Simvastatin Capsules

This product itself is inactive. The hydrolysis product after oral absorption competitively inhibits the rate-limiting enzyme hydroxymethylglutaryl coenzyme A reductase in the cholesterol synthesis process in the body, reducing the synthesis of cholesterol and increasing the synthesis of low-density lipoprotein receptors. The main site of action is in the liver, resulting in lower blood cholesterol and low-density lipoprotein cholesterol levels, moderately lower serum triglyceride levels and increased blood high-density lipoprotein levels. This has an effect on the prevention and treatment of atherosclerosis and coronary heart disease. In mice, 3 to 4 times the human dose can cause cancer, but no increase in tumor occurrence has been observed in large-scale long-term clinical trials in humans. Existing studies have not found that this product has a mutagenic effect.

The chemical name of this product is: 2,2-dimethylbutyric acid-8-[(4R,6R)-6-2-[(1S,2S,6S,8S,8aR)-1,2,6,7,8,8a-hexahydro-8-hydroxy-2,6-dimethyl-1-naphthyl]ethyltetrahydro-4-hydroxy-2H-pyran-2-one] ester. Molecular formula: C25H38O5 Molecular weight: 418.57

This product is a capsule with white or off-white contents.

Used for the treatment of hypercholesterolemia and combined hyperlipidemia; prevention and treatment of coronary heart disease and cerebral stroke.

Common adult dosage, oral: 10-20 mg, once a day, taken at dinner. The dosage can be adjusted as needed, but the maximum dosage should not exceed 80 mg per day.

1 The most common adverse reaction of this product is gastrointestinal discomfort, and others include headache, rash, dizziness, blurred vision and taste disturbance. 2 It may occasionally cause a reversible increase in blood aminotransferase. Therefore, liver function needs to be monitored. 3 Rare adverse reactions include impotence and insomnia. 4 Rare adverse reactions include myositis, myalgia, and rhabdomyolysis, which are manifested as muscle pain, fatigue, fever, and are accompanied by increased blood creatine phosphokinase, myoglobinuria, etc. Rhabdomyolysis can lead to renal failure, but it is rare. The combination of this product with immunosuppressants, folic acid derivatives, niacin, gemfibrozil, erythromycin, etc. can increase the risk of myopathy. 5 Hepatitis, pancreatitis and allergic reactions such as angioedema have been reported.

1. Patients who are allergic to simvastatin should not use this drug. Patients who are allergic to other HMG-CoA reductase inhibitors should use this drug with caution. 2. Patients with active liver disease or unexplained persistent elevation of blood aminotransferase should not use this drug.

Precautions for children: The safety and effectiveness of the drug for children have not been determined. Simvastatin is not currently recommended for children. Precautions for pregnancy and lactation: 1. There is no data on the use of simvastatin by pregnant women. Simvastatin is contraindicated for pregnant women. Because atherosclerosis is a chronic process, discontinuation of lipid-lowering drugs during pregnancy has little effect on the long-term effects of treating primary hypercholesterolemia. Moreover, cholesterol and other products of its biosynthetic pathway are essential components for fetal development, including the synthesis of steroids and cell membranes. Because methylhydroxyglutaryl coenzyme A (HMG-CoA) reductase inhibitors such as simvastatin can reduce cholesterol synthesis, and can also reduce other products of the cholesterol biosynthetic pathway. Therefore, pregnant women taking simvastatin may be harmful to the fetus. Among women of childbearing age, simvastatin can only be used for those women who are unlikely to become pregnant. If a woman becomes pregnant while taking the drug, she should stop taking simvastatin and inform the elderly of the possible effects on the fetus. Precautions: In elderly patients (over 65 years old), in controlled clinical trials using simvastatin, its effects on lowering total cholesterol and low-density lipoprotein (LDL) cholesterol were the same as those in other populations, and the frequency of adverse reactions and abnormal laboratory tests did not increase significantly.

1. The combination of this product with oral anticoagulants can prolong the prothrombin time and increase the risk of bleeding. 2. The combination of this product with immunosuppressants such as cyclosporine, erythromycin, gemfibrozil, niacin, etc. can increase the risk of myolysis and acute renal failure. 3. Colestipol and cholestyramine can reduce the bioavailability of this product, so this product should be taken 4 hours after taking the former.

Keep away from light and store in sealed container.

10 mg

24 months

Nantong Huashan Pharmaceutical Co., Ltd.

• Founded in:

  1993-12-24

• Address:

  No. 78 Tongsheng Avenue, Economic and Technological Development Zone, Nantong City, Jiangsu Province (Production and operation address: No. 78 Tongsheng Avenue, Economic and Technological Development Zone, Nantong City, Jiangsu Province, 5th Floor, Building No. 3, Economic and Technological Development Zone, Nantong City, Jiangsu Province)

• Tax NO.:

  913206916083078799

• Registered Funds:

  14.4101 million yuan

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