Explore the essential details about fenofibrate, a medication used to manage high cholesterol levels. Discover its uses, side effects, interactions, and dosing guidelines to make informed decisions for your well-being.

Fenofibrate: A Comprehensive Overview

Fenofibrate is a prescription medication primarily used to treat high cholesterol levels, specifically severe hypertriglyceridemia (very high levels of triglycerides). It belongs to a class of drugs called fibric acid derivatives, which work by increasing the breakdown and removal of “bad” cholesterol (low-density lipoprotein or LDL) from the body. This, in turn, helps reduce the risk of cholesterol buildup in the blood vessels, potentially leading to serious health issues such as heart attack or stroke.

FDA-Approved Formulations and Brand Names

Fenofibrate is available in two forms: oral tablet and oral capsule. The oral tablet is marketed under the brand names Fenoglide, Tricor, and Triglide, and is also available as a generic drug. The availability of both brand-name and generic versions provides patients with options to find the most suitable and cost-effective treatment option.

Indications and Uses

Fenofibrate is primarily used to treat three types of cholesterol problems:

1. Mixed dyslipidemia: High levels of LDL (bad) cholesterol and triglycerides, combined with low levels of HDL (good) cholesterol.
2. Severe hypertriglyceridemia: Extremely high levels of triglycerides.
3. Primary hypercholesterolemia: Very high levels of LDL cholesterol.

By addressing these cholesterol imbalances, fenofibrate helps to improve the overall cholesterol profile and reduce the risk of cardiovascular events.

Mechanism of Action

Fenofibrate belongs to the class of fibric acid derivatives, and it works by increasing the breakdown and removal of “bad” cholesterol (LDL) from the body. This process helps to lower high levels of triglycerides and increase levels of “good” cholesterol (HDL), ultimately reducing the risk of cholesterol buildup in the blood vessels.

Potential Side Effects

Like any medication, fenofibrate can cause both mild and serious side effects. The more common side effects may include headache, back pain, nausea, indigestion, stuffy or runny nose, and stomach pain. These mild side effects may subside within a few days or a couple of weeks.

However, fenofibrate can also lead to more serious side effects, such as liver problems, severe allergic reactions, and severe muscle problems (including myopathy and rhabdomyolysis). If you experience any of these serious side effects, it is crucial to contact your doctor immediately or seek emergency medical attention.

Dosage and Administration

Fenofibrate is typically taken once daily, with or without food. The recommended dosage may vary based on the specific condition being treated, the patient’s response to the medication, and any other underlying medical conditions. It is essential to follow the instructions provided by your healthcare provider and to not exceed the prescribed dosage.

Interactions and Precautions

Fenofibrate may interact with other medications, including certain cholesterol-lowering drugs (statins), anticoagulants, and some diabetes medications. It is crucial to inform your healthcare provider about all the medications, supplements, and herbal products you are currently taking to ensure safe and effective use of fenofibrate.

Additionally, certain medical conditions, such as liver or kidney problems, may require adjustments to the fenofibrate dosage or close monitoring by your healthcare provider. It is essential to discuss your medical history and any existing conditions with your doctor before starting this medication.

Key Takeaways

Fenofibrate is a versatile medication used to manage various cholesterol imbalances, including severe hypertriglyceridemia, mixed dyslipidemia, and primary hypercholesterolemia. By understanding its uses, side effects, dosing, and potential interactions, patients can work closely with their healthcare providers to optimize their treatment and achieve the desired cholesterol management goals.

Side Effects, Dosage, Uses, and More

Highlights for fenofibrate

1. Fenofibrate oral tablet is available as brand-name drugs and as a generic drug. Brand names: Fenoglide, Tricor, and Triglide.
2. Fenofibrate comes in two forms: oral tablet and oral capsule.
3. Fenofibrate oral tablet is used to treat high cholesterol levels. It’s mainly used to treat severe high triglycerides (a type of bad cholesterol).

Serious liver damage warning: Fenofibrate can cause serious liver damage. This can occur within the first few weeks of treatment or after several months of treatment. It can require a liver transplant and may be life threatening. Symptoms of liver damage include dark urine, an upset stomach or stomach pain, muscle pain, feeling tired, or yellowing of your skin or eyes. Contact your doctor immediately if you experience any of these symptoms.

Severe allergic reaction warning: Fenofibrate can cause severe allergic reactions. These can include anaphylaxis and angioedema (swelling), and can be life threatening. Some reactions can occur days or weeks after starting this drug. Among the possible reactions are Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms, an issue that is called DRESS. Call 911 or go to the emergency room right away if you have a rash, swelling of your face, tongue, or throat, or trouble breathing.

Severe muscle problems warning: This medication can cause severe muscle problems, including myopathy, which can cause muscle pain, tenderness, or weakness. Myopathy can also lead to rhabdomyolysis. This condition causes muscle to break down, and it can cause kidney damage and even death. If you notice unusual pain or weakness in your muscles, call your doctor right away, especially if you feel more tired than usual or have a fever. Your doctor may decide to stop your treatment with this medication. Call your doctor right away if muscle problems last after you have stopped taking this drug.

Fenofibrate is a prescription drug. It comes in two forms: oral tablet and oral capsule.

The oral tablet is available as the brand-name drugs Fenoglide, Tricor, and Triglide. It’s also available as a generic drug. Generic drugs usually cost less than the brand-name version. In some cases, they may not be available in every strength or form as the brand-name drug.

Fenofibrate may be used as part of a combination therapy. This means you may need to take it with other cholesterol drugs, such as statins.

Why it’s used

Fenofibrate is used to improve cholesterol levels in three types of cholesterol problems:

• Mixed dyslipidemia: high levels of LDL (bad) cholesterol and triglycerides, and low levels of HDL (good) cholesterol
• Severe hypertriglyceridemia: very high levels of triglycerides
• Primary hypercholesterolemia: very high levels of LDL cholesterol

Fenofibrate helps lower high levels of harmful cholesterol, mainly triglycerides. It also helps increase levels of HDL (good) cholesterol.

How it works

Fenofibrate belongs to a class of drugs called fibric acid derivatives. A class of drugs is a group of medications that work in a similar way. These drugs are often used to treat similar conditions.

Fenofibrate works by increasing the breakdown and removal of bad cholesterol from your body. This helps reduce the risk of cholesterol building up in your blood vessels and causing serious health problems, such as heart attack or stroke.

Fenofibrate oral tablet can cause mild or serious side effects. The following list contains some of the key side effects that may occur while taking fenofibrate. This list does not include all possible side effects.

For more information on the possible side effects of fenofibrate, or tips on how to deal with a troubling side effect, talk with your doctor or pharmacist.

More common side effects

The more common side effects that can occur with use of fenofibrate include:

• headache
• back pain
• nausea
• indigestion
• stuffy or runny nose
• stomach pain

If these effects are mild, they may go away within a few days or a couple of weeks. If they’re more severe or don’t go away, talk to your doctor or pharmacist.

