Teramet XR Controlled-release Tablet 50/1000 mg

Adult dose

For antidiabetic therapy, the dosage of this drug should not exceed the maximum recommended daily doses of sitagliptin 100 mg and metformin 2000 mg, considering the patient's current treatment regimen, efficacy, and tolerability. This drug should be taken once daily with meals to reduce gastrointestinal side effects from metformin, preferably in the evening, with gradual dose increases. To maintain controlled-release characteristics, this drug should be swallowed whole and not divided, crushed, or chewed. There have been reports of the drug being inadequately dissolved and excreted in the stool. It is not known whether the active ingredient of the drug was included in the materials excreted in the stool. If patients repeatedly report that this medication has been found in their stool, healthcare professionals should evaluate whether blood glucose is being adequately controlled (refer to usage precautions, section 5, general precautions). Take one table of this drug 100/1000 mg controlled-release formulation once daily. Patients taking 50/500 mg controlled-release or 50/1000 mg controlled-release formulations should take two tablets simultaneously once daily. 1. For patients not currently treated with metformin: For patients who have no prior experience with diabetes medication treatment and have difficulty achieving adequate blood glucose control with monotherapy, or for those unable to achieve adequate blood glucose control with sitagliptin monotherapy, the initial dosage is 100 mg sitagliptin and 1000 mg metformin once daily. If adequate blood glucose control is not achieved with the initial dosage, the dosage of metformin can be gradually increased up to the maximum recommended dose of 2000 mg to reduce gastrointestinal side effects. Patients with renal impairment who are receiving a reduced dose of sitagliptin should not be transitioned to this drug (refer to usage precautions section 2, do not administer to the following patients). 2. For patients receiving metformin therapy: - The recommended initial dosage of this drug for patients not achieving adequate blood glucose control with metformin monotherapy is 100 mg sitagliptin and the existing dosage of metformin. - Patients transitioning to this drug from a combination therapy of sitagliptin and metformin may begin with the existing dosages of sitagliptin and metformin. - Patients who were previously taking immediate-release metformin at 850 mg or 1000 mg twice daily can start with 50/1000 mg controlled-release formulation at a dosage of two tablets once daily. 3. For patients unable to achieve adequate blood glucose control with combination therapy of metformin and sulfonylureas, metformin and insulin, or metformin and thiazolidinediones: The initial dosage of this drug is 100 mg sitagliptin per day, and the initial dosage of metformin should be adjusted considering the patient's blood glucose levels and previous dosages. To reduce gastrointestinal side effects from metformin, the dosage should be gradually increased. When used in combination with sulfonylureas or insulin, the possibility of reducing the dosage of sulfonylureas or insulin to decrease the risk of hypoglycemia should be considered (refer to usage precautions section 5, general precautions). No studies have been conducted to evaluate the safety and efficacy of transitioning patients from other oral hypoglycemic agents to this drug. Changes in diabetes treatment can affect blood glucose control, so caution is advised and appropriate monitoring should be in place. In patients with renal impairment: This drug may be used with appropriate dose 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) without accompanying symptoms that may increase the risk of lactic acidosis. The starting dose of metformin is to administer 500 mg or 850 mg once daily, and this drug should not be started in such patients. The maximum recommended dose of metformin is 1000 mg daily. Kidney function should be closely monitored every 3-6 months. If CrCl <45 mL/min or eGFR <45 mL/min/1.73m2 decreases, this drug should be discontinued immediately. In patients with liver impairment: This drug should not be administered to patients with liver dysfunction due to the metformin component (refer to usage precautions section 2, do not administer to the following patients).

This drug is used for the treatment of diabetes and contains two components: sitagliptin and metformin. There is a risk of hypersensitivity reactions; if symptoms such as skin rash or difficulty breathing occur, discontinue use immediately and consult a doctor. There is a risk of pancreatitis, so if sudden abdominal pain, vomiting, or fever occurs, consult a physician immediately. This drug should not be administered to patients with impaired kidney function, serious infections, heart failure, or acute myocardial infarction. If a procedure using iodinated contrast agents is planned, this drug should be discontinued for a period before and after the procedure to avoid potential kidney problems. It is recommended that pregnant or nursing women not take this medication for safety reasons. Hypoglycemia may occur, so caution is advised when skipping meals or engaging in vigorous exercise, and the risk of hypoglycemia may be increased if taken with other antidiabetic medications. This drug is not recommended for patients with impaired liver function, and regular liver and kidney function tests should be conducted. A rare complication known as lactic acidosis may occur, characterized by excessive buildup of lactic acid in the body, with symptoms such as muscle pain, weakness, difficulty breathing, and abdominal pain. If these occur, notify medical staff immediately. Alcohol consumption may increase the risk of lactic acidosis; therefore, it is advisable to avoid drinking while on this medication. Regular monitoring of blood sugar, kidney function, and hematological tests is required while taking this drug, and consult a physician immediately if any unusual symptoms arise. Additionally, there may be other medications that interact with this drug, so inform your doctor or pharmacist of any other medications you are taking. Elderly patients frequently have decreased kidney function, so extreme caution is needed during use, and regular testing is recommended. In case of overdose, seek medical care immediately to receive appropriate treatment, and blood dialysis may be performed if necessary.

Serious side effects

• Urticaria
• angioedema
• anaphylaxis
• Stevens-Johnson syndrome
• acute pancreatitis
• acute renal failure
• severe hypoglycemia
• bullous pemphigoid
• elevated liver enzymes
• liver abnormalities (jaundice)

Mild side effects

• Diarrhea
• nausea
• vomiting
• abdominal pain
• upper respiratory infection
• nasopharyngitis
• headache
• myalgia
• limb pain
• back pain

Store this medication in a tightly sealed container to prevent exposure to air or moisture. It is best to maintain the storage temperature between 1 degree and 30 degrees Celsius to preserve the medication's efficacy and safety for a prolonged period.

Appearance

Bright green, double convex, oval-shaped controlled-release film-coated tablet

Package unit

28 tablets/bottle, 56 tablets/bottle, 200 tablets/bottle