Empagliflozin 10 mg Tablets

Adult dose

The recommended dosage of this medicine is 10 mg once daily for monotherapy and additional combination therapy with insulin or other blood glucose-lowering agents. If there is good tolerance to 10 mg, the dose may be increased to 25 mg once daily when further blood sugar control is necessary. This medicine can be taken with or without food. The tablets should be swallowed whole. If a dose is missed, it should be taken as soon as remembered.

This medicine should not be used in patients with allergic reactions to the active ingredient or any component. It should not be administered to patients with type 1 diabetes or diabetic ketoacidosis. It is not used in patients with severely impaired kidney function, particularly those with a glomerular filtration rate below 30 mL/min/1.73m2 or in patients with end-stage renal disease or undergoing dialysis. Additionally, this medicine contains lactose and should not be administered to patients with metabolic disorders such as galactose intolerance, lactase deficiency, or glucose-galactose malabsorption. Patients with renal impairment should be closely monitored for kidney function when using this medicine, and if the glomerular filtration rate is below 60 mL/min/1.73m2, dosage adjustment or discontinuation should be considered. In patients with heart failure classified as NYHA class III-IV, its use is not recommended, and it should be used with caution in class I-II patients. When used in combination with insulin or sulfonylureas, there may be an increased risk of hypoglycemia, requiring dosage adjustments. This medicine has been reported to cause primarily hypoglycemia, genital infections, increased urination, urinary tract infections, decreased fluid volume, increased blood creatinine levels, and other adverse reactions. Severe metabolic abnormalities such as ketoacidosis may occur; therefore, treatment should be stopped immediately if related symptoms appear and a medical evaluation should be sought. Elderly patients, especially those over 75 years old, are at higher risk for fluid loss; therefore, caution is needed and physical status should be closely monitored in situations that may cause fluid volume loss. This medicine may increase the risk of serious urinary infections, such as urosepsis and pyelonephritis, so prompt treatment is necessary if there are signs of infection. There may also be an increased risk of genital fungal infections, so monitoring and appropriate treatment are required. A positive reaction may appear on urine glucose tests, which should be taken into consideration. Caution is required when driving or operating machinery due to the risk of hypoglycemia, especially when taken with insulin or sulfonylureas. It should be avoided during pregnancy, and treatment should be discontinued immediately upon confirmation of pregnancy. For breastfeeding, it is recommended to discontinue breastfeeding as this medicine may be excreted in breast milk. The safety and effectiveness of this medicine in children, i.e., patients under 18 years of age, have not been established; therefore, it should not be used. No specific toxic symptoms have been reported in cases of overdose, but appropriate treatment based on clinical condition is necessary. This medicine should be kept out of reach of children, and transferring it to another container should be avoided.

Serious side effects

• Hives
• angioedema
• ketoacidosis
• urosepsis
• pyelonephritis
• necrotizing fasciitis

Mild side effects

• Hypoglycemia
• vulvovaginal candidiasis
• vulvitis
• balanitis
• other genital infections
• increased urination
• urination difficulties
• itching
• rash
• increased serum lipids

This medicine may be sensitive to air and moisture, so it must be stored in a tightly sealed container. It is also advisable to store it at room temperature, avoiding extremes of cold or hot, with a temperature maintained between 1 degree and 30 degrees.

Appearance

Light yellow, round film-coated tablets

Package unit

30 tablets/PTP (10 tablets/PTP × 3), 10 tablets/PTP (10 tablets/PTP × 1)