Metformin and Glibenclamide Tablets (Ⅰ)

Genetic toxicity: The results of mutagenicity tests of glibenclamide and metformin were negative. Reproductive toxicity: Rats took glibenclamide 300mg/kg/day (in mg/㎡, about 150 times the maximum recommended daily dose for humans), or took metformin 600mg/kg/day (in mg/㎡, equivalent to 3 times the maximum recommended daily dose of 2000mg for humans). No teratogenic effect was found. A recent study showed that congenital abnormalities of the fetus are related to abnormal blood sugar in pregnant women during pregnancy. Therefore, 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. The results of studies on lactating rats showed that metformin hydrochloride can be secreted into breast milk and can reach the level in plasma. Carcinogenicity: Rats were given glibenclamide for 18 months at a dose of 300mg/kg/day, and no carcinogenicity was observed. Mice were given it for 2 years and no carcinogenicity was observed.

This product is a compound preparation, and its components are: each tablet contains 2.5 mg of glibenclamide and 500 mg of metformin hydrochloride.

This product is a film-coated tablet, which appears white or off-white after removing the coating.

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Oral administration, taken with meals. For second-line treatment of type 2 diabetes only: The recommended starting dose is twice a day, one tablet (2.5mg/500mg) at a time. However, for patients who have previously taken glibenclamide and/or metformin, the first dose of this drug should not exceed the dose of glibenclamide and/or metformin previously taken to avoid hypoglycemia. The dose should be gradually increased until the lowest dose that provides good control of the patient's hyperglycemia is reached. The maximum daily dose should not exceed four tablets (10mg/2000mg).

1. Hypoglycemia reaction. This product contains sulfonylurea drugs. All sulfonylurea drugs may cause severe hypoglycemia. 2. Gastrointestinal reactions: loss of appetite, nausea, vomiting, upper abdominal distension, abdominal pain, heartburn, metallic taste in the mouth, jaundice, liver damage, etc. 3. Skin reactions: skin allergies such as itching, erythema, urticaria, papules, photosensitivity, etc. 4. Blood system: granulocytopenia, thrombocytopenia, hemolytic anemia, aplastic anemia, etc. 5. Other reactions: joint pain, muscle pain, vasculitis, hypothyroidism, dizziness, weakness, fatigue, weight loss, etc.

The following patients are contraindicated: 1. Those who are known to be allergic to metformin or glibenclamide. 2. Patients with insulin-dependent diabetes. 3. Patients with diabetes accompanied by acute or chronic metabolic acidosis, including diabetic ketoacidosis, hepatic and renal insufficiency, heart failure, acute myocardial infarction, thyroid disease, severe infection and trauma, major surgery, and clinical hypotension and hypoxia. 4. Lactating women and pregnant women.

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

1. Taking it together with sulfonamide drugs may cause hypoglycemia. 2. Glibenclamide interacts with ciprofloxacin and may cause hypoglycemia; when used together with miconazole, it may cause severe hypoglycemia. 3. When taken together with alcohol, it may cause abdominal cramps, nausea, vomiting, headache, facial flushing and hypoglycemia. 4. When used together with beta-blockers, it may increase the risk of hypoglycemia and mask the symptoms of hypoglycemia, such as increased pulse rate and blood pressure. 5. When used together with chloramphenicol, guanethidine, insulin, monoamine oxidase inhibitors, phenylbutazone, hydroxyphenylbutazone, probenecid, and salicylates, it may enhance the hypoglycemic effect. 6. Adrenal cortical hormones, epinephrine, phenytoin sodium, thiazide diuretics, and thyroxine may increase blood sugar levels. When used together with this class of drugs, the dosage of this class of drugs may be increased.

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Metformin hydrochloride 0.25g and glibenclamide 1.25mg

18 months

Jinyao Darrentang Group Co., Ltd. Xinxin Pharmaceutical Factory

• Founded in:

  2000-10-20

• Address:

  Chenglinzhuang Industrial Zone, Tianjin

• Tax NO.:

  91120110103738323L

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