Empamax Tablet 25 mg (Empagliflozin L-Proline)

Adult dose

The recommended dosage for this medication is 10 mg once daily for monotherapy and additional combination therapy with other blood glucose-lowering agents such as insulin. In cases where tolerance is good but additional blood sugar control is needed, the dosage may be increased to 25 mg once daily. This medication can be taken without regard to meals. The tablets should be swallowed whole. If a dose is missed, take it as soon as you remember, but do not take double the dose in one day.

This medication should not be administered to patients who have an allergic reaction to the active ingredient or components. It is considered unsafe for use in patients with type 1 diabetes or diabetic ketoacidosis. This medication should not be given to patients with severely impaired kidney function, specifically those with a glomerular filtration rate below 30 mL/min/1.73m2 or patients with end-stage renal disease, or those undergoing dialysis. In patients with mildly impaired kidney function, this medication should be used cautiously, and dosage adjustment or discontinuation may be necessary based on kidney function levels. In patients with mild to moderate heart failure, caution is advised, and it is not recommended for patients with severe heart failure. When used in conjunction with blood glucose-lowering agents such as insulin or sulfonylureas, the risk of hypoglycemia may necessitate a reduction in the dosage of these medications. Caution should be exercised for potential side effects such as hypoglycemia, infections, particularly genital and urinary tract infections, urinary abnormalities, dehydration symptoms, alterations in blood tests, etc. Serious metabolic anomalies such as ketoacidosis may rarely occur, so if symptoms like nausea, vomiting, abdominal pain, or shortness of breath appear, immediate consultation with healthcare providers is necessary. Elderly patients may have a higher incidence of side effects related to fluid loss, so caution is particularly important. This medication may affect the body's hydration status, so in situations of dehydration risk, blood pressure and fluid status should be closely monitored before and after administration. Additionally, this medication can rarely cause serious infections such as perineal necrosis, so if there is pain, swelling, or fever in that area, immediate notification to the healthcare provider is advised. It is recommended that women who are pregnant or planning to become pregnant do not use this medication, and breastfeeding should be discontinued if nursing. Children below 18 years of age should not use this medication as safety and efficacy have not been established. No specific toxic reactions have been reported in cases of overdose, but appropriate treatment may be necessary depending on the clinical condition. This medication may interact with other drugs, so if taking any other medications, inform your healthcare provider, especially with diuretics or insulin where caution is needed. Exercise caution when driving or operating machinery due to the risk of hypoglycemia.

Serious side effects

Hives, angioedema, perineal necrosis, ketoacidosis, urosepsis and pyelonephritis, severe allergic reactions, severe skin reactions, liver abnormalities (jaundice), severe neurological symptoms, severe edema or urinary disturbances, difficulty breathing, asthma attacks, respiratory abnormalities accompanied by cough and fever, acute kidney injury, acute cholecystitis, autoimmune hepatitis, cholelithiasis, pyelonephritis, sepsis, perineal necrosis (Fournier's gangrene), severe heart failure

Mild side effects

• Hypoglycemia
• vulvovaginal candidiasis
• vulvitis
• balanitis
• other genital infections
• increased urination
• rash
• itching
• increased blood creatinine
• decreased glomerular filtration rate

This medication is sensitive to air and moisture, so it should be stored in a tightly closed container. The recommended storage temperature is between 1 and 30 degrees Celsius at room temperature.

Appearance

Light yellow, double convex, oval film-coated tablet

Package unit

30 tablets/box [10 tablets/ptp x 3], 30 tablets/bottle