Fenofibrate Micro 90mg Capsules
It is used to lower bad cholesterol, lower triglycerides, and raise good cholesterol (HDL).
Drug Class
Antilipemic agent, Fibrate
Pharmacologic Class
Peroxisome proliferator-activated receptor alpha (PPARΞ±) agonist
Pregnancy Category
Category C
FDA Approved
Jul 2001
DEA Schedule
Not Controlled
Overview
What is this medicine?
Fenofibrate is a medication used to help lower high levels of cholesterol and triglycerides (fats) in your blood. It works by helping your body break down and remove these fats more effectively, which can reduce your risk of heart disease and other related problems.
How to Use This Medicine
Taking Your Medication Correctly
To 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, ask your pharmacist for guidance.
If you have difficulty swallowing, consult with your doctor for advice. Take your medication with a full glass of water to help it go down smoothly.
If you're taking cholestyramine or colestipol, be sure to take them at least 4 hours before or 1 hour after your medication to avoid any interactions.
Continue taking your medication as directed by your doctor or healthcare provider, even if you start to feel better. It's essential to swallow the medication whole, without chewing, crushing, opening, or dissolving it.
Storing and Disposing of Your Medication
To maintain the quality and effectiveness of your medication, store it at room temperature with the lid tightly closed. Some brands require storage in the original container, so be sure to check with your doctor or pharmacist if you're unsure. Do not remove the anti-moisture cube or packet from the container.
What to Do If You Miss a Dose
If you miss a dose, skip it and resume your regular dosing schedule. Do not take more than one dose in a 24-hour period, unless your doctor has specifically instructed you to do so.
To 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, ask your pharmacist for guidance.
If you have difficulty swallowing, consult with your doctor for advice. Take your medication with a full glass of water to help it go down smoothly.
If you're taking cholestyramine or colestipol, be sure to take them at least 4 hours before or 1 hour after your medication to avoid any interactions.
Continue taking your medication as directed by your doctor or healthcare provider, even if you start to feel better. It's essential to swallow the medication whole, without chewing, crushing, opening, or dissolving it.
Storing and Disposing of Your Medication
To maintain the quality and effectiveness of your medication, store it at room temperature with the lid tightly closed. Some brands require storage in the original container, so be sure to check with your doctor or pharmacist if you're unsure. Do not remove the anti-moisture cube or packet from the container.
What to Do If You Miss a Dose
If you miss a dose, skip it and resume your regular dosing schedule. Do not take more than one dose in a 24-hour period, unless your doctor has specifically instructed you to do so.
Lifestyle & Tips
- Take this medication exactly as prescribed by your doctor, usually once daily with a meal.
- Continue to follow a low-fat, low-cholesterol diet as recommended by your doctor or dietitian.
- Engage in regular physical activity as advised by your healthcare provider.
- Limit alcohol intake.
- Maintain a healthy weight.
- 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:
90 mg orally once daily with meals
Dose Range:
90 - 90 mg
Condition-Specific Dosing:
hypercholesterolemia_mixed_dyslipidemia:
90 mg orally once daily with meals. Dosage should be individualized based on patient response and lipid levels.
severe_hypertriglyceridemia:
90 mg orally once daily with meals. Dosage should be individualized based on patient response and lipid levels.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established (Safety and efficacy not established in pediatric patients)
Adolescent:
Not established (Safety and efficacy not established in pediatric patients)
Dose Adjustments
Renal Impairment:
Mild:
No dosage adjustment required for CrCl 60-89 mL/min.
Moderate:
Reduce dose to 45 mg once daily for CrCl 30-59 mL/min. Monitor renal function closely.
Severe:
Contraindicated for CrCl < 30 mL/min.
Dialysis:
Contraindicated in patients with end-stage renal disease (ESRD) requiring dialysis.
Hepatic Impairment:
Mild:
Use with caution; monitor liver function tests.
Moderate:
Use with caution; monitor liver function tests. Consider lower starting dose.
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 peroxisome proliferator-activated receptor alpha (PPARΞ±) agonist. It activates PPARΞ±, which upregulates the expression of genes involved in lipid metabolism, including lipoprotein lipase (LPL) and apolipoprotein A-I (apoA-I) and A-II (apoA-II). This leads to increased catabolism of triglyceride-rich lipoproteins (VLDL) and increased synthesis of HDL-C. It also reduces the synthesis of VLDL and apoC-III.
