Sitameron Tablets 50/850 Milligrams

Adult dosage

The dose of this medication is determined based on the patient's current treatment regimen, efficacy, and tolerability, ensuring it does not exceed the maximum recommended daily doses of sitagliptin 100 mg and metformin 2000 mg for each component. This medication is generally taken twice daily with food, and the dosage should be gradually increased to reduce gastrointestinal adverse reactions caused by metformin. 1. For patients not currently being treated with metformin: In cases where a sufficient blood sugar control is difficult on monotherapy or where adequate control cannot be achieved with sitagliptin monotherapy, the initial dosage of this medication can be 50/500 mg taken twice daily, with one tablet per dose, or can be increased to 50/1000 mg taken twice daily, with one tablet per dose. Patients with renal impairment who are reducing the dose of sitagliptin should not switch to this medication (refer to Usage Precautions 2. Do not administer in the following patients). 2. For patients currently on metformin therapy: - The recommended initial dosage for patients who cannot achieve adequate blood sugar control with metformin monotherapy is a total daily amount of sitagliptin 50 mg taken twice daily (total daily amount 100 mg) and the existing dosage of metformin. - Patients transitioning from sitagliptin and metformin combination therapy can initiate based on their existing doses of sitagliptin and metformin. 3. In the case of inadequate blood sugar control with combination therapy involving metformin and sulfonylureas, metformin and insulin, or metformin and thiazolidinediones: The initial dosage for this medication is sitagliptin 50 mg taken twice daily (total daily amount 100 mg), while the initial dosage of metformin should be considered based on the patient's blood glucose level and current dosage. The dosage should be gradually increased to mitigate gastrointestinal adverse reactions associated with metformin. If combined with sulfonylureas or insulin, dosage reductions for sulfonylureas or insulin may be considered to minimize the risk of hypoglycemia induced by sulfonylureas or insulin (refer to Usage Precautions 5. General Precautions). Safety and efficacy studies for patients switching from other oral hypoglycemic agents to this medication have not been conducted. Any changes to the type 2 diabetes treatment regimen could influence blood glucose control, hence careful monitoring is necessary regarding blood glucose levels. Renal impairment This medication can be used under dose adjustments for patients with moderate renal impairment stage 3a (creatinine clearance rate [CrCl] ≥ 45 and < 60 mL/min or estimated glomerular filtration rate [eGFR] ≥ 45 and < 60 mL/min/1.73m2) if accompanied by no other symptoms that could increase the risk of lactic acidosis. The starting dose of metformin should be 500 mg or 850 mg once daily, hence this medication should not be initiated. The maximum recommended dose of metformin is 500 mg twice daily. Kidney function should be closely monitored every 3-6 months. If kidney function declines to CrCl < 45 mL/min or eGFR < 45 mL/min/1.73m2, this medication should be immediately discontinued. Liver impairment This medication should not be administered to patients with liver dysfunction due to its metformin component (refer to Usage Precautions 2. Do not administer in the following patients).

This medication is a diabetes treatment containing two components that help control blood sugar levels. When taking this medication, caution must be taken for hypersensitivity reactions. Rarely, severe allergic reactions may occur, so if symptoms such as rash, hives, or difficulty breathing arise, immediately stop taking the drug and inform a healthcare professional. Pancreatitis, an inflammation of the pancreas, may develop; therefore, if symptoms such as abdominal pain, nausea, vomiting, or fever appear after taking this medication, consult a doctor immediately. One of the components in this medication may pose risks to patients with renal dysfunction; therefore, patients with impaired kidney function or those with heart failure, acute myocardial infarction, or severe infections should not take it. Additionally, this medication should be discontinued before tests involving radioiodine contrast agents and should only be resumed after confirming normal kidney function post-examination. Women who are pregnant or may become pregnant, as well as breastfeeding women, are advised not to take this medication. Hypoglycemia may occur while taking this medication, so extra caution should be taken when skipping meals or engaging in vigorous exercise, as the risk of hypoglycemia can be heightened when taken with other blood sugar-lowering agents. This medication should also be administered with caution to patients with impaired liver function, and regular monitoring of liver and kidney function tests is required. Alcohol consumption can increase the risk of a serious side effect known as lactic acidosis, so excessive drinking should be avoided while on this medication. In cases of surgeries, except for minor surgeries where there are no restrictions on food and fluid intake, this medication should be stopped 48 hours prior to surgery and can be resumed after confirming that kidney function has recuperated post-surgery. While taking this medication, it is important to adhere to a dietary regimen and regular exercise, as well as routinely check blood sugar and kidney function. In case of overdose, symptomatic treatment such as removing the medication from the gastrointestinal tract will be conducted, and since this medication can be partially removed by dialysis, dialysis treatment may be beneficial if necessary. If symptoms such as skin blisters or severe joint pain and muscle pain appear during the course of treatment, inform the doctor immediately. Elderly patients may experience diminished kidney function, so dose adjustments and regular monitoring of kidney function are necessary. Finally, this medication can interact with other drugs, so if you are taking any other medications, you must inform your healthcare provider.

Serious side effects

Urticaria, angioedema, anaphylaxis, Stevens-Johnson syndrome, rash, cutaneous vasculitis, exfoliative dermatitis, acute pancreatitis, fatal/non-fatal hemorrhagic or necrotizing pancreatitis, acute renal failure, dyspnea, unstable angina, acute myocardial infarction, serious hypoglycemia, severe lactic acidosis, severe joint pain with disability, blistering dermatitis, hospitalization due to blistering dermatitis, elevated liver enzymes.

Mild side effects

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

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 to ensure the effectiveness and safety of the medication for a long time.

Appearance

Pink oval film-coated tablets

Package unit

PTP - 28 tablets/box[(14 tablets/PTP*2)], PTP - 56 tablets/box[(14 tablets/PTP*4)]