Product Overview
[Drug Name]
Generic Name: Fenofibrate Tablets
Trade Name: Disa
English Name: Fenofibrate Tablets
Chinese Pinyin: Feinuobeite Pian
[Ingredients]
Chemical Name: Isopropyl 2-methyl-2-[4(4-chlorobenzoyl)phenoxy]propionate. Molecular Formula: C20H21ClO4
Molecular Weight: 360.84
[Properties]
This product is a white or off-white tablet.
[Indications]
This product is used to treat hyperlipidemia in adults who have not responded well to dietary control therapy. It is more effective in lowering triglycerides and mixed hyperlipidemia than cholesterol.
[Dosage and Administration]
Usual Adult Dosage: Oral: 0.1g (1 tablet) three times a day. Maintenance dose: 0.1g (1 tablet) one to two times a day. To reduce gastric discomfort, the drug can be taken with food. The dosage should be reduced for patients with renal insufficiency and the elderly. Discontinue the drug after two months of treatment if no effect is seen.
[Adverse Reactions]
1) The incidence rate is about 2%-15%; 2) Gastrointestinal reactions include abdominal discomfort, diarrhea, constipation (about 5%), rash (2%); 3) Nervous system adverse reactions include fatigue, headache, loss of libido, impotence, dizziness, insomnia (about 3%-4%); 4) This product is a derivative of clofibric acid and may cause myositis, myopathy and rhabdomyolysis syndrome, leading to elevated blood creatine phosphokinase; rhabdomyolysis occurs, mainly manifested by myalgia combined with elevated blood creatine phosphokinase, myoglobinuria, and may lead to renal failure, but it is relatively rare; in patients with nephrotic syndrome and other renal damage leading to decreased blood albumin or patients with hyperthyroidism, the risk of myopathy increases (about 1%); 5) There is a tendency to increase gallstones, which can cause gallbladder disease and even require surgery; 6) Mild to moderate hematological changes may occur in the early stages of treatment, such as decreased hemoglobin, hematocrit and white blood cells; 7) Occasionally, blood aminotransferase levels may increase, including alanine and aspartate aminotransferase.
[Contraindications]
1) Fenofibrate is contraindicated in patients allergic to it.
2) It is contraindicated in patients with a history of gallbladder disease or cholelithiasis, as it may increase the excretion of cholesterol into bile, thereby causing gallstones.
3) It is contraindicated in patients with severe renal insufficiency, hepatic insufficiency, primary biliary cirrhosis, or persistent liver dysfunction of unknown cause.
[Precautions]
1) This product may interfere with diagnosis. Platelet count, blood urea nitrogen, aminotransferase, and blood calcium may increase when taking it; blood alkaline phosphatase, gamma-glutamyl transpeptidase, and bilirubin may decrease. Regular checks should be performed during medication: ① Complete blood count and platelet count; ② Liver function tests; ③ Blood cholesterol, triglycerides, or low-density lipoprotein; ④ Blood creatine phosphokinase. 2) If clinical symptoms suggestive of myopathy (such as myalgia, tenderness, fatigue, etc.) or a significant elevation in blood creatine phosphokinase (CK), the drug should be discontinued. While treating hyperlipidemia, it is also important to monitor and treat underlying conditions that may contribute to hyperlipidemia, such as hypothyroidism and diabetes. 3) Certain medications, such as estrogens, thiazide diuretics, and beta-blockers, can also cause hyperlipidemia. After discontinuation, corresponding anti-hyperlipidemic treatment is no longer necessary. 4) Dietary therapy remains the primary treatment for hyperlipidemia. Exercise and weight loss, combined with other measures, are superior to any other medication.
[Use in Special Populations]
Precautions for Children:
The efficacy and safety of this product in children have not yet been confirmed by experimental studies. Therefore, this product should not be used in children.
Precautions for Pregnancy and Lactation:
This product is contraindicated in pregnant and lactating women. No experimental data are available for use in humans.
Precautions for Elderly Patients:
The clearance of a single oral dose of this drug in elderly patients is similar to that in adults. However, if renal function is impaired, the dosage of this drug should be appropriately reduced.
[Drug Interactions]
1) This drug has the effect of enhancing the efficacy of coumarin anticoagulants. Concomitant use may prolong the prothrombin time. Therefore, when used together, the oral anticoagulant dose should be reduced and the dosage adjusted based on test results. If this drug 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 these drugs. Bile acid binding drugs can also bind to other concurrently taken drugs, thereby affecting the absorption of other drugs.
2) This drug should be used with caution in combination with HMG-CoA reductase inhibitors, such as pravastatin, fluvastatin, and simvastatin. This can cause myopathy, including myalgia, rhabdomyolysis, and increased blood creatine phosphokinase. In severe cases, the drug should be discontinued. 3) This product is primarily excreted via the kidneys. When used in combination with immunosuppressants, such as cyclosporine, or other nephrotoxic drugs, there is a risk of worsening renal function. The dose should be reduced or discontinued. 4) When used in combination with other highly protein-bound drugs, this product can increase their free form and enhance their efficacy, such as tolbutamide and other sulfonylurea hypoglycemic drugs, phenytoin, and furosemide. If these drugs are taken during lipid-lowering therapy, the doses of these hypoglycemic and other drugs should be adjusted.
[Pharmacological Action]
This product is a clofibric acid derivative, a lipid-regulating drug. It lowers blood low-density lipoprotein (LDL), cholesterol, and triglycerides by inhibiting the production of very low-density lipoprotein (VLDL) and triglycerides and simultaneously increasing their catabolism. It also increases the production of apolipoproteins A1 and A11, thereby increasing high-density lipoprotein (HDL). This product also has the effect of lowering serum uric acid in healthy individuals and patients with hyperuricemia. Animal studies have shown that fenofibrate is teratogenic and carcinogenic.
[Storage] Store in a dark, airtight container. [Strength] 0.1g
[Packaging] Boxed, 0.1g x 40s/box
[Expiration Date] 24 months
[Approval Number] National Medicine Standard H37022898
[Manufacturer] Company Name: Disha Pharmaceutical Group Co., Ltd.