Serious side effects

Call your doctor right away if you have serious side effects. Call 911 if your symptoms feel life-threatening or if you think you’re having a medical emergency. Serious side effects and their symptoms can include the following:

• Liver problems. Symptoms can include:
  • yellowing of your skin or the whites of your eyes
  • dark-colored urine
  • pain in the abdomen (stomach area)
  • decreased appetite
  • unexplained or unusual weakness
• Severe allergic reactions. Symptoms can include:
  • swelling of the face, eyes, lips, tongue, hands, arms, feet, ankles, or lower legs
  • trouble breathing or swallowing
  • rash
  • peeling or blistering skin

Fenofibrate oral tablet can interact with several other medications. Different interactions can cause different effects. For instance, some can interfere with how well a drug works, while others can cause increased side effects.

Below is a list of medications that can interact with fenofibrate. This list does not contain all drugs that may interact with fenofibrate.

Before taking fenofibrate, be sure to tell your doctor and pharmacist about all prescription, over-the-counter, and other drugs you take. Also tell them about any vitamins, herbs, and supplements you use. Sharing this information can help you avoid potential interactions.

If you have questions about drug interactions that may affect you, ask your doctor or pharmacist.

Blood-thinning drug

Warfarin is a drug that’s used to thin the blood. Taking it with fenofibrate raises your risk of bleeding. If you take these drugs together, your doctor may do blood tests more often or change your dosage of warfarin.

Cholesterol drugs

Taking fenofibrate with certain cholesterol drugs called bile acid sequestrants may make it harder for your body to absorb fenofibrate. To prevent this, you should take fenofibrate 1 hour before taking the bile acid sequestrant, or 4–6 hours after taking it. Examples of bile acid sequestrants include:

• cholestyramine
• colesevelam
• colestipol

Also, taking fenofibrate with cholesterol drugs called statins raises your risk of rhabdomyolysis. This is a serious condition that breaks down muscle. Examples of statin drugs include:

• atorvastatin
• fluvastatin
• lovastatin
• pitavastatin
• pravastatin
• rosuvastatin
• simvastatin

Diabetes drugs

Taking fenofibrate with certain diabetes drugs called sulfonylureas raises your risk of low blood sugar. Examples of these drugs include:

• glimepiride
• glipizide
• glyburide

Gout drug

Colchicine is a drug used to treat gout. Taking it with fenofibrate raises your risk of muscle pain.

Immunosuppressants

Taking fenofibrate with certain drugs that suppress your body’s immune response can increase the level of fenofibrate in your body. This raises your risk of side effects from fenofibrate. Examples of these drugs include:

• cyclosporine
• tacrolimus

The fenofibrate dosage your doctor prescribes will depend on several factors. These include:

• the type and severity of the condition you’re using fenofibrate to treat
• your age
• the form of fenofibrate you take
• other medical conditions you may have

Typically, your doctor will start you on a low dosage and adjust it over time to reach the dosage that’s right for you. They’ll ultimately prescribe the smallest dosage that provides the desired effect.

The following information describes dosages that are commonly used or recommended. However, be sure to take the dosage your doctor prescribes for you. Your doctor will determine the best dosage to suit your needs.

Drug forms and strengths

Generic: Fenofibrate

• Form: oral tablet
• Strengths: 40 mg, 48 mg, 54 mg, 107 mg, 120 mg, 145 mg, 160 mg

Brand: Fenoglide

• Form: oral tablet
• Strengths: 40 mg, 120 mg

Brand: Tricor

• Form: oral tablet
• Strengths: 48 mg, 145 mg

Brand: Triglide

• Form: oral tablet
• Strength: 160 mg

Dosage for primary hypercholesterolemia and mixed dyslipidemia

Adult dosage (ages 18 years and older)

Brand-name drugs

• Fenoglide: 120 mg per day.
• Tricor: 145 mg per day.
• Triglide: 160 mg per day.

Generic drug

• Fenofibrate: 120–160 mg per day, depending on the generic product prescribed.

Child dosage (ages 0–17 years)

This medication has not been studied in children. It should not be used in people younger than 18 years.

Senior dosage (ages 65 years and older)

The kidneys of older adults may not work as well as they used to. This can cause your body to process drugs, including fenofibrate, more slowly. As a result, a higher amount of a drug stays in your body for a longer time. This increases your risk of side effects.

Your doctor may start you on a lowered dosage or a different dosing schedule. This can help keep levels of this drug from building up too much in your body.

Dosage for severe hypertriglyceridemia

Adult dosage (ages 18 years and older)

Brand-name drugs:

• Fenoglide: 40–120 mg per day.
• Tricor: 48–145 mg per day.
• Triglide: 160 mg per day.

Generic drug

• Fenofibrate: 40–120 mg per day or 48–160 mg per day, depending on the generic product prescribed.

Child dosage (ages 0–17 years)

This medication has not been studied in children. It should not be used in people younger than 18 years.

Senior dosage (ages 65 years and older)

The kidneys of older adults may not work as well as they used to. This can cause your body to process drugs, including fenofibrate, more slowly. As a result, a higher amount of a drug stays in your body for a longer time. This increases your risk of side effects.

Your doctor may start you on a lowered dosage or a different dosing schedule. This can help keep levels of this drug from building up too much in your body.

Special dosage considerations

For people with kidney disease: If you have mild kidney disease, you may need a lower dose of fenofibrate.

This drug comes with several warnings.

Muscle pain warning

This drug raises your risk of muscle pain and a serious muscle problem called rhabdomyolysis. The risk is higher if you take the drug along with statins.

Liver damage warning

Fenofibrate can cause abnormal results in tests of liver function. These abnormal results can indicate liver damage. This drug can also cause other liver damage and inflammation after years of use.

Gallstones warning

Fenofibrate raises your risk of gallstones.

Pancreatitis warning

Fenofibrate raises your risk of pancreatitis (inflammation of the pancreas).

Severe allergic reaction warning

Fenofibrate can cause severe allergic reactions. These can include anaphylaxis and angioedema (swelling), and can be life-threatening. Some reactions can occur days or weeks after starting this drug. These include Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms. This last type of reaction is often called DRESS.

Symptoms of a severe reaction can include:

• rash, especially if it appears suddenly
• peeling or blistering skin
• nausea and vomiting
• trouble breathing
• itching
• hives

If you develop these symptoms, call 911 or go to the nearest emergency room.

Don’t take this drug again if you’ve ever had an allergic reaction to it. Taking it again could be fatal (cause death).

Warnings for people with certain health conditions

For people with liver disease: Fenofibrate can cause liver problems, which could lead to liver failure. Let your doctor know if you have a history of liver disease. Your doctor can tell you if fenofibrate is safe for you. If you have active liver disease, you should not take fenofibrate.

For people with kidney disease: Fenofibrate may cause abnormal results from tests of kidney function. These changes are typically temporary and not harmful. To be safe, your doctor may monitor your kidney function more often. If you have severe kidney disease, you should not take fenofibrate.

Warnings for other groups

For pregnant women: There haven’t been enough studies done in humans to show if fenofibrate poses a risk to a human fetus. Research in animals has shown a risk to the fetus when the mother takes the drug. However, animal studies don’t always predict the way humans would respond.

Talk with your doctor if you’re pregnant or planning to become pregnant. This drug should be used only if the potential benefit justifies the potential risk.

If you become pregnant while taking this drug, call your doctor right away.

For women who are breastfeeding: Fenofibrate may pass into breast milk and cause side effects in a child who is breastfed. Talk with your doctor if you breastfeed your child. You may need to decide whether to stop breastfeeding or stop taking this medication.

Fenofibrate oral tablet is used for long-term treatment. It comes with risks if you don’t take it as prescribed.

