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LIPOFEN®
(fenofibrate) Capsules, USP
LIPOFEN® (fenofibrate capsules, USP), is a lipid regulating agent available as hard gelatin capsules for oral administration. Each hard gelatin capsule contains 50 or 150 mg of fenofibrate. The chemical name for fenofibrate is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1methylethyl ester with the following structural formula:
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The empirical formula is C20H21O4C1 and the molecular weight is 360.83; fenofibrate is insoluble in water. The melting point is 79-82°C. Fenofibrate is a white solid which is stable under ordinary conditions.
LIPOFEN (fenofibrate capsules, USP) meets USP Dissolution Test 2.
Inactive Ingredients: Each hard gelatin capsule contains Gelucire 44/14 (lauroyl macrogol glyceride type 1500), polyethylene glycol 20,000, polyethylene glycol 8000, hydroxypropylcellulose, sodium starch glycolate, gelatin, titanium dioxide, shellac, propylene glycol, may also contain black iron oxide, FD&C Blue #1, FD&C Blue #2, FD&C Red #40, D&C Yellow #10.
Fenofibrate has been associated with a rare but serious side effect of the muscles. Contact your doctor at once if you have unusual muscle pain, tenderness, or weakness especially if accompanied by fever or flu-like feeling.
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 using fenofibrate and call your doctor at once if you have any of these serious side effects:
Read All Potential Side Effects and See Pictures of Lipofen »
Before taking fenofibrate, tell your doctor or pharmacist if you are allergic to it; or to other "fibrates" (such as fenofibric acid); or if you have any other allergies. This product may contain inactive ingredients (such as soy, found in some Canadian brands), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, gallbladder disease, liver disease (such as biliary cirrhosis, hepatitis), alcohol use.
Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
This medication is not recommended for use during...
Last reviewed on RxList: 11/11/2011
This monograph has been modified to include the generic and brand name in many instances.
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