Fenofibrate 200mg 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. 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 an increase in HDL-C. These actions result in a reduction in total cholesterol, LDL-C, VLDL-C, and triglycerides, and an increase 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 immediately or seek emergency medical attention:

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.
Pancreas problems (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: Contact your doctor if you experience very bad 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. This can also lead to kidney problems. Inform your doctor if you have difficulty urinating or notice a change in your urine output.
Severe skin reactions: Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious reactions can occur, which may affect body organs and can be fatal. 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 any areas of skin; fever; chills; body aches; shortness of breath; or swollen glands.
Low blood cell counts: This can lead to bleeding problems, infections, or anemia. Contact your doctor if you have signs of infection, such as fever, chills, or sore throat; unexplained bruising or bleeding; or if you feel very tired or weak.

Other Side Effects

Most people do not experience significant side effects, but some may occur. 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 symptoms you experienced.
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.

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 verify that 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 work and other laboratory tests as directed by your doctor. Adhere to the diet and exercise plan recommended by your doctor.

Be aware that this medication can cause liver problems, which may be severe and potentially lead to a liver transplant or 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 side effects.

If you are pregnant or planning to become pregnant, notify your doctor. You and your doctor will need to discuss the potential benefits and risks of using this medication during pregnancy.

• Statins (HMG-CoA reductase inhibitors): Increased risk of myopathy, rhabdomyolysis, and acute renal failure. Use with caution, especially at higher statin doses.
• Warfarin: Potentiates anticoagulant effect, increasing INR and risk of bleeding. Requires close INR monitoring and dose adjustment of warfarin.
• Cyclosporine: Can cause severe renal dysfunction and reduced fenofibric acid levels. Monitor renal function and fenofibric acid levels.
• Colchicine: Increased risk of myopathy/rhabdomyolysis.

• Bile acid sequestrants (e.g., cholestyramine, colestipol): Can interfere with fenofibrate absorption. Administer fenofibrate at least 1 hour before or 4-6 hours after bile acid sequestrants.
• Ezetimibe: Increased risk of cholelithiasis.
• Oral contraceptives: May alter lipid profiles, potentially reducing fenofibrate efficacy.

• Unexplained muscle pain, tenderness, or weakness (especially if accompanied by fever or malaise)
• Yellowing of skin or eyes (jaundice)
• Dark urine
• Severe abdominal pain (may indicate pancreatitis or gallstones)
• Nausea, vomiting, loss of appetite
• Unusual fatigue or weakness

Fenofibrate is Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. Use during pregnancy should only be considered if the potential benefit justifies the potential risk to the fetus.

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.

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

Use with caution in elderly patients due to the higher incidence of decreased renal function in this population. Renal function should be monitored closely, and dose adjustments may be necessary based on creatinine clearance.

• Fenofibrate 200mg capsules are typically a micronized formulation, which should be taken with food to optimize absorption.
• Fenofibrate is particularly effective at lowering very high triglyceride levels and increasing HDL-C.
• Regular monitoring of liver function tests (LFTs) and renal function is crucial, especially during the first year of treatment and in patients with pre-existing renal impairment.
• Patients should be advised to report any unexplained muscle pain, tenderness, or weakness immediately, as this could indicate myopathy or rhabdomyolysis.
• When co-administering with statins, the risk of muscle-related adverse events is increased; careful patient selection and monitoring are essential.
• Fenofibrate can potentiate the effects of warfarin, requiring close INR monitoring and potential dose reduction of warfarin.
• In some patients, fenofibrate may paradoxically increase LDL-C, especially in those with severe hypertriglyceridemia. Monitor lipid panel closely.

• Other Fibrates (e.g., Gemfibrozil, Fenofibrate (other formulations like 145mg, 160mg))
• Statins (e.g., Atorvastatin, Rosuvastatin, Simvastatin) - primary for LDL-C lowering, but some also lower TG.
• Omega-3 Fatty Acid Esters (e.g., Icosapent ethyl, Omega-3-acid ethyl esters) - for severe hypertriglyceridemia.
• PCSK9 Inhibitors (e.g., Alirocumab, Evolocumab) - primarily for LDL-C lowering, but can also lower TG.
• Niacin (Nicotinic Acid) - for dyslipidemia, but less commonly used due to side effects.
• Bempedoic Acid (with or without ezetimibe) - for LDL-C lowering.
• Diet and lifestyle modifications (cornerstone of lipid management).

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, 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.