Glucitapamine Extended Release Tablet 50/1000 mg

Adult dose

This medication is taken once daily, 1 tablet or 2 tablets at a time. The dosage should be determined, considering the patient’s current treatment regimen, efficacy, and tolerability, without exceeding Sitagliptin 100 mg and Metformin 2000 mg. To reduce gastrointestinal side effects caused by Metformin, it should be taken at dinner and the dosage should gradually increase. In combination therapy with Sitagliptin and Metformin, this medication should be taken once daily, 1 tablet of 100/1000 mg extended release or 2 tablets of 50/500 mg or 50/1000 mg extended release each time. 1. Patients who are currently not being treated with Metformin: For those with no prior experience of diabetes drug therapy and who have difficulties achieving adequate blood sugar control through monotherapy, or who cannot obtain sufficient blood sugar control with Sitagliptin monotherapy, the initial dosage of this medication is Sitagliptin 100 mg and Metformin 1000 mg per day. If sufficient blood sugar control is not achieved with the initial dose, the Metformin dosage can be gradually increased up to the maximum recommended daily dose of 2000 mg to minimize gastrointestinal side effects. Patients with renal impairment who are already receiving reduced doses of Sitagliptin should not be switched to this medication. 2. Patients being treated with Metformin: - The recommended initial dose of this medication for patients unable to achieve adequate blood sugar control with Metformin monotherapy is the existing dose of Metformin plus Sitagliptin 100 mg per day. - Patients switching from combined therapy with Sitagliptin and Metformin can start with the existing dosage of Sitagliptin and Metformin. - Patients previously taking immediate-release tablets of Metformin as 2 doses of 850 mg or 1000 mg daily can start with 2 tablets of this medication 50/1000 mg extended release once daily. 3. In cases where sufficient blood sugar control is not achieved with combined therapy of Metformin and sulfonylureas, Metformin and insulin, or Metformin and thiazolidinediones: The initial dose of this medication is Sitagliptin 100 mg per day, and the initial Metformin dose should consider the patient’s blood sugar levels and existing dosages. To reduce gastrointestinal side effects caused by Metformin, the dosage should be gradually increased. When taken in combination with sulfonylureas or insulin, a reduction in the doses of sulfonylureas or insulin should be considered to reduce the risk of hypoglycemia caused by sulfonylureas or insulin. The safety and efficacy of switching patients previously treated with other oral hypoglycemic agents to this medication have not been studied. Any change in Type 2 diabetes treatment may affect blood sugar control, so careful monitoring is essential. For patients with renal impairment, this medication can be used under the following 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), provided no other symptoms that might increase the risk of lactic acidosis are present. The starting dose of Metformin should be either 500 mg or 850 mg once daily, and this medication should not be initiated. The maximum recommended dose of Metformin is 1000 mg per day. Renal function should be closely monitored every 3-6 months. If CrCl < 45 mL/min or eGFR < 45 mL/min/1.73m2 indicates reduced renal function, this medication should be discontinued immediately. For patients with liver impairment: Due to the Metformin component, this medication should not be given to patients with compromised liver function.

This medication contains both Sitagliptin and Metformin, which are used to treat diabetes. First, the Sitagliptin component can rarely cause serious allergic reactions, which may manifest as skin conditions such as hives, angioedema, or Stevens-Johnson syndrome, so caution is needed. Furthermore, acute pancreatitis may occur; if symptoms such as abdominal pain or vomiting arise, consult a doctor immediately. Although rare, the Metformin component can cause a serious metabolic disturbance called lactic acidosis, which poses higher risks in patients with impaired kidney function or liver function, as well as those with severe infections or dehydration. This drug should not be administered to patients with moderate or severe renal impairment, and regular kidney function checks should be performed before and during treatment. Additionally, this medication is not recommended for use in pregnant women, breastfeeding individuals, or children under 18, as its safety has not been established. This medication carries a risk of hypoglycemia; therefore, patients should closely monitor their blood sugar levels, especially when taken with insulin or sulfonylureas. Excessive alcohol consumption can increase the risk of lactic acidosis, so it's important to avoid alcohol while taking this medication. Before and after surgery, the administration of this drug should be temporarily suspended according to oral intake status and kidney function, and it should be resumed after recovery. Moreover, this medication contains Tartrazine (E102), a dye that may cause allergic reactions in some individuals, so caution is advised. During the course of this medication, it's crucial to maintain a regular diet and exercise, consistently check blood sugar and kidney function, and consult healthcare professionals immediately if any abnormal symptoms appear. In the event of an overdose, immediate medical attention is necessary, and Sitagliptin can be partially removed through hemodialysis. This drug can interact with several other medications, so if you are taking other drugs, it's essential to inform your healthcare provider.

Serious side effects

Hives, severe hypersensitivity reactions (anaphylaxis, angioedema, Stevens-Johnson syndrome, and other exfoliative skin disorders), acute pancreatitis including hemorrhagic or necrotizing pancreatitis, worsened renal function (including acute renal failure), lactic acidosis, severe hypoglycemia, acute renal failure, blistering dermatitis, elevated liver enzymes, acute renal failure, angioedema, anaphylaxis, cutaneous vasculitis, acute myocardial infarction, sepsis, acute renal failure, decreased renal function, liver issues

Mild side effects

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

This medication is sensitive to air and moisture; therefore, it should be stored in a tightly closed container. It is also important to store it at room temperature, between 1 and 30 degrees Celsius, to maintain its efficacy.

Appearance

Bright green oval extended release film-coated tablet

Package unit

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