Prescription Drug Information: FENOFIBRATE (Page 5 of 5)
OVERDOSAGE
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 AND ADMINISTRATION
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.
HOW SUPPLIED
Fenofibrate tablet, 54 mg are yellow, film-coated, oval shape tablets debossed with “G” on one side and “351” on the other side.
Bottles of 30 | NDC 33261-0966-30 |
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Keep out of reach of children. Protect from moisture.
Dispense in tightly-closed, light-resistant container as defined in the USP, with a child-resistant closure, as required.
REFERENCES
- GOLDBERG AC, et al. Fenofibrate for the Treatment of Type IV and V Hyperlipoproteinemias: A Double-Blind, Placebo-Controlled Multicenter US Study. Clinical Therapeutics , 11, pp. 69 – 83, 1989.
- NIKKILA EA. Familial Lipoprotein Lipase Deficiency and Related Disorders of Chylomicron Metabolism. In Stanbury J.B., et a l. (eds.): The Metabolic Basis of Inherited Disease , 5th edition, McGraw-Hill, 1983, Chap. 30, pp. 622 – 642.
- BROWN WV, et al. Effects of Fenofibrate on Plasma Lipids: Double-Blind, Multicenter Study In Patients with Type IIA or IIB Hyperlipidemia. Arteriosclerosis. 6, pp. 670 – 678, 1986.
Dist. by:
Global Pharmaceuticals
Division of IMPAX Laboratories, Inc.
Philadelphia, PA 19124 USA
Repackaged By :
Aidarex Pharmaceuticals LLC,
Corona, CA 92880
Rev. 03/11
295-08
PRINCIPAL DISPLAY PANEL — 54 mg Tablet Bottle Label
NDC 33261-0966-30
Fenofibrate
Tablets
54 mg
Rx only30 Tablets
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Labeler — Aidarex Pharmaceuticals LLC (801503249) |
Revised: 01/2014 Aidarex Pharmaceuticals LLC
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