Sitagliptin and Metformin Tablet 50/850 mg

Adult dose

The dosage of this medicine is determined based on each patient's current therapy, efficacy, and tolerance, provided it does not exceed a total dose of 100 mg Sitagliptin and 2000 mg Metformin. Generally, it is taken in two doses a day with food, with a gradual increase in dosage to reduce gastrointestinal side effects caused by Metformin. 1. Patients not currently treated with Metformin: The initial dose of this medicine is 50/500 mg taken twice daily, with each dose being one tablet. The dose can be increased to 50/1000 mg taken twice daily, with each dose being one tablet. Patients with renal impairment who are on reduced doses of Sitagliptin should not be switched to this medicine (refer to Usage Precautions 2. Do not administer to the following patients). 2. Patients currently receiving Metformin therapy: - The recommended initial dose for patients who cannot achieve sufficient blood sugar control on Metformin alone is 50 mg Sitagliptin taken twice daily (total of 100 mg) and the existing dose of Metformin. - Patients switching from the combination therapy of Sitagliptin and Metformin can start at their current doses of both medications. 3. In cases where sufficient blood sugar control cannot be achieved with combination therapy of Metformin and sulfonylureas, Metformin and insulin, or Metformin and thiazolidinediones: The initial dose of this medicine is 50 mg Sitagliptin taken twice daily (total of 100 mg), while the initial dose of Metformin should be considered based on the patient's blood glucose level and existing doses. To minimize gastrointestinal adverse effects caused by Metformin, dosage should be gradually increased. When co-administered with sulfonylureas or insulin, it may be necessary to consider a reduction in the doses of sulfonylureas or insulin to reduce the risk of hypoglycemia induced by them (refer to Usage Precautions 5. General Precautions). Research on the safety and effectiveness of switching to this medicine from other oral hypoglycemic agents has not been conducted. Any change in the treatment regimen for type 2 diabetes may cause changes in blood sugar control, so caution and appropriate monitoring are needed. In patients with renal impairment: This medicine may be used 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) if no other symptoms that may increase the risk of lactic acidosis are present, based on the following dose adjustments. The starting dose of Metformin is 500 mg or 850 mg administered once daily, so treatment should not begin with this medicine. The maximum recommended dose of Metformin is 500 mg taken twice daily. Kidney function should be closely monitored every 3-6 months. If CrCl < 45 mL/min or eGFR < 45 mL/min/1.73m2 indicates a decrease in kidney function, this medicine should be discontinued immediately. In patients with liver impairment: This medicine should not be administered to patients with liver dysfunction due to its Metformin component (refer to Usage Precautions 2. Do not administer to the following patients).

This medicine contains Sitagliptin and Metformin hydrochloride, and is primarily used for the treatment of type 2 diabetes. During the use of this medicine, severe allergic reactions may occur, so if symptoms such as skin rash, hives, or difficulty breathing appear, discontinue use immediately and consult a doctor. Serious inflammation of the pancreas, known as pancreatitis, may occur. If severe abdominal pain, nausea, or vomiting arises, notify medical personnel immediately. This medicine is not to be administered to patients with severely impaired kidney function or those with serious infections, dehydration, heart failure, or acute myocardial infarction. Particularly, before and after examinations that use contrast agents, the use of this medicine should be discontinued and can be resumed only after kidney function has been confirmed to be normal. It is safe not to use this medicine in women who are pregnant or may become pregnant, and in breastfeeding mothers. This medicine can cause hypoglycemia, so caution should be taken during irregular meals or excessive exercise. Increased vigilance for hypoglycemic symptoms is required when taken with other diabetes medications like insulin or sulfonylureas. A rare but very dangerous metabolic abnormality called lactic acidosis may occur; if sudden muscle pain, difficulty breathing, weakness, or abdominal pain arises, immediate hospital attention is necessary. Additionally, this medicine is not recommended for patients with liver dysfunction or those who engage in excessive alcohol consumption. Elderly patients are more likely to have reduced kidney function; thus, it is necessary to regularly check kidney function while taking this medicine, and dosage adjustments may be needed. Before surgery, the use of this medicine should be discontinued for a certain period, and can be resumed only after confirming normal kidney function post-surgery. While taking this medication, regular blood tests should be performed to monitor kidney function and hematological values, and caution is needed as vitamin B12 deficiency may occur. There may be interactions with other medications taken in conjunction with this medicine, so if there are medications currently in use, it is essential to inform a doctor or pharmacist. In case of overdose, seek immediate medical treatment, as drug removal may be possible through dialysis. While taking this medicine, regular blood glucose monitoring and health status checks should be performed to ensure safe treatment.

Serious side effects

Hives, severe swelling (angioedema), anaphylaxis, rash, exfoliative skin diseases such as Stevens-Johnson syndrome, acute pancreatitis (including fatal and non-fatal hemorrhagic or necrotizing pancreatitis), severe allergic reactions, acute kidney failure, difficulty breathing, severe joint pain accompanied by serious complications, bullous pemphigoid, liver abnormalities (elevation of liver enzymes), thrombocytopenia, severe neurological symptoms (severe headache, seizures, confusion, visual disturbances,

Mild side effects

• Diarrhea
• nausea
• vomiting
• abdominal pain
• upper respiratory tract infection
• nasopharyngitis
• headache
• hypoglycemia
• constipation
• muscle pain

This medicine should be stored in an airtight container, and it is recommended to keep it at room temperature between 1 and 30 degrees Celsius. Proper storage helps maintain the medicine's effectiveness and ensures safe use.

Appearance

Pink oval film-coated tablet

Package unit

30 tablets/box[(10 tablets/PTP x 3)]