Metaline Tablets 50/1000mg

Adult dose

The dosage of this medication is determined within the limits of the maximum recommended daily dosage for each component: sitagliptin 100 mg and metformin 2000 mg, considering each patient's current treatment regimen, efficacy, and tolerability. 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. Patients currently not treated with metformin: In cases where previous antidiabetic medication treatment has not been effective in achieving sufficient blood glucose control or when sufficient blood glucose control cannot be achieved with sitagliptin monotherapy, the initial dosage of this medication can be 50/500 mg taken twice daily, with an increase to 50/1000 mg taken twice daily, one tablet at a time. Patients with renal impairment who are having their sitagliptin dosage reduced should not be switched to this medication (refer to Precautions for Use 2. Do not administer to the following patients). 2. Patients currently being treated with metformin: - For patients where sufficient blood glucose control cannot be achieved with metformin monotherapy, the recommended initial dosage of this medication is the total daily amount of sitagliptin 50 mg taken twice daily (100 mg total daily) along with the existing metformin dosage. - Patients switching from combination therapy with sitagliptin and metformin can start at their existing dosages. 3. For cases where sufficient blood glucose control cannot be achieved with the combination of metformin and sulfonylureas, metformin and insulin, or metformin and thiazolidinediones: The initial dosage of this medication can be sitagliptin 50 mg taken twice daily (100 mg total daily), and the initial dosage of metformin should be based on the patient's blood glucose levels and existing dosages. To reduce gastrointestinal adverse reactions caused by metformin, the dosage should be gradually increased. When taken in combination with sulfonylureas or insulin, consideration should be given to reducing the doses of sulfonylureas or insulin to minimize the risk of hypoglycemia induced by them (refer to Precautions for Use 5. General Cautions). The safety and efficacy of switching from other oral hypoglycemic agents to this medication has not been evaluated in studies. Any change in treatment regimen for type 2 diabetes may result in changes in blood glucose control, requiring careful monitoring. For patients with renal impairment: This medication can 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) provided they do not have other symptoms that increase the risk of lactic acidosis, with dosage adjustments specified below. The starting dose of metformin should be 500 mg or 850 mg taken once daily, and treatment should not begin with this medication. The maximum recommended dosage for metformin is 500 mg taken twice daily. Renal function should be closely monitored every 3-6 months. If CrCl < 45 mL/min or eGFR < 45 mL/min/1.73m2 occurs, this medication must be discontinued immediately. For patients with hepatic impairment: This medication should not be administered to patients with liver dysfunction due to the metformin component (refer to Precautions for Use 2. Do not administer to the following patients).

This medication contains sitagliptin and metformin, which are used for the treatment of diabetes. First, sitagliptin can seldom cause severe allergic reactions, so if symptoms such as skin rash or difficulty breathing occur, it is essential to stop taking the medication immediately and consult a doctor. Additionally, acute pancreatitis may occur, so symptoms such as abdominal pain, vomiting, or nausea should be reported immediately. Metformin can rarely cause a life-threatening condition known as lactic acidosis. If this occurs, symptoms such as muscle pain, difficulty breathing, fatigue, and abdominal pain may appear, so caution is required. Patients with impaired kidney function or serious infections, heart failure, or acute myocardial infarction should not take this medication. Furthermore, the drug should be temporarily discontinued before and after tests using iodine contrast agents until normal kidney function is confirmed. It is advisable not to use this drug in pregnant or breastfeeding women, or in children under 18 years of age. While taking this medication, regular monitoring of kidney function and blood tests are recommended, including monitoring vitamin B12 levels. There is a risk of hypoglycemia; therefore, caution is needed when skipping meals or engaging in vigorous exercise, and dosage adjustments should be discussed with a doctor when used in conjunction with insulin or sulfonylurea medications. Alcohol can increase the risk of lactic acidosis; thus, it is safer to avoid drinking alcohol while using this medication. In cases of surgery, severe infection, or dehydration, it is recommended to temporarily stop taking the medication and resume after recovery. If symptoms such as skin blisters, rash, severe joint pain, or muscle pain occur while using this medication, consult a doctor immediately. In case of overdose, visit a medical institution immediately to receive appropriate treatment. Sitagliptin can be partially removed through hemodialysis. It is important for the patient and their family to thoroughly understand the side effects and risks associated with this medication, and to immediately inform medical personnel of any unusual symptoms.

Serious side effects

• Hives
• severe swelling (angioedema)
• chest tightness
• difficulty breathing
• anaphylaxis
• Stevens-Johnson syndrome
• severe skin adverse reactions
• acute pancreatitis
• acute renal failure
• shortness of breath

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 from entering, and it is best kept at room temperature between 1 and 30 degrees Celsius. By storing it this way, the efficacy of the medication can be maintained and deterioration can be prevented.

Appearance

Dark red oval film-coated tablet

Package unit

28 tablets/box [(14 tablets/PTPX2)], 56 tablets/box [(14 tablets/PTPX4)]