Lovastatin Tablets

This product competitively inhibits the rate-limiting enzyme hydroxymethylglutaryl coenzyme A reductase in the cholesterol synthesis process in vivo, 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, thereby playing a role in the prevention and treatment of atherosclerosis and coronary heart disease. This product also reduces serum triglyceride levels and increases blood high-density lipoprotein levels. 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 main ingredient of this product is lovastatin. Its chemical name is: (S)-2-methylbutyric acid-(1S,3S,7S,8S,8aR)-1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-{2-[(2R,4R)-4-hydroxy-6-oxo-2-tetrahydropyranyl]-ethyl}-1-naphthyl ester. Structural formula: (see lovastatin dispersible tablets). Molecular formula: C24H36O5. Molecular weight: 404.55

This product is white or off-white tablets.

Used to treat hypercholesterolemia and combined hyperlipidemia.

The usual oral dose for adults is 10-20 mg, once a day, taken at dinner. The dose can be adjusted as needed, but the maximum dose should not exceed 80 mg per day.

1 The most common adverse reactions of this product are gastrointestinal discomfort, diarrhea, flatulence, 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 lovastatin are contraindicated. Patients who are allergic to other HMG-CoA reductase inhibitors should use with caution. 2. Patients with active liver disease or unexplained persistent elevation of blood aminotransferase are contraindicated.

Precautions for children: Limited use in children, long-term safety has not been established. Precautions for pregnancy and lactation: Because this product can cause fetal maldevelopment in animal experiments and it is unclear whether it is excreted in breast milk, it is not recommended for use in pregnant women and nursing mothers. Precautions for the elderly: Elderly patients need to adjust the dose according to liver and kidney function.

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, azithromycin, clarithromycin, erythromycin, danazol, itraconazole, 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 in a light-proof and airtight container. The validity period is tentatively set at two years.

10mg

24 months

North China Pharmaceutical Company.Ltd

• Founded in:

  1992-12-20

• Address:

  No. 388, Heping East Road, Shijiazhuang City

• Tax NO.:

  91130100104397700P

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  1,715,730,370 yuan

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