Metformin Glibenclamide Capsules (Ⅰ)

This product is a compound preparation of oral antihyperglycemic drugs glibenclamide and metformin hydrochloride. Metformin hydrochloride can reduce the production of glycogen in the liver, reduce the absorption of sugar by the intestine, and can increase insulin sensitivity by increasing the uptake and utilization of peripheral sugar. Glibenclamide is a sulfonylurea hypoglycemic drug, which mainly produces hypoglycemic effects by stimulating pancreatic β cells to secrete insulin. Toxicological study Genetic toxicity: The results of glibenclamide and metformin mutagenicity tests were negative. Reproductive toxicity: Rats took glibenclamide 300mg/kg/day (in mg/m2, about 150 times the maximum recommended daily dose for humans), or took metformin 600mg/kg/day (in mg/m2, equivalent to 3 times the maximum recommended daily dose of 2000mg for humans), and no teratogenic effects were found. A recent study showed that congenital abnormalities of the fetus are related to abnormal blood sugar in pregnant women during pregnancy, so it is recommended to use insulin as much as possible to keep pregnant women's blood sugar at normal levels. Although it is not known whether glibenclamide is excreted in human milk, many sulfonylurea drugs are known to be excreted in human milk. Studies in lactating rats showed that metformin hydrochloride can be secreted into breast milk and can reach the level of plasma. Carcinogenicity: No carcinogenicity was observed in rats given glibenclamide for 18 months at a dose of 300 mg/kg/day, and no carcinogenicity was observed in mice given it for 2 years. Carcinogenicity tests of metformin given to rats for 104 weeks and mice for 91 weeks at doses of 900 mg/kg/day and 1500 mg/kg/day (both equivalent to 4 times the maximum recommended daily dose of 2000 mg for humans in mg/m2) found no carcinogenicity. Female rats in the 900 mg/kg/day group had an increase in benign interstitial uterine polyps.

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.

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1. For patients with type 2 diabetes who cannot satisfactorily control blood sugar with diet and exercise therapy, the recommended starting dose is 1 tablet (glibenclamide/metformin: 1.25mg/250mg) once a day, taken with meals. 2. For patients who are undergoing first-time treatment and whose baseline HbAlc>9% or FPG>200mg/dl, 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 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 use sulfonylurea alone

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.

1. Kidney disease or renal insufficiency (male: serum creatinine ≥1.5mg/dl; 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. Hypotension and hypoxia before intravenous pyelography or arterial angiography, major surgery, and clinical conditions. 6. Type 1 diabetes patients.

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 uncontrollable 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, also 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 sulfonylureas can enhance the hypoglycemic effect of sulfonylureas. Ciprofloxacin can enhance the hypoglycemic effect of glibenclamide

Seal tightly and store in a cool, dry place.

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

18 months

Tianjin Baihai Pharmaceutical Co., Ltd.

• Founded in:

  2002-06-20

• Address:

  Fuxing Road, Shigezhuang Town, Wuqing District

• Tax NO.:

  91120222738481461F

• Registered Funds:

  9 million yuan

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