If you stop taking the drug suddenly or don’t take it at all: Your cholesterol levels may not be controlled. This raises your risk of serious health problems such as heart disease, heart attack, or stroke.

If you miss doses or don’t take the drug on schedule: Your medication may not work as well or may stop working completely. For this drug to work well, a certain amount needs to be in your body at all times.

If you take too much: You could have dangerous levels of the drug in your body. Symptoms of an overdose of this drug can include:

• headache
• back pain
• nausea
• muscle pain
• diarrhea
• common cold
• upper respiratory tract infection

If you think you’ve taken too much of the drug, call your doctor or local poison control center. If your symptoms are severe, call 911 or go to the nearest emergency room.

What to do if you miss a dose: Take your dose as soon as you remember. But if you remember just a few hours before your next scheduled dose, take only one dose. Never try to catch up by taking two doses at once. This could result in dangerous side effects.

How to tell if the drug is working: Your cholesterol levels should improve. You won’t feel fenofibrate working, but your doctor will check your cholesterol levels using blood tests. Your doctor may adjust your dosage based on the results of these tests.

Keep these considerations in mind if your doctor prescribes fenofibrate for you.

General

• Fenofibrate tablets should be taken with food. This can help increase the amount of drug your body absorbs.
• Take this drug at the time(s) recommended by your doctor.
• Don’t cut or crush the tablets.

Storage

• Store Fenoglide and Tricor tablets at room temperature between 59°F and 86°F (15°C and 30°C).
• Store generic fenofibrate tablets and Triglide tablets between 68°F and 77°F (20°C and 25°C).
• Don’t store these medications in moist or damp areas, such as bathrooms.
• Keep Triglide in its moisture-protective container until you’re ready to take it.

Refills

A prescription for this medication is refillable. You should not need a new prescription for this medication to be refilled. Your doctor will write the number of refills authorized on your prescription.

Travel

When traveling with your medication:

• Always carry your medication with you. When flying, never put it into a checked bag. Keep it in your carry-on bag.
• Don’t worry about airport X-ray machines. They can’t harm your medication.
• You may need to show airport staff the pharmacy label for your medication. Always carry the original prescription-labeled container with you.
• Don’t put this medication in your car’s glove compartment or leave it in the car. Be sure to avoid doing this when the weather is very hot or very cold.

Clinical monitoring

Your doctor will monitor your health during your treatment with this drug. They’ll do blood tests to help make sure your cholesterol levels are within the range your doctor feels is best for you. The tests will also tell if your medication is working.

Also, your doctor will likely monitor certain health issues. This can help make sure you stay safe while taking this drug. These issues include:

• Kidney function. Blood tests can check how well your kidneys are working. If your kidneys aren’t working well, your doctor may lower your dosage of this drug.
• Liver function. Blood tests can check how well your liver is working. If your tests are abnormal, it may mean that fenofibrate is causing damage to your liver. Your doctor may switch you to a different medication.
• Lipid levels. Blood tests can check how well this drug is lowering your cholesterol and triglycerides. Your doctor may change your therapy based upon these results.

Your diet

In addition to taking this drug, you should follow a heart-healthy diet to help control your cholesterol levels. Talk with your doctor about a diet plan that’s right for you.

Availability

Not every pharmacy stocks this drug. When filling your prescription, be sure to call ahead to make sure your pharmacy carries it.

Prior authorization

Many insurance companies require a prior authorization for this drug. This means your doctor will need to get approval from your insurance company before your insurance company will pay for the prescription.

There are other drugs available to treat your condition. Some may be better suited for you than others. Talk to your doctor about other drug options that may work for you.

Disclaimer: Healthline has made every effort to make certain that all information is factually correct, comprehensive, and up-to-date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or other healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.

Side Effects, Dosage, Uses, and More

Highlights for fenofibrate

1. Fenofibrate oral tablet is available as brand-name drugs and as a generic drug. Brand names: Fenoglide, Tricor, and Triglide.
2. Fenofibrate comes in two forms: oral tablet and oral capsule.
3. Fenofibrate oral tablet is used to treat high cholesterol levels. It’s mainly used to treat severe high triglycerides (a type of bad cholesterol).

Serious liver damage warning: Fenofibrate can cause serious liver damage. This can occur within the first few weeks of treatment or after several months of treatment. It can require a liver transplant and may be life threatening. Symptoms of liver damage include dark urine, an upset stomach or stomach pain, muscle pain, feeling tired, or yellowing of your skin or eyes. Contact your doctor immediately if you experience any of these symptoms.

Severe allergic reaction warning: Fenofibrate can cause severe allergic reactions. These can include anaphylaxis and angioedema (swelling), and can be life threatening. Some reactions can occur days or weeks after starting this drug. Among the possible reactions are Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms, an issue that is called DRESS. Call 911 or go to the emergency room right away if you have a rash, swelling of your face, tongue, or throat, or trouble breathing.

Severe muscle problems warning: This medication can cause severe muscle problems, including myopathy, which can cause muscle pain, tenderness, or weakness. Myopathy can also lead to rhabdomyolysis. This condition causes muscle to break down, and it can cause kidney damage and even death. If you notice unusual pain or weakness in your muscles, call your doctor right away, especially if you feel more tired than usual or have a fever. Your doctor may decide to stop your treatment with this medication. Call your doctor right away if muscle problems last after you have stopped taking this drug.

Fenofibrate is a prescription drug. It comes in two forms: oral tablet and oral capsule.

The oral tablet is available as the brand-name drugs Fenoglide, Tricor, and Triglide. It’s also available as a generic drug. Generic drugs usually cost less than the brand-name version. In some cases, they may not be available in every strength or form as the brand-name drug.

Fenofibrate may be used as part of a combination therapy. This means you may need to take it with other cholesterol drugs, such as statins.

Why it’s used

Fenofibrate is used to improve cholesterol levels in three types of cholesterol problems:

• Mixed dyslipidemia: high levels of LDL (bad) cholesterol and triglycerides, and low levels of HDL (good) cholesterol
• Severe hypertriglyceridemia: very high levels of triglycerides
• Primary hypercholesterolemia: very high levels of LDL cholesterol

Fenofibrate helps lower high levels of harmful cholesterol, mainly triglycerides. It also helps increase levels of HDL (good) cholesterol.

How it works

Fenofibrate belongs to a class of drugs called fibric acid derivatives. A class of drugs is a group of medications that work in a similar way. These drugs are often used to treat similar conditions.

Fenofibrate works by increasing the breakdown and removal of bad cholesterol from your body. This helps reduce the risk of cholesterol building up in your blood vessels and causing serious health problems, such as heart attack or stroke.

Fenofibrate oral tablet can cause mild or serious side effects. The following list contains some of the key side effects that may occur while taking fenofibrate. This list does not include all possible side effects.

For more information on the possible side effects of fenofibrate, or tips on how to deal with a troubling side effect, talk with your doctor or pharmacist.

More common side effects

The more common side effects that can occur with use of fenofibrate include:

• headache
• back pain
• nausea
• indigestion
• stuffy or runny nose
• stomach pain

If these effects are mild, they may go away within a few days or a couple of weeks. If they’re more severe or don’t go away, talk to your doctor or pharmacist.

