Empagliflozin 25 mg tablet

Adult dose

The recommended dosage of this medication for monotherapy and additional combination therapy with other hypoglycemic agents such as insulin is 10 mg once daily. If this dosage of 10 mg is well tolerated and additional blood sugar control is needed, it may be increased to 25 mg once daily. This medication can be taken regardless of meals. The tablets should be swallowed whole. Do not double the dose.

This medication should not be used in patients who are allergic to the active ingredient or its components. Additionally, it should not be administered to patients with type 1 diabetes or diabetic ketoacidosis. Patients with severely impaired kidney function, namely those with an estimated glomerular filtration rate (eGFR) below 30 mL/min/1.73 m2 or those with end-stage renal disease or on dialysis, should not receive this medication. This medication contains lactose; therefore, patients with genetic conditions such as lactose intolerance, lactase deficiency, or glucose-galactose malabsorption should not use it. In patients with mildly impaired kidney function, the dosage of this medication should be adjusted or discontinued, and regular monitoring of kidney function is essential. In patients with mild to moderate heart failure, caution should be exercised when using this medication, and it is not recommended for patients with severe heart failure. When used with insulin or insulin secretagogues, there is a risk of hypoglycemia, and the dosages of these medications may need to be reduced. Patients should be aware that side effects such as hypoglycemia, urinary tract infections, genital infections, increased urination, and decreased fluid volume may occur while taking this medication. Particularly, severe metabolic acidosis known as ketoacidosis can occur, and immediate treatment should be sought if symptoms arise. Elderly patients or those at risk of fluid volume loss should be cautious as dehydration or hypotension may occur. Additionally, this medication may rarely cause serious infections such as genital necrosis; thus, if pain or swelling occurs around the genital area, medical personnel should be notified immediately. It is recommended that pregnant or breastfeeding women do not use this medication, and if pregnancy is confirmed, cessation of treatment should occur. The safety and efficacy in children under 18 years of age have not been established. In case of overdose, appropriate treatment should be initiated based on clinical conditions, and this medication may increase urine output. This medication may interact with other drugs, so if other medications are being taken, healthcare providers should be informed. Caution is necessary while driving or operating machinery due to the risk of hypoglycemia. Regular monitoring of kidney function and blood sugar levels is important while on this medication.

Serious side effects

• Urticaria
• angioedema
• genital necrosis
• ketoacidosis
• urosepsis
• pyelonephritis
• rash
• angioedema
• genital necrosis
• ketoacidosis

Mild side effects

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

This medication should be stored in a tightly closed container to prevent exposure to air or moisture, at room temperature between 1 to 30 degrees Celsius. Proper storage will help maintain the medication's efficacy and safety.

Appearance

Pale yellow, double-convex, oval, film-coated tablet

Package unit

10 tablets/box [10 tablets/PTP x 1], 30 tablets/box [10 tablets/PTP x 3], 30 tablets/bottle