Metformin Hydrochloride Tablets

[Pharmacology and Toxicology] This product is a hypoglycemic drug. This product can reduce fasting and postprandial hyperglycemia in patients with type 2 diabetes, and HbAlc can be reduced by 1%~2%. The mechanism of this product in lowering blood sugar may be: 1. Increase the sensitivity of peripheral tissues to insulin and increase insulin-mediated glucose utilization. 2. Increase the utilization of glucose by non-insulin-dependent tissues, such as the brain, blood cells, renal medulla, intestines, skin, etc. 3. Inhibit hepatic gluconeogenesis and reduce hepatic glucose output. 4. Inhibit the uptake of glucose by intestinal wall cells. 5. Inhibit the biosynthesis and storage of cholesterol and reduce blood triglyceride and total cholesterol levels. Unlike the action of insulin, this product has no effect on promoting fat synthesis and no obvious hypoglycemic effect on normal people. It generally does not cause hypoglycemia when used alone for type 2 diabetes. [Pharmacokinetics] Metformin is mainly absorbed by the small intestine, with an absorption half-life of 0.9~2.6 hours and a bioavailability of 50%~60%. Two hours after oral administration of 0.5g of metformin, its plasma concentration reaches a peak value of nearly 2μg/ml. A high level of metformin accumulates in the gastrointestinal wall, which is 10 to 100 times the plasma concentration. The content in the saliva of the kidney and liver is about twice the plasma concentration. Metformin has a stable structure and does not bind to plasma proteins. It is excreted in the urine in its original form and is rapidly cleared. Its plasma half-life is 1.7 to 4.5 hours, and 90% is cleared within 12 hours. A part of this product can be secreted by the renal tubules, so the renal clearance rate is greater than the glomerular filtration rate. Since this product is mainly excreted by the kidney in its original form, it can accumulate in the body in large quantities when used in renal dysfunction, causing hyperlactatemia or lactic acidosis.

The main ingredient of this product is metformin hydrochloride, and its chemical name is 1,1-dimethylbiguanide hydrochloride.

This product is an enteric film-coated tablet, which appears white after removing the coating.

It is used for patients with type 2 diabetes who are not satisfied with diet control alone, especially those who are obese and have hyperinsulinemia. This drug not only has the effect of lowering blood sugar, but also may reduce weight and hyperinsulinemia. It can be effective for patients with poor efficacy of certain sulfonylureas. For example, it is more effective when used in combination with sulfonylureas, intestinal glycosidase inhibitors or thiazolidinediones hypoglycemic drugs than when used alone. It can also be used for patients treated with insulin to reduce the amount of insulin.

Oral administration: Adults start with 0.25g once, 2-3 times a day, and then adjust the dosage according to blood sugar and urine sugar levels, generally 1g-1.5g per day, and no more than 2g per day. Take half an hour before meals, enteric-coated tablets can reduce gastrointestinal reactions.

1. Common symptoms include: nausea, vomiting, diarrhea, metallic taste in the mouth. 2. Sometimes there is weakness, tiredness, dizziness, and rash. 3. Although the incidence of lactic acidosis is very low, it should be paid attention to. Clinical manifestations include vomiting, abdominal pain, hyperventilation, mental disorder, and increased lactic acid concentration in the blood that cannot be explained by uremia, ketoacidosis or salicylic acid poisoning. 4. It can reduce the intestinal absorption of vitamin B12, reduce hemoglobin, produce megaloblastic anemia, and also cause malabsorption.

The following conditions should not be used: 1. Type 2 diabetes with ketoacidosis, liver and kidney dysfunction (serum creatinine exceeds 1.5mg/dl), pulmonary insufficiency, heart failure, acute myocardial infarction, severe infection and trauma, major surgery, and clinical hypotension and hypoxia. 2. Diabetes with severe chronic complications (such as diabetic nephropathy, diabetic fundus lesions). 3. Before intravenous pyelography or arterial angiography. 4. Alcoholics. 5. Patients with severe heart and lung diseases. 6. Patients with vitamin B12, folic acid and iron deficiency. 7. Patients with poor systemic condition (such as malnutrition, dehydration).

Precautions for children: The maximum daily dose of this product for patients with type 2 diabetes aged 10-16 years is 2000 mg. 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: Elderly patients over 65 years old should use this product with caution 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 their creatinine clearance test shows that their renal function is not reduced.

1. When used in combination with insulin, the hypoglycemic effect is enhanced, so the dosage should be adjusted. 2. This product can enhance the anticoagulant effect of anticoagulants (such as warfarin), which may cause bleeding tendency. 3. Cimetidine can increase the bioavailability of this product and reduce the renal clearance rate, so the dosage of this product should be reduced.

Keep tightly closed.

0.25g (as metformin hydrochloride)

24 months.

Changzhou Pharmaceutical Factory Co., Ltd.

• Founded in:

  2001-12-14

• Address:

  No. 518, Laodong East Road, Changzhou

• Tax NO.:

  91320400137158490L

• Registered Funds:

  108 million yuan

• Website:

  Log in to view

• Email:

  Log in to view