Serious side effects

Call your doctor right away if you have serious side effects. Call 911 if your symptoms feel life-threatening or if you think you’re having a medical emergency. Serious side effects and their symptoms can include the following:

• Liver problems. Symptoms can include:
  • yellowing of your skin or the whites of your eyes
  • dark-colored urine
  • pain in the abdomen (stomach area)
  • decreased appetite
  • unexplained or unusual weakness
• Severe allergic reactions. Symptoms can include:
  • swelling of the face, eyes, lips, tongue, hands, arms, feet, ankles, or lower legs
  • trouble breathing or swallowing
  • rash
  • peeling or blistering skin

Fenofibrate oral tablet can interact with several other medications. Different interactions can cause different effects. For instance, some can interfere with how well a drug works, while others can cause increased side effects.

Below is a list of medications that can interact with fenofibrate. This list does not contain all drugs that may interact with fenofibrate.

Before taking fenofibrate, be sure to tell your doctor and pharmacist about all prescription, over-the-counter, and other drugs you take. Also tell them about any vitamins, herbs, and supplements you use. Sharing this information can help you avoid potential interactions.

If you have questions about drug interactions that may affect you, ask your doctor or pharmacist.

Blood-thinning drug

Warfarin is a drug that’s used to thin the blood. Taking it with fenofibrate raises your risk of bleeding. If you take these drugs together, your doctor may do blood tests more often or change your dosage of warfarin.

Cholesterol drugs

Taking fenofibrate with certain cholesterol drugs called bile acid sequestrants may make it harder for your body to absorb fenofibrate. To prevent this, you should take fenofibrate 1 hour before taking the bile acid sequestrant, or 4–6 hours after taking it. Examples of bile acid sequestrants include:

• cholestyramine
• colesevelam
• colestipol

Also, taking fenofibrate with cholesterol drugs called statins raises your risk of rhabdomyolysis. This is a serious condition that breaks down muscle. Examples of statin drugs include:

• atorvastatin
• fluvastatin
• lovastatin
• pitavastatin
• pravastatin
• rosuvastatin
• simvastatin

Diabetes drugs

Taking fenofibrate with certain diabetes drugs called sulfonylureas raises your risk of low blood sugar. Examples of these drugs include:

• glimepiride
• glipizide
• glyburide

Gout drug

Colchicine is a drug used to treat gout. Taking it with fenofibrate raises your risk of muscle pain.

Immunosuppressants

Taking fenofibrate with certain drugs that suppress your body’s immune response can increase the level of fenofibrate in your body. This raises your risk of side effects from fenofibrate. Examples of these drugs include:

• cyclosporine
• tacrolimus

The fenofibrate dosage your doctor prescribes will depend on several factors. These include:

• the type and severity of the condition you’re using fenofibrate to treat
• your age
• the form of fenofibrate you take
• other medical conditions you may have

Typically, your doctor will start you on a low dosage and adjust it over time to reach the dosage that’s right for you. They’ll ultimately prescribe the smallest dosage that provides the desired effect.

The following information describes dosages that are commonly used or recommended. However, be sure to take the dosage your doctor prescribes for you. Your doctor will determine the best dosage to suit your needs.

Drug forms and strengths

Generic: Fenofibrate

• Form: oral tablet
• Strengths: 40 mg, 48 mg, 54 mg, 107 mg, 120 mg, 145 mg, 160 mg

Brand: Fenoglide

• Form: oral tablet
• Strengths: 40 mg, 120 mg

Brand: Tricor

• Form: oral tablet
• Strengths: 48 mg, 145 mg

Brand: Triglide

• Form: oral tablet
• Strength: 160 mg

Dosage for primary hypercholesterolemia and mixed dyslipidemia

Adult dosage (ages 18 years and older)

Brand-name drugs

• Fenoglide: 120 mg per day.
• Tricor: 145 mg per day.
• Triglide: 160 mg per day.

Generic drug

• Fenofibrate: 120–160 mg per day, depending on the generic product prescribed.

Child dosage (ages 0–17 years)

This medication has not been studied in children. It should not be used in people younger than 18 years.

Senior dosage (ages 65 years and older)

The kidneys of older adults may not work as well as they used to. This can cause your body to process drugs, including fenofibrate, more slowly. As a result, a higher amount of a drug stays in your body for a longer time. This increases your risk of side effects.

Your doctor may start you on a lowered dosage or a different dosing schedule. This can help keep levels of this drug from building up too much in your body.

Dosage for severe hypertriglyceridemia

Adult dosage (ages 18 years and older)

Brand-name drugs:

• Fenoglide: 40–120 mg per day.
• Tricor: 48–145 mg per day.
• Triglide: 160 mg per day.

Generic drug

• Fenofibrate: 40–120 mg per day or 48–160 mg per day, depending on the generic product prescribed.

Child dosage (ages 0–17 years)

This medication has not been studied in children. It should not be used in people younger than 18 years.

Senior dosage (ages 65 years and older)

The kidneys of older adults may not work as well as they used to. This can cause your body to process drugs, including fenofibrate, more slowly. As a result, a higher amount of a drug stays in your body for a longer time. This increases your risk of side effects.

Your doctor may start you on a lowered dosage or a different dosing schedule. This can help keep levels of this drug from building up too much in your body.

Special dosage considerations

For people with kidney disease: If you have mild kidney disease, you may need a lower dose of fenofibrate.

This drug comes with several warnings.

Muscle pain warning

This drug raises your risk of muscle pain and a serious muscle problem called rhabdomyolysis. The risk is higher if you take the drug along with statins.

Liver damage warning

Fenofibrate can cause abnormal results in tests of liver function. These abnormal results can indicate liver damage. This drug can also cause other liver damage and inflammation after years of use.

Gallstones warning

Fenofibrate raises your risk of gallstones.

Pancreatitis warning

Fenofibrate raises your risk of pancreatitis (inflammation of the pancreas).

Severe allergic reaction warning

Fenofibrate can cause severe allergic reactions. These can include anaphylaxis and angioedema (swelling), and can be life-threatening. Some reactions can occur days or weeks after starting this drug. These include Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms. This last type of reaction is often called DRESS.

Symptoms of a severe reaction can include:

• rash, especially if it appears suddenly
• peeling or blistering skin
• nausea and vomiting
• trouble breathing
• itching
• hives

If you develop these symptoms, call 911 or go to the nearest emergency room.

Don’t take this drug again if you’ve ever had an allergic reaction to it. Taking it again could be fatal (cause death).

Warnings for people with certain health conditions

For people with liver disease: Fenofibrate can cause liver problems, which could lead to liver failure. Let your doctor know if you have a history of liver disease. Your doctor can tell you if fenofibrate is safe for you. If you have active liver disease, you should not take fenofibrate.

For people with kidney disease: Fenofibrate may cause abnormal results from tests of kidney function. These changes are typically temporary and not harmful. To be safe, your doctor may monitor your kidney function more often. If you have severe kidney disease, you should not take fenofibrate.

Warnings for other groups

For pregnant women: There haven’t been enough studies done in humans to show if fenofibrate poses a risk to a human fetus. Research in animals has shown a risk to the fetus when the mother takes the drug. However, animal studies don’t always predict the way humans would respond.

Talk with your doctor if you’re pregnant or planning to become pregnant. This drug should be used only if the potential benefit justifies the potential risk.

If you become pregnant while taking this drug, call your doctor right away.

