Forxiga 10 mg (Dapagliflozin Propanediol Hydrate)

Adult dose

The recommended dose of this medication is 10 mg once daily, used in monotherapy and as an adjunct therapy. In initial combination therapy, 5 mg or 10 mg may be administered once daily. For chronic heart failure and chronic kidney disease patients, 10 mg once daily is also recommended. It can be taken orally at any time of the day, regardless of meals, and the tablets should be swallowed whole.

Child dose

The efficacy and safety of this medication in pediatric patients under 18 years have not been established, and there are no relevant data.

This medication should not be used in patients with allergies to the active ingredient or excipients, and those with type 1 diabetes or diabetic ketoacidosis. Patients with lactose intolerance or specific genetic conditions, as well as those undergoing dialysis, should not receive it. Caution should be exercised in patients with volume depletion or kidney function impairment, and blood pressure and renal function should be monitored regularly before and during treatment. The blood sugar control effect of this medication decreases in patients with significantly reduced kidney function, and it is not recommended for patients with very low renal function. The most common side effect is genital infections, which may occur more frequently in women. Hypoglycemia may occur mainly when used with insulin or sulfonylureas, so caution is needed when combining these medications. This medication may cause dehydration or hypotension, so patients, especially the elderly or those taking diuretics, should carefully monitor their fluid status. There is a risk of developing severe metabolic anomalies known as diabetic ketoacidosis, so immediate treatment should be sought if related symptoms appear. Serious urinary infections, such as urinary tract infections and pyelonephritis, have been reported, so prompt treatment is necessary if there are any symptoms of infection. The safety of this medication in patients with severely impaired liver function has not been fully established, so caution is advised. Pregnant or nursing women are advised not to use this medication, and it should be discontinued if pregnancy is confirmed. Elderly patients require closer observation due to a higher risk of fluid volume decrease and kidney function impairment. This medication may increase the risk of hypoglycemia when used with insulin or insulin secretagogues, potentially requiring dosage adjustment of these drugs. In case of overdose, there is no specific antidote; instead, symptom-related treatment should be administered while closely monitoring the condition. During the use of this medication, blood sugar control should be regularly checked, and immediate medical consultation is necessary if any abnormal symptoms occur. Moreover, this medication has not established safety and effectiveness in children, so it is advisable not to use it in this population. Lastly, this medication should be kept out of the reach of children and stored in its original container to maintain quality.

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, paleness, severe allergic reactions, high fever with severe rash, blisters, skin peeling, oral/ocular mucosal pain, severe skin adverse reactions, shortness of breath or difficulty breathing, asthma attacks, respiratory distress with cough and fever, breathing problems, yellowing of the skin or eyes (jaundice), extreme lethargy, liver issues (jaundice), sudden and severe complications.

Mild side effects

Vulvovaginitis, balanitis and related genital infections, urinary tract infections, fungal infections, hypoglycemia, dry mouth, dizziness, constipation, back pain, urinary pain, polyuria, nocturia, increased hematocrit, decreased creatinine clearance at the start of treatment, dyslipidemia, elevated creatinine levels at the start of treatment, elevated blood urea, weight loss, edema, chest pain, fatigue, foreign body sensation, facial swelling, facial pain, warmth, flu-like symptoms.

This medication must be stored in a tightly closed container to protect it from air and humidity. It is important to maintain a storage temperature between 1 and 30 degrees Celsius. This will ensure the medication's effectiveness is preserved safely.

Appearance

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

Package unit

28 tablets (7 tablets/PTP×4)