Bezafibrate Capsules

This product is a lipid-regulating drug of the clofibric acid derivative class. It has two mechanisms for lowering blood lipids. First, it 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, it 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.

Benzofibrate. Chemical name: [p-4-chlorobenzoyl-β-aminoethylphenoxy]isobutyric acid Molecular weight: C19H20ClNO4

This product is a capsule, and the contents are white granules or powder.

Used to treat hypertriglyceridemia, hypercholesterolemia, and combined hyperlipidemia.

Common dosage for adults: 3 times a day, 0.2-0.4 g each time. It can be taken after or with meals. For patients with good efficacy, the maintenance dose can be 2 times a day, 0.4 g each time. In case of renal dysfunction, the dosage is adjusted according to the creatinine clearance rate: 40-60 ml/min, 2 times a day, 0.4 g each time; 15-40 ml/min, 1 time a day or every other day, 0.4 g each time; below 15 ml/min, 1 time every 3 days, 0.4 g each time.

1. The 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. 2. Occasionally, 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. 3. Occasionally, there is an increase in blood aminotransferase.

1. Patients who are allergic to bezafibrate are contraindicated. 2. Patients with gallbladder disease or cholelithiasis are contraindicated, as this product may aggravate the symptoms of gallbladder disease. 3. Patients with hepatic insufficiency or primary biliary cirrhosis are contraindicated. 4. Patients with severe renal insufficiency are contraindicated, as taking this product may cause rhabdomyolysis and severe hyperkalemia in patients with renal insufficiency; patients with nephrotic syndrome causing hypoalbuminemia are contraindicated, 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 them, you should pay attention to reducing the dosage of oral anticoagulants and monitor the prothrombin time frequently to adjust the dosage 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 dosage 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, to treat hyperlipidemia will increase the occurrence of severe muscle toxicity of both.

Seal tightly and store in a cool (not exceeding 20°C) dry place.

0.2g

24 months

Nantong Jiuhe Pharmaceutical Co., Ltd.

• Founded in:

  2002-07-29

• Address:

  No. 118, Jianghai West Road, Chengao Industrial Park, Rudong, Jiangsu Province

• Tax NO.:

  91320623741329559W

• Registered Funds:

  10.18 million yuan

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