Empagliflozin/Metformin Tablet 12.5/500 mg

Adult dose

The recommended dosage of this drug is 1 tablet per dose, twice a day. The dosage for each component should not exceed the maximum recommended daily doses of 25 mg of empagliflozin and 2000 mg of metformin, and should be determined based on each patient's current treatment regimen, efficacy, and tolerability. For patients who cannot achieve adequate blood sugar control with metformin alone or in combination with other drugs such as insulin, the recommended dosage is empagliflozin 5 mg twice a day.

This drug can cause a rare but serious condition known as lactic acidosis. Lactic acidosis occurs when there is an excessive accumulation of lactate in the body and can be life-threatening in severe cases. Therefore, this drug should not be used in patients with impaired renal function or severe infections, dehydration, or heart failure. Additionally, caution is required when using this drug together with insulin or sulfonylurea as it may cause hypoglycemia. Regular tests should be conducted to ensure normal renal function while taking this drug, and it should not be used in cases of severely impaired renal function. Before and after tests using iodine contrast agents, this drug should be temporarily discontinued and resumed only after confirming normal renal function. Patients about to undergo surgery should also stop taking this drug 48 hours prior to surgery and can resume after renal function has recovered post-surgery. Women who are pregnant or may become pregnant, and breastfeeding women should not use this drug; particularly during pregnancy, insulin treatment is recommended. If dehydration, severe infections, or acute heart failure occur while taking this drug, it should be stopped immediately and a doctor consulted. This drug may cause side effects such as urinary tract infections, genital infections, increased urination, gastrointestinal disturbances (nausea, vomiting, diarrhea), hypoglycemia, and others. Elderly patients or those at risk of decreased fluid volume should exercise increased caution. Additionally, as vitamin B12 levels may decrease, regular blood tests are advised. The risk of lactic acidosis increases when taken with alcohol, so alcohol should be avoided. Regular meals and exercises should be maintained for blood sugar control while on this drug, and immediate action should be taken if hypoglycemic symptoms appear. Finally, this drug is not recommended for children, and elderly patients may require dosage adjustments based on renal function. In cases of overdose, immediate medical attention is required, and treatment such as dialysis may be necessary if lactic acidosis is suspected.

Serious side effects

Hives, severe swelling (edema), feeling of tightness in the chest, difficulty breathing, cold sweats, pallor, severe rash with high fever, blisters, skin peeling, oral/ocular mucosal pain, shortness of breath or breathing difficulties, asthma attacks, cough accompanied by fever leading to respiratory difficulty, yellowing of the skin or eyes (jaundice), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, vision changes, paralysis, urination

Mild side effects

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

This drug should be stored in a tightly closed container to protect it from air and moisture, and it is safe to store it at room temperature between 1 to 30 degrees Celsius. Proper storage will help maintain the drug's effectiveness for a longer period.

Appearance

A film-coated tablet that is oval, convex on both sides, and has a light brownish-purple color.

Package unit

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