Empagliflozin/Metformin Hydrochloride Tablet 5/850 mg

Adult dose

The recommended dosage for this medication is 1 tablet per administration, twice daily. The dosage is determined considering each patient's treatment regimen, efficacy, and tolerance, not exceeding the maximum daily recommended doses of 25 mg of empagliflozin and 2000 mg of metformin. For patients who are unable to achieve adequate blood glucose control with metformin alone or in combination with other medications, the recommended dosage is 5 mg of empagliflozin taken twice a day (total daily amount of 10 mg) along with the current dose of metformin. If tolerance for 10 mg of empagliflozin is good and additional blood glucose control is needed, it can be increased to 25 mg (total daily amount). For patients transitioning to this medication from a regimen of empagliflozin (10 mg total daily dose or 25 mg) and metformin, it should be administered according to their previous doses of empagliflozin and metformin. When this medication is used in conjunction with sulfonylureas or insulin, reductions in the doses of these medications should 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, it should be taken as soon as remembered. However, double dosing should not occur, and in such cases, the missed dose should be skipped. Special populations: Renal impairment patients: No dosage adjustment is needed for mild renal impairment patients. Due to the presence of metformin, doses may be adjusted 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 only if there are no additional symptoms that increase the risk of lactic acidosis. For these patients, the starting dose of metformin should be 500 mg or 850 mg taken once daily, requiring initiation of empagliflozin and metformin as separate single agents. The maximum daily dose of metformin hydrochloride that can be administered through this medication is 1000 mg, which can be given as 500 mg twice daily. Kidney function should be carefully monitored every 3-6 months (refer to precautions, 3. Caution is advised in the following patients, see item 1). If CrCl < 45 ml/min or eGFR < 45 ml/min/1.73m2 indicate renal function decline, this medication must be discontinued immediately (refer to precautions 2. Do not administer in the following patients, see item 2). Elderly patients: Consideration should be given to the risks associated with renal function and fluid volume depletion in patients aged 75 and older.

This drug helps control blood glucose levels. However, there are specific points to be cautious about when taking this medication. First, there is a rare side effect known as severe lactic acidosis that can occur, which can be very dangerous. Additionally, hypoglycemia can occur when taken with other diabetes medications, so blood glucose levels should be monitored closely. This medication should not be administered to patients with moderate to severe renal impairment, and use should also be avoided in patients with acute kidney issues, severe infections, or heart problems. Patients undergoing examinations requiring iodine contrast media should temporarily halt the medication and resume only after normal kidney function is confirmed post-examination. Regular kidney function tests should be conducted while taking this medication, and particular care is necessary during times of dehydration or severe vomiting and diarrhea that may cause fluid loss. Moreover, when taken with insulin or sulfonylureas, there may be an increased risk of hypoglycemia, necessitating dosage adjustments. This drug can cause gastrointestinal disturbances (diarrhea, vomiting, etc.), urinary tract infections, genital infections, and increased urination. Genital infections can occur frequently, so immediate consultation with healthcare professionals is necessary if symptoms appear. It is safest for pregnant women or those who may become pregnant, as well as breastfeeding women, to avoid using this medication. For elderly patients, considering the commonality of renal function decline, dosage adjustments and regular kidney function monitoring are needed. Alcohol consumption may increase the risk of lactic acidosis, so it is advisable to avoid drinking while on this medication. If sudden weight loss, severe fatigue, difficulty breathing, abdominal pain, or vomiting occur during this treatment, the physician must be notified immediately. Also, symptoms of hypoglycemia include dizziness, cold sweat, and severe hunger, which should be closely monitored. Finally, it is important to consult healthcare professionals regarding the temporary discontinuation of this medication prior to surgery or significant examinations.

Serious side effects

• Hives
• erythema multiforme
• lactic acidosis
• ketoacidosis
• urosepsis
• pyelonephritis
• perineal necrosis
• acute kidney injury
• acute pyelonephritis
• cerebral infarction

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 protect it from air and moisture. It is also advisable to avoid storing it in excessively hot or cold locations, and to keep it at room temperature between 1 to 30 degrees Celsius.

Appearance

White film-coated tablets that are oval, convex on both sides with a yellowish tint

Package unit

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