Fenofibrate 50mg Capsules

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. Activation of PPARα leads to: 1) Increased synthesis of lipoprotein lipase (LPL), which enhances the catabolism of triglyceride-rich lipoproteins (VLDL). 2) Reduced production of apolipoprotein C-III (apoC-III), an inhibitor of LPL activity. 3) Increased synthesis of apolipoproteins A-I and A-II, which are components of HDL. These actions result in significant reductions in plasma triglycerides and VLDL-cholesterol, and modest increases in HDL-cholesterol.

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 medical attention immediately:

Allergic reactions: Rash, hives, itching, red, swollen, blistered, or peeling skin with or without fever, wheezing, tightness in the chest or throat, trouble 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, tiredness, decreased appetite, upset stomach or stomach pain, light-colored stools, vomiting, or yellow skin or 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 or eyes, or fever with chills.
Severe joint pain or swelling.
Blood clots: Chest pain or pressure, coughing up blood, shortness of breath, swelling, warmth, numbness, change of color, or pain in a leg or arm, or trouble speaking or swallowing.
Muscle problems: Muscle pain or weakness, especially if you feel very tired or weak or have a fever. Additionally, inform your doctor if you experience difficulty urinating or a change 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 notice red, swollen, blistered, or peeling skin; red or irritated eyes; sores in your mouth, throat, nose, eyes, genitals, or any areas of skin; fever; chills; body aches; shortness of breath; or swollen glands.
Low blood cell counts: If you experience signs of infection, such as fever, chills, or sore throat, unexplained bruising or bleeding, or feel very tired or weak, contact your doctor right away, as low blood cell counts can lead to bleeding problems, infections, or anemia.

Other Side Effects

Most people do not experience significant side effects, but some may occur. If you notice any of the following side effects or any other symptoms that bother you or do not go away, 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, such as foods or drugs. Be sure to describe the symptoms you experienced.
Certain health conditions, including:
+ Gallbladder disease
+ Kidney disease
+ Liver disease
+ Elevated liver enzymes
If you are taking any of the following medications:
+ Atorvastatin
+ Fluvastatin
+ Lovastatin
+ Pitavastatin
+ Pravastatin
+ Rosuvastatin
+ 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 for personalized guidance.

This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist. They will help you determine whether it is safe to take this medication with your other medications and health conditions. Never 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 tests and other laboratory examinations as instructed by your doctor. Adhere to the diet and exercise plan recommended by your doctor.

Be aware that this medication can cause liver problems, which in some cases have been severe, resulting in the need for a liver transplant or leading to death. If you have any concerns or questions, discuss them with your doctor.

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

If you are pregnant or planning to become pregnant, notify your doctor. It is crucial to discuss the potential benefits and risks of using this medication during pregnancy to make an informed decision.

• Gemfibrozil (increased risk of myopathy/rhabdomyolysis)

• Statins (HMG-CoA Reductase Inhibitors) - increased risk of myopathy, rhabdomyolysis, and renal failure. Use with caution and monitor for muscle symptoms and CK levels.
• Warfarin - potentiates anticoagulant effect, increasing risk of bleeding. Requires close INR monitoring and possible warfarin dose reduction.
• Cyclosporine - increased risk of nephrotoxicity and severe renal dysfunction. Monitor renal function closely.
• Colchicine - increased risk of myopathy/rhabdomyolysis.

• Bile Acid Sequestrants (e.g., Cholestyramine, Colestipol, Colesevelam) - may reduce fenofibrate absorption. Administer fenofibrate at least 1 hour before or 4-6 hours after bile acid sequestrants.
• Ezetimibe - theoretical increased risk of cholelithiasis, though clinical significance is unclear.
• Oral Contraceptives - may slightly alter lipid profiles, but generally not clinically significant.

• Unexplained muscle pain, tenderness, or weakness (especially if accompanied by fever or malaise)
• Dark urine
• Yellowing of skin or eyes (jaundice)
• Unusual fatigue or weakness
• Nausea, vomiting, or abdominal pain (especially right upper quadrant)
• Swelling (edema)
• Signs of bleeding or bruising (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. Animal studies have shown adverse effects at high doses.

L3 (Moderately Safe). It is unknown 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. Consider potential risks to the infant (e.g., effects on lipid metabolism) versus benefits to the mother.

Safety and effectiveness have not been established in pediatric patients. Use is generally not recommended.

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 be taken with meals to optimize absorption, especially for conventional formulations.
• 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.
• When co-administered with statins, the risk of muscle-related side effects increases; careful patient selection and monitoring are essential.
• Fenofibrate can potentiate the effects of warfarin, requiring close INR monitoring and potential dose adjustments of warfarin.
• Different fenofibrate formulations (conventional, micronized, nanocrystallized) are not bioequivalent and should not be interchanged on a milligram-for-milligram basis without consulting a healthcare professional.

• Statins (e.g., Atorvastatin, Rosuvastatin, Simvastatin) - primary agents for LDL-C lowering, also reduce triglycerides.
• Niacin (Nicotinic Acid) - lowers triglycerides and LDL-C, raises HDL-C, but often limited by flushing side effect.
• Omega-3 Fatty Acids (prescription strength) - effective for severe hypertriglyceridemia.
• PCSK9 Inhibitors (e.g., Alirocumab, Evolocumab) - primarily for severe hypercholesterolemia, not typically for hypertriglyceridemia.
• Bile Acid Sequestrants (e.g., Cholestyramine) - primarily for LDL-C lowering.

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. 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 it's a good idea to check with your pharmacist. If you have any questions or concerns about this medication, don't hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.