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Trilipix
(fenofibric acid) Capsule, Delayed Release for Oral Use
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:
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The empirical formula is C22H28ClNO5 and the molecular weight is 421.91. Choline fenofibrate is freely soluble in water. The melting point is approximately 210°C. 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.
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 »
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.
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Last reviewed on RxList: 10/12/2011
This monograph has been modified to include the generic and brand name in many instances.
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