Metformin Hydrochloride Enteric-coated Tablets

1. Pharmacological action: Metformin hydrochloride is a hypoglycemic drug that improves blood glucose tolerance in patients with type 2 diabetes and reduces basal and postprandial blood glucose. The mechanism of action of metformin hydrochloride is different from other types of oral anti-diabetic drugs. It can reduce the production of glycogen, reduce intestinal absorption of sugar, and increase insulin sensitivity by increasing peripheral sugar uptake and utilization. Unlike sulfonylurea drugs, metformin hydrochloride will not cause hypoglycemia in patients with type 2 diabetes or patients with normal blood sugar (except for special circumstances - see precautions). After treatment with metformin hydrochloride, insulin secretion remains unchanged, while fasting insulin levels and daily plasma insulin levels are reduced. 2. Genetic toxicity: The results of the Ames test, mouse lymphocyte gene mutation test, human lymphocyte chromosome aberration test and mouse micronucleus test of this product are all negative. 3. Reproductive toxicity: Male and female rats were given metformin hydrochloride at a dose of up to 600 mg/kg/day (equivalent to 3 times the maximum daily dose recommended by human clinical practice based on body surface area), and no effect on fertility was observed. When rats and rabbits were given metformin hydrochloride at a dose of up to 600 mg/kg/day (equivalent to 2 and 6 times the maximum daily dose recommended by human clinical practice based on body surface area), there was no teratogenic effect. The results of studies on lactating rats showed that metformin hydrochloride can be secreted into breast milk and can reach the level in plasma.

The main ingredient of this product is metformin hydrochloride. Chemical name: 1,1-dimethylbiguanide hydrochloride Molecular weight: C4H11N5·HCl

This product is enteric-coated tablets, which appear white after removing the coating.

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1. Diabetes treatment should be individualized according to the blood sugar test results. Start with a small dose and gradually increase the dose according to the patient's condition. The maximum recommended dose for adults is 1.8g per day. The usual starting dose is 0.25g, twice a day, before meals. After about a week, if the condition is not well controlled, it can be increased to 3 times a day, 0.25g each time, and gradually increased to 1.8g per day, taken in divided doses. 2. The starting dose for pediatric patients is generally 0.25g, twice a day, before meals. The dose can be increased as appropriate according to blood sugar control, and the maximum dose can be 1.13g per day, taken in divided doses.

Common adverse reactions of this product include diarrhea, nausea, vomiting, bloating, fatigue, indigestion, abdominal discomfort and headache. Other rare adverse reactions include abnormal stool, hypoglycemia, myalgia, dizziness, abnormal nails, rash, increased sweating, abnormal taste, chest discomfort, chills, flu symptoms, hot flashes, palpitations, weight loss, etc. Metformin can reduce the absorption of vitamin B12, but rarely causes anemia. It is rare for this product to cause lactic acidosis within the therapeutic dose range.

(1) Contraindicated in patients with kidney disease or the following conditions: renal dysfunction caused by heart failure (shock), acute myocardial infarction and sepsis (serum creatinine level ≥1.5 mg/dL (male), ≥1.4 mg/dL (female) or abnormal creatinine clearance). (2) Congestive heart failure requiring drug treatment, and other serious heart and lung diseases. (3) Severe infection and trauma, surgical operation, clinical hypotension and hypoxia, etc. (4) Known allergy to metformin hydrochloride. (5) Acute or chronic metabolic acidosis, including diabetic ketoacidosis with or without coma, and diabetic ketoacidosis requiring insulin treatment. (6) Alcoholics. (7) Patients receiving intravascular injection of iodinated contrast agents should temporarily stop using this product. (8) Patients with uncorrected vitamin B12 and folic acid deficiency.

Precautions for children: The maximum daily dose of this product for patients with type 2 diabetes aged 0-16 years is 1.8g. This product is not recommended for children under 10 years old. Precautions for pregnancy and lactation: This product is not recommended for pregnant women. Lactating women should use this product with caution. If this product must be used, breastfeeding should be stopped. Precautions for the elderly: When elderly patients over 65 years old use metformin, they should be cautious and have their renal function checked regularly. The maximum dose is usually not used. This product is not recommended for patients over 80 years old unless the creatinine clearance test shows that renal function is not reduced.

1. No changes in the pharmacokinetic parameters of metformin were found when metformin and glibenclamide were used in combination as a single dose. 2. When metformin was used in combination with furosemide (Lasix), the AUC of metformin increased, but there was no change in renal clearance; at the same time, the Cmax and AUC of furosemide decreased, the terminal half-life was shortened, and there was no change in renal clearance. 3. Cationic drugs secreted through the renal tubules (such as amiloride, digoxin, morphine, procainamide, quinidine, quinine, ranitidine, triamterene, trimethoprim and vancomycin) may theoretically compete with metformin for the renal tubular transport system and interact with it. Therefore, close monitoring and adjustment of the dose of this product and/or interacting drugs are recommended. 4. When metformin was used in combination with cimetidine, the plasma and whole blood AUC of metformin increased, but the two drugs alone did not change.

seal.

0.5g

36 months

Lesheng Pharmaceutical Shijiazhuang Co., Ltd.

• Founded in:

  2002-12-10

• Address:

  No. 198, Xiangjiang Road, Shijiazhuang High-tech Zone

• Tax NO.:

  9113010180441898XY

• Registered Funds:

  830,000 yuan

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