FENOFIBRATE CAPSULES, MICRONIZED

/FENOFIBRATE CAPSULES, MICRONIZED
FENOFIBRATE CAPSULES, MICRONIZED2018-09-06T09:12:40+00:00

Prescription Drug Name:

FENOFIBRATE CAPSULES, MICRONIZED

ID:

635d7332-0a5b-490e-9ec1-b05740efcf38

Code:

34391-3

DESCRIPTION


id: 89e05494-48ed-4537-801d-53a41045be82
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3

Fenofibrate Capsules (micronized), is a lipid regulating agent available as capsules for oral administration. Each capsule contains 67 mg, 134 mg or 200 mg of micronized 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 79-82°C. Fenofibrate is a white solid which is stable under ordinary conditions. Inactive Ingredients: Each capsule also contains croscarmellose sodium, NF; hydroxypropyl methylcellulose, USP; magnesium sulfate, NF; microcrystalline cellulose, NF; and sodium lauryl sulfate, NF.

CLINICAL PHARMACOLOGY


id: e1bbbb20-b1a5-4234-bfae-7b637f4387b1
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 the 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 apo AI and apo AII). 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 a (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 PPARa 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: f36d7c9a-217e-4d62-822e-12c24e8ed7a0
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3

Fenofibrate capsules are contraindicated in patients who exhibit hypersensitivity to fenofibrate. Fenofibrate capsules are contraindicated in patients with hepatic or severe renal dysfunction, including primary biliary cirrhosis, and patients with unexplained persistent liver function abnormality. Fenofibrate capsules are contraindicated in patients with preexisting gallbladder disease (see WARNINGS).

OVERDOSAGE


id: 40a09eeb-509c-467d-b3cd-725977aba928
displayName: OVERDOSAGE SECTION
FDA Article Code: 34088-5

There is no specific treatment for overdose with fenofibrate capsules. 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: b1ea19cd-20ee-4c4b-9bc1-01f8c62831ad
displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7

Patients should be placed on an appropriate lipid-lowering diet before receiving fenofibrate capsules, and should continue this diet during treatment with fenofibrate capsules. Fenofibrate capsules 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 capsules is 200 mg per day. For adult patients with hypertriglyceridemia, the initial dose is 67 to 200 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 200 mg per day. Treatment with fenofibrate capsules should be initiated at a dose of 67 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 67 mg/day. Lipid levels should be monitored periodically and consideration should be given to reducing the dosage of fenofibrate capsules if lipid levels fall significantly below the targeted range.

HOW SUPPLIED


id: 66d3476e-5f3a-4219-b9f1-d22f4fcc9463
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5

Fenofibrate Capsules – Each #3 gelatin capsule contains 67 mg of fenofibrate, micronized. Each capsule is imprinted in black with “G 0511”.

Bottles of 30 Bottles of 60 NDC 35356-925-30 NDC 35356-925-60
Fenofibrate Capsules – Each #1 gelatin capsules contains 134 mg of fenofibrate, micronized. Each capsule is imprinted in black with “G 0522”.
Bottles of 30 NDC 35356-905-30
Bottles of 60 NDC 35356-905-60
Fenofibrate Capsules – Each #1 gelatin capsules contains 200 mg of fenofibrate, micronized. Each capsule is imprinted in black with “G 0533”.
Bottles of 100 NDC 0115-0533-01
Bottles of 500 NDC 0115-0533-02

REFERENCES


id: 29ca69cb-54b9-4fd4-b9ce-63d9ae7b44de
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.

Image of 67mg Label


id: 086fa729-71c3-4621-95ca-4ff972f54fb4
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4

Image of 134mg Label


id: 94fa4435-30ed-4d8d-8389-0711ae26aa25
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4