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Metformin hydrochloride tablets

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Indications: It is suitable for patients with type 2 diabetes who are not satisfied with simple dietary control, especially those with obesity and hyperinsulinemia. This medicine can not only lower blood sugar, but also reduce weight and hyperinsulinemia. It can be effective for some patients with poor sulfonylureas. For example, combined with sulfonylureas, intestinal glucosidase inhibitors or thiazolidinediones, they are more effective than those used alone. They can also be used for insulin. Treat patients to reduce insulin dosage.

Approval date: January 05, 2007

Revised date: October 01, 2010 December 01, 2015

Please read the instructions carefully and use under the guidance of a physician

【Drug Name】

Common name: metformin hydrochloride tablets

English name: Metformin Hydrochloride Tablets

Phonetic script: Hansuan Erjiashuanggua Pian

[Ingredients]

The main ingredient of this product is metformin hydrochloride.

Chemical name: 1,1-dimethyl biguanide hydrochloride.

Molecular formula: C4H11N5 · HCL

Molecular weight: 165.63

[Properties] This product is a white enteric film-coated tablet, which is white after removing the coating.

[Specifications] 0.25g

【Dosage】

Oral, adults start 0.25g (1 tablet) once, 2 to 3 times a day, and then adjust the dose according to blood glucose and urine sugar conditions, generally 1g to 1.5g (4 to 6 tablets) per day, up to 2g per day ( 8 tablets). Taken half an hour before a meal, enteric-coated tablets can reduce gastrointestinal reactions.

【Adverse reactions】

1. Common are: nausea, vomiting, diarrhea, stomach pain, metallic taste in the mouth.

2. Sometimes fatigue, tiredness, dizziness, rash.

3. Although the incidence of lactic acidosis is very low, attention should be paid to it. The clinical manifestations are vomiting, abdominal pain, excessive ventilation, and psychiatric disorders, and the increase in blood lactic acid concentration cannot be explained by uremia, ketoacidosis or salicylic acidosis.

4. Can reduce intestinal absorption of vitamin B12, reduce hemoglobin, produce giant red blood cell anemia, and also cause malabsorption.

[Taboo]

Type 1.2 diabetes with ketoacidosis, liver and renal insufficiency (serum creatinine exceeding 1.5 mg / 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 disease).

3. Before intravenous pyelography or arteriography.

4. Alcoholics.

5. Patients with severe heart and lung disease.

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

7. Patients with poor general condition (eg malnutrition, dehydration).

【Precautions】

    1. This type of diabetes should not be used alone (can be combined with insulin).

2. Regularly check fasting blood glucose, urine glucose and urine ketone body during medication, and regularly measure blood creatinine and blood lactic acid concentrations.

3. People with a previous history of lactic acidosis should be used with caution.

[Medication for pregnant and lactating women] Banned during pregnancy and lactating women.

[Children's medication] This experiment has not been performed and there are no reliable references.

[Medicine for the elderly] Lactic acidosis may occur in patients over 70 years of age and should be used with caution.

【medicine interactions】

1. Combined with insulin, the hypoglycemic effect is strengthened, the dose should be adjusted.

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

3. This product can cause abdominal pain, acidemia and hypothermia if taken with alcoholic beverages.

4. This product can cause hypoglycemia when used in combination with sulfonylureas.

[Drug overdose]

This experiment was not performed and there are no reliable references.

[Pharmacology and Toxicology]

This product is a hypoglycemic drug. This product can reduce fasting and postprandial blood glucose in patients with type 2 diabetes, HbAlc can be reduced by 1% to 2%. The mechanism of this product may be:

1. Increase the sensitivity of surrounding tissues to insulin and increase insulin-mediated glucose utilization.

2. Increase the use of glucose by non-insulin-dependent tissues, such as brain, blood cells, kidney callus, intestines, skin, etc.

3. Inhibit liver gluconeogenesis and reduce liver glucose output.

4. Inhibit glucose uptake by intestinal wall cells.

5. Inhibit cholesterol biosynthesis and storage, reduce blood triglycerides and total cholesterol levels. Unlike insulin, this product does not promote fat synthesis, has no significant hypoglycemic effect on normal people, and generally does not cause hypoglycemia when used alone for type II diabetes.

【Pharmacokinetics】

Metformin is mainly absorbed by the small intestine, with an absorption half-life of 0.9 to 2.6 hours, a bioavailability of 50% to 60% of oral metformin for 0.58-2 hours, and its plasma concentration reached a peak of nearly 2 μg / ml. Metformin is accumulated in the gastrointestinal tract wall at a level of 10 to 100 times the plasma concentration. The content of saliva in the kidney and liver is more than twice the plasma concentration. Metformin is stable in structure and does not bind to plasma proteins. It is excreted in the urine in its original form and is rapidly eliminated. The plasma half-life is 1.7 to 4.5 hours and 90% within 12 hours. Be expelled. A part of this product can be secreted by the renal tubules, so the rate of renal expulsion is greater than the glomerular filtration rate. Since this product is mainly excreted by the kidneys in the original form, this product can accumulate a large amount in the body when renal function declines, causing hyperlactate Disease or lactic acidosis.

[Storage] Keep sealed.

[Packing] Aluminum plastic, 12 pieces / board, 4 plates / box;

Plastic bottle, 100 tablets / bottle.

[Validity] 30 months

[Executive Standards] 2015 Chinese Pharmacopoeia

[Approval number] National Medicine Standard H32020197

【manufacturer】