fenofibrate micronized 

Action and Spectrum

Actions and Spectrum 

The action of fenofibrate micronized is to activate peroxisome proliferator-activated receptors (PPARs), which are found in the liver and other tissues. This activation leads to an increase in the expression of genes involved in lipid metabolism, resulting in a decrease in plasma triglycerides and an increase in high-density lipoprotein (HDL) cholesterol levels. 

The spectrum of fenofibrate micronized is primarily focused on treating hypertriglyceridemia (elevated triglyceride levels in the blood), mixed dyslipidemia (abnormal lipid levels involving both triglycerides and cholesterol), and hypercholesterolemia (elevated cholesterol levels). It is also used to prevent cardiovascular events in patients with diabetes, and in the treatment of familial hypercholesterolemia. 

Drug Interaction

Adverse Reaction

Frequency defined  

1-10% 

Increased ALT (3%) 

Nausea (2.3%) 

Constipation (2.1%) 

Headache (3.2%) 

Increased CPK (3%) 

Abdominal pain (4.6%) 

Back pain (3.4%) 

Increased AST (3.4%)  

Postmarketing Reports 

Severely depressed HDL levels 

Anemia 

Hepatitis, cirrhosis 

Renal failure 

Myalgia, rhabdomyolysis, muscle spasms, arthralgia 

Pancreatitis 

Black Box Warning

Black Box Warning:  

The drug can cause renal function impairment, including worsening kidney disease, and may lead to myopathy (muscle weakness, pain, or tenderness) including rhabdomyolysis. 

Contraindication / Caution

Contraindication/Caution:  

Hypersensitivity to fenofibrate micronized or any of its components. 

Liver disease, including severe liver impairment or active liver disease.  

Gallbladder disease or biliary cirrhosis 

Severe kidney disease or kidney failure.  

Pancreatitis (inflammation of the pancreas).  

Pregnancy or breastfeeding. 

Pregnancy / Lactation

Pregnancy warnings:     

Pregnancy category: N/A 

Lactation: Excreted into human milk is unknown 

Pregnancy Categories:         

Category A: Studies that were well-controlled and met expectations revealed no risk to the fetus in either the first or second trimester. 

Category B: There were a lack of studies on pregnant women and no evidence of risk to the fetus in animal experiments.   

Category C: there was evidence of risk of adverse effects in animal reproduction studies, and no adequate evidence in human studies must take care of potential risks in pregnant women.    

Category D: adequate data with sufficient evidence of human fetal risk from various platforms, but despite the potential risk, and used only in emergency cases for potential benefits.   

Category X: Drugs listed in this category outweigh the risks over benefits. Hence these categories of drugs need to be avoided by pregnant women.    

Category N: There is no data available for the drug under this category

Pharmacology

Pharmacology:  

fenofibrate micronized is a medication that belongs to a class of drugs known as fibric acid derivatives 

Pharmacodynamics:  

The drug is a peroxisome proliferator-activated receptor alpha (PPAR-alpha) agonist. PPAR-alpha is a nuclear receptor that regulates lipid metabolism. 

Pharmacokinetics: 

Absorption 

fenofibrate micronized is well absorbed after oral administration, with peak plasma concentrations occurring within 4 to 6 hours after dosing.  

Distribution 

The drug has a plasma protein binding capacity exceeding 99%. It possesses a considerable volume of distribution, with its primary distribution occurring in the liver, adipose tissue, and kidneys.  

Metabolism 

The drug is extensively metabolized in the liver via oxidation and conjugation pathways. The major metabolite is fenofibric acid, which is pharmacologically active.  

Excretion and elimination:  

fenofibrate micronized and its metabolites are eliminated primarily in the urine, with a small amount eliminated in the feces. The elimination half-life of fenofibrate micronized is approximately 20 hours. 

Adminstartion

Administration:  

fenofibrate micronized is usually taken once a day, with or without food. Your doctor may recommend a specific time of day to take the medication. 

Patient Information Leaflet

Patient information leaflet 

Generic Name: fenofibrate micronized 

Why do we use fenofibrate micronized?  

Reducing triglycerides: fenofibrate micronized can also lower triglyceride levels in people with high triglycerides. 

Preventing pancreatitis: High triglyceride levels can increase the risk of pancreatitis (inflammation of the pancreas).The drug can help lower triglycerides and reduce the risk of pancreatitis. 

Treating diabetic dyslipidemia: To address diabetic dyslipidemia, individuals with diabetes often exhibit elevated triglyceride levels and decreased HDL cholesterol.  

Improving cardiovascular health: This medication may aid in improving cardiovascular health by decreasing the likelihood of cardiovascular events, such as stroke and heart attack, among those with low HDL cholesterol and high triglyceride levels.