Stamezin Tablets 50/850 milligrams

Adult dose

This medication is typically taken twice a day with food, and the dosage should be gradually increased to minimize gastrointestinal side effects from metformin. 1. For patients currently not receiving metformin treatment: - The initial dosage is 50/500 mg taken twice daily, with the option to increase to 50/1000 mg taken twice daily. 2. For patients receiving treatment with metformin: - The suggested initial dosage for patients who cannot achieve sufficient glycemic control with metformin monotherapy is sitagliptin 50 mg taken twice daily (total of 100 mg) along with the current metformin dosage. - For patients switching from co-administered metformin and sulfonylureas, or metformin and insulin, or metformin and thiazolidinediones where sufficient glycemic control was not achieved: The initial dosage is sitagliptin 50 mg taken twice daily (total of 100 mg), and the initial metformin dosage should consider the patient's blood glucose levels and current dosage. To minimize gastrointestinal side effects from metformin, the dosage should be gradually increased. When used in combination with sulfonylureas or insulin, consider reducing the dosages of these agents to mitigate the risk of hypoglycemia (refer to precautions 5. General caution). Studies reviewing the safety and efficacy of switching from other oral hypoglycemic agents to this medication have not been conducted. As any change in type 2 diabetes treatment may affect blood sugar control, careful monitoring is imperative. Renal impairment: This medication can be used with dosage adjustments 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) only if there are no other accompanying symptoms that could increase the risk of lactic acidosis. The starting dosage of metformin should not exceed 500 mg or 850 mg taken once daily; therefore, treatment should not start with this medication. The maximum recommended dosage of metformin is 500 mg twice daily. Kidney function should be carefully monitored every 3-6 months. If CrCl < 45 mL/min or eGFR < 45 mL/min/1.73m2 indicate worsening renal function, this medication should be discontinued immediately. Liver impairment: This medication 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 medication is composed of sitagliptin and metformin, and is used for the treatment of diabetes. While taking this medication, serious allergic reactions may occur; therefore, if symptoms such as skin rash, itching, or difficulty breathing arise, stop taking the drug immediately and consult a doctor. It may cause inflammation of the pancreas (pancreatitis); thus, if symptoms such as abdominal pain, nausea, or vomiting occur, it should be carefully monitored, and a doctor must be informed. This medication should not be administered to patients with poor kidney function, severe heart disease, acute infections, pregnant or nursing women. It should also be avoided in cases of severe liver dysfunction or dehydration, severe diarrhea, or vomiting. During treatment, hypoglycemic symptoms may occur, so patients should avoid irregular meals and excessive exercise, and be well aware of hypoglycemic symptoms. Particularly, caution is needed when used in combination with insulin or sulfonylureas, as the risk of hypoglycemia may increase. Taking this medication with alcohol may be risky; thus, it is advisable to avoid drinking. Patients scheduled for surgery should discontinue this medication 48 hours prior to the procedure and may resume only after confirming normal renal function post-surgery. Regular blood tests and kidney function tests should be conducted, and monitoring for vitamin B12 deficiency is necessary. If sudden symptoms such as difficulty breathing, muscle pain, weakness, or abdominal pain occur during treatment, inform medical personnel immediately. Elderly patients may experience decreased kidney function, so dosage adjustment and regular kidney function testing are particularly important. In case of overdose, seek medical attention immediately for appropriate treatment, and blood dialysis may be helpful. There may be potential for drug interactions, thus if taking other medications, inform the doctor or pharmacist.

Serious side effects

Hives, severe swelling (angioedema), chest tightness, difficulty breathing, anaphylaxis, rash, severe allergic reactions, severe skin reactions (including Stevens-Johnson syndrome), acute pancreatitis, acute renal failure, shortness of breath, severe and disabling joint pain, blistering similar to pemphigus, thrombocytopenia, rhabdomyolysis, liver abnormalities (increased liver enzymes, jaundice), severe neurological symptoms (headache, confusion, visual disturbances)

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 air or moisture from entering. It is best to store it at room temperature between 1 to 30 degrees Celsius. This will help maintain the medication’s effectiveness and ensure safe use.

Appearance

Pink oval film-coated tablets

Package unit

30 tablets/box [10 tablets/AluAlu X3]