Sitagliptin Metformin Duo Tablet 50/1000 mg

Adult dose

In antidiabetic therapy, the dosage of this medication is determined based on each component's maximum recommended daily dose of sitagliptin 100 mg and metformin 2000 mg, considering each patient's current treatment regimen, efficacy, and tolerability. This medication is generally taken twice a day with meals, and the dosage should be gradually increased to reduce gastrointestinal side effects caused by metformin. 1. For patients currently not treated with metformin: If the patient has not previously experienced diabetes drug therapy and has difficulty achieving adequate blood sugar control with monotherapy or cannot adequately achieve blood sugar control with sitagliptin monotherapy, the initial dosage of this medication can be taken as 50/500 mg twice daily, with an increase to 50/1000 mg, 1 tablet twice daily. Patients with renal impairment who are receiving a reduced dose of sitagliptin should not be converted to this medication (see precautions 2. Do not administer to the following patients). 2. For patients already treated with metformin: - The recommended initial dosage of this medication for patients who cannot achieve sufficient blood sugar control with metformin alone is a total daily amount of sitagliptin 50 mg twice daily (total daily amount 100 mg) alongside the current metformin dosage. - Patients transitioning from combined therapies of sitagliptin and metformin can start at their existing dosage of sitagliptin and metformin. 3. For patients not achieving sufficient blood sugar control with combinations of metformin and sulfonylureas, metformin and insulin, or metformin and thiazolidinediones: The initial dosage of this medication is sitagliptin 50 mg twice daily (total daily amount 100 mg), while the initial dosage of metformin should consider the patient's blood sugar levels and existing dosages. Dosing should be gradually increased to minimize gastrointestinal side effects caused by metformin. When co-administered with sulfonylureas or insulin, a reduction in the dose of sulfonylureas or insulin should be considered to minimize the risk of hypoglycemia (see precautions 5. General precautions). Studies to evaluate the safety and efficacy of transitioning from other oral hypoglycemic agents to this medication have not been conducted. Any changes in the treatment regimens for type 2 diabetes may affect blood sugar control, thus careful monitoring is required. Renal impairment patients This medication can be used in stage 3a moderate renal impairment (creatinine clearance [CrCl] ≥ 45 and < 60 mL/min or estimated glomerular filtration rate [eGFR] ≥ 45 and < 60 mL/min/1.73m2) under dosage adjustments, provided there are no accompanying symptoms that could increase the risk of lactic acidosis. The starting dose of metformin should be either 500 mg or 850 mg once daily, and switching to this treatment should not occur. The maximum recommended dose of metformin is 500 mg twice daily. Renal function should be monitored carefully every 3-6 months. If CrCl < 45 mL/min or eGFR < 45 mL/min/1.73m2 occurs, this medication should be discontinued immediately. Liver impairment patients This medication should not be administered to patients with liver dysfunction due to the metformin component (see precautions 2. Do not administer to the following patients).

This medication contains sitagliptin and metformin and is used in the treatment of diabetes. Severe allergic reactions may occur while taking this medication, so if symptoms such as skin rash, hives, or difficulty breathing develop, discontinue use immediately and consult a doctor. If symptoms of acute pancreatitis, such as severe abdominal pain, vomiting, or fever, occur, discontinue the medication immediately and inform healthcare professionals. The medication should not be taken by patients with certain health conditions such as severe renal impairment, dehydration, severe infections, heart failure, or acute myocardial infarction. If you are scheduled to undergo tests using iodinated contrast agents, this medication should be discontinued for a period before and after the test, and it can only be resumed once kidney function is confirmed to be normal. Women who are pregnant or may become pregnant and breastfeeding women should not take this medication. There is a rare but serious risk of lactic acidosis while receiving this medication. If symptoms such as muscle pain, weakness, difficulty breathing, or abdominal pain develop, inform a doctor immediately. Due to the risk of hypoglycemia, special caution should be exercised with irregular meals, excessive exercise, or concurrent use with other hypoglycemic agents; if hypoglycemic symptoms occur, appropriate measures should be taken immediately. Regular kidney function and blood tests should be conducted to monitor for abnormalities during treatment with this medication, and checking vitamin B12 levels periodically is also recommended. Alcohol consumption can increase the risk of lactic acidosis, so excessive drinking should be avoided while on this medication. If surgery is to be performed, this medication should be discontinued at least 48 hours prior to the procedure, and it can be resumed only after confirming normal kidney function post-surgery. If new skin conditions, severe joint pain, or blistering skin disorders develop while taking this medication, notify healthcare professionals immediately. Elderly patients are more prone to renal function decline, so dosage should be adjusted and regular monitoring of kidney function should be performed. In the event of overdose, immediate medical attention is required, and some components can be removed through dialysis. It is important to follow a diet and regular exercise program while taking this medication and to conduct regular blood sugar and kidney function tests.

Serious side effects

• Hives
• severe swelling (edema)
• anaphylaxis
• angioedema
• chest tightness
• difficulty breathing
• acute pancreatitis
• acute renal failure
• severe rash with fever
• blisters

Mild side effects

• Nausea
• vomiting
• diarrhea
• headache
• upper respiratory infection
• nasopharyngitis
• abdominal pain
• constipation
• muscle pain
• limb pain

This medication should be stored in a tightly sealed container to prevent air exposure, and it is recommended to keep it at room temperature between 1 to 30 degrees Celsius. Storing it this way helps maintain the medication's effectiveness.

Appearance

Pink oval film-coated tablets

Package unit

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