For women who are breastfeeding: Fenofibrate may pass into breast milk and cause side effects in a child who is breastfed. Talk with your doctor if you breastfeed your child. You may need to decide whether to stop breastfeeding or stop taking this medication.

Fenofibrate oral tablet is used for long-term treatment. It comes with risks if you don’t take it as prescribed.

If you stop taking the drug suddenly or don’t take it at all: Your cholesterol levels may not be controlled. This raises your risk of serious health problems such as heart disease, heart attack, or stroke.

If you miss doses or don’t take the drug on schedule: Your medication may not work as well or may stop working completely. For this drug to work well, a certain amount needs to be in your body at all times.

If you take too much: You could have dangerous levels of the drug in your body. Symptoms of an overdose of this drug can include:

• headache
• back pain
• nausea
• muscle pain
• diarrhea
• common cold
• upper respiratory tract infection

If you think you’ve taken too much of the drug, call your doctor or local poison control center. If your symptoms are severe, call 911 or go to the nearest emergency room.

What to do if you miss a dose: Take your dose as soon as you remember. But if you remember just a few hours before your next scheduled dose, take only one dose. Never try to catch up by taking two doses at once. This could result in dangerous side effects.

How to tell if the drug is working: Your cholesterol levels should improve. You won’t feel fenofibrate working, but your doctor will check your cholesterol levels using blood tests. Your doctor may adjust your dosage based on the results of these tests.

Keep these considerations in mind if your doctor prescribes fenofibrate for you.

General

• Fenofibrate tablets should be taken with food. This can help increase the amount of drug your body absorbs.
• Take this drug at the time(s) recommended by your doctor.
• Don’t cut or crush the tablets.

Storage

• Store Fenoglide and Tricor tablets at room temperature between 59°F and 86°F (15°C and 30°C).
• Store generic fenofibrate tablets and Triglide tablets between 68°F and 77°F (20°C and 25°C).
• Don’t store these medications in moist or damp areas, such as bathrooms.
• Keep Triglide in its moisture-protective container until you’re ready to take it.

Refills

A prescription for this medication is refillable. You should not need a new prescription for this medication to be refilled. Your doctor will write the number of refills authorized on your prescription.

Travel

When traveling with your medication:

• Always carry your medication with you. When flying, never put it into a checked bag. Keep it in your carry-on bag.
• Don’t worry about airport X-ray machines. They can’t harm your medication.
• You may need to show airport staff the pharmacy label for your medication. Always carry the original prescription-labeled container with you.
• Don’t put this medication in your car’s glove compartment or leave it in the car. Be sure to avoid doing this when the weather is very hot or very cold.

Clinical monitoring

Your doctor will monitor your health during your treatment with this drug. They’ll do blood tests to help make sure your cholesterol levels are within the range your doctor feels is best for you. The tests will also tell if your medication is working.

Also, your doctor will likely monitor certain health issues. This can help make sure you stay safe while taking this drug. These issues include:

• Kidney function. Blood tests can check how well your kidneys are working. If your kidneys aren’t working well, your doctor may lower your dosage of this drug.
• Liver function. Blood tests can check how well your liver is working. If your tests are abnormal, it may mean that fenofibrate is causing damage to your liver. Your doctor may switch you to a different medication.
• Lipid levels. Blood tests can check how well this drug is lowering your cholesterol and triglycerides. Your doctor may change your therapy based upon these results.

Your diet

In addition to taking this drug, you should follow a heart-healthy diet to help control your cholesterol levels. Talk with your doctor about a diet plan that’s right for you.

Availability

Not every pharmacy stocks this drug. When filling your prescription, be sure to call ahead to make sure your pharmacy carries it.

Prior authorization

Many insurance companies require a prior authorization for this drug. This means your doctor will need to get approval from your insurance company before your insurance company will pay for the prescription.

There are other drugs available to treat your condition. Some may be better suited for you than others. Talk to your doctor about other drug options that may work for you.

Disclaimer: Healthline has made every effort to make certain that all information is factually correct, comprehensive, and up-to-date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or other healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.

Fenofibrate – description of the substance, pharmacology, use, contraindications, formula

Contents

• Structural formula

• Russian name

• English name

• Latin name

• chemical name

• Gross formula

• Pharmacological group of the substance Fenofibrate

• Nosological classification

• CAS code

• pharmachologic effect

• Characteristic

• Pharmacology

• The use of the substance Fenofibrate

• Contraindications

• Application restrictions

• Use during pregnancy and lactation

• Side effects of Fenofibrate

• Interaction

• Overdose

• Dosage and administration

• Precautionary measures

• Trade names with the active substance Fenofibrate

Structural formula

Russian name

Fenofibrate

English name

Fenofibrate

Latin name

Fenofibratum ( born Fenofibrati)

Chemical name

2-[4-(4-Chlorobenzoyl)phenoxy]-2-methylpropanoic acid 1-methylethyl ester

General formula

C ₂₀ H 9007 3 21 ClO ₄

Pharmacological group of the substance Fenofibrate

Fibrates

Nosological classification

List of ICD-10 codes

CAS code

49562-28-9

Pharmacological action

Pharmacological action –

antiplatelet , hypolipidemic , uricosuric .

Description

Lipid-lowering agent.

White, practically insoluble in water; soluble in acetone, ether, benzene, chloroform. Molecular weight 360.83.

Pharmacology

By activating PPARα receptors (peroxisome proliferator-activated alpha receptors), fenofibric acid (the active metabolite of fenofibrate) enhances lipolysis and plasma clearance of atherogenic high triglyceride lipoproteins by activating lipoprotein lipase and reducing the synthesis of apolipoprotein CIII. Activation of PPARα also leads to increased synthesis of apolipoproteins AI and AII.

The effects on lipoproteins described above lead to a decrease in the content of the LDL and VLDL fraction, which include apolipoprotein B, and an increase in the content of the HDL fraction, which include apolipoproteins AI and AII.

By correcting impaired VLDL synthesis and catabolism, fenofibrate increases LDL clearance and reduces the content of dense and small LDL particles, which increase in patients with an atherogenic lipid phenotype (a common disorder in patients at risk of coronary artery disease).

In clinical studies, fenofibrate has been shown to reduce total cholesterol by 20-25% and triglycerides by 40-55% while increasing HDL-cholesterol by 10-30%. In patients with hypercholesterolemia, in whom LDL-cholesterol levels decreased by 20-35%, the use of fenofibrate led to a decrease in the ratios: “total cholesterol / HDL-cholesterol”, “LDL-cholesterol / HDL-cholesterol” and “Apo B / Apo AI ”, which are markers of atherogenic risk.

Given the effect on LDL-cholesterol and triglycerides, the use of fenofibrate is effective in patients with hypercholesterolemia, both accompanied and not accompanied by hypertriglyceridemia, including secondary hyperlipoproteinemia, incl. in type 2 diabetes mellitus. In addition, it reduces elevated plasma levels of fibrinogen and uric acid; with long-term therapy reduces extravascular cholesterol deposits.

