- Indications and Usage Hypertriglyceridemia: Indicated to lower triglyceride (TG) levels in adult patients with severe hypertriglyceridemia (TG ≥ 500 mg/dL). Mixed Dyslipidemia: Indicated to lower cholesterol in adult patients with primary hypercholesterolemia or mixed dyslipidemia.
- Dosage and Administration Recommended Dosage: The usual dosage is 105 mg once daily. For patients with mild to moderate renal impairment, an initial dosage of 35 mg once daily is recommended. Administration: Tablets should be swallowed whole. They can be taken with or without food. Renal Impairment: Contraindicated in patients with severe renal impairment.
- Mechanism of Action Fenofibric acid is a fibratic agent that activates peroxisome proliferator-activated receptor-alpha (PPAR-α). This activation increases lipoprotein lipase activity, enhancing the catabolism of triglyceride-rich particles and reducing the production of apolipoprotein C-III.
- Safety and Warnings Myopathy and Rhabdomyolysis: There is an increased risk of myopathy and rhabdomyolysis, particularly when combined with HMG-CoA reductase inhibitors (statins). Hepatotoxicity: Elevations in serum transaminases may occur; liver function tests should be monitored. Cholelithiasis: Fibrates may increase cholesterol excretion into bile, potentially leading to gallstones and cholecystitis. Renal Function: Increases in serum creatinine may occur, especially in patients with pre-existing renal impairment.
- Adverse Reactions and Clinical Research Common Adverse Reactions: The most common adverse reactions include abdominal pain, diarrhea, constipation, myalgia, headache, and elevated liver enzymes. Clinical Research: Clinical trials have demonstrated significant reductions in triglyceride levels and improvements in lipid profiles compared to placebo.
- Drug Interactions Warfarin and Other Anticoagulants: Fenofibric acid may enhance the effect of coumarin anticoagulants, increasing the risk of bleeding. Dose reduction of the anticoagulant is often necessary. HMG-CoA Reductase Inhibitors: Concomitant use with statins increases the risk of myopathy and rhabdomyolysis. Cyclosporine: May increase the risk of renal toxicity when used concomitantly.
- Pharmaceutical Information Composition: The active ingredient is fenofibric acid. Appearance: The tablets are typically white to off-white. Storage: Store in a tightly closed container at controlled room temperature, protecting from moisture.
Yuesiliping Fenofibric Acid Tablets
Brand Name: 悦斯立平 ®（Yuesiliping®）
Generic Name: Fenofibric Acid
Strength: 35 mg per tablet, 75 tablets per box
Manufacturer: Changchun Haiyue Pharmaceutical Limited By Share Ltd.
Marketing Authorization Holder: Changchun Haiyue Pharmaceutical Limited By Share Ltd.
Approval Date in China: May 10, 2022
Registration Number: 国药准字H20223283
Storage: Seal tightly, store below 30°C and protect from light. Keep out of reach of children. Refer to the full package insert for detailed storage specifications.
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