Fenofibrate 145mg Tablets
It is used to lower bad cholesterol, lower triglycerides, and raise good cholesterol (HDL).
Drug Class
Antilipemic Agents, Fibrates
Pharmacologic Class
Peroxisome Proliferator-Activated Receptor Alpha (PPARΞ±) Agonists
Pregnancy Category
Category C
FDA Approved
Feb 2004
DEA Schedule
Not Controlled
Overview
What is this medicine?
Fenofibrate is a medication used to help lower very high levels of triglycerides (a type of fat) in your blood and to increase your 'good' cholesterol (HDL). It works by helping your body break down and remove fats more effectively. It's often used along with a healthy diet and exercise.
How to Use This Medicine
Taking Your Medication Correctly
To ensure you get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely.
Some brands of this medication should be taken with food, while others can be taken with or without food. If you're unsure about your specific brand, consult your pharmacist.
If you have difficulty swallowing, discuss this with your doctor. Take your medication with a full glass of water.
If you are taking cholestyramine or colestipol, take these medications at least 4 hours before or 1 hour after your prescribed medication.
Continue taking your medication as directed by your doctor or healthcare provider, even if you start feeling well.
Important Administration Instructions
- Swallow your medication whole; do not chew, break, or crush it.
- Do not take any tablets that are chipped or broken.
Storing and Disposing of Your Medication
Store your medication at room temperature with the lid tightly closed. Some brands require storage in their original container, so do not remove the anti-moisture cube or packet. If you're unsure about the storage requirements for your brand, consult your doctor or pharmacist.
What to Do If You Miss a Dose
If you miss a dose, skip it and return to your regular dosing schedule. Do not take more than one dose in a 24-hour period unless your doctor instructs you to do so.
To ensure you get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely.
Some brands of this medication should be taken with food, while others can be taken with or without food. If you're unsure about your specific brand, consult your pharmacist.
If you have difficulty swallowing, discuss this with your doctor. Take your medication with a full glass of water.
If you are taking cholestyramine or colestipol, take these medications at least 4 hours before or 1 hour after your prescribed medication.
Continue taking your medication as directed by your doctor or healthcare provider, even if you start feeling well.
Important Administration Instructions
- Swallow your medication whole; do not chew, break, or crush it.
- Do not take any tablets that are chipped or broken.
Storing and Disposing of Your Medication
Store your medication at room temperature with the lid tightly closed. Some brands require storage in their original container, so do not remove the anti-moisture cube or packet. If you're unsure about the storage requirements for your brand, consult your doctor or pharmacist.
What to Do If You Miss a Dose
If you miss a dose, skip it and return to your regular dosing schedule. Do not take more than one dose in a 24-hour period unless your doctor instructs you to do so.
Lifestyle & Tips
- Continue to follow a low-fat, low-cholesterol diet as recommended by your doctor.
- Engage in regular physical activity.
- Maintain a healthy weight.
- Limit alcohol intake, as it can increase triglyceride levels.
- Do not stop taking this medication without consulting your doctor, even if you feel well.
Available Forms & Alternatives
Available Strengths:
- Fenofibrate 43mg Capsules
- Fenofibrate 130mg Capsules
- Fenofibrate 130mg Capsules
- Fenofibrate 43mg Capsules
- Fenofibrate 120mg Tablets
- Fenofibrate 40mg Tablets
- Fenofibrate 50mg Capsules
- Fenofibrate 120mg Tablets
- Fenofibrate 150mg Capsules
- Fenofibrate 40mg Tablets
- Fenofibrate 145mg Tablets
- Fenofibrate 48mg Tablets
- Fenofibrate 134mg Capsules
- Fenofibrate 200mg Capsules
- Fenofibrate 67mg Capsules
- Fenofibrate 160mg Tablets
- Fenofibrate 145mg Tablets
- Fenofibrate 134mg Capsules
- Fenofibrate 54mg Tablets
- Fenofibrate 200mg Capsules
- Fenofibrate 67mg Capsules
- Fenofibrate Micro 90mg Capsules
Dosing & Administration
Adult Dosing
Standard Dose:
145 mg orally once daily with meals
Dose Range:
145 - 145 mg
Condition-Specific Dosing:
hypertriglyceridemia:
145 mg orally once daily with meals
primary hypercholesterolemia or mixed dyslipidemia:
145 mg orally once daily with meals
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No dose adjustment for CrCl 50-80 mL/min for 145mg formulation.
