Fenofibrate 40mg Tablets

Fenofibrate is a prodrug that is rapidly hydrolyzed to its active metabolite, fenofibric acid. Fenofibric acid activates peroxisome proliferator-activated receptor alpha (PPARα), a nuclear receptor that regulates lipid metabolism. Through activation of PPARα, fenofibric acid increases lipolysis and elimination of triglyceride-rich particles from plasma by activating lipoprotein lipase and reducing production of apolipoprotein C-III (an inhibitor of lipoprotein lipase activity). It also increases the synthesis of apolipoproteins A-I and A-II, leading to increased HDL-C levels. These actions result in reductions in total cholesterol, LDL-C, triglycerides, and apolipoprotein B, and increases in HDL-C.

Urgent Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:

Allergic reactions: Rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, difficulty breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat. In rare cases, allergic reactions can be life-threatening.
Liver problems: Dark urine, fatigue, decreased appetite, stomach pain or upset, light-colored stools, vomiting, or yellow skin and eyes.
Pancreatitis: Severe stomach pain, severe back pain, or severe upset stomach or vomiting.
Gallstones: Sudden pain in the upper right belly area, right shoulder area, or between the shoulder blades, yellow skin and eyes, or fever with chills.
Severe joint pain or swelling: Contact your doctor if you experience unusual or persistent joint pain or swelling.
Blood clots: Chest pain or pressure, coughing up blood, shortness of breath, swelling, warmth, numbness, color change, or pain in a leg or arm, or difficulty speaking or swallowing.
Muscle problems: Muscle pain or weakness, especially if accompanied by fatigue, weakness, or fever. Notify your doctor if you experience difficulty urinating or changes in urine output, as this can lead to kidney problems.
Severe skin reactions: Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious reactions, which can be life-threatening. Seek medical help immediately if you experience red, swollen, blistered, or peeling skin; red or irritated eyes; sores in your mouth, throat, nose, eyes, genitals, or skin; fever; chills; body aches; shortness of breath; or swollen glands.
Low blood cell counts: If blood cell counts become severely low, it can lead to bleeding problems, infections, or anemia. Contact your doctor if you experience signs of infection, such as fever, chills, or sore throat; unexplained bruising or bleeding; or excessive fatigue or weakness.

Other Possible Side Effects

Like all medications, this drug can cause side effects. Many people may not experience any side effects or only minor ones. If you are concerned about any of the following side effects or if they persist, contact your doctor:

Headache
Back pain
Stomach pain

This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances. Be sure to describe the allergic reaction and its symptoms.
Certain health conditions, such as gallbladder disease, kidney disease, liver disease, or elevated liver enzymes.
If you are taking any of the following medications: atorvastatin, fluvastatin, lovastatin, pitavastatin, pravastatin, rosuvastatin, or simvastatin.
If you are breastfeeding or plan to breastfeed. Note that you should not breastfeed while taking this medication, and you may need to avoid breastfeeding for 5 days after your last dose. Consult your doctor to determine the best course of action.

Please note that this is not an exhaustive list of potential interactions. To ensure your safety, it is crucial to:

Inform your doctor and pharmacist about all medications you are taking, including prescription and over-the-counter drugs, natural products, and vitamins.
Discuss all your health problems with your doctor.
Verify that it is safe to take this medication with all your other medications and health conditions.
Do not start, stop, or change the dose of any medication without first consulting your doctor.

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Regularly undergo blood work and other laboratory tests as directed by your doctor to monitor your condition. Adhere to the diet and exercise plan recommended by your doctor to ensure optimal management of your health.

Be aware that this medication can cause liver problems, which may be severe and potentially life-threatening, requiring a liver transplant or resulting in death. If you have any concerns or questions, discuss them with your doctor.

If you are 65 years or older, exercise caution when using this medication, as you may be more susceptible to experiencing side effects.

If you are pregnant or planning to become pregnant, consult your doctor to discuss the potential benefits and risks associated with using this medication during pregnancy, allowing for an informed decision about your care.

• Statins (HMG-CoA reductase inhibitors): Increased risk of myopathy/rhabdomyolysis.
• Warfarin: Potentiation of anticoagulant effect, increased risk of bleeding.
• Cyclosporine: Increased risk of renal dysfunction.

• Bile acid sequestrants (e.g., cholestyramine, colestipol): May reduce fenofibrate absorption. Administer fenofibrate at least 1 hour before or 4-6 hours after bile acid sequestrants.
• Colchicine: Possible increased risk of myopathy/rhabdomyolysis (though less established than with statins).

• Oral contraceptives: May slightly alter lipid profiles, but generally not clinically significant.

• Unexplained muscle pain, tenderness, or weakness (especially if accompanied by malaise or fever)
• Dark urine
• Yellowing of skin or eyes (jaundice)
• Unusual fatigue or weakness
• Abdominal pain
• Nausea or vomiting
• Signs of bleeding (e.g., unusual bruising, prolonged bleeding from cuts, blood in urine or stool) if on warfarin

Category C. There are no adequate and well-controlled studies in pregnant women. Fenofibrate should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Lipid levels naturally increase during pregnancy, and the need for lipid-lowering therapy is generally not established.

It is not known whether fenofibric acid is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Generally not recommended.

Safety and efficacy have not been established in pediatric patients. Use is generally not recommended unless the potential benefit clearly outweighs the potential risks, and only under specialist supervision.

No overall differences in safety or effectiveness have been observed between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Renal function should be monitored.

• Fenofibrate should always be taken with food to optimize absorption and efficacy.
• Regular monitoring of liver function tests (LFTs) and renal function is crucial, especially during the first year of treatment.
• Patients should be advised to report any unexplained muscle pain, tenderness, or weakness immediately, as this could indicate myopathy or rhabdomyolysis.
• Fenofibrate is particularly effective at lowering very high triglyceride levels and can also improve HDL-C and LDL-C.
• When co-administering with bile acid sequestrants, separate doses by at least 1 hour before or 4-6 hours after the sequestrant to avoid reduced absorption of fenofibrate.
• Patients on warfarin require close monitoring of INR when initiating or discontinuing fenofibrate, or changing its dose, due to potential for increased anticoagulant effect.

• Other fibrates (e.g., Gemfibrozil)
• Statins (e.g., Atorvastatin, Rosuvastatin, Simvastatin) - primary agents for LDL-C lowering, some also lower triglycerides.
• Omega-3 fatty acid ethyl esters (e.g., Icosapent ethyl, Omega-3-acid ethyl esters) - for severe hypertriglyceridemia.
• PCSK9 inhibitors (e.g., Alirocumab, Evolocumab) - for severe hypercholesterolemia.
• Niacin (Nicotinic acid) - for dyslipidemia (less commonly used due to side effects).
• Bempedoic acid (Nexletol) - for hypercholesterolemia.
• Ezetimibe (Zetia) - for hypercholesterolemia.

If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about this medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. When seeking help, be prepared to provide details about the medication, including the amount taken and the time it happened, to ensure you receive the best possible care.