Metformin Glibenclamide Capsules (Ⅰ)

Drug action: This product is a compound preparation of the oral antihyperglycemic drugs glibenclamide and metformin hydrochloride. Metformin hydrochloride can reduce the production of liver glycogen, reduce intestinal absorption of sugar, and increase insulin sensitivity by increasing peripheral sugar uptake and utilization. Glibenclamide is a sulfonylurea hypoglycemic drug, which mainly produces a hypoglycemic effect by stimulating pancreatic β cells to secrete insulin. Toxicological studies: Genetic toxicity: The results of the mutagenicity tests of glibenclamide and metformin were negative. Reproductive toxicity: Rats took glibenclamide 300 mg/kg/day (measured in mg/m2, about 150 times the maximum recommended daily dose for humans), or took metformin 600 mg/kg/day (measured in mg/m2, equivalent to the maximum recommended daily dose for humans) and had no adverse reactions.

This product is a compound preparation, and its components are: each tablet contains 1.25 mg of glibenclamide and 250 mg of metformin hydrochloride.

This product is a capsule, and the contents are white or off-white granules or powder.

1. For patients with type 2 diabetes whose blood sugar levels are not satisfactorily controlled by diet control and/or exercise therapy alone. 2. Can be used as a second-line drug for patients with type 2 diabetes whose blood sugar levels are not satisfactorily controlled by sulfonylurea or metformin hydrochloride alone.

Personalized Dosing 1 For patients with type 2 diabetes who cannot satisfactorily control blood sugar with diet and exercise therapy, the recommended starting dose is once a day. 1 tablet (glibenclamide/metformin: 1.25mg/250mg) at a time, taken with meals. 2 For patients with a baseline HbAlc 9% or FPG 200mg/dl who are undergoing treatment for the first time, the starting dose is 1 tablet (1.25mg/250mg) twice a day, taken with breakfast and dinner. Every two weeks, the daily dose of this product can be increased to reach the minimum effective therapeutic dose. 3 For patients who have previously taken other hypoglycemic drugs, the recommended starting dose is 2 tablets (2.5mg/500m

1 Gastrointestinal reactions may include diarrhea, nausea, vomiting, stomach discomfort, and a metallic taste in the mouth. 2 Sometimes there are weakness, tiredness, dizziness, headache, and rash. 3 The incidence of lactic acidosis is very low, and the clinical manifestations are vomiting, abdominal pain, hyperventilation, mental disorders, and increased lactic acid concentration in the blood that cannot be explained by uremia or ketoacidosis. 4 Rare but serious symptoms include jaundice, liver damage, bone marrow suppression, granulocytopenia (manifested as sore throat, fever, infection), thrombocytopenia (manifested as bleeding, purpura), etc. 5 It can reduce the intestinal absorption of vitamin B12, reduce hemoglobin, produce megaloblastic anemia, and can also cause poor absorption.

The following patients are contraindicated: 1. Renal disease or renal insufficiency (male: serum creatinine; female: serum creatinine ≥1.4mg/dl. Or abnormal creatinine clearance), renal insufficiency caused by cardiogenic shock, myocardial infarction, sepsis. 2. Congestive heart failure requiring drug treatment. 3. Allergic to metformin or glibenclamide. 4. Acute and chronic metabolic acidosis, including diabetic ketoacidosis. 5. Before intravenous pyelography or arteriography, major surgery, and clinical hypotension and hypoxia. 6. Patients with type 1 diabetes.

Precautions for children: Children are prohibited from taking this product. Precautions for pregnancy and lactation: Precautions for pregnant and lactating women. Precautions for the elderly: Renal function declines with age. Elderly patients should monitor their renal function at all times when using this product. Generally, elderly patients should not take the highest dose of this product.

Thiazides and other diuretics, corticosteroids, phenothiazines, thyroid preparations, sex hormones, oral contraceptives, phenytoin, niacin, sympathomimetics, calcium channel blockers, and isoniazid can cause difficult-to-control hyperglycemia. When patients take this product and the above drugs at the same time, they should pay attention to changes in the patient's blood sugar level. When stopping taking the above drugs, pay attention to whether hypoglycemia occurs. Some protein inhibitors (such as salicylic acid, sulfonamides, chloramphenicol, probenecid, etc.) have little effect on metformin. Sulfonylureas have a high binding rate to serum proteins and are more likely to interact with these drugs than metformin. Nonsteroidal anti-inflammatory drugs, other strong protein inhibitors, salicylates, and sulfonamides can enhance the blood sugar-lowering effect of sulfonylureas. Ciprofloxacin can enhance the effect of glibenclamide

Store in a sealed, dry place. Valid for 24 months.

Each tablet contains 250mg of metformin hydrochloride and 1.25mg of glibenclamide

36 months

Shanxi Sanjin Pharmaceutical Co., Ltd.

• Founded in:

  1999-01-28

• Address:

  No. 1001, Middle Section of Tongge Street, Xiaohe Industrial Park, Shanxi Transformation and Comprehensive Reform Demonstration Zone

• Tax NO.:

  91140100713652658Q

• Registered Funds:

  66 million yuan

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