Sitagliptin/Metformin Extended-Release Tablets 100/1000 mg

Adult dose

The 100/1000 mg extended-release tablet should be taken once a day, with a single tablet per dose. Patients taking the 50/500 mg extended-release tablet or the 50/1000 mg extended-release tablet should take two tablets simultaneously once a day. 1. For patients who are not currently treated with metformin: The initial dosage is a total daily dose of 100 mg of sitagliptin and 1000 mg of metformin. 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 daily dose of 2000 mg to reduce gastrointestinal adverse effects caused by metformin. 2. For patients currently being treated with metformin: - The recommended initial dose of this medicine for patients who cannot achieve adequate blood glucose control on metformin monotherapy is the existing daily dosage of sitagliptin 100 mg and metformin. - Patients switching to this medicine from combination therapy of sitagliptin and metformin can start with the existing dosage of sitagliptin and metformin. - Patients who were taking the immediate-release formulation of metformin 850 mg or 1000 mg twice daily can start at 1 dose of 2 tablets of the 50/1000 mg extended-release tablet once daily. 3. For those unable to achieve sufficient blood glucose control with the combination therapy of metformin and sulfonylureas, metformin and insulin, or metformin and thiazolidinediones: The initial dose is a total daily of 100 mg of sitagliptin and the initial dose of metformin should be determined based on the patient's blood glucose levels and existing dosages. If transferring from other oral hypoglycemic agents, the safety and efficacy of this medicine have not been studied. Any changes in the treatment regimen for type 2 diabetes may alter blood glucose control, so caution and close monitoring are required.

This medicine contains both sitagliptin and metformin and is used for diabetes treatment. Firstly, caution should be taken as serious allergic reactions may occur during the use of this medicine. If symptoms such as rash, hives, difficulty in breathing, or swelling of the face or neck occur, discontinue use immediately and consult a doctor. Additionally, acute pancreatitis, which is inflammation of the pancreas, may rarely occur, so if symptoms like abdominal pain, nausea, vomiting, or fever occur, a hospital visit should be made immediately. The metformin component in this medicine can cause a serious metabolic complication called lactic acidosis, which can be very rare but fatal, so caution is advised. Symptoms of lactic acidosis include shortness of breath, muscle pain, weakness, abdominal pain, and abnormal breathing; if these symptoms occur, inform medical personnel immediately. Patients with reduced kidney function or severe liver disease should not take this medicine, and kidney function should be regularly monitored even when kidney function is only slightly decreased. This medicine should be discontinued in specific situations, for example, during dehydration, severe infections, heart disease, and before and after surgeries, as well as before and after undergoing tests with radiopaque contrast agents, and the decision to continue should be made in consultation with a physician. There is also a risk of hypoglycemia; therefore, especially when taking insulin or other antihyperglycemic agents, blood glucose levels should be checked frequently and symptoms of hypoglycemia should be monitored diligently. Excessive alcohol consumption can increase the risk of side effects from this medicine, so it should be avoided during treatment. It is safer for women who are pregnant or may become pregnant, as well as those who are breastfeeding, to avoid this medicine. In children, the safety and effectiveness have not been sufficiently established, and it is not recommended for those under 18 years of age. Finally, it is important to continuously manage health status by maintaining regular meals, exercise, and regular monitoring of blood glucose and kidney function while taking this medicine.

Serious side effects

Hives, severe swelling (angioedema), anaphylaxis, rash, exfoliative skin disease (including Stevens-Johnson syndrome), severe skin adverse reactions, acute pancreatitis, acute kidney failure, elevated liver enzyme levels, jaundice, severe and disabling joint pain, bullous pemphigoid, severe allergic reactions, lactic acidosis, acute kidney function deterioration, hypoglycemia (severe), severe edema, increased blood pressure, serious neurological symptoms (seizures, altered consciousness)

Mild side effects

• Upper respiratory tract infection
• nasopharyngitis
• diarrhea
• nausea
• vomiting
• abdominal pain
• headache
• muscle pain
• limb pain
• back pain

This medicine should be stored in a tightly closed container, protected from exposure to air and moisture, and it is recommended to keep it at room temperature between 1 to 30 degrees Celsius. Storing it this way will help safely maintain the effectiveness of the medicine.

Appearance

Light blue, oval-shaped, bi-convex extended-release film-coated tablets

Package unit

Bottle - 100 tablets/bottle, Bottle - 30 tablets/bottle