Pharmacokinetics
Absorption:
Bioavailability:
Variable, enhanced by food. Fenofibrate is a prodrug, rapidly hydrolyzed to its active metabolite, fenofibric acid.
Tmax:
4-5 hours (for fenofibric acid)
FoodEffect:
Absorption is increased by approximately 35% when taken with food. Fenofibrate Micro formulations are designed to optimize absorption with or without food, but generally recommended with food for consistency.
Distribution:
Vd:
Not available (for fenofibric acid, approximately 30 L)
ProteinBinding:
Greater than 99% (fenofibric acid, primarily to albumin)
CnssPenetration:
Limited
Elimination:
HalfLife:
20-23 hours (for fenofibric acid)
Clearance:
Not available
ExcretionRoute:
Primarily renal (approximately 70% as fenofibric acid and its glucuronide conjugate), 25% fecal.
Unchanged:
Less than 2% (fenofibric acid in urine)
Pharmacodynamics
OnsetOfAction:
Within days to weeks for lipid-lowering effects.
PeakEffect:
Approximately 6-8 weeks for maximal lipid-lowering effects.
DurationOfAction:
Maintained with once-daily dosing due to long half-life of fenofibric acid.
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 or seek medical attention immediately:
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 trouble 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 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 severe side effects, and some may only have minor side effects. However, if you notice any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor or seek medical attention:
Headache
Back pain
Stomach pain
This is not an exhaustive list of all 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.
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 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 trouble 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 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 severe side effects, and some may only have minor side effects. However, if you notice any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor or seek medical attention:
Headache
Back pain
Stomach pain
This is not an exhaustive list of all 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.
Seek Immediate Medical Attention If You Experience:
- Unexplained muscle pain, tenderness, or weakness, especially if accompanied by fever or unusual tiredness (could be signs of muscle damage)
- Dark-colored urine
- Yellowing of the skin or eyes (jaundice)
- Severe stomach pain, with or without nausea and vomiting (could be signs of pancreatitis or gallstones)
- Unusual bleeding or bruising (if taking blood thinners like warfarin)
- Signs of liver problems (e.g., persistent nausea, vomiting, loss of appetite, dark urine, yellow eyes/skin)
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 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 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.
If you are pregnant or planning to become pregnant, notify your doctor. It is crucial to discuss the potential benefits and risks of using this medication during pregnancy to make an informed decision.
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.
If you are pregnant or planning to become pregnant, notify your doctor. It is crucial to discuss the potential benefits and risks of using this medication during pregnancy to make an informed decision.
Overdose Information
Overdose Symptoms:
- No specific symptoms of overdose have been reported, but potential effects could include exacerbation of known side effects such as muscle pain, liver enzyme elevations, or gastrointestinal disturbances.
What to Do:
In case of suspected overdose, contact a poison control center immediately (e.g., 1-800-222-1222 in the US) or seek emergency medical attention. Treatment is generally supportive and symptomatic. Hemodialysis is not effective in removing fenofibric acid.
Drug Interactions
Contraindicated Interactions
- Cyclosporine (increased risk of renal dysfunction)
- Statins (concomitant use with severe renal impairment due to increased risk of myopathy/rhabdomyolysis)
Major Interactions
- Statins (HMG-CoA reductase inhibitors - increased risk of myopathy, rhabdomyolysis, and renal failure, especially with higher doses of statins or in patients with renal impairment)
- Warfarin (potentiates anticoagulant effect, increasing risk of bleeding)
- Colchicine (increased risk of myopathy/rhabdomyolysis)
Moderate Interactions
- Bile acid sequestrants (e.g., cholestyramine, colestipol - may interfere with fenofibrate absorption; administer fenofibrate 1 hour before or 4-6 hours after sequestrant)
- Oral contraceptives (may alter lipid levels, requiring dose adjustment of fenofibrate)
- Fibrates (other fibrates - generally not recommended due to increased risk of adverse effects)
Minor Interactions
- Not available
Monitoring
Baseline Monitoring
Lipid Panel (Total Cholesterol, LDL-C, HDL-C, Triglycerides)
Rationale: To establish baseline lipid levels and assess the need for therapy.
Timing: Prior to initiation of therapy.
