Fenofibrate Capsules (II)

Pharmacological action This product is a new preparation containing 200mg of highly bioavailable fenofibrate. Fenofibrate can reduce serum cholesterol by 20-25% and triglycerides by 40-50%. The reduction of cholesterol is achieved by reducing low-density atherogenic components (VLDL and LDL) and by reducing the total cholesterol/HDL cholesterol ratio (this ratio is increased in atherogenic hyperlipidemia), thereby improving the distribution of cholesterol in plasma. The relationship between high cholesterol and atherosclerosis, as well as the relationship between atherosclerosis and the risk of coronary artery disease have been confirmed. Low levels of HDL can increase the risk of coronary artery disease, and elevated triglycerides can increase the risk of cardiovascular disease, but it is not certain that this relationship exists independently. In addition, triglycerides may be related not only to atherosclerosis, but also to thrombosis. By effectively extending the treatment period (significantly reducing cholesterol), extravascular cholesterol deposition (tendon and tubercle xanthomas) can be significantly regressed or even completely eliminated. In patients with hyperlipidemia, fenofibrate has a prouric acid effect, which can reduce plasma uric acid by an average of 25%. Fenofibrate treatment increases apoAⅠ and decreases apoB, thereby improving the apoAⅠ/apoB ratio, which is considered a marker of atherosclerosis. Animal studies and human clinical studies have shown that fenofibrate has an anti-platelet aggregation effect, which is achieved by reducing the aggregation reaction caused by ADP, arachidonic acid and adrenaline. Fenofibrate activates PPARα (peroxisome proliferator-activated receptor α), activates lipolytic enzymes and reduces apolipoprotein CⅢ synthesis, which significantly increases plasma fat degradation and triglyceride clearance. Toxicological studies found tumors and/or hepatocellular carcinomas in the liver of mice and rats when the dose exceeded 45 mg/kg. Acinar cell carcinoma and adenocarcinoma of the pancreas were also found in rats at this dose. Leydig cell tumors were found in the testicles of rats that had long-term use of 60 mg/kg. The results of carcinogenic studies showed that the incidence of tumors in rodents treated with fenofibrate increased significantly in three organs: liver (tumors and hepatocellular carcinoma), pancreas (acinar cell tumors and adenocarcinomas) and testis (Leydig cell tumors). The results of toxicity studies in rats and mice showed that excessive catalase stimulation can cause toxic reactions. This change only occurs in small rodents and has not been found in other animal specimens. And it has no relevance to human treatment. The following experimental results confirm that fenofibrate has no potential mutagenic effect: Ames test, mouse lymphoma test, chromosome aberration test, and irregular DNA synthesis test. Reproductive studies have shown that fenofibrate has no teratogenic effect, but when used at a toxic dose for pregnant women, it can cause some embryotoxicity in rats and rabbits. When rats were given doses above 75 mg/kg/day, delayed delivery and reduced postnatal survival occurred.

The active ingredient of this product is fenofibrate. Chemical name: 2-methyl-2-[4-(4-chlorobenzoyl)phenoxy]propionic acid isopropyl ester. Chemical structure: Molecular formula: C20H21ClO4 Molecular weight: 360.84

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

For use in adults, it is used to treat hypercholesterolemia (type IIa), endogenous hypertriglyceridemia, simple type (type IV) and mixed type (type IIb and III) in adults who are not well treated with dietary control therapy, especially when blood cholesterol continues to rise after dietary control, or when there are other concurrent risk factors. Diet should be controlled during medication. At present, there are no long-term clinical controlled studies to prove the effectiveness of fenofibrate in the primary and secondary prevention of atherosclerotic complications.

This drug can be taken for a long time in combination with diet control, and the efficacy should be monitored regularly. Oral administration. 0.2g (1 tablet) once a day, taken with meals. When cholesterol levels are normal, it is recommended to reduce the dose.

- Muscle dysfunction (diffuse pain, tenderness, weakness) and rare severe rhabdomyolysis have been reported when used in combination with other fibrates. Most of these adverse reactions are reversible after discontinuation of the drug (see the Warning section for details). - Other less common, moderate adverse reactions have also been reported: gastric or intestinal digestive disorders, 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 may 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 situations: those who are allergic to fenofibrate; those with impaired liver function; those with impaired renal function (see the Warning section for details); those with known phototoxicity or photosensitivity reactions when using fenofibrate or structurally similar drugs, especially ketoprofen, during treatment; combined use with other fibrates (see the Drug Interactions section for details); children are contraindicated; this drug is generally not recommended for use with HMG-CoA reductase inhibitors (see the Drug Interactions section for details) and should not be used during breastfeeding (see the Pregnancy and Lactation section for details).

Precautions for children: Children are prohibited from using it. Precautions for pregnancy and lactation: Results of animal tests during pregnancy showed no teratogenic effects. So far, clinical teratogenicity and embryotoxicity have not been found, but the follow-up of fenofibrate use during pregnancy is not sufficient to rule out any danger, so it should be prohibited for pregnant women in general. Fibrates are not used in pregnant women, except when dietary control cannot effectively reduce high triglycerides (>10g/L) and increases the risk of acute pancreatitis in the mother. There is currently no data on the entry of fenofibrate into the mother during lactation, but it is prohibited during lactation. Precautions for the elderly: It is recommended to use the normal adult dose, and the dose can be reduced if there is renal impairment.

Concomitant use of other fibrates with the following drugs is contraindicated: Increased incidence of adverse reactions such as rhabdomyolysis and pharmacodynamic antagonism between the two molecules. Concomitant use of drugs not recommended HMG-CoA reductase inhibitors: Increased incidence of muscle adverse reactions such as rhabdomyolysis. Drugs to be used with caution Oral anticoagulants: Increased risk of bleeding after concomitant use of oral anticoagulants (due to their displacement reaction with plasma proteins). Check and monitor the INR more frequently. Adjust the dose of oral anticoagulants during treatment with fenofibrate and after 8 days of discontinuation.

Store in a cool (not exceeding 20°C) and dry place.

0.2 g

24 months

Zhejiang Jingxin Pharmaceutical Co., Ltd.

• Founded in:

  1999-02-13

• Address:

  No. 800, Xinchang Avenue East Road, Yulin Street, Xinchang County, Zhejiang Province

• Tax NO.:

  91330000704503984N

• Registered Funds:

  861.02914 million yuan

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