Fenofibrate

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Generic Name of Fenofibrate - Learn More

Fenofibrate

Fenofibrate Precaution - What You Need to Know

Fenofibrate should be used with caution in individuals with pre-existing liver or kidney conditions, as it can exacerbate hepatic dysfunction and renal impairment. Liver function tests should be monitored regularly, and the drug should be discontinued if significant liver enzyme elevations occur. In patients with severe renal impairment (e.g., creatinine clearance less than 30 mL/min), fenofibrate is contraindicated due to the increased risk of adverse effects and potential drug accumulation. It should also be used with caution in those with a history of gallstones or other biliary disorders, as fenofibrate may increase the risk of gallbladder-related complications. Pregnant or breastfeeding women should consult with their healthcare provider, as fenofibrate is classified under pregnancy category C, meaning potential risks have not been ruled out. Monitoring of lipid levels is necessary to ensure therapeutic efficacy. There is no significant misuse or dependency potential associated with fenofibrate, but patients should adhere to prescribed dosing to avoid complications.

Fenofibrate Indication - Uses and Benefits

Fenofibrate is primarily indicated for the treatment of hyperlipidemia, including elevated triglycerides and cholesterol levels. It is used to reduce elevated low-density lipoprotein (LDL) cholesterol, total cholesterol, and triglycerides, and to increase high-density lipoprotein (HDL) cholesterol. Fenofibrate is particularly beneficial for patients with mixed dyslipidemia, a condition in which both elevated triglycerides and low HDL cholesterol are present. It is often used when lifestyle changes alone are insufficient or for patients who do not respond adequately to statin therapy. In addition, fenofibrate is indicated for the treatment of hypertriglyceridemia, which can lead to pancreatitis if left untreated. Off-label, fenofibrate may be used in certain individuals with diabetic dyslipidemia or in patients with lipid disorders associated with chronic kidney disease, although this is less common. Clinical guidelines support its use as a second-line agent for lipid management in patients with dyslipidemia not adequately controlled by statins alone.

Fenofibrate Contraindications - Important Warnings

Fenofibrate is contraindicated in patients with severe liver disease, including cirrhosis, active liver disease, or unexplained persistent liver enzyme elevations. It is also contraindicated in patients with severe renal impairment (creatinine clearance less than 30 mL/min) due to the increased risk of drug accumulation and renal toxicity. Fenofibrate should not be used in patients with a known hypersensitivity to the drug or any of its components. Additionally, patients with gallbladder disease or a history of gallstones should avoid using fenofibrate, as the drug can increase the risk of gallbladder-related complications. Pregnant and breastfeeding women are advised to avoid fenofibrate unless the benefits outweigh the risks, as it is classified as a pregnancy category C drug. Fenofibrate is not recommended for use in children under 18 years of age, as safety and efficacy in pediatric populations have not been well established.

Fenofibrate Side Effects - What to Expect

Common side effects of fenofibrate include gastrointestinal disturbances, such as nausea, abdominal pain, diarrhea, and flatulence. These effects are usually mild and can be minimized by taking the drug with food. Other more serious side effects include liver enzyme abnormalities, which can be detected through routine liver function tests. If elevated liver enzymes persist, the drug should be discontinued. Muscle pain, tenderness, or weakness can occur, especially when fenofibrate is taken in combination with statins, and may indicate a more serious condition, such as rhabdomyolysis. In rare cases, fenofibrate can cause gallstones, pancreatitis, or an allergic reaction, which can manifest as skin rashes, itching, or difficulty breathing. Long-term use can also lead to renal impairment, so kidney function should be monitored regularly. In some individuals, fenofibrate may affect blood glucose control, leading to an increased risk of hypoglycemia, particularly when used in combination with antidiabetic drugs. Patients should contact their healthcare provider immediately if they experience any unexplained muscle pain, weakness, or signs of liver dysfunction.

