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

IMAGE LABEL
(click image for full-size original)
FENOFIBRATE fenofibrate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:33261-966(NDC:0115-5511)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FENOFIBRATE (FENOFIBRATE) FENOFIBRATE 54 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM
HYPROMELLOSES
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
HYPROMELLOSE 2910 (3 MPA.S)
HYPROMELLOSE 2910 (6 MPA.S)
HYPROMELLOSE 2910 (50 MPA.S)
POLYETHYLENE GLYCOLS
POLYDEXTROSE
TITANIUM DIOXIDE
TRIACETIN
D&C YELLOW NO. 10
FD&C YELLOW NO. 6
Product Characteristics
Color YELLOW Score no score
Shape OVAL Size 9mm
Flavor Imprint Code G;351
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:33261-966-30 30 TABLET (30 TABLET) in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076509 02/01/2010
Labeler — Aidarex Pharmaceuticals LLC (801503249)

Revised: 01/2014 Aidarex Pharmaceuticals LLC

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