Empogaduo Tablets 5/850 mg (Empagliflozin, Metformin Hydrochloride)

Adult dose

The recommended dose of this medication is 1 tablet once twice a day. The dosage of this medication should be determined considering the current treatment regimen, efficacy, and tolerability of each patient without exceeding the daily maximum recommended doses of Empagliflozin 25 mg and Metformin 2000 mg for each component. For patients who cannot achieve sufficient blood sugar control with Metformin alone or in combination with other medications such as insulin, the recommended dosage is Empagliflozin 5 mg twice a day (10 mg total per day) and the current dosage of Metformin. If Empagliflozin 10 mg (total daily dose) is well tolerated and additional blood sugar control is needed, the dosage may be increased to Empagliflozin 25 mg (total daily dose). Patients transitioning to this medication from a regimen of Empagliflozin (total daily dose of 10 mg or 25 mg) and Metformin will be administered the previous doses of Empagliflozin and Metformin. When this medication is used in combination with sulfonylureas or insulin, consideration can be given to reducing the dosages of sulfonylureas or insulin to minimize 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 associated with Metformin. If a dose is missed, it should be taken as soon as remembered. However, a double dose should not be taken at once, and in such cases, the missed dose should be skipped. Special Populations. Renal Impairment Patients. Dose adjustments are not required for patients with mild renal impairment. This medication contains Metformin, so for patients with an estimated glomerular filtration rate (eGFR) of 45-59 ml/min/1.73 m² or creatinine clearance (CrCl) of 45-59 ml/min, it may be used with dose adjustment if no other symptoms that increase the risk of lactic acidosis are present. The initial dose of Metformin for these patients should be 500 mg or 850 mg once daily, starting with treatment with Empagliflozin and Metformin as separate single agents. The maximum daily dosage of Metformin Hydrochloride that can be administered with this medication is 1000 mg, which can be given as 500 mg twice a day. Kidney function should be closely monitored every 3-6 months (refer to Precautions, 3. Caution in Administering to the Following Patients 1). If CrCl < 45 ml/min or eGFR < 45 ml/min/1.73 m² indicates reduced kidney function, this medication should be discontinued immediately (refer to Precautions 2. Do Not Administer to the Following Patients 2). Elderly Patients. Patients over 75 years old should consider the risks associated with renal function and fluid volume depletion.

This medication is an antidiabetic agent that helps control blood sugar, with the two components working together to lower blood sugar levels. This medication can cause rare side effects such as severe lactic acidosis, and should not be used in patients with impaired kidney function or conditions such as acute infections, dehydration, or heart disease. When taken with insulin or sulfonylureas, caution should be exercised as hypoglycemia may occur. Patients with moderate to severe renal impairment, those in acute renal situations, patients with type 1 diabetes, pregnant or breastfeeding women, and those with heart failure should not take this medication. If undergoing surgery or tests involving iodinated contrast agents, the medication should be discontinued for a certain period prior, and can only be resumed after kidney function is confirmed to be normal. Elderly patients or those with slight renal impairment should regularly undergo kidney function testing while adjusting the dosage of this medication. During the course of this medication, care should be taken to avoid dehydration or fluid loss, and if gastrointestinal disturbances such as vomiting or diarrhea occur, the doctor should be consulted. Furthermore, this medication may increase the risk of genital and urinary tract infections, thus treatment should be sought immediately if any relevant symptoms arise. Vitamin B12 levels may decrease, so it is advisable to check blood tests if there are signs of anemia or neurological symptoms. Women who are pregnant or may become pregnant should not take this medication, and it is also best avoided during breastfeeding. In the event of overdose, serious side effects such as lactic acidosis may occur, so adherence to the prescribed dosage is critical, and if side effects are suspected, immediate medical attention should be sought. This medication may interact with other drugs, so if other medications are being taken, it is essential to inform a doctor or pharmacist. Finally, this medication should be stored out of reach of children and kept in its original container for safety.

Serious side effects

Hives, severe swelling (angioedema), chest tightness, difficulty breathing, cold sweats, pallor (severe allergic reaction), high fever with severe rash, blisters, skin peeling, oral/ocular mucosal pain (severe skin adverse reactions), shortness of breath or difficulty breathing, asthma attacks, abnormal respiratory symptoms accompanied by cough and fever (respiratory issues), yellowing of skin or eyes (jaundice), extreme lethargy (liver issues), sudden and severe complications

Mild side effects

Hypoglycemia, urinary tract infection, genital infection, increased urination, nausea, vomiting, diarrhea, abdominal pain, loss of appetite, constipation, abnormal liver function tests, hepatitis, altered taste, itching, rash, erythema, angioedema, urinary difficulty, interstitial nephritis, thirst, increased serum lipids, increased serum creatinine/decreased glomerular filtration rate, increased hematocrit, decreased and deficient vitamin B12, vulvovaginitis, balanitis, perineal necrosis

This medication is sensitive to air and moisture, so it should be stored in a sealed container. Additionally, it is best stored at room temperature between 1 to 30 degrees Celsius. This will help maintain the effectiveness of the medication for a longer period.

Appearance

White, oval, biconvex film-coated tablet with a yellowish tint

Package unit

For domestic use - 10 tablets/box [(10 tablets/PTP x 1)], for domestic use - 60 tablets/box [(10 tablets/PTP x 6)], for domestic use - 30 tablets/bottle, for domestic use - 60 tablets/bottle