Product Overview
[Drug Name]
Generic Name: Fenofibrate Capsules
Trade Name: Libang Shitaining Fenofibrate Capsules 0.2g x 15 capsules
[Main Ingredients]
The main ingredient of this product is fenofibrate.
[Properties]
This product is a capsule containing a white or off-white crystalline powder.
[Indications/Main Functions]
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. However, this product cannot completely replace dietary control therapy and should only be used as an adjunct to dietary control.
[Specifications]
0.2g x 15 capsules
[Dosage and Administration]
The usual adult dosage is oral: 0.1g capsules three times daily, with a maintenance dose of 0.1g once or twice daily. To reduce gastric discomfort, the drug can be taken with food. The dosage should be reduced in patients with renal insufficiency and the elderly. If no effect is seen after two months of treatment, the drug should be discontinued.
[Adverse Reactions]
The incidence rate is approximately 2% to 15%. Gastrointestinal reactions include abdominal discomfort, diarrhea, and constipation, most commonly (approximately 5%); rash (2%); and neurologic adverse reactions include fatigue, headache, loss of libido, impotence, dizziness, and insomnia (approximately 3% to 4%). This product is a clofibric acid derivative and may cause myositis, myopathy, and rhabdomyolysis, leading to elevated blood creatine phosphokinase. Rhabdomyolysis, primarily manifested by myalgia combined with elevated blood creatine phosphokinase and myoglobinuria, can lead to renal failure, but is rare. The risk of myopathy is increased in patients with nephrotic syndrome or other renal impairment leading to hypoalbuminemia, or in patients with hyperthyroidism (approximately 1%). It has a tendency to increase the incidence of gallstones, potentially leading to gallbladder disease and the need for surgery. Mild to moderate hematologic changes, such as decreased hemoglobin, hematocrit, and white blood cell count, may occur in the early stages of treatment. Rarely, elevated blood aminotransferases, including alanine and aspartate aminotransferase, may occur.
[Contraindications]
Fenofibrate is contraindicated in patients allergic to it; those with a history of gallbladder disease or cholelithiasis. This drug can increase cholesterol excretion into bile, leading to gallstones. It is also contraindicated in patients with severe renal insufficiency, hepatic insufficiency, primary biliary cirrhosis, or persistent liver dysfunction of unknown cause.
[Drug Interactions]
This drug should be used with caution with HMG-CoA reductase inhibitors, such as pravastatin, fluvastatin, and simvastatin. Myopathy, including myalgia, rhabdomyolysis, and elevated blood creatine phosphokinase, can occur; in severe cases, the drug should be discontinued. If this drug is used in combination with bile acid-binding resins, such as cholestyramine, fenofibrate should be taken at least one hour before or four to six hours after these drugs. Bile acid-binding drugs can also bind to other concurrently taken medications, potentially affecting their absorption. This drug enhances the efficacy of coumarin anticoagulants and may prolong the prothrombin time when used concomitantly. Therefore, the oral anticoagulant dose should be reduced when used concomitantly, and the dosage should be adjusted based on test results. This drug is primarily excreted via the kidneys. When used concomitantly with immunosuppressants such as cyclosporine or other nephrotoxic drugs, there is a risk of worsening renal function, and the dose should be reduced or discontinued. When used concomitantly with other highly protein-bound drugs, such as tolbutamide and other sulfonylurea hypoglycemics, phenytoin, and furosemide, the free form of these drugs may increase, potentially enhancing their efficacy. If these drugs are taken during lipid-lowering therapy, the doses of these and other hypoglycemic drugs should be adjusted.
[Precautions]
This drug may interfere with diagnosis. When taking this drug, platelet count, blood urea nitrogen, aminotransferases, and serum calcium may increase; blood alkaline phosphatase, γ-glutamyl transpeptidase, and bilirubin may decrease. During medication, regular checks should be performed: complete blood count and platelet count; liver function tests; blood cholesterol, triglycerides, or low-density lipoprotein cholesterol; and blood creatine phosphokinase. If clinical symptoms suggestive of myopathy (such as myalgia, tenderness, fatigue, etc.) or a significant elevation in blood creatine phosphokinase are present, 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. Certain medications, such as estrogens, thiazide diuretics, and beta-blockers, can also cause hyperlipidemia. After discontinuation of these medications, corresponding anti-hyperlipidemic treatment is no longer necessary. Dietary therapy remains the primary treatment for hyperlipidemia, and combined with exercise and weight loss, it is superior to any other drug therapy.
[Pediatric Use]
The efficacy and safety of this drug in children have not yet been confirmed by experimental studies, so this drug should not be used in children.
[Elderly Use]
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 dose should be appropriately reduced.
[Pharmacology and Toxicology]
This product is a biologic lipid-regulating drug based on fenofibrate. It inhibits the production of very low-density lipoprotein (VLDL) and triglycerides and simultaneously increases their catabolism, thereby lowering blood LDL, cholesterol, and triglycerides. It also increases the production of apolipoproteins A1 and A11, thereby increasing high-density lipoprotein (HDL). This product also lowers serum uric acid in healthy individuals and patients with hyperuricemia. Animal studies have shown that fenofibrate is teratogenic and carcinogenic.
