FENOFIBRATE TABLETS, 54 mg and 160 mg

/FENOFIBRATE TABLETS, 54 mg and 160 mg
FENOFIBRATE TABLETS, 54 mg and 160 mg2018-09-06T09:12:40+00:00

Prescription Drug Name:

FENOFIBRATE TABLETS, 54 mg and 160 mg

ID:

80ae2eaf-98af-4ca0-b6f8-d4ceb2c01e2b

Code:

34391-3

DESCRIPTION


id: 47e08996-b657-41fd-a36f-b4676cbedca8
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3

Fenofibrate tablets is a lipid regulating agent available as tablets for oral administration. Each tablet contains 54 mg or 160 mg of fenofibrate. The chemical name for fenofibrate is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methylpropanoic acid, 1-methylethyl ester with the following structural formula: The molecular formula is C20H21O4Cl and the molecular weight is 360.83; fenofibrate is insoluble in water. The melting point is 79-82°C. Fenofibrate is a white solid which is stable under ordinary conditions. Each tablet also contains the following inactive ingredients: croscarmellose sodium, NF; hypromellose type 2208/100,000 cP, USP; magnesium sulfate, NF; and microcrystalline cellulose, NF. The film-coating material contains hypromellose type 2910/ 3 cP, 6 cP and 50 cP, macrogol, polydextrose, titanium dioxide and triacetin.

CLINICAL PHARMACOLOGY


id: a141dae1-9469-4c06-a91b-8b64174f5d8e
displayName: CLINICAL PHARMACOLOGY SECTION
FDA Article Code: 34090-1

A variety of clinical studies have demonstrated that elevated levels of total cholesterol (total-C), low density lipoprotein cholesterol (LDL-C), and apolipoprotein B (apo B), an LDL membrane complex, are associated with human atherosclerosis. Similarly, decreased levels of high density lipoprotein cholesterol (HDL-C) and its transport complex, apolipoprotein A (apo AI and apo AII) are associated with the development of atherosclerosis. Epidemiologic investigations have established that cardiovascular morbidity and mortality vary directly with level of total-C, LDL-C, and triglycerides, and inversely with the level of HDL-C. The independent effect of raising HDL-C or lowering triglycerides (TG) on the risk of cardiovascular morbidity and mortality has not been determined. Fenofibric acid, the active metabolite of fenofibrate, produces reductions in total cholesterol, LDL cholesterol, apolipoprotein B, total triglycerides and triglyceride rich lipoprotein (VLDL) in treated patients. In addition, treatment with fenofibrate results in increases in high density lipoprotein (HDL) and apoproteins apoAI and apoAII. The effects of fenofibric acid seen in clinical practice have been explained in vivo in transgenic mice and in vitro in human hepatocyte cultures by the activation of peroxisome proliferator activated receptor α (PPARα). Through this mechanism, fenofibrate increases lipolysis and elimination of triglyceride-rich particles from plasma by activating lipoprotein lipase and reducing production of apoprotein C-III (an inhibitor of lipoprotein lipase activity). The resulting fall in triglycerides produces an alteration in the size and composition of LDL from small, dense particles (which are thought to be atherogenic due to their susceptibility to oxidation), to large buoyant particles. These larger particles have a greater affinity for cholesterol receptors and are catabolized rapidly. Activation of PPARα also induces an increase in the synthesis of apoproteins A-I, A-II and HDL-cholesterol. Fenofibrate also reduces serum uric acid levels in hyperuricemic and normal individuals by increasing the urinary excretion of uric acid.

CONTRAINDICATIONS


id: 81346a9d-1c1f-43c3-962d-3a8e49edbe61
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3

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).

OVERDOSAGE


id: 7d301d72-4565-4f84-83b4-d683f5874996
displayName: OVERDOSAGE SECTION
FDA Article Code: 34088-5

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


id: 8318d4ff-b2da-4fb9-ad77-99e6f01171fe
displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7

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


id: 3b088826-c745-42a8-96a3-385f8d7124ab
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5

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 54868-5697-1
Bottles of 90 NDC 54868-5697-0
Fenofibrate tablet, 160 mg are white to off-white, film-coated, modified capsule shaped tablets, debossed with “G352” on one side and plain on the other side.
Bottles of 30 NDC 54868-5660-0
Bottles of 90 NDC 54868-5660-1

REFERENCES


id: 2ad178a9-882c-4d5f-aa32-94fa92c3caf6
displayName: REFERENCES SECTION
FDA Article Code: 34093-5

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 al. (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.

PRINCIPAL DISPLAY PANEL – 54 mg Tablet Bottle Label


id: 4bba18c1-00c8-446e-856b-93c448754092
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4

Fenofibrate  Tablets 54 mg* Rx only

PRINCIPAL DISPLAY PANEL – 160 mg Tablet Bottle Label


id: 600067bf-b385-4144-896a-c438d43367a1
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4

Fenofibrate
Tablets
160 mg* Rx only