Empaglutine Duo Tablet 12.5/500 mg

Adult dose

The recommended dosage for this medication is 1 tablet once, twice a day. It should be determined considering each patient's current therapy, efficacy, and tolerability, ensuring the daily maximum recommended doses of empagliflozin 25 mg and metformin 2000 mg are not exceeded. For patients who cannot achieve sufficient blood glucose control with metformin alone or in combination with other drugs like insulin, the recommended dosage is 5 mg of empagliflozin twice a day (total daily dose of 10 mg) along with their current metformin dosage. If tolerability for empagliflozin at a total daily dose of 10 mg is good and additional blood glucose control is needed, it can be increased to 25 mg (total daily dose). Patients converting from empagliflozin (total daily dose of 10 mg or 25 mg) and metformin therapy should receive their existing doses of empagliflozin and metformin. In cases of co-administration of this medication with sulfonylureas or insulin, dose reduction of sulfonylureas or insulin may be considered to reduce the risk of hypoglycemia (refer to precautions 4. Adverse reactions and 6. Interactions). This medication should be taken with meals to reduce gastrointestinal side effects related to metformin. If a dose is missed, take it as soon as remembered, but do not double the dose, and in such cases, skip the missed dose. Special populations Patients with kidney impairment No dosage adjustment is needed for patients with mild kidney impairment. This medication contains metformin so dosage adjustment can be considered for patients with an estimated glomerular filtration rate (eGFR) of 45-59 ml/min/1.73m2, provided they do not have other symptoms that increase the risk of lactic acidosis. For these patients, the starting dose of metformin is 500 mg or 850 mg once daily, therefore empagliflozin and metformin should be initiated with individual monotherapy. The daily maximum dose of metformin hydrochloride that can be administered with this medication is 1000 mg and can be given as 500 mg twice daily. Kidney function must be monitored carefully every 3-6 months (refer to precautions 3. Exercise caution in administering to the following patients 1). If CrCl < 45 ml/min or eGFR < 45 ml/min/1.73m2 indicating reduced kidney function, this medication should be discontinued immediately (refer to precautions 2. Do not administer to the following patients 2). Elderly patients Patients aged 75 and older should consider the risks of decreased kidney function and fluid volume depletion.

This medication helps control blood sugar levels. However, there are several precautions to be aware of while taking this medication. First, it can rarely cause a serious condition called lactic acidosis, which is a dangerous buildup of lactic acid in the body. Additionally, caution is needed as hypoglycemia may occur when used with other diabetes medications. Patients with poor kidney function, acute kidney issues, heart failure, serious infections, or those scheduled for surgery should not take this medication. Also, it is safest for pregnant or breastfeeding women to avoid using this medication. Regular kidney function tests should be conducted while taking this medication, and if conditions such as dehydration, severe vomiting, or diarrhea occur, immediate consultation with a doctor is necessary. Furthermore, when taken with insulin or other hypoglycemic agents, dose adjustment may be necessary to reduce the risk of hypoglycemia. This medication may increase the risk of urinary tract infections or genital infections, so prompt treatment is required if symptoms of infection appear. Additionally, it may reduce fluid volume, leading to lowered blood pressure, so caution is particularly needed in the elderly or those with cardiovascular conditions. Patients with poor liver function should also avoid this medication, and consumption of alcohol should be limited as it can increase the risk of lactic acidosis. If symptoms such as fever, pain or swelling around the genital area, rash, etc. arise while taking this medication, notify a doctor immediately, and severe cases may require emergency treatment. This medication is not recommended for children, and elderly patients should be monitored frequently for kidney function while taking it. Lastly, if an overdose occurs, immediate medical treatment is necessary, especially if symptoms of lactic acidosis are suspected.

Serious side effects

Hives, angioedema, perineal necrosis, lactic acidosis, ketoacidosis, urosepsis, pyelonephritis, severe edema, severe allergic reactions, severe rash with high fever, blisters, skin peeling, mucosal pain in mouth/eyes, difficulty breathing or shortness of breath, asthma attacks, respiratory issues accompanied by cough and fever, jaundice (yellowing of skin or eyes), severe malaise, sudden and severe headaches, thunderclap headaches, seizures

Mild side effects

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

This medication should be stored in a tightly sealed container to avoid contact with air or moisture, and it is advised to keep it at room temperature between 1 degree and 30 degrees Celsius. Storing it this way helps maintain the medication's effectiveness for a longer period.

Appearance

Light brownish-purple, oval, convex, film-coated tablet

Package unit

10 tablets/box [10 tablets/PTP x 1], 60 tablets/box [10 tablets/PTP x 6], 30 tablets/bottle, 60 tablets/bottle