Moderate:
Reduce dose to 48 mg or 54 mg (depending on specific formulation) once daily for CrCl 30-49 mL/min.
Severe:
Contraindicated for CrCl <30 mL/min.
Dialysis:
Contraindicated.
Hepatic Impairment:
Mild:
Not specifically studied, use with caution.
Moderate:
Not specifically studied, use with caution.
Severe:
Contraindicated in patients with active liver disease, including primary biliary cirrhosis and unexplained persistent liver function abnormalities.
Pharmacology
Mechanism of Action
Fenofibrate is a prodrug that is rapidly hydrolyzed to its active metabolite, fenofibric acid. Fenofibric acid activates peroxisome proliferator-activated receptor alpha (PPARΞ±), a nuclear receptor that regulates lipid metabolism. Through PPARΞ± activation, 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.
Pharmacokinetics
Absorption:
Bioavailability:
Variable depending on formulation (micronized vs. nanocrystallized), generally well absorbed. 145mg formulations are designed for enhanced absorption.
Tmax:
4-5 hours (for fenofibric acid)
FoodEffect:
Food enhances absorption of fenofibrate, especially for the 145mg formulation, and should be taken with meals.
Distribution:
Vd:
Approximately 30 L (for fenofibric acid)
ProteinBinding:
>99% (primarily to albumin for fenofibric acid)
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 20-23 hours (for fenofibric acid)
Clearance:
Not available (primarily renal excretion)
ExcretionRoute:
Primarily renal (60-90% as fenofibric acid and its glucuronide conjugate), approximately 25% fecal.
Unchanged:
<1% (fenofibrate)
Pharmacodynamics
OnsetOfAction:
Lipid-lowering effects typically begin within days to weeks.
PeakEffect:
Maximum therapeutic effect on lipids is usually observed within 2-4 weeks of initiating therapy.
DurationOfAction:
Effects persist as long as the drug is administered.
Safety & Warnings
Side Effects
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, redness, swelling, blistering, or peeling skin with or without fever; wheezing; tightness in the chest or throat; difficulty breathing, swallowing, or speaking; hoarseness; or swelling of the mouth, face, lips, tongue, or throat. In rare cases, allergic reactions can be life-threatening.
Liver problems: Dark urine, fatigue, decreased appetite, stomach pain or upset, light-colored stools, vomiting, or yellow skin and eyes.
Pancreatitis: Severe stomach pain, back pain, or vomiting.
Gallstones: Sudden pain in the upper right abdomen, right shoulder, or between the shoulder blades; yellow skin and eyes; or fever with chills.
Severe joint pain or swelling: Contact your doctor if you experience intense joint pain or swelling.
Blood clots: Chest pain or pressure, coughing up blood, shortness of breath, swelling, warmth, numbness, color changes, or pain in a leg or arm; or difficulty speaking or swallowing.
Muscle problems: Muscle pain or weakness, especially if accompanied by fatigue, weakness, or fever. Notify your doctor if you experience difficulty urinating or changes 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 can occur, potentially affecting internal organs and being life-threatening. Seek medical help immediately if you experience:
+ Red, swollen, blistered, or peeling skin
+ Red or irritated eyes
+ Sores in the mouth, throat, nose, eyes, genitals, or skin
+ Fever, chills, body aches, or shortness of breath
+ Swollen glands
Low blood cell counts: This can increase the risk of bleeding, infections, or anemia. Contact your doctor if you experience:
+ Signs of infection, such as fever, chills, or sore throat
+ Unexplained bruising or bleeding
+ Fatigue or weakness
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 potential side effects. If you have questions or concerns, 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.
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, redness, swelling, blistering, or peeling skin with or without fever; wheezing; tightness in the chest or throat; difficulty breathing, swallowing, or speaking; hoarseness; or swelling of the mouth, face, lips, tongue, or throat. In rare cases, allergic reactions can be life-threatening.
