[English name] Metformin Hydrochloride Tablets Chinese Pinyin: Yansuan Erjiashuanggua Pian 

[Ingredients] Metformin hydrochloride.

Chemical name: 1,1-dimethyl diformin hydrochloride.

Chemical structure formula: Molecular formula: C4H11N5 · HCl Molecular weight: 165.63 [Characteristics] This product is sugar coated or film coated tablet, which is white after removing the coating.

[indication] For diabetic patients with unsatisfactory dietary control, especially those with obesity and hyperinsulinemia, this drug can not only reduce blood sugar, but also may have the effect of weight loss and hyperinsulinemia.

It is effective in some patients with poor sulfonylureas, such as sulfonylureas, small intestinal glycosidase inhibitors or thiazolidinediones, which is better than that used alone.

Can also be used in patients treated with insulin to reduce insulin dosage.

[Specification] 0.25g [usage and dosage] Oral adults began 0.25g (1 tablet), 2~3 times a day, then according to the curative effect, the general daily amount of 1~1.5g (4~6 tablets), no more than 2g (8 tablets).

Taking it immediately during or after a meal can reduce gastrointestinal reactions.

[Adverse reactions] 1. Common are: nausea, vomiting, diarrhea, metallic taste in the mouth.

2. Sometimes you have fatigue, fatigue, dizziness, and skin rash.

3. Although the incidence of lactic acidosis is very low, it should be noted.

Clinical manifestations are vomiting, abdominal pain, excessive ventilation, mental disorders, and increased lactate concentration in the blood can not be explained by uremia, ketoacidosis or salicylate poisoning.

4. Can reduce intestinal absorption of vitamin B12, reduce hemoglobin, produce macroerythroid anemia, can also cause malabsorption.

[taboo] The following conditions should be disabled: Type 1. Diabetes mellitus is associated with ketoacidosis, hepatic and renal dysfunction (serum creatinine over 1.5 mg/dl), pulmonary insufficiency, heart failure, acute myocardial infarction, severe infection and trauma, major surgery, and clinical hypotension and hypoxia.

2. Diabetes mellitus combined with serious chronic complications (such as diabetic nephropathy, diabetic fundus lesions).

3. Before intravenous pyelography or arteriography.

4. Alcoics.

5. Patients with severe heart and lung diseases.

6. Patients with vitamin B12, folic acid, and iron deficiency.

7. Patients with a poor general condition (e. g., malnutrition, dehydration).

[Notes] 1. Type I diabetes mellitus should not be used alone (in combination with insulin).

2. During the medication, fasting blood glucose, urine sugar and urinary ketone body should be frequently checked, and blood creatinine and blood lactate concentration should be measured regularly.

3. Use with caution in patients with a previous history of lactic acidosis.

[Drugs for pregnant women and lactating women] Pregnant women and lactating women are prohibited.

[Drug for children] is not clear.

[Elderly medication] Patients over 70 years old can have lactic acidosis, which should be used with caution.

[Drug interaction] 1. Use the dosage with insulin, strengthen the hypoglycemic effect, and the dose should be adjusted.

2. This product can enhance the anticoagulant effect of anticoagulants (such as warfarin, etc.), which can cause bleeding tendency.

3. If this product is taken with alcohol drinks, abdominal pain, acidemia and hypothermia may occur.

4. It can cause hypoglycemia when used with sulfonylurea.

[Overdose] This experiment was not performed and no reliable references.

[Pharmacological toxicology] Pharmacological effect: this product is a hypoglycemic agent.

This product can reduce fasting and postprandial hyperglycemia in patients with diabetes, and HbAlc can decrease by 1%~2%. The mechanism of hypoglycemia may be as follows: 1. Increase the sensitivity of surrounding tissues to insulin and increase insulin-mediated glucose utilization.

2. Increase the glucose utilization of non-insulin-dependent tissues, such as brain, blood cells, renal medulla, intestine, skin, etc.

3. Inhibit hepatic glycogen coneogenesis and reduce hepatic sugar output.

4. Inof glucose uptake by intestinal wall cells.

5. Inhibit the biosynthesis and storage of cholesterol, and reduce the blood triglyceride and total cholesterol levels.

Different from the effect of insulin, this product has no effect on promoting fat synthesis, no obvious hypoglycemic effect on normal people, and generally does not cause hypoglycemia when applied type diabetes alone.

Toxicology: This experiment was not performed and has no reliable references available.

[Pharmacokinetics] Metformin is mainly absorbed by the small intestine with an absorption half-life of 0.9 to 2.6 hours and a bioavailability of 50% to 60%.

Two hours after oral administration of metformin 0.5g, its plasma concentration peaked at nearly 2 μg/ml.

Higher levels of metformin are concentrated in the wall of the gastrointestinal tract, about 10 to 100 times the plasma concentration.

The salivary content of kidney and liver is more than twice that of plasma concentration. Metformin has stable structure, does not bind to plasma protein, and is excreted in urine and is cleared rapidly. The half-life of plasma is 1.7~4.5 hours, and 90% is cleared within 12 hours.

Part of this product can be secreted by the renal tubules, so the renal clearance rate is greater than the glomerular filtration rate. Because this product is mainly excreted by the kidney, this product can accumulate in the body in renal function decline, causing hyperlactatemia or lactic acidosis.

[Storage] Seal it for storage.

[Packaging] Plastic bottles, 48 pieces / bottle, 60 pieces / bottle.

[Expiry date] 48 months 

[Approval No.] Chinese drug approval word H31022081 

[Drug Marketing License Holder] Shanghai Xinyi Pharmaceutical Factory Co., LTD 

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