Empagliflozin 25 mg Tablets (Empagliflozin)

Adult dose

The recommended dose of this medication is 10 mg once daily, and if well tolerated and additional blood sugar control is needed, it may be increased to 25 mg once daily. When used in combination with sulfonylureas or insulin, the doses of these medications may need to be adjusted to reduce the risk of hypoglycemia. This medication can be taken regardless of meals, and should be swallowed whole. If a dose is missed, it should be taken as soon as remembered but not as a double dose on the same day.

This medication should not be administered to patients with allergies to the active ingredient or any components. It should not be used in patients with type 1 diabetes or diabetic ketoacidosis. This medication should not be administered to patients with significantly impaired kidney function, specifically those with a glomerular filtration rate below 30 mL/min/1.73m² or those in end-stage renal disease or undergoing dialysis. Due to the presence of lactose in this medication, it is safer for patients with genetic issues like lactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption to refrain from taking it. For patients with mildly impaired kidney function, the dosage of this medication should be adjusted or discontinued, and regular kidney function checks are crucial. In patients with heart failure classified as NYHA class I-II, caution should be exercised in use, and it is not recommended for those in NYHA class III-IV. When taken alongside insulin or other hypoglycemic agents like sulfonylureas, there may be an increased risk of hypoglycemia, necessitating dosage adjustments of those medications. While taking this medication, side effects such as hypoglycemia, genital infections, urinary tract infections, increased urination, decreased fluid volume, and others may occur, and if any unusual symptoms arise, consultation with healthcare professionals is required. Particularly, serious metabolic abnormalities such as ketoacidosis can occur, and should symptoms such as nausea, vomiting, abdominal pain, or difficulty breathing develop, immediate hospital visit is essential. Elderly patients, especially those aged 75 and above, are at a higher risk of fluid loss and should be monitored regularly for fluid status and blood pressure during treatment with this medication. Severe urinary infections like urosepsis or pyelonephritis have been reported, so swift treatment is necessary in cases of urinary infection symptoms. There is an increased risk of genital fungal infections, so prior infection history should be closely observed in patients. As this medication can affect urination function, patients with bladder base disorders should consult their doctor before taking it. While taking this medication, urine tests may show positive results for glucose, so this should be noted. In cases of driving or operating machinery, caution is needed due to the risk of hypoglycemia, particularly when used with insulin or sulfonylureas. Reports of limb amputation have been noted, so diabetic patients should maintain thorough foot care. Rare but serious infections such as perineal necrosis can occur, and if symptoms such as pain, swelling, or redness in the perineal area arise, immediate notification to healthcare professionals is necessary. Use during pregnancy is not recommended, and if pregnancy is confirmed, administration should be stopped immediately. In nursing mothers, since this medication may be excreted in breast milk, it is safer to discontinue breastfeeding. In pediatric patients under 18 years of age, the safety and efficacy of this medication have not been established, thus it should not be used. Although no specific toxicity has been reported in cases of overdose, patients should be closely monitored and receive appropriate treatment if overdose occurs. This medication should be kept out of reach of children and it is advisable not to transfer it to other containers.

Serious side effects

• Hives
• angioedema
• perineal necrosis
• ketoacidosis
• urosepsis
• pyelonephritis

Mild side effects

• Hypoglycemia
• genital mycotic infections
• vulvovaginitis
• balanitis and other genital infections
• increased urination
• rashes
• itching
• increased serum creatinine
• decreased glomerular filtration rate
• increased serum lipids

This medication is sensitive to air and moisture, so it should be stored in a tightly sealed container. Additionally, it is recommended to store the medication at room temperature between 1°C and 30°C, avoiding excessively hot or cold conditions.

Appearance

Light yellow, oval, biconvex, film-coated tablets

Package unit

30 tablets/bottle