Liver problems: Dark urine, fatigue, decreased appetite, stomach pain or upset, light-colored stools, vomiting, or yellow skin and eyes.
Pancreatitis: Severe stomach pain, back pain, or vomiting.
Gallstones: Sudden pain in the upper right abdomen, right shoulder, or between the shoulder blades; yellow skin and eyes; or fever with chills.
Severe joint pain or swelling: Contact your doctor if you experience intense joint pain or swelling.
Blood clots: Chest pain or pressure, coughing up blood, shortness of breath, swelling, warmth, numbness, color changes, or pain in a leg or arm; or difficulty speaking or swallowing.
Muscle problems: Muscle pain or weakness, especially if accompanied by fatigue, weakness, or fever. Notify your doctor if you experience difficulty urinating or changes 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 can occur, potentially affecting internal organs and being life-threatening. Seek medical help immediately if you experience:
+ Red, swollen, blistered, or peeling skin
+ Red or irritated eyes
+ Sores in the mouth, throat, nose, eyes, genitals, or skin
+ Fever, chills, body aches, or shortness of breath
+ Swollen glands
Low blood cell counts: This can increase the risk of bleeding, infections, or anemia. Contact your doctor if you experience:
+ Signs of infection, such as fever, chills, or sore throat
+ Unexplained bruising or bleeding
+ Fatigue or weakness
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 potential side effects. If you have questions or concerns, 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.
Seek Immediate Medical Attention If You Experience:
- Unexplained muscle pain, tenderness, or weakness, especially if accompanied by fever or unusual tiredness.
- Dark-colored urine.
- Yellowing of your skin or the whites of your eyes (jaundice).
- Severe stomach pain, with or without nausea and vomiting.
- Unusual fatigue or weakness.
Before Using This Medicine
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 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 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 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.
Precautions & Cautions
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 to monitor your condition. Adhere to the diet and exercise plan recommended by your doctor to ensure optimal management of your health.
Be aware that this medication can cause liver problems, which may be severe and potentially life-threatening, requiring 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 medication, as you may be more susceptible to side effects due to your age.
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, as this will help you make an informed decision about your care.
Be aware that this medication can cause liver problems, which may be severe and potentially life-threatening, requiring 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 medication, as you may be more susceptible to side effects due to your age.
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, as this will help you make an informed decision about your care.
Overdose Information
Overdose Symptoms:
- No specific symptoms of overdose have been reported, but potential effects could include severe gastrointestinal upset, liver dysfunction, or muscle pain.
What to Do:
There is no specific antidote for fenofibrate overdose. Treatment should be symptomatic and supportive. If an overdose is suspected, contact a poison control center immediately (e.g., 1-800-222-1222 in the US) or seek emergency medical attention.
Drug Interactions
Contraindicated Interactions
- Cyclosporine (increased risk of renal dysfunction)
- Severe renal impairment (CrCl <30 mL/min)
Major Interactions
- Oral anticoagulants (e.g., Warfarin - potentiates anticoagulant effect, monitor INR closely)
- Statins (HMG-CoA reductase inhibitors - increased risk of myopathy/rhabdomyolysis, use with caution and monitor for muscle symptoms)
- Bile acid sequestrants (e.g., Cholestyramine, Colestipol - may reduce fenofibrate absorption, administer fenofibrate 1 hour before or 4-6 hours after sequestrant)
Moderate Interactions
- Colchicine (increased risk of myopathy)
- Other fibrates (e.g., Gemfibrozil - increased risk of myopathy, generally avoid co-administration)
Monitoring
Baseline Monitoring
Fasting Lipid Panel (Total Cholesterol, LDL-C, HDL-C, Triglycerides)
Rationale: To establish baseline lipid levels and assess treatment efficacy.
Timing: Prior to initiation of therapy.
Liver Function Tests (ALT, AST)
Rationale: To assess baseline liver function and monitor for drug-induced hepatotoxicity.
Timing: Prior to initiation of therapy.
Renal Function (Serum Creatinine, eGFR)
Rationale: To assess baseline renal function and guide dosing, as fenofibrate is primarily renally eliminated.
