combination therapy with other glucose-lowering agents such as insulin. For initial combination therapy, when used in conjunction with metformin, the initial recommended dosage is 5 mg or 10 mg once daily. For patients with chronic heart failure and chronic kidney disease, the recommended dosage is 10 mg once daily. It can be taken orally at any time of the day, regardless of food intake.

Child dose

The safety and efficacy of dapagliflozin in pediatric patients under 18 years of age have not been established.

This medication should not be used in patients who are allergic to the active ingredients or additives of this drug. It should not be administered to patients with type 1 diabetes or diabetic ketoacidosis. Patients with lactose intolerance or certain genetic metabolic disorders should not use this medication due to the lactose content. This medication should not be administered to patients undergoing dialysis. Patients with reduced fluid volume or renal dysfunction should use this medication with caution and should regularly check their kidney function and fluid status. Particularly in elderly patients or those on diuretics, and in patients with reduced renal function, careful management is necessary as the risk of hypotension or kidney damage may be increased. The blood sugar control effect of this drug may vary according to kidney function, and it is not recommended for patients with significantly reduced kidney function. During treatment with this medication, genital infections and urinary tract infections may occur, so immediate treatment should be sought if symptoms of infection appear. There is a risk of hypoglycemia, so close observation for hypoglycemic symptoms is necessary when used in combination with medications such as insulin or sulfonylureas. Dehydration or hypotension symptoms may occur due to reduced fluid volume, so adequate hydration and consultation with a physician in case of symptom occurrence are required. Serious metabolic disturbances like diabetic ketoacidosis may occur, so if symptoms such as vomiting, abdominal pain, or breathing difficulties are present, notify medical personnel immediately. Women who are pregnant or nursing should preferably not use this medication; if pregnancy is confirmed, treatment should be discontinued. The safety and efficacy of this medication have not been sufficiently established for children, so it should not be used in pediatric patients. In case of an overdose, there is no specific antidote, and appropriate treatment should be administered according to the symptoms, following the physician's directions. This medication does not significantly affect the ability to drive or operate machinery, but caution is necessary in the case of hypoglycemia.

Serious side effects

• Urticaria, severe swelling (edema), sweating → severe allergic reaction
• High fever with severe rash, blisters, skin peeling, mouth/eye mucosal pain → severe skin adverse reaction
• Shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by cough + fever → respiratory issues
• Interstitial nephritis, yellowing of the skin or eyes (jaundice), profound fatigue → liver issues (jaundice)
• Sudden, very severe headache,

Mild side effects

Vulvitis, balanitis and related genital infections, urinary tract infections, hypoglycemia, thirst, dizziness, constipation, dry mouth, back pain, dysuria, polyuria, nocturia, interstitial nephritis, increased hematocrit, decreased renal creatinine clearance at the beginning of treatment, dyslipidemia, increased serum creatinine during early treatment, elevated blood urea, weight loss, urine abnormalities, urgency, edema, urticaria, sweating, itching, headache, perianesthesia.

This medication must be stored in a tightly sealed container to protect it from air and moisture. It is best to keep the medication at room temperature between 1°C and 30°C, avoiding excessively cold or hot places.

Appearance

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

Package unit

Bottle - 30 tablets/bottle, Bottle - 100 tablets/bottle, Box - 28 tablets/box[((7 tablets/Alu-Alu)x4)]