Empaglutam Duo Tablet 5/500 mg

Adult dose

The recommended dose of this medication is 1 tablet, taken twice daily. For patients who cannot achieve adequate blood sugar control with monotherapy of metformin or in combination with other medications such as insulin, the recommended dose is 5 mg of empagliflozin twice daily (total daily dosage of 10 mg) along with the existing dose of metformin. If good tolerance to 10 mg of empagliflozin (total daily dosage) is achieved, and further blood sugar control is needed, escalations can be made up to 25 mg of empagliflozin (total daily dosage).

This medication can cause a rare but severe condition called lactic acidosis; if this symptom occurs, discontinue use immediately and consult a doctor. When used in combination with other diabetes medications, hypoglycemia may occur; hence, carefully monitor blood glucose levels. Do not use if you are allergic to the active ingredient or any component of this medication. Patients with moderate to severe renal impairment, acute kidney problems, severe infections, or heart failure should not take this medication. Before and after examinations using iodine contrast agents, discontinue this medication and restart only after confirming normal kidney function. If a surgery is planned, discontinue this medication 48 hours prior to the procedure, and resume after recovery of kidney function post-surgery. Patients with poor nutritional status, liver dysfunction, or women who are pregnant or breastfeeding should not use this medication. This medication might affect kidney function, so regular kidney function tests should be performed, especially in the elderly or those with impaired kidney function. Due to the risk of hypoglycemia, caution is needed when skipping meals, having irregular eating habits, or engaging in vigorous exercise, and if symptoms of hypoglycemia occur, immediate action should be taken. Urinary or genital infections may occur; if such symptoms develop, consult a doctor. Fluid loss or dehydration may happen; thus, particularly elderly patients should be mindful of fluid intake, and if dehydration symptoms occur, the medication may be temporarily discontinued. Vitamin B12 deficiency may develop, so blood tests are necessary during long-term use. Alcohol intake may increase the risk of lactic acidosis; hence, avoid drinking alcohol during treatment. During treatment, if symptoms such as fever, pain around the genital area, or swelling appear, seek immediate medical attention, as severe cases may require urgent care. Elderly patients are at a higher risk for decreased kidney function and fluid loss, so special caution is necessary during treatment. In case of overdose, immediate medical intervention is necessary, especially due to the risk of lactic acidosis, making prompt treatment important. This medication has not been proven safe or effective for use in children; therefore, it is not recommended for individuals under 18 years old. During treatment, regular blood tests and physical examinations are required to monitor for adverse reactions, and immediate consultation with healthcare personnel should occur if abnormal symptoms emerge.

Serious side effects

Urticaria, erythema nodosum, necrotizing fasciitis, lactic acidosis, ketoacidosis, hepatic dysfunction (including hepatitis), severe allergic reactions, severe skin reactions, heart failure, myocardial infarction, cerebrovascular accident, acute kidney injury, urosepsis, pyelonephritis, seizures, confusion, vision abnormalities, paralysis, severe edema accompanied by increased blood pressure, severe hypoglycemia, necrotizing fasciitis (Fournier’s gangrene), worsening heart failure, acute cholecystitis, autoimmune disorders

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 sealed container to avoid exposure to air or moisture. It is recommended to maintain storage temperature between 1 degree and 30 degrees Celsius.

Appearance

Orange-yellow, biconvex oval film-coated tablet

Package unit

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