Trilipix

DRUG DESCRIPTION

Trilipix (fenofibric acid) is a lipid regulating agent available as delayed release capsules for oral administration. Each delayed release capsule contains choline fenofibrate, equivalent to 45 mg or 135 mg of fenofibric acid. The chemical name for choline fenofibrate is ethanaminium, 2-hydroxy-N,N,N-trimethyl, 2{4-(4-chlorobenzoyl)phenoxy] -2-methylpropanoate (1:1) with the following structural formula:

Trilipix (fenofibric acid) Structural Formula Illustration

The empirical formula is C22H28ClNO5 and the molecular weight is 421.91. Choline fenofibrate is freely soluble in water. The melting point is approximately 210C. Choline fenofibrate is a white to yellow powder, which is stable under ordinary conditions.

Each delayed release capsule contains enteric coated mini-tablets comprised of choline fenofibrate and the following inactive ingredients: hypromellose, povidone, water, hydroxylpropyl cellulose, colloidal silicon dioxide, sodium stearyl fumarate, methacrylic acid copolymer, talc, triethyl citrate. The capsule shell of the 45 mg capsule contains the following inactive ingredients: gelatin, titanium dioxide, yellow iron oxide, black iron oxide, and red iron oxide. The capsule shell of the 135 mg capsule contains the following inactive ingredients: gelatin, titanium dioxide, yellow iron oxide, and FD&C Blue #2.

What are the possible side effects of fenofibric acid (Fibricor, Trilipix)?

In rare cases, fenofibric acid can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. Stop taking fenofibric acid and call your doctor right away if you have muscle pain, tenderness, or weakness especially if you also have fever, nausea or vomiting, and dark colored urine.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop taking fenofibric acid and call...

Read All Potential Side Effects and See Pictures of Trilipix

What are the precautions when taking fenofibric acid capsule (Trilipix)?

Before taking fenofibric acid, tell your doctor or pharmacist if you are allergic to it; or to other "fibrates" (such as fenofibrate); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: gallbladder disease, liver disease (such as biliary cirrhosis, hepatitis).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: alcohol use, kidney disease.

Older adults may be more sensitive to the effects of this drug, especially muscle problems.

This...

Read All Potential Precautions of Trilipix


Trilipix Consumer (continued)

SIDE EFFECTS: Nausea and headache may occur. If either of these effects persist or worsen, tell your doctor promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

This medication may infrequently cause gallstones and liver problems. If you notice any of the following unlikely but very serious side effects, tell your doctor immediately: persistent nausea/vomiting, severe stomach/abdominal pain, dark urine, yellowing eyes/skin.

This drug may infrequently cause muscle problems (which can rarely lead to a very serious condition called rhabdomyolysis). Tell your doctor immediately if you develop any of these symptoms: muscle pain/tenderness/weakness (especially with fever or unusual tiredness), change in the amount of urine.

Tell your doctor immediately if any of these rare but very serious side effects occur: easy bleeding/bruising, signs of infection (such as fever, persistent sore throat), chest pain, pain/redness/swelling of arms or legs.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking fenofibric acid, tell your doctor or pharmacist if you are allergic to it; or to other "fibrates" (such as fenofibrate); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: gallbladder disease, liver disease (such as biliary cirrhosis, hepatitis).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: alcohol use, kidney disease.

Older adults may be more sensitive to the effects of this drug, especially muscle problems.

This medication is not recommended for use during pregnancy. It may harm an unborn baby. Discuss the risks and benefits with your doctor.

It is unknown if this medication passes into breast milk. Breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.


Trilipix Patient Information Including Side Effects

Brand Names: Fibricor, Trilipix

Generic Name: fenofibric acid (Pronunciation: FEN oh FYE brik AS id)

  • What is fenofibric acid (Trilipix)?
  • What are the possible side effects of fenofibric acid (Trilipix)?
  • What is the most important information I should know about fenofibric acid (Trilipix)?
  • What should I discuss with my healthcare provider before taking fenofibric acid (Trilipix)?
  • How should I take fenofibric acid (Trilipix)?
  • What happens if I miss a dose (Trilipix)?
  • What happens if I overdose (Trilipix)?
  • What should I avoid while taking fenofibric acid (Trilipix)?
  • What other drugs will affect fenofibric acid (Trilipix)?
  • Where can I get more information?

What is fenofibric acid (Trilipix)?

Fenofibric acid helps reduce cholesterol and triglycerides (fatty acids) in the blood. High levels of these types of fat in the blood are associated with an increased risk of atherosclerosis (clogged arteries).

Fenofibric acid is used to treat high cholesterol and high triglyceride levels. It is sometimes given together with other cholesterol-lowering medications.

Fenofibric acid may also be used for other purposes not listed in this medication guide.

What are the possible side effects of fenofibric acid (Trilipix)?

In rare cases, fenofibric acid can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. Stop taking fenofibric acid and call your doctor right away if you have muscle pain, tenderness, or weakness especially if you also have fever, nausea or vomiting, and dark colored urine.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop taking fenofibric acid and call your doctor at once if you have any of these other serious side effects:

  • sharp stomach pain spreading to your back or shoulder blade;
  • stomach pain just after eating a meal;
  • nausea, vomiting, fever, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • pain or swelling in one or both legs; or
  • chest pain, sudden cough, wheezing, rapid breathing, fast heart rate.

Less serious side effects may include:

  • headache, dizziness;
  • tired feeling;
  • joint pain, mild back pain;
  • runny or stuffy nose, sore throat; or
  • diarrhea, constipation, bloating, indigestion.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about fenofibric acid (Trilipix)?

You should not use fenofibric acid if you have liver disease, gallbladder disease, severe kidney disease (or if you are on dialysis), or if you are breast-feeding a baby.

Before you take fenofibric acid, tell your doctor if you have kidney disease, diabetes, or underactive thyroid.

Fenofibric acid is only part of a complete program of treatment that may also include diet, exercise, weight control, and other medications. Follow your diet, medication, and exercise routines very closely.

Avoid drinking alcohol while taking fenofibric acid. Alcohol can raise triglyceride levels, and may also damage your liver while you are taking fenofibric acid.

Avoid eating foods that are high in fat or cholesterol. Fenofibric acid will not be as effective in lowering your cholesterol if you do not follow a cholesterol-lowering diet plan.

In rare cases, fenofibric acid can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. Call your doctor right away if you have muscle pain, tenderness, or weakness especially if you also have fever, nausea or vomiting, and dark colored urine.

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