Metformin Hydrochloride Extended Release Tablets

Pharmacology: It can promote the binding of insulin to receptors and improve the sensitivity of diabetic patients to insulin, increase the anaerobic glycolysis of sugar in peripheral tissues and promote the utilization of sugar, inhibit fat decomposition, reduce plasma free fatty acid levels, weaken insulin resistance and improve the utilization of glucose, thereby playing the role of lowering blood sugar, lowering blood lipids and inhibiting arteriosclerosis. Toxicology: The oral LD50 of metformin hydrochloride in rats is 1.0g/kg, and the subcutaneous injection LD50 is 0.3g/kg.

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

This product is white long strip tablets.

(1) It is used for patients with type 2 diabetes (non-insulin-dependent type 2 diabetes) who are not satisfied with diet alone, especially those who are obese. It may have the effect of reducing weight. (2) It is effective for patients with type 2 diabetes who have poor response to sulfonylureas.

Oral administration, during or after meals. The initial dosage is usually once a day, one tablet (500 mg) at a time, taken at dinner, and the dosage is adjusted according to blood sugar and urine sugar. The maximum daily dose does not exceed (2000 mg) 4 tablets. If once a day, 4 tablets (2000 mg) each time cannot achieve satisfactory therapeutic effects, it can be changed to twice a day, 2 tablets (1000 mg) each time.

Some patients experience gastrointestinal discomfort after taking this product orally, such as nausea, vomiting, diarrhea, abdominal pain, constipation, bloating, indigestion, heartburn, as well as dizziness, headache, flu-like symptoms, abnormal taste, muscle pain, hypotension, palpitations, flushing, chills, chest discomfort, rash, weakness, tiredness, etc.

Patients with the following diseases are contraindicated to use metformin hydrochloride: 1. Kidney disease or renal insufficiency caused by cardiovascular failure, acute myocardial infarction and sepsis (such as blood creatinine level ge; 1.5mg/dl (male), ge; 1.4mg/dl (female) or abnormal creatinine clearance). 2. Congestive heart failure requiring drug treatment, and other serious cardiopulmonary diseases. 3. Patients who have received radiotherapy including parenteral administration of iodinated contrast agents should suspend the use of metformin hydrochloride, because the use of such products can cause acute changes in renal function. 4. Known allergies to metformin hydrochloride and any ingredients in this product. 5. Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. 6. Severe infection and trauma, major surgical operations, clinical hypotension and hypoxia, etc. 7. Alcoholism. 8. Uncorrected vitamin B12 and folic acid deficiency.

Precautions for children: The safety and efficacy of this product for children have not been established and it is not recommended for use. Precautions for pregnancy and lactation: This product is not recommended for pregnant women. Lactating women should use this product with caution. If it 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 their creatinine clearance test shows that their renal function is not reduced.

Intravascular injection of iodinated contrast agents for radiological examinations (such as intravenous urography, intravenous cholangiography, angiography, and CT examinations with intravenous contrast agents) - Intravenous use of iodinated contrast agents can cause acute changes in renal function, and patients receiving metformin may develop lactic acidosis (see [Contraindications]). Therefore, patients who are scheduled to undergo such examinations should temporarily stop taking this product before and 48 hours after the examination until renal function returns to normal. Tissue hypoxia - Cardiovascular failure (shock) caused by any reason, acute congestive heart failure, acute myocardial infarction, or other conditions characterized by hypoxemia can be accompanied by lactic acidosis and can also lead to prerenal azotemia. Patients treated with this product should immediately stop taking the above conditions. Surgery - Patients who need to undergo surgery should temporarily stop taking this product (except for minor surgery with unrestricted food and fluid intake) until the diet is restored and renal function is restored before restarting the medication. Drinking - Alcohol is known to affect the effect of metformin on lactate metabolism. Therefore, patients receiving this product should be warned to avoid sudden or prolonged excessive drinking. Impaired liver function------Some patients with lactic acidosis have liver impairment, so patients with clinical or laboratory evidence of liver disease should avoid using this product. Vitamin B12 level------In a 29-week clinical controlled trial of metformin hydrochloride tablets, it was observed that about 70% of patients had normal serum vitamin B12 levels in the past, and after taking the drug, their serum vitamin B12 levels dropped below normal levels, but there was no clinical manifestation. This decrease may be due to interference with the absorption of vitamin B12 by the B12 intrinsic factor complex. The decrease in vitamin B12 levels is rarely accompanied by anemia, and it can be quickly restored after discontinuation of metformin hydrochloride tablets or vitamin B12 supplementation. It is recommended that patients taking this product should have hematological parameters measured annually, and appropriate analysis and treatment should be carried out when obvious abnormalities occur. Some patients (those who do not take or absorb enough vitamin B12 and calcium) may be more susceptible to decreased vitamin B12 levels. It is beneficial for such patients to measure serum vitamin B12 levels every 2 to 3 years. Changes in clinical status in patients with previously well-controlled type 2 diabetes --- Patients with type 2 diabetes who were previously taking metformin and whose blood sugar was well controlled and who develop laboratory abnormalities or clinical abnormalities (especially fatigue or unspeakable discomfort) should promptly seek evidence of ketoacidosis or lactic acidosis. Measurements include serum electrolytes, ketone bodies, blood sugar, blood pH, lactate, pyruvate, and metformin levels. If any type of acidosis is present, the drug should be discontinued immediately and other appropriate treatments should be initiated. (See WARNINGS) Hypoglycemia --- Patients treated with this drug alone will not normally experience hypoglycemia, but hypoglycemia may occur when they eat too little, do not replenish enough calories after strenuous exercise, are used in combination with other glucose-lowering drugs (such as sulfonylureas and insulin), or drink alcohol. Elderly, debilitated, or malnourished patients, as well as those with reduced adrenal and pituitary function and alcoholism, are more susceptible to hypoglycemia. Hypoglycemia in elderly patients and those taking beta-adrenal blockers is difficult to recognize. Poor blood sugar control------When patients who regularly take a certain hypoglycemic drug experience stress, such as fever, coma, infection and surgery, their blood sugar will be temporarily poorly controlled. At this time, this product must be discontinued and insulin should be used temporarily. It can be resumed after the acute condition is relieved. After a period of use, the hypoglycemic effect of oral hypoglycemic drugs will be reduced. This phenomenon may be due to the progression of the underlying disease or a reduced response to the drug. It is called secondary failure and should be distinguished from primary failure caused by the ineffectiveness of the drug at the beginning of treatment. Secondary failure may occur with this product or sulfonylureas alone, as well as with this product combined with sulfonylureas. At this time, changes in treatment should be considered, including the start of insulin treatment.

Store in sealed container. The validity period is tentatively set at 18 months.

0.5 g

24 months.

Topfond Pharmaceutical Co., Ltd.

• Founded in:

  2013-11-13

• Address:

  No. 2 Guangming Road, Yicheng District, Zhumadian City

• Tax NO.:

  91411700083473072R

• Registered Funds:

  420 million yuan

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