After oral administration, fenofibrate is rapidly hydrolyzed by esterases. In plasma, only the main active metabolite of fenofibrate is found – fenofibric acid, T _max of which in plasma is reached within 2-3 hours. The binding of fenofibric acid to plasma proteins is about 99%, ss “> C _ss is achieved within 1 week Fenofibrate and fenofibric acid do not undergo oxidative metabolism with the participation of cytochrome P450. 1/2 “> T _1/2 fenofibric acid – approximately 20 hours. Excreted mainly by the kidneys (fenofibric acid and its glucuronide). Does not accumulate.

The clearance of fenofibric acid after a single dose of fenofibrate orally does not change depending on age and is 1.2 l/h in elderly patients (77–87 years), and 1.1 l/h in young patients.

In patients with severe renal insufficiency (Cl creatinine <30 ml / min), the exposure of fenofibric acid is increased by 2.7 times and cumulation is observed with repeated administration. In case of impaired renal function of mild and moderate severity (Cl creatinine 30–80 ml / min), 1/2 "> T 9 increases0073 1/2 fenofibric acid.

Two different formulations of fenofibrate, “micronized” and “non-micronized”, were compared in clinical studies. Comparison of blood samples from healthy volunteers after ingestion of these forms showed that 67 mg of the “micronized” form is bioequivalent to 100 mg of the “non-micronized” form.

Application of the substance Fenofibrate

Hyperlipidemia type IIa, IV and V types, as well as type IIb and III with insufficient dietary efficacy, elevated blood cholesterol levels during dynamic examination and / or the presence of concomitant risk factors.

Contraindications

Hypersensitivity, liver failure (including biliary cirrhosis), severe renal failure (Cl creatinine <30 ml / min), gallbladder disease, photosensitivity or phototoxicity with treatment with fibrates or ketoprofen in history, age up to 18 years (adequate and good controlled studies have not been conducted).

Restrictions on use

Hepatic and/or renal insufficiency, hypothyroidism, alcoholism, old age, history of hereditary muscle diseases, concomitant use of oral anticoagulants, HMG-CoA reductase inhibitors.

Pregnancy and lactation

Possible during pregnancy if the expected effect of therapy outweighs the potential risk to the fetus.

FDA Fetal Category C.

Stop breastfeeding during treatment.

Side effects of the substance Fenofibrate

From the side of the nervous system and sensory organs: dizziness, headache, fatigue.

From the side of the cardiovascular system and blood (hematopoiesis, hemostasis): venous thromboembolism (pulmonary embolism, deep vein thrombosis), increased hemoglobin levels, leukocytosis.

From the digestive tract: abdominal pain, nausea, vomiting, diarrhea, flatulence, pancreatitis, cholelithiasis, increased levels of hepatic transaminases and creatine phosphokinase, hepatitis.

From the genitourinary system: acute renal failure, sexual dysfunction.

Musculoskeletal side: myalgia, myositis, muscle spasm, muscle weakness, rhabdomyolysis.

Allergic reactions: skin rashes, itching, urticaria.

Other: interstitial pneumonia, photosensitivity, alopecia, hypercreatinemia, increased plasma urea.

Interactions

Fenofibrate enhances the effect of oral anticoagulants and may increase the risk of bleeding, which is associated with the displacement of the anticoagulant from the binding sites with blood plasma proteins (with simultaneous use, care should be taken). At the beginning of treatment with fenofibrate, it is recommended to reduce the dose of the anticoagulant by approximately 1/3, followed by a gradual dose adjustment under the control of the INR level.

Simultaneous treatment with fenofibrate and cyclosporine may reduce renal function (it is necessary to monitor the state of renal function in such patients and stop fenofibrate in case of a serious change in laboratory parameters). When coadministering fenofibrate and potentially nephrotoxic agents, the risks and benefits should be carefully assessed and fenofibrate should be used at the lowest effective dose.

When taking fenofibrate concomitantly with HMG-CoA reductase inhibitors or other fibrates, the risk of rhabdomyolysis, myopathy and acute renal failure is increased (combined use is not recommended). Bile acid sequestrants reduce the absorption of fenofibrate (fenofibrate should be taken 1 hour before or 4-6 hours after taking them).

In vitro studies”> in vitro showed that fenofibrate and fenofibric acid are not inhibitors of cytochrome P450 isoenzymes CYP3A4, CYP2D6, CYP2E1 and CYP1A2. At therapeutic concentrations, these compounds are weak inhibitors of CYP2C19 and CYP2A isoenzymes 6 and weak or moderate inhibitors of CYP2C9

Overdose

No cases of overdose have been reported

Treatment: If overdose is suspected, symptomatic and, if necessary, supportive treatment should be given No specific antidote known Hemodialysis is ineffective

Dosage and administration

Inside, 200-400 mg/day in 3 doses, micronized forms – 145-200 mg 1 time per day.

Precautions

Liver transaminases should be monitored every 3 months during the first year of therapy; with an increase in ALT by 2 times or more, the appearance of myalgia and muscle weakness, fenofibrate is canceled. In the first 3 months of treatment, it is recommended to determine the concentration of creatinine (in case of an increase in the concentration of creatinine by more than 50% above the upper limit of normal, treatment should be suspended).

Treatment should be carried out for a long time, in combination with a hypocholesterol diet and under the supervision of a physician. The effectiveness of therapy should be assessed by the content of lipids (total cholesterol, LDL, triglycerides) in the blood serum. In the absence of a therapeutic effect after 3–6 months of treatment, the advisability of prescribing concomitant or alternative therapy should be considered.

In patients with hyperlipidemia who are taking estrogens or hormonal contraceptives containing estrogen, it is necessary to determine whether the hyperlipidemia is primary or secondary in nature, since an increase in lipid levels may be caused by estrogens.

The risk of rhabdomyolysis may be increased in patients with a predisposition to myopathy and/or rhabdomyolysis, including age over 70 years, history of hereditary muscle disease, impaired renal function, hypothyroidism, alcohol abuse.

Co-administration of fenofibrate and a statin is acceptable only if the patient has severe mixed dyslipidemia and high cardiovascular risk, no history of muscle disease, and carefully monitored for signs of developing toxic effects on muscle tissue.

Trade names with the active substance Fenofibrate

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Lek. form
All lek. capsule forms sustained-release capsules substance-powder tablets, film-coated

Dosage
All dosages 145 mg 200 mg 250 mg No dosage

Manufacturer
All manufacturers Veropharm AO Canonpharma production ZAO Koprima S.L. Laboratories Fournier S.A. Nobelpharma Ilach Sanayi ve Tijaret A. Sh. Recipharm Fontaine Fournier Laboratories Ireland Limited

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instructions for use, price, analogues, composition, indications

Oval, biconvex tablets, film-coated white or almost white. On a cross section – almost white color.

Active substance: fenofibrate – 145 mg.

Excipients: corn starch, colloidal silicon dioxide, croscarmellose sodium, mannitol, magnesium stearate, povidone K-30, microcrystalline cellulose; Film casing: Opadry II white, including: polyvinyl alcohol, macrogol (polyethylene glycol 4000), talc, titanium dioxide.

hypolipidemic agents. fibrates. Code ATX : C10AB05.

Pharmacological properties

Pharmacodynamics

By activating PAPP-alpha (peroxisome proliferator-activated alpha receptors), fenofibrate enhances lipolysis and the excretion of atherogenic high-triglyceride lipoproteins from blood plasma by activating lipoprotein lipase and reducing the synthesis of apoprotein CIII. Activation of PAPP-alpha also leads to increased synthesis of apoproteins AI and AII.

