Empagliflozin/Metformin Tablet 12.5/1000 mg

Adult dose

The recommended dosage of this medication is 1 tablet per dose, taken twice daily. The dosage for each patient is determined based on their current treatment, effectiveness, and tolerance, ensuring it does not exceed the maximum recommended daily doses for each component: empagliflozin 25 mg and metformin 2000 mg. For patients who cannot achieve adequate blood glucose control with metformin alone or in combination with other medications such as insulin, the recommended dosage is empagliflozin 5 mg taken twice daily (total daily amount of 10 mg) along with the existing metformin dosage. If tolerance to empagliflozin 10 mg (total daily amount) is good, and additional blood glucose control is needed, the dosage can be increased to 25 mg (total daily amount). For patients transitioning to this medication from a combination of empagliflozin (total daily amount of 10 mg or 25 mg) and metformin, the existing dosages of empagliflozin and metformin should be administered. When taking this medication with sulfonylureas or insulin, it may be wise to consider reducing their dosages to decrease the risk of hypoglycemia (refer to the precautions for adverse reactions and interactions). This medication should be taken with meals to minimize gastrointestinal side effects associated with metformin. If a dose is missed, it should be taken as soon as remembered. However, do not take two doses at once; if that happens, skip the missed dose. Special Populations Patients with Renal Impairment No dosage adjustment is needed for patients with mild renal impairment. Due to the inclusion of metformin, dosage adjustments may be possible for patients with an estimated glomerular filtration rate (eGFR) of 45-59 ml/min/1.73m2 or a creatinine clearance (CrCl) of 45-59 ml/min, provided there are no other symptoms indicating an increased risk of lactic acidosis. For these patients, the starting dosage of metformin is 500 mg or 850 mg once daily, so treatment should begin with separate doses of empagliflozin and metformin. The maximum daily dose of metformin hydrochloride that can be administered is 1000 mg, given as 500 mg twice a day. Renal function should be closely monitored every 3 to 6 months (refer to precautions for care and caution in certain patient populations). If CrCl < 45 ml/min or eGFR < 45 ml/min/1.73m2 indicates reduced renal function, this medication should be discontinued immediately (refer to precautions regarding contraindications). Elderly Patients Patients over 75 years old need to consider the risks of renal function and fluid volume reduction.

This medication is used for the treatment of diabetes and contains components that help control blood glucose levels. Caution should be exercised as this medication may cause a rare side effect known as severe lactic acidosis. Lactic acidosis is a dangerous condition that occurs when there is an excessive buildup of lactic acid in the body, which can be fatal in severe cases. Additionally, co-administration with other diabetes medications like insulin or sulfonylureas may lead to severe hypoglycemia. Patients with moderate to severe renal impairment, acute renal issues, heart failure, acute myocardial infarction, and severe infections should not use this medication. Before and after tests using iodine-based contrast agents, this medication should be temporarily discontinued due to the risk of renal damage and lactic acidosis, and can be resumed only after renal function has returned to normal. Women who are pregnant or may become pregnant, as well as breastfeeding mothers, should not take this medication, nor is it recommended for children or adolescents under 18 years of age. During treatment, regular monitoring of renal function and serum creatinine levels should be conducted to keep track of kidney status, and patients at risk of fluid loss should be particularly cautious. This medication may increase the risk of urinary tract infections and genital infections; if any symptoms of infection appear, patients should inform healthcare providers immediately. Also, the metformin component can cause gastrointestinal disorders (diarrhea, nausea, vomiting, etc.) and reduced absorption of vitamin B12; thus, it may be necessary to check and supplement vitamin B12 levels if needed. Alcohol intake increases the risk of lactic acidosis; therefore, excessive drinking should be avoided during treatment. Patients should be alert for symptoms of hypoglycemia while taking this medication, particularly when co-administered with insulin or sulfonylureas. If surgery is planned, this medication should be stopped 48 hours prior, and can be resumed only after renal function has been confirmed to be normal post-surgery. During treatment, patients should consult a doctor immediately if symptoms such as fever, pain, swelling, or rashes around the genitals or perineum occur, as there is a rare risk of serious perineal necrosis. Elderly patients, especially those over 75 years of age, are at higher risk for fluid loss; therefore, caution is required during treatment, and appropriate dosage adjustments based on renal function are necessary. In cases of overdose, severe side effects such as lactic acidosis may occur, requiring immediate medical treatment, and blood dialysis may be necessary. This medication should be kept out of reach of children and stored in its original container for safety.

Serious side effects

Hives, angioedema, severe swelling, chest tightness, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, skin peeling, pain in the mucous membranes of the mouth/eyes, shortness of breath or difficulty breathing, asthma attacks, abnormal breathing with coughing and fever, jaundice (yellowing of the skin or eyes), extreme fatigue, sudden and severe headache, thunderclap headache, seizures, cognitive confusion, visual disturbances, paralysis,

Mild side effects

• Hypoglycemia
• urinary tract infections
• genital infections
• increased urination
• nausea
• vomiting
• diarrhea
• abdominal pain
• loss of appetite
• constipation

This medication should be stored in a tightly closed container to prevent air or moisture from entering, and it is best kept at room temperature between 1 degree and 30 degrees Celsius. Maintaining appropriate temperature and container conditions will safely preserve the medication's effectiveness.

Appearance

A bilaterally convex oval film-coated tablet with a dark brownish-purple color.

Package unit

60 tablets/bottle, 10 tablets/box [10 tablets/PTP x 1], 60 tablets/box [10 tablets/PTP x 6]