Liver Function Tests (ALT, AST, ALP, Bilirubin)
Rationale: To assess baseline hepatic function and rule out active liver disease.
Timing: Prior to initiation of therapy.
Renal Function (Serum Creatinine, eGFR)
Rationale: To assess baseline renal function and guide appropriate dosing.
Timing: Prior to initiation of therapy.
Complete Blood Count (CBC)
Rationale: To establish baseline and monitor for potential hematologic abnormalities.
Timing: Prior to initiation of therapy.
Routine Monitoring
Lipid Panel (Total Cholesterol, LDL-C, HDL-C, Triglycerides)
Frequency: Every 4-8 weeks initially, then every 3-6 months once stable.
Target: Individualized based on treatment goals (e.g., LDL-C < 100 mg/dL, Triglycerides < 150 mg/dL).
Action Threshold: Failure to achieve lipid goals, or significant adverse changes.
Liver Function Tests (ALT, AST)
Frequency: Every 3 months during the first year of treatment, then periodically thereafter (e.g., annually) or as clinically indicated.
Target: Within normal limits.
Action Threshold: Persistent ALT/AST > 3 times upper limit of normal (ULN) requires discontinuation. Elevations > ULN should prompt closer monitoring.
Renal Function (Serum Creatinine, eGFR)
Frequency: Periodically (e.g., annually) or as clinically indicated, especially in elderly or those with pre-existing renal impairment.
Target: Stable, within acceptable limits for age/condition.
Action Threshold: Significant increase in creatinine or decrease in eGFR requires dose adjustment or discontinuation.
Complete Blood Count (CBC)
Frequency: Periodically (e.g., annually) or as clinically indicated.
Target: Within normal limits.
Action Threshold: Significant decrease in hemoglobin, hematocrit, or white blood cell count.
Creatine Kinase (CK)
Frequency: As clinically indicated, especially if muscle pain, tenderness, or weakness occurs.
Target: Within normal limits.
Action Threshold: Significant elevation (> 5 times ULN) or symptoms of myopathy/rhabdomyolysis requires immediate discontinuation.
Symptom Monitoring
- Unexplained muscle pain, tenderness, or weakness (especially if accompanied by malaise or fever)
- Dark urine
- Yellowing of skin or eyes (jaundice)
- Severe abdominal pain
- Nausea, vomiting
- Unusual fatigue
- Swelling (edema)
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:
Limited human data. Animal studies have shown adverse effects at high doses.
Second Trimester:
Limited human data. Risk of fetal harm cannot be ruled out.
Third Trimester:
Limited human data. Risk of fetal harm cannot be ruled out.
Lactation
Fenofibric acid is excreted into the milk of lactating rats. It is unknown 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.
Infant Risk:
Risk is unknown due to lack of human data. Potential for adverse effects on infant lipid metabolism or other organ systems.
Pediatric Use
Safety and efficacy have not been established in pediatric patients. Use is generally not recommended.
Geriatric Use
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 should be cautious, generally 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.
Clinical Information
Clinical Pearls
- Always take fenofibrate with food to optimize absorption and reduce gastrointestinal upset.
- Regular monitoring of liver function tests (LFTs) and renal function is crucial, especially during the first year of therapy and in patients with pre-existing renal impairment.
- Educate patients about the signs and symptoms of myopathy (muscle pain, tenderness, weakness) and rhabdomyolysis, and advise them to report these immediately.
- Fenofibrate can potentiate the effects of warfarin; close monitoring of INR is essential when co-administered.
- While fenofibrate primarily targets triglycerides, it can also modestly lower LDL-C and raise HDL-C.
- Consider the specific formulation (e.g., micro-ionized, nanocrystallized) as they may have different dosing equivalencies and food requirements.
Alternative Therapies
- Statins (HMG-CoA reductase inhibitors - e.g., atorvastatin, rosuvastatin, simvastatin)
- Ezetimibe (cholesterol absorption inhibitor)
- PCSK9 inhibitors (e.g., evolocumab, alirocumab)
- Omega-3 fatty acid ethyl esters (e.g., icosapent ethyl, omega-3-acid ethyl esters)
- Niacin (nicotinic acid)
- Bile acid sequestrants (e.g., cholestyramine, colestipol, colesevelam)
Cost & Coverage
Average Cost:
$30 - $150 per 30 capsules (generic)
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'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 facilitate prompt and effective treatment.