^Description Section
Fenofibrate tablets, USP is a lipid regulating agent available as tablets for oral administration. Each tablet contains 54 mg or 160 mg of fenofibrate, USP. The chemical name for fenofibrate is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester with the following molecular structure:
structure
The molecular formula is C20H21O4Cl and the molecular weight is 360.83; fenofibrate, USP is very soluble in methylene chloride, slightly soluble in alcohal and prectically insoluble in water. The melting point is 79 - 82° C. Fenofibrate, USP is a white or almost white crystalline powder.
Inactive Ingredients: Each tablet contains colloidal silicon dioxide, crospovidone, lecithin (soya), microcrystalline cellulose, polyvinyl alcohol, povidone, pregelatinized starch, sodium lauryl sulfate, sodium stearyl fumarate, talc, titanium dioxide and xanthan gum.
Meets USP Dissolution Test 2.
^Contraindications Section
Fenofibrate tablets are contraindicated in patients who exhibit hypersensitivity to fenofibrate.
Fenofibrate tablets are contraindicated in patients with hepatic or severe renal dysfunction, including primary biliary cirrhosis, and patients with unexplained persistent liver function abnormality.
Fenofibrate tablets are contraindicated in patients with preexisting gallbladder disease (See WARNINGS).
^Adverse Reactions Section
^Precautions Section
^Indications & Usage Section
^Warnings Section
^Overdosage Section
There is no specific treatment for overdose with fenofibrate tablets. General supportive care of the patient is indicated, including monitoring of vital signs and observation of clinical status, should an overdose occur. If indicated, elimination of unabsorbed drug should be achieved by emesis or gastric lavage; usual precautions should be observed to maintain the airway. Because fenofibrate is highly bound to plasma proteins, hemodialysis should not be considered.
^Dosage & Administration Section
Patients should be placed on an appropriate lipid-lowering diet before receiving fenofibrate tablets, and should continue this diet during treatment with fenofibrate tablets. Fenofibrate tablets should be given with meals, thereby optimizing the bioavailability of the medication.
For the treatment of adult patients with primary hypercholesterolemia or mixed hyperlipidemia, the initial dose of fenofibrate tablets is 160 mg per day.
For adult patients with hypertriglyceridemia, the initial dose is 54 to 160 mg per day. Dosage should be individualized according to patient response, and should be adjusted if necessary following repeat lipid determinations at 4 to 8 week intervals. The maximum dose is 160 mg per day.
Treatment with fenofibrate tablets should be initiated at a dose of 54 mg/day in patients having impaired renal function, and increased only after evaluation of the effects on renal function and lipid levels at this dose. In the elderly, the initial dose should likewise be limited to 54 mg/day.
Lipid levels should be monitored periodically and consideration should be given to reducing the dosage of fenofibrate tablets if lipid levels fall significantly below the targeted range.
^Package Label.principal Display Panel
^Clinical Pharmacology Section