Egliptin IR Tablet 50/1000 mg

Adult dose

In the treatment of diabetes, the dosage of this drug is determined by considering each patient's current therapy, effectiveness, and tolerance, without exceeding the maximum recommended daily dosage of sitagliptin 100 mg and metformin 2000 mg. This drug is generally taken twice daily with food and the dosage should be gradually increased to minimize gastrointestinal side effects caused by metformin. 1. Patients not currently being treated with metformin: If there has been no prior experience with diabetes medications, and it is difficult to control blood glucose adequately with monotherapy or sufficient blood glucose control cannot be achieved with sitagliptin alone, the initial dosage of this drug should be 50/500 mg taken twice daily (1 tablet at a time), and it can be increased to 50/1000 mg, 1 tablet twice daily. Patients with renal impairment who are receiving reduced dosing of sitagliptin should not be switched to this drug (refer to precautions 2. Do not administer to the following patients). 2. Patients currently being treated with metformin: - For patients who cannot achieve sufficient blood sugar control with metformin monotherapy, the recommended initial dosage of this drug is sitagliptin 50 mg twice daily (total of 100 mg daily) along with the existing dosage of metformin. - Patients switching from combined therapy of sitagliptin and metformin may start with the existing doses of sitagliptin and metformin. 3. For patients who cannot achieve sufficient blood sugar control with combined therapy of metformin and sulfonylurea or metformin and insulin, or metformin and thiazolidinedione: The initial dosage of this drug is sitagliptin 50 mg twice daily (total of 100 mg daily), with the starting dose of metformin adjusted based on the patient's blood glucose levels and existing doses. To minimize gastrointestinal side effects caused by metformin, the dosage should be gradually increased. When administered in conjunction with sulfonylureas or insulin, consideration should be given to reducing the doses of sulfonylureas or insulin to reduce the risk of hypoglycemia (refer to precautions 5. General precautions). No studies have been conducted on the safety and efficacy of switching patients from other oral hypoglycemic agents to this drug. Changes in any treatment for type 2 diabetes can affect blood sugar control, thus careful monitoring is required. Patients with renal impairment This drug may be used with adjusted dosing in patients with moderate renal impairment stage 3a (creatinine clearance [CrCl] ≥ 45 and < 60 mL/min or estimated glomerular filtration rate [eGFR] ≥ 45 and < 60 mL/min/1.73m2) who do not have other symptoms that would increase the risk of lactic acidosis. Start the metformin dosage with 500 mg or 850 mg, taken once daily, so this drug should not be initiated. The maximum recommended dosage of metformin is 1000 mg taken daily in two doses. Kidney function should be carefully monitored every 3 to 6 months. If CrCl < 45 mL/min or eGFR < 45 mL/min/1.73m2 is noted, this drug should be discontinued immediately. Patients with liver impairment This drug should not be administered to patients with liver dysfunction due to the metformin component (refer to precautions 2. Do not administer to the following patients).

This drug contains sitagliptin and metformin and is used for diabetes treatment. Serious allergic reactions may occur while taking this medication, so if symptoms such as rash, hives, or difficulty breathing appear, you should stop taking the medication immediately and consult a doctor. There is a risk of pancreatitis, which is inflammation of the pancreas, so if symptoms such as abdominal pain, nausea, or vomiting occur, you should go to the hospital immediately. Patients with severely impaired kidney function or serious conditions such as heart failure or acute myocardial infarction should not take this drug. If you are scheduled to undergo examinations using radiocontrast agents, you should stop taking this drug for a certain period before and after the examination and should resume after confirming that kidney function is normal. This medication should not be administered to pregnant women or breastfeeding women or those who may become pregnant. Patients with irregular meals, malnutrition, or excessive exercise, or those who are taking other medications should be careful as there is a risk of hypoglycemia or lactic acidosis. This drug may cause side effects such as gastrointestinal discomfort, diarrhea, headache, upper respiratory infections, and hypoglycemia symptoms, so symptoms should be closely monitored. The risk of hypoglycemia is increased when taken with insulin or sulfonylureas, so if necessary, the dosage of those medications should be adjusted. Patients with liver dysfunction should avoid taking this drug and kidney function should also be regularly checked, and if abnormalities are found, the medication should be discontinued. Alcohol may increase the risk of side effects of this drug, so it is important to avoid excessive drinking while taking this medication. If surgery is planned, you should stop taking this drug 48 hours before the surgery and resume only after kidney function has been confirmed to be normal post-surgery. If sudden muscle pain, joint pain, skin rash, or blisters occur during the use of this drug, you should immediately inform a physician and receive appropriate treatment. Elderly patients may have reduced kidney function, so the dosage should be adjusted when taking this drug and kidney function should be frequently monitored. In case of overdose, you should immediately visit a medical institution for appropriate treatment, and dialysis may be helpful. Regular blood sugar tests and blood tests, as well as monitoring kidney function during the use of this drug, are essential.

Serious side effects

Hives, severe swelling (edema), anaphylaxis, angioedema, rash, severe allergic reactions, Stevens-Johnson syndrome, exfoliative dermatitis, severe rash with fever, blisters, epidermal loss, mucosal pain in mouth/eyes, severe skin reactions, difficulty breathing, respiratory distress, asthma attacks, abnormal breathing accompanied by cough and fever, yellowing of the skin or eyes (jaundice), general malaise, liver abnormalities (jaundice), sudden

Mild side effects

Diarrhea, nausea, vomiting, abdominal pain, upper respiratory infections, nasopharyngitis, headache, muscle pain, limb pain, back pain, itching, thrombocytopenia, severe joint pain accompanied by disability, itching, dizziness, decreased appetite, constipation, malaise, indigestion

This drug should be stored in a tightly closed container to prevent air and moisture from entering. It is also advisable to store the medication at room temperature, ideally between 1 to 30 degrees Celsius, without being too hot or too cold.

Appearance

Oval film-coated tablets in dark red color

Package unit

56 tablets - 56 tablets/box [(14 tablets/PTP x 4)], 30 tablets - 30 tablets/bottle, 200 tablets - 200 tablets/bottle