Fenofibrate 48mg 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, which are components of HDL-C. These actions result in reductions in total cholesterol, LDL-C, triglycerides, 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 medical attention immediately:

Allergic Reaction: 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 deadly. 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 like fever, chills, or sore throat; any 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
+ 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 to determine the best course of action.

Please note that this is not an exhaustive list of all 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 medications, 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 tests and other laboratory examinations as instructed by your doctor. Adhere to the dietary and exercise plan recommended by your doctor.

Be aware that this medication can cause liver problems, which in some cases may be severe, potentially leading to the need for 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 drug, 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 associated with using this medication during pregnancy to make an informed decision.

• Statins (HMG-CoA reductase inhibitors): Increased risk of myopathy/rhabdomyolysis. Use with caution, consider lower doses of statin, and monitor for muscle symptoms and CK levels.
• Oral anticoagulants (e.g., Warfarin): Potentiates anticoagulant effect, increasing risk of bleeding. Reduce anticoagulant dose and monitor INR frequently.
• Cyclosporine: May impair renal function, leading to increased fenofibric acid levels and potential for toxicity. Monitor renal function and fenofibric acid levels.

• Colchicine: Increased risk of myopathy/rhabdomyolysis. Use with caution.
• Bile acid sequestrants (e.g., Cholestyramine, Colestipol): May decrease fenofibrate absorption. Administer fenofibrate at least 1 hour before or 4-6 hours after the bile acid sequestrant.
• Glitazones (e.g., Pioglitazone, Rosiglitazone): Potential for additive effects on lipid parameters, but also increased risk of fluid retention and heart failure. Use with caution.

• Unexplained muscle pain, tenderness, or weakness (especially if accompanied by fever or malaise)
• Abdominal pain, nausea, vomiting (signs of pancreatitis or gallstones)
• Yellowing of skin or eyes (jaundice), dark urine, light-colored stools (signs of liver problems)
• Unusual fatigue or weakness
• Signs of allergic reaction (rash, itching, swelling, severe dizziness, trouble breathing)

Use during pregnancy should be avoided unless the potential benefit justifies the potential risk to the fetus. Limited human data suggest no increased risk of major birth defects, but animal studies show adverse effects at high doses.

It is not known whether fenofibric acid is excreted in human milk. 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 in pediatric patients have not been established. 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 48mg is a micronized or nanocrystallized formulation, which has improved bioavailability compared to older, non-micronized formulations. It is not directly interchangeable milligram-for-milligram with older formulations (e.g., 160mg).
• Always take fenofibrate with food to optimize absorption and efficacy.
• Monitor liver function tests (LFTs) and renal function regularly, especially during the first year of treatment.
• Educate patients on the signs and symptoms of myopathy (muscle pain, weakness) and pancreatitis (severe abdominal pain) and instruct them to report these immediately.
• Fenofibrate can potentiate the effects of warfarin; close INR monitoring and dose adjustment of warfarin are crucial when initiating or discontinuing fenofibrate.
• While fibrates can raise HDL-C and lower triglycerides, their primary role in cardiovascular risk reduction is often debated, and they are typically used when triglycerides are very high or in combination with statins for mixed dyslipidemia, with careful consideration of risks.

• Other Fibrates (e.g., Gemfibrozil)
• Statins (HMG-CoA reductase inhibitors) for hypercholesterolemia
• Omega-3 Fatty Acid Esters (e.g., Icosapent ethyl, Omega-3-acid ethyl esters) for hypertriglyceridemia
• PCSK9 Inhibitors (for severe hypercholesterolemia)
• Niacin (Nicotinic Acid) for dyslipidemia (less commonly used due to side effects)
• Bile Acid Sequestrants (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.