"The U.S. Food and Drug Administration today notified Ranbaxy Laboratories, Ltd., that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug product"...
Triglide (fenofibrate) Tablets, is a lipid regulating agent available as tablets for oral administration. Each tablet contains 50 mg or 160 mg of fenofibrate. The chemical name for fenofibrate is 2-[4-(4-chlorobenzoyl) phenoxy] 2-methyl-propanoic acid, 1-methylethyl 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° to 82°C. Fenofibrate is a white solid which is stable under ordinary conditions.
Inactive Ingredients: Each tablet contains crospovidone, lactose monohydrate, mannitol, maltodextrin, carboxymethylcellulose sodium, egg lecithin, croscarmellose sodium, sodium lauryl sulfate, colloidal silicon dioxide, magnesium stearate, and monobasic sodium phosphate.
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;...
What are the precautions when taking fenofibrate (Triglide)?
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), 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 pregnancy. Consult your doctor for...
Last reviewed on RxList: 2/15/2013
This monograph has been modified to include the generic and brand name in many instances.
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