Empagliflozin 25 mg Tablet

Adult dose

The recommended dosage of this medication for monotherapy and additional combined therapy with insulin or other antidiabetic agents is once daily 10 mg. If the patient tolerates 10 mg well and requires further blood sugar control, the dose can be increased to 25 mg once daily. This medication can be administered without regard to meals. Tablets should be swallowed whole. If a dose is missed, take it as soon as you remember.

This medication should not be used in patients with an allergic reaction to the active ingredient or any of its components. It should not be administered to patients with Type 1 diabetes or diabetic ketoacidosis. Patients with severely impaired renal function, end-stage renal disease, or those undergoing dialysis should not use this medication. Since this medication contains lactose, patients with lactose intolerance, galactose intolerance, or hereditary lactose intolerance should not take it. Patients with some degree of impaired renal function should use this medication cautiously, and dose adjustments or discontinuation may be necessary based on renal function status. In cases of severe heart failure, the use of this medication is not recommended, so caution is advised. When combined with insulin or insulin secretagogues, there may be a risk of hypoglycemia, which may require dose adjustment. While taking this medication, side effects such as hypoglycemia, genital infections, increased urination, urinary tract infections, and fluid depletion may occur, so symptoms should be closely monitored. Particularly, serious metabolic diseases such as ketoacidosis may occur; if symptoms arise, immediate consultation with healthcare professionals is required. Elderly patients or those at high risk of fluid volume loss should be cautious of dehydration and hypotension, and if necessary, the administration of this medication may be temporarily suspended. This medication may affect kidney function, so regular renal function monitoring is recommended. There is a risk of serious urinary tract infections such as urosepsis and pyelonephritis; if infection symptoms appear, prompt treatment is necessary. Use of this medication during pregnancy is not recommended, and it should be discontinued if pregnancy is confirmed. In breastfeeding patients, this medication may be excreted in breast milk, so it is safer to halt breastfeeding. Its safety and efficacy have not been established in children under 18 years of age, so it is not used in this population. No specific toxic symptoms have been reported in cases of overdose; however, appropriate treatment is required depending on the patient's condition. This medication should be kept out of reach of children and should not be transferred to other containers. When driving or operating machinery, particularly when used with insulin or sulfonylureas, caution against the risk of hypoglycemia is advised. Rare serious side effects such as limb amputation or perineal necrosis have been reported, so if relevant symptoms occur, immediate notification to healthcare professionals is necessary.

Serious side effects

• Urticaria
• angioedema
• ketoacidosis
• rash
• subcutaneous tissue reactions
• urosepsis
• pyelonephritis
• perineal necrosis

Mild side effects

• Hypoglycemia
• vulvovaginitis
• balanitis
• and other genital infections
• increased urination
• urinary tract infection
• fluid volume depletion
• elevated serum creatinine
• decreased glomerular filtration rate
• itching

This medication should be stored in a sealed container to protect it from air and moisture. The recommended storage temperature is room temperature between 1 degree and 30 degrees.

Appearance

Pale yellow oval film-coated tablet

Package unit

30 tablets/box [(10 tablets/PTP × 3)]