Idiangduo Tablet 12.5/500 mg

Adult dose

The recommended dose of this medication is 1 tablet, twice daily. The dosage is determined based on the existing treatment regimen, efficacy, and tolerance, without exceeding 25 mg of empagliflozin and 2000 mg of metformin. In cases where blood sugar control is insufficient, empagliflozin 5 mg twice daily (total 10 mg per day) and the previous dose of metformin should be used. In cases where tolerance to empagliflozin 10 mg is adequate and additional blood sugar control is needed, the dosage may be increased to empagliflozin 25 mg (total 25 mg per day). In patients switching from a regimen of empagliflozin (total 10 mg or 25 mg daily) and metformin, the existing doses of empagliflozin and metformin should be continued. When this medication is combined with sulfonylureas or insulin, dosage reduction of sulfonylureas or insulin should be considered to reduce the risk of hypoglycemia (refer to Section 4. Precautions and Section 6. Interactions). This medication should be taken with meals 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 in such cases.

This medication can cause severe lactic acidosis, so patients must consult a doctor immediately if symptoms of lactic acidosis such as fatigue, myalgia, shortness of breath, weakness, or abdominal pain occur. When used in combination with insulin or sulfonylurea medications, the risk of hypoglycemia may increase, necessitating careful monitoring of blood sugar status and adjustment of medication dosage if needed. This medication should not be administered to patients with moderate to severe renal impairment or acute renal failure, and regular kidney function tests should be performed. Treatment should be discontinued in acute diseases such as severe infections, dehydration, heart failure, and acute myocardial infarction, and can be resumed once the condition improves. If a patient is to undergo a test using iodinated contrast media, this medication should be stopped for at least 48 hours before and after the test, and it should be resumed only after confirming normal kidney function. Pregnant women or those who may become pregnant, as well as nursing mothers, should not use this medication, and it is important to consult a doctor regarding pregnancy plans. During treatment with this medication, caution must be taken to avoid fluid loss, and immediate medical attention should be sought for symptoms such as diarrhea, vomiting, or dehydration. This medication may increase the risk of genitourinary and urinary tract infections, so prompt treatment is necessary if any infection symptoms develop. Long-term use may decrease vitamin B12 levels, and regular blood tests should be performed to monitor vitamin status. Elderly patients or those with decreased kidney function should have their dosage adjusted and kidney function checked frequently, and it is advisable to avoid the maximum dose. In cases of overdose, serious side effects such as lactic acidosis may occur, so it is essential to adhere strictly to the dosage and visit a hospital immediately in case of overdose. Alcohol intake should be avoided during treatment with this medication, as alcohol may increase the risk of lactic acidosis. Symptoms of hypoglycemia can occur particularly when used in combination with other antidiabetic agents, so appropriate measures should be taken if symptoms arise. Safety and efficacy have not been established for this medication in pediatric patients, and it is recommended not to use it in individuals under 18 years of age. Regular medical consultations and examinations are necessary during treatment, and immediate consultation with medical personnel should occur if any abnormal symptoms arise.

Serious side effects

Urticaria, angioedema, perineal necrosis, ketoacidosis, lactic acidosis, urosepsis, pyelonephritis, hepatic dysfunction (including hepatitis), severe allergic reactions (including urticaria and angioedema), severe skin reactions (severe rash, blistering, skin peeling, oral/ocular mucosal pain), severe edema (systemic severe edema), difficulty breathing, asthma attacks, severe rashes accompanied by high fever, chest tightness, difficulty in breathing, pallor, sweating

Mild side effects

• Nausea
• vomiting
• diarrhea
• abdominal pain
• loss of appetite
• constipation
• altered taste
• itching
• rash
• headache

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture. It is advisable to maintain a storage temperature between 1 and 30 degrees Celsius.

Appearance

Light brownish-purple, biconvex oval film-coated tablet

Package unit

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