Empagliflozin 25 mg Tablet

Adult dose

The recommended dosage of this medication is 10 mg once a day for monotherapy and additional combination therapy with insulin or other blood sugar-lowering agents. If the 10 mg dose has good tolerance and additional blood sugar control is needed, the dose may be increased to 25 mg once a day. This medicine can be taken regardless of meals. The tablet should be swallowed whole. If a dose is missed, take it as soon as remembered.

This medicine should not be used in patients who have allergic reactions to the active ingredient or any components. It should not be administered to patients with type 1 diabetes or diabetic ketoacidosis. Use of this medicine is not recommended in patients with severely impaired renal function, end-stage renal disease, or those undergoing dialysis. Since this medicine contains lactose, it should not be used in patients with lactose intolerance, galactose intolerance, lactase deficiency, or glucose-galactose malabsorption. Caution is required when administering to patients with slightly impaired renal function, and dosage adjustment or discontinuation is necessary if the glomerular filtration rate falls below a certain level. Use in patients with mild or moderate heart failure should be approached with caution, while its use is not recommended for severe heart failure patients. When this medicine is used in conjunction with insulin or insulin secretagogues, there may be a risk of hypoglycemia, necessitating dosage adjustments. Caution should be taken for the possibility of hypoglycemia when used alongside sulfonylureas or insulin, and symptoms should be monitored. Side effects such as genital infections, urinary tract infections, increased urination, etc., can occur, especially genital infections are more common in women. Due to fluid volume decrease, dehydration or low blood pressure may occur, therefore elderly patients or those taking antihypertensive medications should be cautious. Rarely, serious metabolic acidosis known as ketoacidosis may occur, necessitating immediate treatment upon symptoms. Cases of liver damage have been reported, so careful observation is necessary if there are suspected liver function abnormalities. It is important to regularly monitor renal function while on this medication. Use during pregnancy is not recommended, and the medication should be discontinued upon confirmation of pregnancy. For nursing women, it is advisable to discontinue breastfeeding while taking this medication. Safety and efficacy in pediatric patients under 18 years of age have not been established. While no special toxicity has been reported for overdose, appropriate treatment is required based on clinical condition. Caution is necessary while driving or operating machinery due to the risk of hypoglycemia. Severe adverse effects such as limb amputation have been reported, hence careful foot care is essential. Rare serious infections such as perineal necrosis may occur, so healthcare providers should be notified immediately if related symptoms occur. This medicine may interact with other medications, so it is crucial to inform healthcare providers of all medications being taken.

Serious side effects

• Hives
• angioedema
• ketoacidosis
• urinary sepsis
• pyelonephritis
• perineal necrosis

Mild side effects

• Hypoglycemia
• vulvovaginitis
• balanitis
• other genital infections
• increased urination
• urinary tract infections
• fluid volume loss
• increased serum creatinine
• decreased glomerular filtration rate
• rash

This medicine should be stored in a tightly closed container to prevent air or moisture from entering. The storage temperature should be maintained between 1 degree and 30 degrees Celsius at room temperature. This helps to preserve the effectiveness of the medication for a longer period.

Appearance

Pale yellow oval film-coated tablets

Package unit

30 tablets/PTP [(10 tablets/PTPX3)], 10 tablets/PTP [(10 tablets/PTPX1)]