Empagliflozin/Metformin Tablet 5/500 mg

Adult dose

The recommended dose for this medication is one tablet twice daily. The maximum recommended daily doses should not exceed 25 mg of empagliflozin and 2000 mg of metformin, taking into consideration each patient's current therapy, efficacy, and tolerability. For patients receiving metformin alone or in combination with other drugs like insulin, a recommended dose is empagliflozin 5 mg twice daily (total daily dose of 10 mg) along with the existing metformin dosage. If further blood glucose control is needed with good tolerability to empagliflozin 10 mg (total daily dose), it may be increased to 25 mg (total daily dose). Patients switching from empiric doses of empagliflozin (10 mg or 25 mg total daily dose) and metformin should maintain their existing doses. When the medication is administered with sulfonylureas or insulin, consider a dose reduction of sulfonylureas or insulin to decrease the risk of hypoglycemia. It should be taken with a meal to reduce gastrointestinal side effects associated with metformin. If a dose is missed, take it as soon as remembered, but do not double the dose; skip the missed dose instead. Special populations: Renal impairment patients. No dose adjustment is needed for mild renal impairment. This medication contains metformin and may be used with caution in patients with estimated glomerular filtration rates (eGFR) of 45-59 ml/min/1.73m2 or creatinine clearance (CrCl) of 45-59 ml/min when no other symptoms that increase the risk of lactic acidosis are present. The starting dose of metformin in these patients is 500 mg or 850 mg once daily, so initiation should begin with single-agent administration of empagliflozin and metformin. The maximum daily dosage permissible of metformin hydrochloride with this medication is 1000 mg, administered as 500 mg twice daily. Renal function should be monitored closely every 3-6 months. If renal function decreases to CrCl < 45 ml/min or eGFR < 45 ml/min/1.73m2, this medication should be discontinued immediately. Elderly: Patients aged 75 years and above should consider the risk of decreased renal function and fluid volume depletion.

This medication is used to treat diabetes and can cause a rare but potentially fatal side effect known as severe lactic acidosis, so caution is needed. If used in combination with other diabetes medications, hypoglycemic symptoms may occur, so blood glucose levels should be closely monitored. It should not be used in patients with moderate to severe renal impairment, serious renal problems, acute infections, or cardiovascular issues. Patients expected to undergo surgery or imaging tests with contrast agents should temporarily discontinue use and resume only after renal function has normalized. It is advisable not to use this medication during pregnancy or lactation. Regular monitoring of renal function, blood glucose, and vitamin B12 levels is necessary during treatment. Side effects may include hypoglycemia, urinary infections, genital infections, increased urination; if symptoms occur, notify healthcare professionals. Alcohol consumption may increase the risk of lactic acidosis, so it is best to avoid it while taking this medication. Elderly patients or those at risk of fluid loss should take care with symptoms of dehydration or hypotension. This medication may interact with others, so it is crucial to inform healthcare professionals of any other medications being taken. In case of overdose, seek immediate medical attention for proper treatment, which may include blood dialysis. Use in children is not recommended as safety and efficacy have not been established. Keep this medication out of the reach of children and store it in its original container to maintain quality.

Serious side effects

Hives, severe swelling (edema), ketoacidosis, lactic acidosis, angioedema, necrotizing fasciitis, severe allergic reactions, severe skin reactions, difficulty breathing, asthma attacks, chest tightness, pallor, cold sweat, shortness of breath or difficulty breathing, jaundice of skin or eyes, liver abnormalities, severe neurological symptoms (headache, lightning headaches, seizures, confusion, vision changes, paralysis), significantly reduced urine output, severe systemic symptoms.

Mild side effects

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

This medication may be sensitive to air and moisture, so it should be stored in a tightly sealed container. It is best to maintain a storage temperature between 1 degree and 30 degrees Celsius to securely preserve its effectiveness.

Appearance

Orange-yellow, bilaterally convex oval film-coated tablet

Package unit

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