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(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, USP. The chemical name for fenofibrate is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1methylethyl ester with the following structural formula:
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;...
Last reviewed on RxList: 2/1/2013
This monograph has been modified to include the generic and brand name in many instances.
Additional Lipofen Information
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.
Tips to keep it under control.