EmpaDuo Tablets 5/500 mg

Adult dose

The recommended dosage of this medication is one tablet once daily, twice a day. Dosage is determined based on the condition of individual patients, within the maximum recommended daily doses of Empagliflozin 25 mg and Metformin 2000 mg. When used in conjunction with Metformin alone or other medications like insulin, the recommended dosage is Empagliflozin 5 mg twice a day (total 10 mg) and the existing dosage of Metformin. If tolerance for Empagliflozin 10 mg is good and additional glucose control is necessary, the dosage can be increased to Empagliflozin 25 mg (total per day). Patients converting to this medication from combinations of Empagliflozin (10 mg or 25 mg daily total) and Metformin should be dosed at their existing doses of both Empagliflozin and Metformin. When this medication is used in combination with sulfonylureas or insulin, dosage reductions of sulfonylureas or insulin should be considered to reduce the risk of hypoglycemia (refer to precautions regarding adverse reactions 4. and interactions 6.). This medication should be taken with meals to minimize gastrointestinal side effects related to Metformin. If a dose is missed, take it as soon as remembered. However, do not take double doses at once; skip the dose if it is missed. Special populations Renal impairment patients No dosage adjustment is needed for mild renal impairment patients. This medication contains Metformin, so patients with an estimated glomerular filtration rate (eGFR) of 45-59 ml/min/1.73m2 or patients with CrCl of 45-59 ml/min not showing other symptoms that might increase the risk of lactic acidosis may use it with dosage adjustment. The initial dosage for these patients is 500 mg or 850 mg once daily, so starting treatment with Empagliflozin and Metformin as separate single agents is necessary. The maximum allowable daily dosage of Metformin Hydrochloride with this medication is 1000 mg, which can be given as 500 mg twice a day. Kidney function should be monitored closely every 3-6 months (for reference, see precautions regarding special populations 3. and precautions regarding specific patients 1)). If CrCl < 45 ml/min or eGFR < 45 ml/min/1.73m2 indicating renal function decline occurs, this medication should be discontinued immediately (for reference, see precautions regarding specific patients 2)). Elderly patients Patients aged 75 and older should consider the risks of decreased renal function and fluid volume.

This medication can cause rare but serious side effects such as severe lactic acidosis, so it should not be administered to patients at high risk of lactic acidosis. Severe hypoglycemia may occur when used with other glucose-lowering agents, so careful observation for hypoglycemic symptoms is required. It should not be used in patients with moderate or severe renal impairment or those at risk of acute kidney injury. In cases of acute conditions such as acute infections, heart failure, pre- and post-surgery, or dehydration, administration of this medication should be temporarily stopped and can be resumed once the patient's condition is stabilized. It is safest not to use this medication in pregnant women or women who may become pregnant, as well as in breastfeeding women. This medication affects kidney function; therefore, regular kidney function tests should be conducted before and during administration, and if kidney function declines, the use of this medication should be discontinued. During the course of treatment, care should be taken for dehydration, hypotension, electrolyte imbalances, and particularly older patients or those with cardiovascular disease should be monitored more closely. The risk of urinary tract and genital infections may increase, so any infection symptoms should be reported to healthcare providers immediately. Vitamin B12 deficiency may occur; thus, periodic checks of vitamin B12 levels during long-term use are recommended. Alcohol consumption may increase the risk of lactic acidosis; therefore, excessive drinking should be avoided while taking this medication. This medication increases fluid excretion, which may cause fluid loss, requiring caution in patients at risk for dehydration or substantial fluid loss. Since there is a risk of hypoglycemia, immediate action should be taken if hypoglycemic symptoms occur, and dosage adjustments may be needed, especially when used with other glucose-lowering agents. Additionally, this medication should be discontinued before and after specific imaging procedures involving contrast agents and can be resumed once kidney function returns to normal after testing. Elderly patients may be at risk for decreased kidney function, so dosage adjustments and regular kidney function monitoring are necessary. During treatment, patients should not suspend or change doses arbitrarily without consulting a physician, and any unusual symptoms should be reported to healthcare providers immediately.

Serious side effects

• Hives, severe swelling (angioedema), severe allergic reactions
• Severe rashes, blisters, skin peeling, pain in mouth/eyes mucosa, severe skin adverse reactions
• Difficulty breathing, asthma attacks, respiratory distress with cough and fever
• Yellowing of the skin or eyes (jaundice), liver abnormalities
• Sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, severe neurological symptoms
• Significant reduction in urine output, systemic

Mild side effects

• Nausea
• vomiting
• diarrhea
• abdominal pain
• loss of appetite
• constipation
• hypoglycemia
• decreased and deficiency of Vitamin B12
• taste disturbances
• itching

This medication should be stored in a tightly closed container to prevent air and moisture from entering. It is advisable to maintain storage temperature between 1 and 30 degrees Celsius at room temperature. This ensures prolonged effectiveness and safe usage.

Appearance

Orange-yellow, biconvex, oval film-coated tablet

Package unit

10 tablets/box [10 tablets/PTPX1], 60 tablets/box [10 tablets/PTPX6], 60 tablets/bottle