Fenofibrate Pregnancy Category ID - Safety Information

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Fenofibrate Mode of Action - How It Works

Fenofibrate is a peroxisome proliferator-activated receptor-alpha (PPAR-α) agonist. It works by activating PPAR-α, a nuclear receptor involved in the regulation of lipid metabolism. Activation of PPAR-α increases the expression of enzymes that promote the breakdown of fatty acids, thereby lowering triglyceride levels. It also increases the activity of lipoprotein lipase, which helps to clear triglyceride-rich lipoproteins from the bloodstream. Additionally, fenofibrate enhances the synthesis of apolipoproteins, which are critical components of HDL cholesterol, leading to an increase in HDL levels. The drug's effects on lipid profiles help reduce the risk of cardiovascular events associated with dyslipidemia, including heart disease and stroke. Fenofibrate's unique mechanism makes it particularly effective in patients with elevated triglycerides and low HDL cholesterol, conditions that are not always adequately managed by statins alone. Its mode of action is distinct from other lipid-lowering agents, such as statins or bile acid sequestrants, providing a complementary approach to lipid management.

Fenofibrate Drug Interactions - What to Avoid

Fenofibrate has several significant drug-drug interactions. It should not be used concurrently with other fibrates or with gemfibrozil, as this combination increases the risk of muscle toxicity, including rhabdomyolysis. Fenofibrate can also potentiate the effects of anticoagulants like warfarin, increasing the risk of bleeding. If co-administration is necessary, more frequent monitoring of coagulation parameters is advised. The drug can interact with statins, increasing the risk of muscle-related side effects. Fenofibrate may increase the effects of sulfonylureas, which are used to manage diabetes, thereby increasing the risk of hypoglycemia, so glucose levels should be monitored more closely. Concomitant use of fenofibrate and certain antihypertensive medications may increase the risk of renal dysfunction, particularly in those with pre-existing renal disease. Food does not significantly affect the absorption of fenofibrate, so it can be taken with or without meals. Alcohol consumption should be avoided as it may exacerbate the risk of liver dysfunction when combined with fenofibrate.

Fenofibrate Adult Dose - Recommended Dosage

The recommended starting dose of fenofibrate for adults is typically 48 to 145 mg once daily, depending on the specific formulation (e.g., regular or extended-release) and the patient’s individual condition. The exact dose may vary based on the severity of hyperlipidemia and the patient's response to treatment. The drug should be taken orally, with or without food. It is important to monitor lipid levels regularly to ensure that the dose is appropriate for the patient’s needs. In patients with renal or liver dysfunction, dose adjustments may be necessary, and these individuals should be closely monitored for any signs of adverse effects. Fenofibrate should not be used in combination with other fibrates unless under the guidance of a healthcare provider, as this increases the risk of serious side effects like rhabdomyolysis.

Fenofibrate Child Dose - Dosage for Children

Fenofibrate is not approved for use in children under the age of 18 due to insufficient safety and efficacy data in pediatric populations. While there are limited studies on its use in children, the risk-benefit profile has not been established, and alternative lipid-lowering treatments should be considered in pediatric patients. If fenofibrate is prescribed off-label in a pediatric setting, the dosage should be determined by a pediatric specialist, and the child should be monitored closely for any potential adverse effects, particularly those related to liver and kidney function.

Fenofibrate Renal Dose - Dosage for Kidney Conditions

In patients with mild to moderate renal impairment (creatinine clearance between 30 and 80 mL/min), the standard dose of fenofibrate can be used, but regular monitoring of kidney function is advised. In patients with severe renal impairment (creatinine clearance less than 30 mL/min), fenofibrate is contraindicated due to the increased risk of drug accumulation and potential nephrotoxicity. In cases of renal insufficiency, a lower starting dose may be required, and close monitoring of renal function and drug efficacy is essential. If renal function deteriorates during treatment, the drug should be discontinued or the dose reduced to prevent further renal complications. Patients with end-stage renal disease or those on dialysis should generally avoid fenofibrate.