Bezafibrate Tablets

This product is a lipid-regulating drug of the clofibric acid derivative class. It has two mechanisms for lowering blood lipids. First, this product increases the activity of lipoprotein lipase and liver lipase, promotes the catabolism of very low-density lipoprotein, and reduces the level of blood triglycerides. Secondly, this product reduces the secretion of very low-density lipoprotein. This product reduces blood low-density lipoprotein and cholesterol, possibly by enhancing the clearance of receptor-bound low-density lipoprotein. This product has a stronger effect on lowering blood triglycerides than lowering blood cholesterol, and also increases high-density lipoprotein. In addition, this product can also reduce blood fibrinogen. Existing studies have not found that this product has carcinogenic or mutagenic effects.

[4-Chlorobenzoyl-beta;-aminoethylphenoxy]isobutyric acid. Its structural formula is: Molecular formula: C19H20ClNO4 Molecular weight: 361.82

This product is a film-coated tablet, which appears white or off-white after the film coating is removed.

It is suitable for hyperlipidemia caused by various reasons, and is effective in lowering cholesterol and triglycerides. It can be used for both familial and non-familial hyperlipidemia. It can be used as a first-line lipid-lowering drug, and as an alternative drug when other lipid-lowering drugs fail. It is especially suitable for patients with hyperlipidemia and diabetes, because it can not only lower blood lipids but also improve glucose tolerance. While lowering lipids, the drug can significantly reduce the risk of atherosclerosis in patients.

Common dosage for adults (1) Oral bezafibrate tablets 3 times a day, 200-400 mg each time. It can be taken after or with meals. For patients with good efficacy, the maintenance dose can be 2 times a day, 400 mg each time. In case of renal dysfunction, the dose is adjusted according to the creatinine clearance: 40-60 ml/min, 2 times a day, 400 mg each time; 15-40 ml/min, 1 time a day or every other day, 400 mg each time; below 15 ml/min, 1 time every 3 days, 400 mg each time. (2) Oral bezafibrate sustained-release tablets: 1 tablet once a day, reduce to half a tablet per day or every other day in case of renal dysfunction.

1The most common adverse reactions are gastrointestinal discomfort, such as indigestion, anorexia, nausea, vomiting, fullness, stomach discomfort, etc. Other less common adverse reactions include headache, dizziness, fatigue, rash, itching, impotence, anemia, and decreased white blood cell count. 2Occasionally, there is cholelithiasis or myositis (myalgia, fatigue). This product is a derivative of clofibric acid, which may cause myositis, myopathy and rhabdomyolysis syndrome, leading to increased blood creatine phosphokinase. Rhabdomyolysis occurs, mainly manifested by myalgia combined with increased blood creatine phosphokinase, myoglobinuria, and can lead to renal failure, but it is rare. In patients with nephrotic syndrome and other renal damage that lead to decreased blood albumin or patients with hyperthyroidism, the risk of myopathy increases. 3Occasionally, blood aminotransferase increases.

1. Patients who are allergic to bezafibrate are prohibited from using this product. 2. Patients with gallbladder disease or cholelithiasis are prohibited from using this product, as this product may aggravate the symptoms of gallbladder disease. 3. Patients with hepatic insufficiency or primary biliary cirrhosis are prohibited from using this product. 4. Patients with severe renal insufficiency are prohibited from using this product, as taking this product may cause rhabdomyolysis and severe hyperkalemia in patients with renal insufficiency; patients with nephrotic syndrome causing hypoalbuminemia are prohibited from using this product, as the risk of myopathy is increased.

Precautions for children: There is no experimental research to confirm the efficacy and safety of this product for children, so it should not be used. Precautions for pregnancy and lactation: The safety of this product during pregnancy has not been established, so it is not recommended for pregnant women. It is unknown whether this product is secreted into breast milk, so it should not be taken by lactating women. Precautions for the elderly: The elderly should adjust the dosage according to the liver and kidney function status. If there is poor renal function, the dosage of this product should be appropriately reduced.

1. This product can significantly enhance the effect of oral anticoagulants. When used with it, attention should be paid to reducing the dose of oral anticoagulants and frequently monitoring the prothrombin time to adjust the dose of anticoagulants. Its mechanism of action is still uncertain. It may be because this product can replace warfarin and other drugs from their protein binding sites, thereby enhancing their effects. 2. When this product is used in combination with other drugs with high protein binding rates, it can also replace them from the protein binding sites, leading to enhanced effects, such as tolbutamide and other sulfonylurea hypoglycemic drugs, phenytoin, furosemide, etc. If the above drugs are taken during lipid-lowering treatment, the doses of hypoglycemic drugs and other drugs should be adjusted. 3. The combined use of clofibric acid derivatives and HMG-CoA reductase inhibitors, such as lovastatin, for the treatment of hyperlipidemia will increase the risk of severe muscle toxicity of both, which can cause myalgia, rhabdomyolysis, increased blood creatine phosphokinase and other myopathy, and should be avoided as much as possible. 4. This product is mainly excreted through the kidneys. When used in combination with immunosuppressants, such as cyclosporine, it can increase the latter's blood concentration and nephrotoxicity, and there is a risk of worsening renal function. The dosage should be reduced or the drug should be discontinued. This product should also be used with caution when used in combination with other nephrotoxic drugs. 5. This product can increase the effect of hypoglycemic drugs.

Keep in a light-proof, airtight, cool place.

0.2 g

24 months

Kun Shan Rotam Reddy Pharmaceutical Co., Ltd.

• Founded in:

  1993-12-31

• Address:

  No. 2158 Huangpujiang Middle Road, Kunshan Development Zone, Jiangsu Province

• Tax NO.:

  91320583608278334C

• Registered Funds:

  $25,416,780

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