Metformin and Glibenclamide Tablets (Ⅰ)

This product is a compound preparation of 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 beta cells to secrete insulin.

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 film-coated tablet, which appears white after removing the coating.

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

1 For patients with type 2 diabetes who cannot control blood sugar satisfactorily with diet and exercise therapy, the recommended starting dose is 1 tablet (glyburide/metformin: 1.25mg/250mg) once a day, taken with meals. 2 For patients who are undergoing treatment for the first time and have a baseline HbAlc 9% or FPG 200mg/dl, the starting dose is 1 tablet (1.25mg/250mg) twice a day, taken with meals in the morning and evening. The daily dose of this product can be increased every two weeks to achieve the minimum effective therapeutic dose. 3 For patients who have previously taken other hypoglycemic drugs, the recommended starting dose is 2 tablets (2.5mg/500mg) twice a day or 4 tablets (5mg/1000mg) twice a day, taken with meals. For patients who cannot control blood sugar well with sulfonylurea or metformin hydrochloride alone, the recommended starting dose is 2 tablets (2.5mg/500mg) twice a day or 4 tablets (5mg/1000mg) twice a day, taken with breakfast and dinner. To avoid hypoglycemia, the starting dose should not exceed the daily dose of sulfonylurea or metformin hydrochloride previously taken. The daily dose should be adjusted gradually, with each increase not exceeding 2 tablets (2.5mg/500mg) until the minimum effective therapeutic dose is reached. 4 The maximum daily dose is recommended not to exceed 8 tablets (10mg/2000mg).

1 Gastrointestinal reactions may include diarrhea, nausea, vomiting, stomach pain, and a metallic taste in the mouth; 2 Sometimes there is weakness, tiredness, dizziness, headache, and rash. 3 The incidence of lactic acidosis is very low, and the clinical manifestations are vomiting, abdominal pain, hyperventilation, and mental disorders. The concentration of lactic acid in the blood increases and 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 malabsorption.

The following patients are contraindicated: 1. Kidney disease or renal insufficiency (male: serum creatinine ge; 1.5mg/dl; female: serum creatinine ge; 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 arterial angiography, major surgery, and clinical hypotension and hypoxia. 6. Patients with type 2 diabetes.

Precautions for children: Not yet clear. Precautions for pregnancy and lactation: Lactating women and pregnant women. Precautions for the elderly: Not yet clear.

Thiazides and other diuretics, corticosteroids, phenothiazines, thyroid preparations, sex hormones, oral contraceptives, phenytoin sodium, niacin, sympathomimetics, calcium channel blockers, and isoniazid can produce uncontrollable hyperglycemia. When patients take this product and the above drugs together, they should pay attention to the changes in the patient's blood sugar level. When stopping taking the above drugs, they should pay attention to whether hypoglycemia occurs. Some protein inhibitors (such as salicylates, 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 hypoglycemic effect of sulfonylureas. There are reports that ciprofloxacin can enhance the hypoglycemic effect of glibenclamide. There are reports that taking miconazole and hypoglycemic drugs together can cause more intense hypoglycemic reactions. Metformin and furosemide can affect each other's pharmacokinetic parameters. Furoxime and metformin can increase each other's Cmax and AUC, but have no significant effect on renal clearance. Nifedipine can enhance the absorption of metformin. Metformin has little effect on nifedipine. Amiloride, digoxin, morphine, procainamide, quinidine, quinine, ranitidine, triamine phthalide, TMP, and vancomycin enhance the pharmacological effects of metformin due to competition for the renal tubular conversion system. Oral cimetidine can increase the plasma concentration, peak value and total blood concentration of metformin by 60%, and increase the plasma and whole blood AUC by 40%. The elimination phase half-life of a single dose does not change. When patients take cationic drugs secreted by the proximal tubule, they should be closely monitored and the dose of this product should be adjusted.

Keep away from light and store in a sealed container.

Metformin hydrochloride 250 mg, Glibenclamide 1.25 mg

24 months

Qingdao Huanghai Pharmaceutical Co., Ltd.

• Founded in:

  1982-02-10

• Address:

  No. 17, Keyuanjingsi Road, Laoshan District, Qingdao

• Tax NO.:

  91370200163567984Y

• Registered Funds:

  182.18928 million yuan

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