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Lipofen

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Lipofen

LIPOFEN®
(fenofibrate) Capsules, USP

Lipofen

DRUG DESCRIPTION

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, USP. The chemical name for fenofibrate is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1methylethyl ester with the following structural formula:

LIPOFEN® (fenofibrate capsules, USP) Structural Formula Illustration

The empirical formula is C20H21O4Cl and the molecular weight is 360.83; fenofibrate is insoluble in water. The melting point is 79-82oC. 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.

What are the possible side effects of fenofibrate?

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:

  • severe stomach pain;
  • nausea, vomiting;
  • unusual weakness;...

Read All Potential Side Effects and See Pictures of Lipofen »

Last reviewed on RxList: 2/1/2013
This monograph has been modified to include the generic and brand name in many instances.

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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