Jardiance 10mg (Empagliflozin)

Adult dose

The recommended dose of this medication is 10 mg once daily for monotherapy and addition to other blood glucose-lowering agents such as insulin. If good tolerance is achieved at 10 mg, and further glycemic control is needed, the dose may be increased to 25 mg once daily. This medication can be taken irrespective of meals. The tablet should be swallowed whole. If a dose is missed, take it as soon as remembered, but do not double the dose for the day.

This medication should not be administered to patients with hypersensitivity to the active ingredient or any components. It should not be used in patients with type 1 diabetes or diabetic ketoacidosis. This medication is not administered to patients with severely impaired kidney function, specifically those with a glomerular filtration rate below 30 mL/min/1.73m2, those with end-stage renal disease, or those undergoing dialysis. Since this medication contains lactose, it should not be used in patients with genetic lactose-related issues, such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption. Patients with a kidney function of less than 60 mL/min/1.73m2 should not initiate treatment with this medication, and those already under treatment may need dosage adjustments. If renal function drops below 45 mL/min/1.73m2, this medication should be discontinued. This medication is not expected to be effective in patients with end-stage renal disease or those undergoing dialysis. In patients with mild to moderate heart failure, it should be used cautiously, and it is not recommended for patients with severe heart failure. When combined with medications like insulin or sulphonylureas, the risk of hypoglycemia may be present, so dosage adjustments may be necessary. Be aware of possible adverse reactions during use, including hypoglycemia, genital infections, increased urination frequency, urinary tract infections, decreased fluid volume, increased serum creatinine, etc. Especially, ketoacidosis can be life-threatening, so if symptoms appear, promptly discontinue treatment and consult a healthcare professional. Elderly patients are at higher risk of fluid loss, so careful monitoring is required, and it is not recommended for patients over 85 years of age. For patients at risk of fluid loss, such as those with hypotension or cardiovascular disease, it should be administered with caution. Serious urinary infections such as urosepsis and pyelonephritis can occur, so if there are signs of infection, treatment should be initiated immediately. This medication may increase the risk of genital fungal infections, so patients with related medical history should be especially cautious. A positive urine glucose test may occur; consider this when interpreting test results. Be cautious of the risk of hypoglycemia when driving or operating machinery. It is recommended not to use this medication during pregnancy, and if pregnancy is confirmed, treatment should be discontinued. During breastfeeding, this medication may be excreted in breast milk, so it is advised to discontinue breastfeeding. The safety and efficacy in children under 18 years of age have not been established, so it should not be used in this population. In case of overdose, appropriate treatment based on clinical symptoms will be necessary, and studies on whether this medication can be removed by hemodialysis are not available. This medication should be stored out of reach of children, and it should not be transferred to another container.

Serious side effects

• Hives
• angioedema
• ketoacidosis
• urosepsis
• pyelonephritis
• perineal necrosis
• severe allergic reactions
• severe skin reactions
• severe edema or urination abnormalities

Mild side effects

• Vulvovaginitis
• vulvar candidiasis
• balanitis
• and other genital infections
• hypoglycemia
• rash
• increased urination
• increased serum lipids
• increased serum creatinine
• decreased glomerular filtration rate

This medication is sensitive to air and moisture, so it must be stored in a tightly sealed container. The storage temperature should be maintained between 1 and 30 degrees Celsius at room temperature.

Appearance

Pale yellow, round film-coated tablet

Package unit

30 tablets/PTP [(10 tablets/PTP x 3)]