Timing: Prior to initiation of therapy.
Creatine Kinase (CK)
Rationale: To establish baseline if patient has risk factors for myopathy (e.g., history of muscle disorders, concomitant statin use).
Timing: Prior to initiation of therapy (optional, based on risk factors).
Routine Monitoring
Fasting Lipid Panel
Frequency: Every 4-8 weeks initially, then every 3-6 months once stable.
Target: Triglycerides <150 mg/dL, HDL-C >40 mg/dL (men), >50 mg/dL (women).
Action Threshold: If target lipids are not achieved or if adverse lipid changes occur, re-evaluate therapy.
Liver Function Tests (ALT, AST)
Frequency: Every 3 months for the first year, then periodically (e.g., annually) thereafter.
Target: Within normal limits.
Action Threshold: Discontinue fenofibrate if ALT or AST levels persist at >3 times the upper limit of normal (ULN).
Renal Function (Serum Creatinine, eGFR)
Frequency: Periodically, especially in elderly patients or those with pre-existing renal impairment.
Target: Stable eGFR.
Action Threshold: If a significant increase in serum creatinine or decrease in eGFR is observed, consider dose reduction or discontinuation.
Creatine Kinase (CK)
Frequency: As needed, if muscle pain, tenderness, or weakness occurs.
Target: Within normal limits.
Action Threshold: Discontinue fenofibrate if CK levels are significantly elevated (>5 times ULN) or if myopathy is diagnosed or suspected.
Symptom Monitoring
- Unexplained muscle pain, tenderness, or weakness (especially if accompanied by fever or malaise)
- Dark urine
- Yellowing of the skin or eyes (jaundice)
- Severe abdominal pain (may indicate pancreatitis or gallstones)
- Nausea
- Vomiting
- Unusual fatigue
Special Patient Groups
Pregnancy
Fenofibrate is classified as 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.
Trimester-Specific Risks:
First Trimester:
Potential for fetal harm based on animal studies, but human data are limited.
Second Trimester:
Limited human data, potential for fetal harm based on animal studies.
Third Trimester:
Limited human data, potential for fetal harm based on animal studies.
Lactation
It is not known whether fenofibric acid is excreted in human milk. Due to 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. Generally, it is advised to avoid use during breastfeeding.
Infant Risk:
L4 (Possibly Hazardous) - Unknown human data, potential for adverse effects in infant.
Pediatric Use
Safety and efficacy have not been established in pediatric patients. Use is generally not recommended.
Geriatric Use
Use with caution in elderly patients due to a higher incidence of decreased renal function. Dose adjustment based on renal function is crucial. Monitor renal function regularly.
Clinical Information
Clinical Pearls
- Fenofibrate 145mg formulations (e.g., TriCor 145mg, Lipofen 150mg) are micronized or nanocrystallized and are not bioequivalent on a milligram-for-milligram basis to older, non-micronized fenofibrate formulations (e.g., 200mg capsules). Always prescribe by specific strength and formulation.
- Always advise patients to take fenofibrate with food to optimize absorption, as food significantly increases bioavailability.
- Emphasize the importance of reporting any muscle pain, tenderness, or weakness immediately, especially if accompanied by fever or malaise, due to the risk of myopathy/rhabdomyolysis.
- Regular monitoring of liver function tests and renal function is critical throughout therapy.
- Fenofibrate is an adjunct to diet and exercise, not a substitute for lifestyle modifications.
Alternative Therapies
- Statins (HMG-CoA reductase inhibitors - primarily for LDL-C reduction)
- Omega-3 Fatty Acids (e.g., Icosapent ethyl, Omega-3-acid ethyl esters - for severe hypertriglyceridemia)
- Niacin (Nicotinic Acid - for TG and HDL-C, but with significant side effects)
- PCSK9 Inhibitors (primarily for LDL-C reduction)
- Bile Acid Sequestrants (primarily for LDL-C reduction)
Cost & Coverage
Average Cost:
$30 - $60 per 30 tablets (generic 145mg)
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (for generic formulations)
General Drug Facts
If your symptoms or health issues persist or worsen, it is 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 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.