Generic name: metformin hydrochloride sustained-release capsule manufacturer: Shenyang Aohua Pharmaceutical Co., Ltd.No.: P2009818145712730 Specification: 0.25g* 20 dosage form: capsule packaging: 300 units: box approval number: National Medicine Zhunzi H 2005/. The main component of this product is metformin hydrochloride, and its chemical name is 1, 1- dimethylbiguanide hydrochloride. ※ [Photo: MC.2005.03.30.18823-SMS-C-5173.bmp] ※ Molecular formula C4H 1 1N5 HCl molecular weight 165.63. Pharmacology, Toxicology and Pharmacology: Metformin hydrochloride is a hypoglycemic agent, which can improve the blood sugar tolerance of patients with type 2 diabetes and reduce basal blood sugar and postprandial blood sugar. The mechanism of metformin hydrochloride is different from other types of oral hypoglycemic agents. It can reduce the production of sugar in the liver and the absorption of sugar in the intestine, and improve the sensitivity of insulin by increasing the intake and utilization of peripheral sugar. Unlike sulfonylureas, metformin hydrochloride does not cause hypoglycemia in patients with type 2 diabetes or patients with normal blood sugar (except in special circumstances-see precautions). After metformin hydrochloride treatment, insulin secretion remained unchanged, while fasting insulin level and daily plasma insulin level decreased. Toxicological study of genotoxicity: Ames test, mouse lymphocyte gene mutation test, human lymphocyte chromosome aberration test and mouse micronucleus test were all negative. Reproductive toxicity: Male rats and female rats were given metformin hydrochloride at a dose as high as 600mg/kg/ day (equivalent to 3 times the maximum daily dose recommended by human clinic), which had no effect on fertility. When metformin hydrochloride is given to rats and rabbits at a dose as high as 600mg/kg/ day (2 times and 6 times the maximum daily dose recommended by human clinic, respectively), there is no teratogenic effect. The research results of lactating rats show that metformin hydrochloride can be secreted into milk, reaching the level of plasma. Carcinogenicity: rats were given metformin hydrochloride 900mg/kg/ day 104 weeks, and mice were given metformin hydrochloride 1500mg/kg/ day 9 1 week (both equivalent to 4 times of the maximum daily dose recommended by human clinic). No carcinogenicity was found in animals. However, in 900 mg/kg/day female rats, the incidence of benign interstitial uterine polyps increased. Indications are suitable for patients with type 2 diabetes who cannot be well controlled only by diet and exercise. This product can be used alone or in combination with sulfonylureas or insulin. Usage and dosage: Take orally, with or after meals. The initial dose is generally once a day, 2 capsules (500mg) at dinner, and the dose is adjusted according to blood sugar and urine sugar. The maximum daily dose should not exceed 8 capsules (2000 mg). If 8 capsules a day (2000mg) cannot achieve satisfactory curative effect, it can be changed to 4 capsules twice a day (1000mg). Drug interaction glibenclamide: when metformin and glibenclamide are used together, the pharmacokinetics of metformin is not affected, but the AUC and Cmax of glibenclamide will decrease. Furosemide: When a single dose of metformin and furosemide were used together, the pharmacokinetic parameters of both drugs changed. The AUC and Cmax of metformin increased by 65438 05% and 22% respectively, but the renal clearance rate did not change significantly. However, the AUC and Cmax values of furosemide decreased by 12% and 3 1% respectively, and the half-life was shortened by 32%, but the renal clearance rate did not change significantly. There is no data about the interaction between two drugs for a long time. Nifedipine: When a single dose of metformin is combined with nifedipine, the AUC and Cmax of metformin increase by 9% and 20% respectively, and the Tmax and half-life are not affected by the increase of urine excretion. Metformin has little effect on the pharmacokinetic parameters of nifedipine. Cationic drugs: such as digoxin, morphine, amiloride, propranolol, quinidine, quinine, ranitidine, aminopterin or vancomycin. Theoretically, cationic drugs are eliminated through renal tubules, which may interact with metformin to compete for renal tubular transport system, so the blood sugar should be carefully monitored and the dosage should be adjusted. Others: when drugs that can cause hyperglycemia are combined with this product, such as corticosteroids, thyroxine, estrogen, oral contraceptives, nicotinic acid, calcium channel blockers, phenobarbital, etc. It may lead to disorder of blood sugar control, so it is necessary to closely monitor blood sugar and closely monitor hypoglycemia when stopping the above drugs.
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