Fenofibrate Capsules

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: 2-methyl-2-[4 (4-chlorobenzoyl) phenoxy] propionate isopropyl ester. Its molecular formula is: C20H21ClO4. Its molecular weight is: 360.84

This product is a capsule, and the contents are white or off-white crystalline powder.

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 that of cholesterol. However, this product cannot completely replace dietary control therapy and can only be used as an auxiliary treatment based on dietary control.

The usual dosage for adults is 0.1g capsules at a time, 3 times a day, and the maintenance dosage 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.

- When used in combination with other fibrates, muscle dysfunction (diffuse pain, tenderness, muscle weakness) and rare rhabdomyolysis have been reported. Most of these adverse reactions are reversible after discontinuation of the drug (see the warning section for details). - Other rare, moderate adverse reactions have also been reported: * gastric or intestinal digestive dysfunction, such as dyspepsia; * elevated transaminases (see the precautions section for details); * allergic skin reactions, such as rash, itching, urticaria, or photosensitivity reactions have been reported occasionally. In some cases, even after discontinuation of the drug for several months, erythema, papules, versicolor and eczema still occur when the skin is exposed to sunlight or artificial ultraviolet light. There are currently no long-term comparative studies to fully evaluate adverse reactions, especially the risk of gallstones.

This drug is contraindicated in the following cases: - patients allergic to fenofibrate; - patients with impaired liver function - patients with impaired renal function (see Warnings); - patients with known phototoxicity or photosensitivity during treatment with fenofibrate or similar drugs, especially ketoprofen; - patients taking it in combination with other fibrates (see Drug Interactions); - patients not taking it in children. This drug is not usually recommended for use with HMG=CoA reductase inhibitors (see Drug Interactions) and should not be used during breastfeeding (see Pregnancy and Lactation).

Precautions for children: children are prohibited from using this drug. Precautions for pregnancy and lactation: this drug should not be used during lactation. Precautions for the elderly: the clearance rate of this drug after a single oral dose in the elderly is similar to that in adults, but if there is poor renal function, the dosage of this product should be appropriately reduced.

This product should be used with caution 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 should be used in combination with bile acid binding resins, such as cholestyramine, at least 1 hour before or 4-6 hours after taking these drugs before taking fenofibrate. 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 has the effect of enhancing the efficacy of coumarin anticoagulants. Simultaneous use can prolong the prothrombin time. Therefore, the dose of oral anticoagulants should be reduced when used in combination, and the dosage should be adjusted according to the test results later. This product is mainly excreted by the kidney. When used in combination with immunosuppressants, such as cyclosporine or other nephrotoxic drugs, there may be a risk of worsening renal function, so the dose should be reduced or 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.

Store in a dry place.

200 mg

36 months.