Fenofibric 45mg DR Capsules

Fenofibric acid, the active metabolite of fenofibrate, is a peroxisome proliferator-activated receptor alpha (PPARα) agonist. It activates PPARα, which upregulates the expression of genes involved in lipid metabolism. This leads to increased lipolysis and elimination of triglyceride-rich particles from plasma by activating lipoprotein lipase (LPL) and reducing the production of apolipoprotein C-III (an inhibitor of LPL). It also increases the synthesis of apolipoproteins A-I and A-II, leading to increased HDL-C levels. The net effect is a reduction in total cholesterol, LDL-C, 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 when taking this medication. If you experience any of the following symptoms, contact your doctor or seek medical attention immediately:

Signs of an allergic reaction, such as:
+ 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
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of liver problems, including:
+ Dark urine
+ Tiredness
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Signs of pancreatitis (pancreas problem), such as:
+ Severe stomach pain
+ Severe back pain
+ Severe upset stomach or vomiting
Signs of gallstones, including:
+ Sudden pain in the upper right belly area, right shoulder area, or between the shoulder blades
+ Yellow skin or eyes
+ Fever with chills
Severe joint pain or swelling
Signs of a blood clot, such as:
+ Chest pain or pressure
+ Coughing up blood
+ Shortness of breath
+ Swelling, warmth, numbness, change of color, or pain in a leg or arm
+ Trouble speaking or swallowing
Muscle problems, including:
+ Muscle pain or weakness, especially if you feel very tired or weak or have a fever
+ Inability to pass urine or changes in urine output
Severe skin reactions, including:
+ Stevens-Johnson syndrome (SJS)
+ Toxic epidermal necrolysis (TEN)
+ Other serious reactions, which can affect body organs and be life-threatening
+ Signs such as 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, which can lead to:
+ Bleeding problems
+ Infections
+ Anemia
+ Signs such as fever, chills, or sore throat; unexplained bruising or bleeding; or feeling very tired or weak

Other Possible Side Effects

Most people do not experience significant side effects, but some may occur. If you experience 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, contact 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 drugs, natural products, and vitamins.
Discuss all your health problems with your doctor.
Verify that it is safe to take this medication with your existing 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 instructed by your doctor. Adhere to the diet and exercise plan recommended by your doctor to ensure safe and effective use of this medication.

Be aware that this drug 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 questions or concerns, 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 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.

• Statins (HMG-CoA reductase inhibitors): Increased risk of myopathy/rhabdomyolysis. Use with caution, especially with higher statin doses or in patients with predisposing factors for myopathy. Consider lower doses of both agents.
• Warfarin: Potentiates anticoagulant effect, increasing risk of bleeding. Monitor INR closely and adjust warfarin dose as needed.
• Cyclosporine: May impair renal function, leading to increased fenofibric acid levels and potential nephrotoxicity. Monitor renal function and fenofibric acid levels if possible.
• Bile Acid Sequestrants (e.g., Cholestyramine, Colestipol): May reduce absorption of fenofibric acid. Administer fenofibric acid at least 1 hour before or 4-6 hours after bile acid sequestrants.

• Colchicine: Increased risk of myopathy/rhabdomyolysis when co-administered with fibrates, especially in patients with renal impairment.
• Oral Contraceptives: May alter lipid profiles, potentially reducing the effectiveness of fenofibric acid in some cases (though clinical significance is often minor).

• Not available

• 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
• Severe abdominal pain (may indicate pancreatitis or gallstones)
• Nausea or vomiting
• Loss of appetite

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. Lipid-lowering drugs are generally considered unnecessary during pregnancy.

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 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. Due to the higher incidence of renal impairment in the elderly, dose selection should be cautious, and renal function should be monitored.

• Fenofibric acid DR capsules can be taken without regard to meals, which is a convenience advantage over some older fenofibrate formulations.
• 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 conditions.
• Educate patients on the signs and symptoms of myopathy (muscle pain, weakness) and advise them to report these immediately, especially if they are also taking a statin.
• Fenofibric acid is primarily used for severe hypertriglyceridemia or mixed dyslipidemia, often when statins alone are insufficient or contraindicated.
• Patients on warfarin require very close INR monitoring and potential dose adjustments when initiating or discontinuing fenofibric acid.
• This formulation is the active metabolite, fenofibric acid, which means it bypasses the first-pass hydrolysis of fenofibrate.

• Other fibrates (e.g., Gemfibrozil, Fenofibrate micronized/nanocrystallized)
• HMG-CoA reductase inhibitors (Statins, e.g., Atorvastatin, Rosuvastatin) - primary agents for LDL-C lowering
• Omega-3 Fatty Acid Esters (e.g., Icosapent ethyl, Omega-3-acid ethyl esters) - for severe hypertriglyceridemia
• PCSK9 Inhibitors (e.g., Alirocumab, Evolocumab) - for severe hypercholesterolemia
• Ezetimibe (Cholesterol absorption inhibitor)
• Bempedoic Acid (ATP Citrate Lyase inhibitor)
• Nicotinic Acid (Niacin) - less commonly used due to side effects
• Bile Acid Sequestrants (e.g., Cholestyramine, Colesevelam)

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 substance taken, the amount, and the time it occurred.