Fenofibrate is a derivative of fibric acid, the ability of which to change the content of lipids in the human body is mediated by the activation of PAPP-alpha. The effects of fenofibrate on lipoproteins described above lead to a decrease in the low-density lipoprotein (LDL) and very low-density lipoprotein (VLDL) fractions, which include apoprotein B, and an increase in the content of the high-density lipoprotein (HDL) fraction, which include apoproteins AI and AII .

In addition, by correcting impaired synthesis and catabolism of VLDL, fenofibrate increases LDL clearance and reduces the content of dense and small LDL particles, an increase in which is observed in patients with an atherogenic lipid phenotype, a common disorder in patients at risk of coronary heart disease. In clinical studies, it was noted that the use of fenofibrate reduces the concentration of total cholesterol by 20-25% and triglycerides by 40-55% with an increase in the concentration of HDL-cholesterol by 10-30%. In patients with hypercholesterolemia, in whom the concentration of LDL-cholesterol is reduced by 20 – 35%, the use of fenofibrate led to a decrease in the ratios: “total cholesterol / HDL-cholesterol”, “LDL-cholesterol / HDL-cholesterol” and “A for B / A for AI”, which are markers of atherogenic risk.

Given the significant effect on the concentration of LDL-cholesterol and triglycerides, the use of fenofibrate is effective in patients with hypercholesterolemia, both accompanied and not accompanied by hypertriglyceridemia, including secondary hyperlipoproteinemia, for example, in type 2 diabetes mellitus. During treatment with fenofibrate, extravascular cholesterol deposits (tendon and tuberous xanthomas) can significantly decrease and even completely disappear. In patients with elevated fibrinogen levels treated with fenofibrate, there was a significant decrease in this indicator, as well as in patients with elevated lipoprotein levels. Other markers of inflammation, such as C-reactive protein, also decrease with fenofibrate treatment.

For patients with dyslipidemia and hyperuricemia, an additional benefit lies in the uricosuric effect of fenofibrate, leading to a decrease in uric acid concentration by approximately 25%.

In a clinical study and in animal experiments, fenofibrate has been shown to reduce platelet aggregation caused by adenosine diphosphate, arachidonic acid and epinephrine.

Pharmacokinetics

Fenofibrate 145 mg film-coated tablets contain 145 mg of micronized fenofibrate.

Fenofibrate in the form of micronized fenofibrate has a higher bioavailability.

The original fenofibrate in the blood plasma is not detected. The main plasma metabolite is fenofibric acid.

Absorption: The maximum plasma concentration (Cmax) is reached 2-4 hours after ingestion. With prolonged use, the concentration of the drug in the blood plasma remains stable. Meal does not affect the maximum plasma concentration and the level of total exposure of the drug, so fenofibrate can be used regardless of food intake.

Distribution: fenofibric acid is strongly associated with plasma albumin (more than 99%).

Half-life: the half-life of fenofibric acid (T1 / 2) is about 20 hours.

Metabolism and excretion: Only the main metabolite of fenofibrate, fenofibric acid, is found in blood plasma. Fenofibrate is not a substrate for the CYP3A4 isoenzyme. Does not take part in microsomal metabolism.

It is excreted mainly by the kidneys in the form of fenofibric acid and glucuronide conjugate. Within 6 days, fenofibrate is excreted almost completely. The total clearance of fenofibric acid, determined in elderly patients, does not change.

The drug does not accumulate after a single dose and with prolonged use. It is not excreted by hemodialysis.

Indications for

Fenofibrate is indicated as an adjunct to diet and other non-drug treatments (eg, exercise, weight loss) for the following conditions:

severe hypertriglyceridemia, with or without low HDL cholesterol;

mixed hyperlipidemia, in the presence of contraindications to the use of statins or intolerance to statins;

mixed hyperlipidemia, in patients with high cardiovascular risk, in addition to a statin, in the absence of adequate control of triglycerides and HDL cholesterol.

The effectiveness of therapy should be monitored by determining the level of lipids in the blood serum. If after several months of therapy (for example, 3 months), an adequate effect is not achieved, the possibility of prescribing additional or other methods of treatment should be considered.

Tablets should be swallowed whole, regardless of the meal, without chewing, with a glass of water.

Adults. One tablet once a day. Patients taking one capsule of fenofibrate 200 mg can switch to one tablet of fenofibrate 145 mg without further dose adjustment. The maximum daily dose is 145 mg.

Elderly patients. It is recommended to take 1 tablet of 145 mg for adults (one tablet once a day).

Application in children. The safety of fenofibrate in children and adolescents under 18 years of age has not been established due to lack of data. Therefore, the use of fenofibrate is not recommended in children and adolescents under 18 years of age.

Impaired kidney function. Patients with impaired renal function should be given a lower dose. In mild to moderate renal failure, it is recommended to start treatment with one capsule of standard fenofibrate 100 mg or 67 mg micronized once a day. In patients with severe renal insufficiency, the use of fenofibrate is not recommended.

Impaired liver function. The use of the drug in patients with liver disease has not been studied.

The drug should be taken for a long time, while continuing to follow the diet that the patient adhered to before starting treatment with Fenofibrate.

If a dose is missed, the next dose should be taken at the usual time the next day. Do not take a double dose to make up for the missed one.

Side effects for therapeutic doses are given with a distribution by frequency and system organ classes according to the WHO classification:

very often – ≥1/10 appointments (> 10%)

often – from ≥1/100 to <1/10 appointments (> 1% and <10%)

infrequently – from ≥1 / 1,000 to <1/100 appointments (> 0. 1% and <1%)

rarely – from ≥1/10000 to <1/1000 appointments (>0.01% and <0.1%)

very rarely – <1/10,000 appointments (<0.01%)

frequency not known – cannot be estimated from the available data.

Gastrointestinal disorders

often – abdominal pain, nausea, vomiting, diarrhea and moderate flatulence.

infrequently – cases of pancreatitis.

Liver and biliary disorders:

often – moderate increase in the concentration of serum transaminases.

infrequently – formation of gallstones.

very rare – hepatitis. If symptoms of hepatitis (jaundice, pruritus) appear, laboratory tests should be performed and, if hepatitis is confirmed, fenofibrate should be discontinued (see Precautions section),

frequency unknown – icterus, complications of cholelithiasis (cholecystitis, cholangitis, biliary colic).

Musculoskeletal and connective tissue disorders:

infrequently – diffuse myalgia, myositis, muscle spasm and weakness.

very rarely – rhabdomyolysis, increased activity of creatine phosphokinase (CPK).

Vascular disorders:

infrequently – venous thromboembolism (pulmonary embolism, deep vein thrombosis).

Blood and lymphatic disorders:

rarely – increase in hemoglobin and leukocytes.

Immune system disorders:

rare – hypersensitivity.

Nervous system disorders:

infrequently – headache.

rarely – fatigue, dizziness.

Respiratory, thoracic and mediastinal disorders

frequency unknown – interstitial pneumopathy.

Skin and subcutaneous fat disorders:

infrequently – skin hypersensitivity reactions: for example, rash, itching, urticaria. rare – alopecia, photosensitivity reactions.

frequency unknown – severe skin reactions (erythema multiforme, Stevens-Johnson syndrome, epidermal toxic necrosis.

Genital and breast disorders:

infrequently – sexual dysfunction.

