Product Overview
[Drug Name]
Generic Name: Fenofibrate Capsules
Trade Name: Libifenofibrate Capsules 0.2g x 10 capsules
[Main Ingredients]
The main ingredient of this product is fenofibrate. Its chemical name is isopropyl 2-methyl-2-[4(4-chlorobenzoyl)phenoxy]propionate.
[Properties]
This product is a capsule containing a white or off-white crystalline powder.
[Indications/Main Functions]
1. For adults. 2. For the treatment of hyperlipidemia (type Ia), endogenous hypertriglyceridemia, simple and mixed types in adults who are unsatisfactory with dietary control, especially when blood cholesterol remains elevated despite dietary control or when there are other concurrent risk factors. 3. Dietary control should be maintained during medication. 4. Currently, there are no long-term controlled clinical studies demonstrating the effectiveness of fenofibrate in the primary and secondary prevention of atherosclerotic complications.
[Specifications]
0.2g*10 tablets
[Dosage and Administration]
This medication is for long-term use in conjunction with dietary control, and efficacy should be monitored regularly. Take one tablet daily with a meal. A reduced dose is recommended when cholesterol levels are normal. Patients with impaired renal function: For patients with mild to moderate renal impairment, a lower initial dose is recommended, followed by dose adjustments based on renal function and lipid profile.
[Adverse Reactions]
The incidence is approximately 2% to 15%. Gastrointestinal side effects 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%-4%). This product, a clofibric acid-based drug, may cause myositis, myopathy, and rhabdomyolysis, leading to elevated blood creatine phosphokinase. Rhabdomyolysis, primarily manifesting as myalgia combined with elevated blood creatine phosphokinase and myoglobinuria, can rarely lead to renal failure. 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 risk of gallstones and may cause gallbladder disease, which may require 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 fenofibrate. It is also contraindicated in patients 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. This can cause myopathy, including myalgia, rhabdomyolysis, and elevated blood creatine phosphokinase. 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 medications. Bile acid-binding drugs can also bind to other concurrent medications, potentially affecting their absorption. This product can enhance the efficacy of coumarin anticoagulants. Concomitant use can prolong the prothrombin time. Therefore, when used together, the oral anticoagulant dosage should be reduced and subsequently adjusted based on test results. 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 and the dosage should be reduced or discontinued. When used in combination with other highly protein-bound drugs, such as tolbutamide and other sulfonylurea hypoglycemics, phenytoin, and furosemide, the free form of these drugs may increase, enhancing their efficacy. If these drugs are taken during lipid-lowering therapy, the dosage of these and other hypoglycemic drugs should be adjusted.
[Precautions]
This product may interfere with diagnosis. Platelet count, blood urea nitrogen, aminotransferases, and blood calcium may increase while taking this product; blood alkaline phosphatase, gamma-glutamyl transpeptidase, and bilirubin may decrease. Regular monitoring during treatment should include: 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, and weakness) or a significant elevation in blood creatine phosphokinase, the drug should be discontinued. While treating hyperlipidemia, it is also important to monitor and treat underlying conditions that may cause 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; combined with exercise and weight loss, it is superior to any other drug therapy. [Use in Pregnant and Breastfeeding Women] This product is contraindicated for pregnant and breastfeeding women. There are no experimental data for this product in humans.
[Pediatric Use]
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. [Elderly Use]
The clearance of this product after a single oral dose in elderly patients is similar to that in adults. However, if renal function is impaired, the dose should be appropriately reduced.
[Pediatric Use]
This product is contraindicated in children.
[Elderly Use]
The recommended adult dose is recommended; if renal function is impaired, the dose may be reduced.
[Overdose]
Because fenofibrate is highly bound to plasma proteins, in the event of an overdose, systemic supportive therapy should be implemented, regardless of hemodialysis.
[Pharmacology and Toxicology]
This product is a biologic lipid-regulating drug similar to clofibric acid. It lowers blood 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. [Pharmacokinetics] After oral administration, this product is well absorbed from the gastrointestinal tract. Taking it with food can enhance fenofibrate absorption. Peak plasma concentrations are reached approximately 4 to 7 hours after oral administration. After a single oral dose, the absorption and elimination half-lives are 4.9 hours and 26.6 hours, respectively, with an apparent volume of distribution of 0.9 L/kg. After continuous treatment, the half-life b is 21.7 hours. The plasma protein binding rate is approximately 99%, and no accumulation has been observed after multiple doses. After absorption, it is primarily distributed in the liver, kidneys, and intestines, followed by the lungs, heart, and adrenal glands. Smaller amounts are found in the testes, spleen, and skin. Metabolized in the liver and kidneys, through carboxyl reduction and glucuronidation, glucuronidated products constitute the majority of metabolites. Radiolabeled, approximately 60% of these metabolites are excreted via the kidneys, while 25% are excreted via the stool. The elimination half-life of this drug is 20 hours, allowing for once-daily dosing. Studies have shown that the clearance of this drug is significantly decreased in patients with severe renal insufficiency, and long-term use may result in accumulation.
