Empavex 12.5/1000 mg (Empagliflozin, Metformin Hydrochloride)

Adult dose

The recommended dose of this medication is one tablet, twice daily. Empagliflozin should be determined within a daily maximum of 25 mg, and metformin should not exceed a daily maximum of 2000 mg. For monotherapy with metformin or in combination with other agents like insulin, use 5 mg of empagliflozin twice daily along with the existing metformin dosage. If additional blood sugar control is needed, increase empagliflozin from 10 mg to 25 mg per day.

This medication can cause a rare side effect called severe lactic acidosis, so it should not be used in patients with impaired kidney function or acute illness. Caution is required when used with other hypoglycemic agents due to the risk of hypoglycemia. This medication should not be administered to patients with moderate or worse kidney function or conditions that can lead to acute kidney injury. It should also be avoided in cases of acute illnesses such as cardiovascular collapse, acute myocardial infarction, or sepsis. It should be temporarily discontinued before and after tests involving iodinated contrast agents, and resumed only after checking kidney function. If surgery is planned, discontinue this medication 48 hours before the procedure and resume after kidney function has returned to normal. It should not be used in patients with poor nutritional status, liver dysfunction, or in pregnant or breastfeeding women. During treatment, regular monitoring of kidney function and serum creatinine levels is necessary to catch any abnormalities. Be cautious of dehydration and hypotension in situations of fluid loss; the medication may be discontinued if necessary. This medication may increase the risk of urinary tract infections and genital infections, and symptoms should be treated immediately. Vitamin B12 levels may decrease, so regular monitoring is needed during long-term use. Excessive alcohol intake can heighten the risk of lactic acidosis, hence alcohol consumption should be avoided. Hypoglycemic symptoms may occur during treatment, especially in conjunction with insulin or sulfonylureas, necessitating dose adjustments. This medication is not recommended for children under 18 years and should be administered cautiously in elderly patients over 75 years. In cases of overdose, treatments such as dialysis might be necessary, so immediate medical attention is required. This medication should be stored out of reach of children and kept in its original container.

Serious side effects

Hives, severe swelling (angioedema), chest tightness, difficulty breathing, cold sweat, paleness, severe rash with fever, blisters, skin peeling, pain on mucous membranes of mouth/eyes, shortness of breath or difficulty breathing, asthma attacks, cough accompanied by fever and respiratory abnormalities, yellowing of skin or eyes (jaundice), feeling very lethargic, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis,

Mild side effects

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

This medication must be stored in a tightly sealed container to avoid exposure to air and moisture. It is best kept at room temperature between 1 and 30 degrees Celsius.

Appearance

A dark brownish purple, biconvex, oval film-coated tablet.

Package unit

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