Empagliflozin/Metformin Tablet 12.5/850 mg (Empagliflozin, Metformin Hydrochloride)

Adult dose

The recommended dosage of this medication is 1 tablet, twice a day. Each patient’s current treatment regimen, efficacy, and tolerability should be considered, ensuring that the total doses of empagliflozin do not exceed 25 mg and metformin do not exceed 2000 mg. For patients unable to achieve adequate blood sugar control with metformin alone or in combination with other medications like insulin, the recommended dosage is 5 mg of empagliflozin twice a day (total 10 mg per day).

This medication can cause a rare but serious side effect called lactic acidosis, so it should not be administered to patients at high risk of lactic acidosis. Caution is necessary when used with other diabetes medications due to the risk of hypoglycemia. This medication should not be used in patients with moderate to severe renal impairment or acute kidney issues. Administration should be discontinued during specific acute conditions such as acute infections, heart dysfunction, and before and after surgery. It is not safe for use during pregnancy or breastfeeding. As this medication affects kidney function, regular kidney function tests should be conducted, especially for elderly patients or those with impaired kidney function. Patients at risk of fluid loss may experience dehydration or hypotension, requiring careful observation. This medication may increase the risk of urinary and genital infections; symptoms should be reported to healthcare professionals immediately. During treatment, patients should be aware of symptoms of hypoglycemia, and dosage adjustments may be necessary if used in conjunction with insulin or other hypoglycemic agents. Regular blood tests are recommended as vitamin B12 levels may decrease. Alcohol consumption should be avoided as it can increase the risk of lactic acidosis. This medication should be temporarily discontinued before and after tests using iodinated contrast agents, and resumed only after confirming normal kidney function. Prior to surgery, this medication should be halted for a period, and resumed only after the recovery of kidney function post-surgery. The safety and efficacy of this medication in children under 18 years have not been established, so it is not recommended for this age group. Elderly patients require dosage adjustments and regular monitoring due to the risks of decreased kidney function and fluid loss. In case of overdose, severe side effects such as lactic acidosis may occur, requiring immediate hospital visit, and dialysis may be necessary. This medication should be stored out of reach of children and kept in its original container for safety.

Serious side effects

Severe lactic acidosis, severe hypoglycemia, severe allergic reactions (hives, angioedema), urosepsis, pyelonephritis, perineal necrosis, ketoacidosis, severe cutaneous adverse reactions (with fever, severe rash, blistering, skin peeling, oral/eye mucosal pain), severe edema or urination abnormalities (marked decrease in urine output, severe systemic swelling, accompanied by blood pressure increase), liver abnormalities (jaundice of skin or eyes, extreme lethargy)

Mild side effects

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

Store this medication in a tightly closed container to protect it from air and moisture. It is recommended to maintain a storage temperature between 1 degree and 30 degrees Celsius.

Appearance

White film-coated tablet with a pink tint, oval and biconvex on both sides

Package unit

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