Fenofibrate Tablets

This product is a blood lipid regulating drug of clofibric acid derivatives. It reduces blood low-density lipoprotein, cholesterol and triglycerides by inhibiting the production of very low-density lipoprotein and triglycerides and increasing their catabolism at the same time; it also increases the production of apolipoprotein A1 and A11, thereby increasing high-density lipoprotein. This product also has the effect of reducing blood uric acid in normal people and patients with hyperuricemia. Animal experiments have shown that fenofibrate is teratogenic and carcinogenic.

The chemical name of this product is: Isopropyl 2-methyl-2-[4-(4-chlorobenzoyl)phenoxy]propionate.

This product is white or off-white tablets.

This product is used to treat hyperlipidemia in adults who have not responded well to dietary control therapy. Its effect on lowering triglycerides and mixed hyperlipidemia is more obvious than its effect on cholesterol.

The usual oral dose for adults is 0.1g each time, 3 times a day, and the maintenance dose is 0.1g each time, 1-2 times a day. To reduce stomach discomfort, it can be taken with food; the dosage should be reduced for patients with renal insufficiency and the elderly; the drug should be discontinued if there is no effect after 2 months of treatment.

The incidence rate is about 2%-15%. Gastrointestinal reactions include abdominal discomfort, diarrhea, and constipation (about 5%); rash (2%); neurological adverse reactions include fatigue, headache, loss of libido, impotence, dizziness, and insomnia (about 3%-4%); 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 as 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. (about 1%); there is a tendency to increase gallstones, which can cause gallbladder disease and even require surgery; in the early stage of treatment, it can cause mild to moderate hematological changes, such as decreased hemoglobin, hematocrit, and leukocytes, and occasionally increased blood aminotransferases, including alanine and aspartate aminotransferases.

It is contraindicated for patients who are allergic to fenofibrate, patients with a history of gallbladder disease or cholelithiasis, as this product can increase the excretion of cholesterol into bile, thus causing gallstones. It is contraindicated for patients with severe renal insufficiency, hepatic insufficiency, primary biliary cirrhosis, or persistent abnormal liver function of unknown cause.

Precautions for children: The efficacy and safety of this product for children have not been confirmed by experimental studies, so this product cannot be used for children. Precautions for pregnancy and lactation: Pregnant and lactating women are prohibited from using this product. There is no experimental data for this product for humans. Precautions for the elderly: The clearance rate of a single oral dose of this product in the elderly is similar to that of adults, but if there is poor renal function, the dosage of this product should be appropriately reduced.

This product has the effect of enhancing the efficacy of coumarin anticoagulants. When used at the same time, it can prolong the prothrombin time. Therefore, when used together, the dose of oral anticoagulants should be reduced, and the dosage should be adjusted according to the test results later. When this product is used in combination with bile acid binding resins, such as cholestyramine, fenofibrate should be taken at least 1 hour before or 4-6 hours after taking these drugs. Because bile acid binding drugs can also be combined with other drugs taken at the same time, thereby affecting the absorption of other drugs. This product should be used with caution in combination with HMG-CoA reductase inhibitors, such as pravastatin, fluvastatin, simvastatin, etc., which can cause myalgia, rhabdomyolysis, increased blood creatine phosphokinase and other myopathy. In severe cases, the drug should be discontinued. This product is mainly excreted by the kidneys. When used in combination with immunosuppressants, such as cyclosporine or other nephrotoxic drugs, there may be a risk of worsening renal function. The dose should be reduced or the drug should be discontinued. When this product is used in combination with other drugs with high protein binding rates, their free forms can be increased and the efficacy can be enhanced, 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.

Seal and store in a dark place.

0.1g

36 months