Laboratory tests:

infrequently – increase in the level of creatinine in the blood.

rarely – increase in the level of urea in the blood.

Contraindications

The drug is strictly contraindicated in the following cases:

hypersensitivity to fenofibrate or other components of the drug,

liver failure (including biliary cirrhosis and persistent liver dysfunction of unknown etiology),

severe renal failure (creatinine clearance < 30 ml / min),

age up to 18 years (efficacy and safety have not been established),

a history of photosensitivity or phototoxicity during treatment with fibrates or ketoprofen,

history of gallbladder disease

breastfeeding period,

chronic or acute pancreatitis, except in cases of acute pancreatitis due to severe hypertriglyceridemia.

Fenofibrate should not be administered to patients allergic to peanuts, peanut butter, soy lecithin or derivatives due to the risk of hypersensitivity reactions.

Only a few reports of fenofibrate overdose have been received. The specific antidote is unknown. If an overdose is suspected, symptomatic and, if necessary, supportive treatment should be prescribed.

Hemodialysis is ineffective.

Before starting treatment with Fenofibrate, appropriate treatment should be carried out to eliminate the cause of secondary hypercholesterolemia, for example, in diseases such as uncontrolled type 2 diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinemia, obstructive liver disease, effects of drug therapy, alcoholism.

The effectiveness of therapy should be assessed by the content of lipids (total cholesterol, LDL, triglycerides) in the blood serum. In the absence of a therapeutic effect after several months of therapy (usually after 3 months), the advisability of prescribing concomitant or alternative therapy should be considered.

In patients with hyperlipidemia taking estrogens or hormonal contraceptives containing estrogen, it is necessary to determine whether the hyperlipidemia is primary or secondary. In such cases, an increase in lipid levels may be caused by estrogen intake.

Liver function: when taking fenofibrate and other lipid-lowering drugs, an increase in the activity of “liver” transaminases has been described in some patients. In most cases, these increases were temporary, minor, and asymptomatic. During the first 12 months of treatment, it is recommended to monitor the activity of transaminases (alanine aminotransferase (ALT), aspartate aminotransferase (ACT)) every 3 months. Patients who have elevated transaminase concentrations during treatment require attention, and in the event of an increase in the concentration of ALT and ACT by more than 3 times compared to the upper limit of the norm, the drug is stopped.

Pancreatitis: Cases of pancreatitis have been described during treatment with fenofibrate. Possible causes of pancreatitis in these cases were: insufficient efficacy of the drug in patients with severe hypertriglyceridemia, direct effects of the drug, as well as secondary events associated with the presence of stones or sediment in the gallbladder, accompanied by obstruction of the common bile duct.

Muscles: Cases of toxic effects on muscle tissue, including very rare cases of rhabdomyolysis, have been described with fenofibrate and other lipid-lowering drugs. The frequency of such a disorder increases in the case of hypoalbuminemia and a history of renal failure. The possibility of this complication increases in cases of hypoalbuminemia and renal failure.

A toxic effect on muscle tissue may be suspected based on patient complaints of weakness, diffuse myalgia, myositis, muscle spasms and convulsions, and / or a pronounced increase in creatine phosphokinase (CPK) activity (more than 5 times compared to the upper limit of normal). In these cases, treatment with fenofibrate should be discontinued.

The risk of developing rhabdomyolysis may be increased 90,063 in 90,064 patients with a predisposition to myopathy and/or rhabdomyolysis, including age over 70 years, burdened history of hereditary muscle diseases, impaired renal function, hypothyroidism, alcohol abuse. Such patients should be prescribed the drug only if the expected benefit outweighs the possible risk of developing rhabdomyolysis. When taking Fenofibrate simultaneously with HMG-CoA reductase inhibitors or other fibrates, the risk of serious toxic effects on muscle fibers increases, especially if the patient suffered from muscle disease before starting treatment. In this regard, the joint appointment of the drug Fenofibrate and a statin is permissible only if the patient has severe mixed dyslipidemia and high cardiovascular risk, in the absence of muscle disease in history and under conditions of close monitoring aimed at identifying signs of development of toxic effects on muscle tissue.

Renal function: when using the drug Fenofibrate as monotherapy or in combination with statins, a reversible increase in serum creatinine concentration was observed in patients. The increase in creatinine concentration was generally stable over time with no evidence of a further increase in serum creatinine concentration during long-term therapy, with a tendency to return to initial values ​​after treatment was discontinued. The clinical significance of these observations has not been established. In patients with renal insufficiency, it is recommended to monitor renal function while taking Fenofibrate. Monitoring of renal function should be carried out in patients at risk of developing renal failure, namely elderly patients and patients with diabetes mellitus. Treatment should be discontinued in the event of an increase in creatinine concentration > 50% of the upper limit of normal. It is recommended to determine the concentration of creatinine during the first 3 months after the start of treatment, as well as periodically after its completion.

Oral anticoagulants

Fenofibrate enhances the effect of oral anticoagulants and may increase the risk of bleeding, which is associated with the displacement of the anticoagulant from the binding sites with plasma proteins.

At the beginning of treatment with fenofibrate, it is recommended to reduce the dose of anticoagulants by about a third, followed by a gradual dose adjustment. Dose selection is recommended to be carried out under the control of the level of INR (international normalized ratio).

Cyclosporine

Several severe cases of reversible decline in renal function have been described during concomitant treatment with fenofibrate and cyclosporine. Therefore, it is necessary to monitor the state of renal function in such patients and discontinue fenofibrate in the event of a serious change in laboratory parameters.

HMG inhibitors- CoA – reductases ( statins ) and others

When taking fenofibrate simultaneously with HMG-CoA reductase inhibitors or other fibrates, the risk of serious toxic effects on muscle fibers increases (see section “Precautions”).

Glitazones

With the concomitant use of fenofibrate and glitazones, cases of a reversible paradoxical decrease in HDL cholesterol levels have been reported. Therefore, it is recommended that HDL cholesterol levels be monitored when these drugs are used in combination, and therapy should be discontinued if HDL cholesterol levels are too low.

Isoenzymes of the system cytochrome Р450

In vitro studies of human liver microsomes have shown that fenofibrate and fenofibric acid are not inhibitors of the following cytochrome P450 isoenzymes (CYP3A4, CYP2D6, CYP2E1 or CYP1A2). At therapeutic concentrations, these compounds are weak inhibitors of CYP2C19 and CYP2A6 isoenzymes and weak or moderate inhibitors of CYP2C9..

Use during pregnancy and lactation

Pregnancy

Few data are available on the use of fenofibrate in pregnant women. In animal experiments, the teratogenic effect of fenofibrate was not observed. Embryotoxicity has been observed in preclinical doses administered at maternally toxic doses. The potential risk to humans is unknown. Therefore, Fenofibrate should only be used during pregnancy after a careful assessment of the risk/benefit ratio.

Breastfeeding period

The drug Fenofibrate is contraindicated for use during breastfeeding (there is not enough data on the use of the drug during this period).

Influence on the ability to drive motor transport and control mechanisms

When using the drug, there was no effect on the ability to drive a car and other mechanisms.

In a place protected from moisture and light at a temperature not exceeding 25 ° C.

Keep out of the reach of children.

2 years.

Do not use after the expiry date stated on the packaging.

10 tablets in a blister pack.