Empagliflozin Tablet 25 mg

Adult dose

The recommended dosage of this medication is 10 mg once daily for monotherapy or additional combination therapy with insulin or other blood glucose-lowering agents. If the patient tolerates 10 mg well but requires additional blood glucose control, the dosage may be increased to 25 mg once daily. This medication can be taken regardless of meals. The tablet should be swallowed whole. If a dose is missed, it should be taken as soon as remembered.

This medication should not be used in patients with known allergic reactions to its active ingredient or any of its components. It should not be administered to patients with type 1 diabetes mellitus or diabetic ketoacidosis. It is not recommended for patients with severely reduced kidney function, specifically those with an estimated glomerular filtration rate (eGFR) of less than 30 mL/min/1.73 m2, or for patients with end-stage renal disease or those undergoing dialysis. Since this medication contains lactose, it should not be given to patients with genetic conditions such as galactose intolerance, lactase deficiency, or glucose-galactose malabsorption. In patients with reduced kidney function, caution should be exercised in administering this medication, and the dosage should be adjusted or discontinued when the eGFR is less than 60 mL/min/1.73 m2. The effectiveness of this medication is not expected in patients with end-stage renal disease or those undergoing dialysis. In patients with heart failure, this medication should be used cautiously in mild to moderate stages (NYHA class I-II), and its use is not recommended in severe stages (NYHA class III-IV). When used in conjunction with insulin or sulfonylureas, there is a risk of hypoglycemia, and the dosages of those medications may need to be adjusted. The most common side effect of this medication is hypoglycemia, and extra caution is advised when combined with insulin or sulfonylureas. Side effects such as genital infections, urinary tract infections, increased urination, decreased fluid volume, and skin rashes may occur, and any unusual symptoms should prompt immediate consultation with a healthcare professional. A rare but serious metabolic acidosis known as ketoacidosis may occur, so if symptoms like nausea, vomiting, abdominal pain, or shortness of breath appear, immediate medical attention is needed. Decreased fluid volume may lead to symptoms of low blood pressure or dehydration, requiring particular caution in the elderly or those with cardiovascular disease. This medication may cause liver damage, thus it should be used with caution in patients with liver function abnormalities. Severe urinary infections such as urosepsis or pyelonephritis have been reported, so treatment should be sought immediately if urinary infection symptoms arise. While taking this medication, patients should be aware that glucose may show positive reactions in urine glucose tests. Use of this medication is not recommended during pregnancy, and it should be discontinued once pregnancy is confirmed. If breast-feeding, it is advisable to stop nursing as this medication can be secreted into breast milk. The safety and efficacy have not been confirmed for children under 18 years, thus it should not be used in this population. No specific toxic reactions have been reported in cases of overdose, but appropriate treatment should be provided based on the clinical state. This medication should be kept out of the reach of children and transferring it to another container is not recommended. Caution is needed when driving or operating machinery due to the risk of hypoglycemia, especially when combined with insulin or sulfonylureas. Diabetic patients should pay attention to foot care, as the risk of lower limb amputation may rarely increase, necessitating regular check-ups. If pain, swelling, or redness occurs around the perineum, serious infection such as perineal necrotizing fasciitis should be suspected and immediate treatment should be sought.

Serious side effects

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

Mild side effects

• Hypoglycemia
• vulvovaginitis
• balanitis
• and other genital infections
• increased urination
• urination difficulties
• rash
• itching
• decreased fluid volume
• increased serum lipids

This medication should be stored in a tightly closed container to protect it from air and moisture. In addition, it is recommended to store the medication at a cool room temperature between 1 degree and 30 degrees Celsius.

Appearance

Pale yellow oval film-coated tablet

Package unit

30 tablets/Blister [10 tablets/Blister x 3]