Flositadol 10/100 mg (Dapagliflozin, Sitagliptin)

Adult dosage

For patients receiving 100 mg of sitagliptin and 10 mg of dapagliflozin, one tablet may be administered once daily regardless of meals. The tablet must be swallowed whole.

This medication may cause allergic reactions due to the sitagliptin component, and in severe cases, it may lead to anaphylaxis or skin conditions. Therefore, if any abnormal symptoms occur within the first 3 months, patients should immediately discontinue use and consult a doctor. Additionally, sitagliptin can cause acute pancreatitis, so if symptoms of pancreatitis, such as abdominal pain or vomiting occur after taking this medication, discontinue use immediately and go to a hospital. This medication should not be used in patients with type 1 diabetes, diabetic ketoacidosis, or those undergoing dialysis. The dapagliflozin component may cause hypotension or renal function deterioration in patients with decreased fluid volume and kidney impairment. Therefore, it is essential to check fluid status and renal function before administration, and monitor for hypotensive symptoms and changes in renal function during the therapy. In patients with significantly impaired renal function, the blood sugar control effect of this medication may be reduced, and its use is not recommended in those with low renal function. If there is an allergy to the Yellow No. 5 component included in this medication, it should be used with caution. During treatment, genital infections or urinary tract infections may occur, and appropriate treatment should be sought if symptoms arise. There is a risk of hypoglycemia; therefore, caution is advised when taking this medication with other hypoglycemic agents such as insulin or sulfonylureas, and dosage adjustments of other medications may be necessary if needed. It is recommended that women who are pregnant or breastfeeding do not use this medication, especially during breastfeeding, as it may excrete into breast milk. Elderly patients or those with reduced renal function require dosage adjustments and renal function tests; they should be cautious due to an increased risk of hypotension from decreased fluid volume. In cases of overdose, there is no specific antidote, so appropriate treatment should be provided based on symptoms, and dialysis may be considered if necessary. Finally, the safety and efficacy of this medication in children have not been established; hence, it should not be used in patients under 18 years of age.

Serious side effects

• Hives
• severe swelling (edema)
• chest tightness
• difficulty breathing
• cold sweat
• pallor
• anaphylaxis
• angioedema
• Stevens-Johnson syndrome
• exfoliative dermatosis

Mild side effects

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

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

Appearance

Yellow to orange, biconvex, round film-coated tablet

Package unit

28 tablets / box [(7 tablets / PTP (Alu-Alu) x 4)]