Fenofibrate 54mg 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 PPARα activation, fenofibric acid increases lipolysis and elimination of triglyceride-rich particles from plasma by activating lipoprotein lipase (LPL) and reducing production of apolipoprotein C-III (an inhibitor of LPL 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, VLDL-C, and 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 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 are unable to pass urine 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 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 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.

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 directed 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, consult your doctor to discuss the potential benefits and risks associated with using this medication during pregnancy.

• Cyclosporine (increased risk of nephrotoxicity)
• Statins (HMG-CoA reductase inhibitors) in patients with severe renal impairment (increased risk of myopathy/rhabdomyolysis)

• Statins (HMG-CoA reductase inhibitors): Increased risk of myopathy, rhabdomyolysis, and acute renal failure. Use with caution, especially in patients with predisposing factors (e.g., renal impairment, hypothyroidism).
• Warfarin: Potentiates anticoagulant effect, increasing INR and risk of bleeding. Close INR monitoring required.
• Bile acid sequestrants (e.g., cholestyramine, colestipol): May reduce fenofibrate absorption. Administer fenofibrate at least 1 hour before or 4 to 6 hours after bile acid sequestrants.

• Colchicine: Increased risk of myopathy/rhabdomyolysis. Use with caution.
• Oral contraceptives: May slightly increase LDL-C and triglyceride levels, potentially counteracting fenofibrate's effects.

• Not specifically identified as minor, but general caution with other hepatotoxic drugs.

• Unexplained muscle pain, tenderness, or weakness (especially if accompanied by fever or malaise)
• Dark urine
• Yellowing of skin or eyes (jaundice)
• Unusual fatigue
• Loss of appetite
• Upper right abdominal pain
• Nausea, vomiting
• Signs of bleeding or bruising (if on warfarin)

Category C. There are no adequate and well-controlled studies in pregnant women. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal studies have shown adverse effects at high doses.

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 efficacy 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 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 therapy.
• Patients should be educated on the signs and symptoms of myopathy (muscle pain, weakness) and advised to report them immediately.
• When co-administered with statins, the risk of myopathy/rhabdomyolysis is increased; careful patient selection and monitoring are essential.
• Fenofibrate can potentiate the effects of warfarin, requiring frequent INR monitoring and potential dose adjustments of the anticoagulant.
• It is contraindicated in severe renal impairment (CrCl <30 mL/min) and active liver disease.
• While primarily used for hypertriglyceridemia, it also has beneficial effects on LDL-C and HDL-C, particularly in patients with mixed dyslipidemia and high triglycerides.

• Statins (e.g., Atorvastatin, Rosuvastatin, Simvastatin) for hypercholesterolemia and mixed dyslipidemia (primary choice for LDL-C lowering)
• Niacin (Nicotinic Acid) for dyslipidemia (less commonly used due to side effects)
• PCSK9 Inhibitors (e.g., Alirocumab, Evolocumab) for severe hypercholesterolemia
• Bempedoic Acid (Nexletol) for hypercholesterolemia
• Ezetimibe (Zetia) for hypercholesterolemia
• Bile Acid Sequestrants (e.g., Cholestyramine, Colestipol, Colesevelam) for hypercholesterolemia

If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further evaluation and guidance. To ensure your safety and the effectiveness of your treatment, never share your medication with others or take someone else's medication. Some medications may come with additional patient information leaflets, so it is a good idea to consult with your pharmacist for more details. If you have any questions or concerns about your medication, do not 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 information about the medication taken, the amount, and the time it was taken, as this will aid in your treatment.