Empagmet 5/500 mg

Adult dose

The recommended dose of this medication is 1 tablet, twice daily. It should be determined within the range not exceeding 25 mg of empagliflozin and 2000 mg of metformin, taking into account the patient's current treatment regimen, efficacy, and tolerability. When used alone or in combination with other medications like insulin, the recommended dosage is 5 mg of empagliflozin twice daily (total 10 mg daily) along with the current metformin dosage. Tolerance to 10 mg of empagliflozin (total 10 mg daily) can be deemed sufficient when additional blood sugar control is needed, allowing for an increase to 25 mg (total daily dose). Patients switching to this medication from a combination of empagliflozin (total daily dose of 10 mg or 25 mg) and metformin should be administered their existing doses. When combined with sulfonylureas or insulin, dosage adjustments 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 adverse effects related to metformin. If a dose is missed, it should be taken as soon as remembered. However, do not take double the dose at once; if this occurs, skip the missed dose. Special groups: Renal impairment patients Dose adjustment is not necessary for mild renal impairment. Since this medication contains metformin, it can only be used in patients with an eGFR of 45–59 ml/min/1.73m2 or CrCl of 45–59 ml/min in the absence of other symptoms that could increase the risk of lactic acidosis. In these patients, the starting dose of metformin should be 500 mg or 850 mg once daily, so the individual mono-therapy of empagliflozin and metformin should be initiated. The maximum daily dose of metformin hydrochloride that can be administered with this medication is 1000 mg, with a regimen of 500 mg twice daily. Renal function should be carefully monitored every 3-6 months (refer to precautions, 3. Caution should be exercised when administering to the following patients No. 1). If CrCl < 45 ml/min or eGFR < 45 ml/min/1.73m2 occurs, this medication should be discontinued immediately (refer to precautions 2. Do not administer to the following patients No. 2). Elderly Patients Patients aged 75 and older should be cautious of renal function and the risk of decreased fluid volume.

This medication helps to control blood sugar levels. However, a rare side effect known as severe lactic acidosis may occur with its use, necessitating caution. When taken with other diabetes medications, there is a risk of hypoglycemia. It should not be used in patients with moderate to severe renal impairment, acute kidney issues, serious infections, cardiac conditions, or a history of diabetic ketoacidosis. Furthermore, administration should be discontinued and renal function verified before and after the use of iodinated contrast agents. Pregnant or breastfeeding women should not take this medication. Regular monitoring of renal function is necessary during treatment, and immediate consultation with a doctor is required for symptoms of dehydration, severe vomiting, or diarrhea. Hypoglycemic symptoms may occur, so close monitoring of blood sugar levels is essential, especially when used with insulin or sulfonylurea medications. There is a risk of urinary or genital infections; therefore, prompt treatment is necessary if related symptoms arise. Vitamin B12 levels may decrease, so monitoring vitamin levels is advisable during long-term use. Alcohol should be avoided as it can increase the risk of lactic acidosis. If surgery is planned, the medication should be stopped 48 hours prior, and reinitiated only after confirming normal renal function post-surgery. Elderly patients or those at risk of fluid loss must carefully monitor their fluid status and blood pressure while taking this medication. Safety and efficacy in children have not been established; therefore, it is not recommended for individuals under 18 years of age. In case of overdose, immediate medical attention is necessary, and if lactic acidosis is suspected, dialysis may be required. Store this medication out of reach of children and in its original container.

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe allergic reactions, severe rash with fever, blisters, peeling skin, pain in oral/ocular mucosa, severe skin adverse reactions, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by cough and fever, respiratory issues, yellowing of skin or eyes (jaundice), severe lethargy, liver abnormalities (jaundice), sudden

Mild side effects

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

This medication may be sensitive to air or moisture, so it should be stored in a tightly sealed container. It is recommended to maintain a storage temperature between 1 and 30 degrees Celsius to preserve the drug's effectiveness for a longer period.

Appearance

Orange-yellow, biconvex, oval film-coated tablet

Package unit

10 tablets/box [(10 tablets/PTP X 1)], 60 tablets/box [(10 tablets/PTP X 6)], 60 tablets/bottle