Product Overview
[Drug Name]
Generic Name: Fenofibrate Dispersible Tablets
Trade Name: Jinmeiji Fenofibrate Dispersible Tablets 0.1g x 24 tablets
[Main Ingredient]
Fenofibrate.
[Properties]
This product is white or off-white tablets.
[Indications/Main Functions]
Hyperlipidemia, hypertriglyceridemia, cardiovascular medicine.
[Specifications]
0.1g x 24 tablets
[Dosage and Administration]
Usual adult dose: Oral. 0.1g three times daily; maintenance dose: 0.1g one to two times daily. 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 is approximately 2% to 15%. Gastrointestinal reactions include abdominal discomfort, diarrhea, and constipation, most commonly (approximately 5%); rash (2%). 2. Neurological adverse reactions include fatigue, headache, loss of libido, impotence, dizziness, and insomnia (approximately 3% to 4%). 3. This product is a clofibric acid-based drug and may cause myositis, myopathy, and rhabdomyolysis, leading to elevated blood creatine phosphokinase. 4. Rhabdomyolysis may occur, primarily manifesting as myalgia combined with elevated blood creatine phosphokinase and myoglobinuria, and may lead to renal failure, but this is rare. 5. 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%). 6. It may increase the risk of gallstones and may cause gallbladder disease, which may require surgery. 7. Mild to moderate hematologic changes may occur in the initial stages of treatment, such as decreased hemoglobin, hematocrit, and white blood cell count. Rarely, elevated blood aminotransferases, including alanine and aspartate aminotransferase, may occur.
[Contraindications]
Fenofibrate is contraindicated in patients allergic to fenofibrate. It is also contraindicated in patients with a history of gallbladder disease or cholelithiasis. This product 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]
1. This product may enhance 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. 2. If this product 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 medications. Bile acid-binding drugs can also bind to other concurrent medications, potentially affecting their absorption. 3. This drug should be used with caution with HMG-CoA reductase inhibitors, such as pravastatin, fluvastatin, and simvastatin. This can cause myopathy, including myalgia, rhabdomyolysis, and elevated blood creatine phosphokinase. In severe cases, the drug should be discontinued. 4. This drug is primarily excreted via the kidneys. When used with immunosuppressants, such as cyclosporine, or other nephrotoxic drugs, there is a risk of worsening renal function. The dose should be reduced or discontinued. 5. When this drug is used 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 dosage of these and other hypoglycemic and other medications 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, 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) 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, antihyperlipidemic 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.
[Overdose]
Because fenofibrate is highly bound to plasma proteins, systemic supportive therapy should be implemented in the event of an overdose, regardless of hemodialysis.
[Pharmacology and Toxicology]
This drug is a biologic lipid-regulating drug similar to clofibric acid. 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 drug 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.
