Fenofibric Acid Delayed-release
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Uses
Fenofibric acid delayed-release capsules are indicated as an adjunct to diet in combination with a statin to reduce TG and increase HDL-C in patients with mixed dyslipidemia and CHD or a CHD risk equivalent who are on optimal statin therapy to achieve their LDL-C goal.
CHD risk equivalents comprise:
• Other clinical forms of atherosclerotic disease (peripheral arterial disease, abdominal aortic aneurysm, and symptomatic carotid artery disease); • Diabetes; • Multiple risk factors that confer a 10-year risk for CHD > 20%Fenofibric acid delayed-release capsules are indicated as adjunctive therapy to diet to reduce TG in patients with severe hypertriglyceridemia. Improving glycemic control in diabetic patients showing fasting chylomicronemia will usually obviate the need for pharmacological intervention. Markedly elevated levels of serum triglycerides (e.g. > 2,000 mg/dL) may increase the risk of developing pancreatitis. The effect of fenofibric acid delayed-release capsules therapy on reducing this risk has not been adequately studied.
Fenofibric acid delayed-release capsules are indicated as adjunctive therapy to diet to reduce elevated low-density lipoprotein cholesterol (LDL-C), total cholesterol (Total-C), triglycerides (TG), and apolipoprotein B (Apo B), and to increase high-density lipoprotein cholesterol (HDL-C) in patients with primary hypercholesterolemia or mixed dyslipidemia.
No incremental benefit of fenofibric acid delayed-release capsules on cardiovascular morbidity and mortality over and above that demonstrated for statin monotherapy has been established. Fenofibrate at a dose equivalent to 135 mg of fenofibric acid delayed-release capsules was not shown to reduce coronary heart disease morbidity and mortality in 2 large, randomized controlled trials of patients with type 2 diabetes mellitus.
Laboratory studies should be performed to establish that lipid levels are abnormal before instituting fenofibric acid delayed-release capsules therapy.
Every reasonable attempt should be made to control serum lipids with non-drug methods including appropriate diet, exercise, weight loss in obese patients, and control of any medical problems such as diabetes mellitus and hypothyroidism that may be contributing to the lipid abnormalities. Medications known to exacerbate hypertriglyceridemia (beta-blockers, thiazides, estrogens) should be discontinued or changed if possible, and excessive alcohol intake should be addressed before triglyceride-lowering drug therapy is considered. If the decision is made to use lipid-altering drugs, the patient should be instructed that this does not reduce the importance of adhering to diet.
Drug therapy is not indicated for patients who have elevations of chylomicrons and plasma triglycerides, but who have normal levels of VLDL.
History
There is currently no drug history available for this drug.
Other Information
Fenofibric Acid Delayed-Release Capsules are a lipid regulating agent available as delayed release capsules for oral administration. Each delayed release capsule contains choline fenofibrate, equivalent to 45 mg or 135 mg of fenofibric acid. The chemical name for choline fenofibrate is ethanaminium, 2-hydroxy-N,N,N-trimethyl, 2-{4-(4-chlorobenzoyl)phenoxy] -2-methylpropanoate (1:1) with the following structural formula:
The empirical formula is C22H28ClNO5 and the molecular weight is 421.91. Choline fenofibrate is freely soluble in water. The melting point is approximately 210°C. Choline fenofibrate is a white to yellow powder, which is stable under ordinary conditions.
Each delayed release capsule contains enteric coated mini-tablets comprised of choline fenofibrate and the following inactive ingredients: hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, methacrylic acid copolymer, stearic acid, talc, triethyl citrate, FD&C blue #1, FD&C blue #2, FD&C red #40, D&C yellow #10, iron oxide black, propylene glycol, and shellac. Additionally, the 45 mg capsule shell contains black iron oxide, D&C yellow #10, FD&C yellow #6, gelatin, red iron oxide, titanium dioxide and yellow iron oxide. The 135 mg capsule shell contains D&C yellow #10, FD&C blue #1, FD&C yellow #6, gelatin and titanium dioxide.
Sources
Fenofibric Acid Delayed-release Manufacturers
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American Health Packaging
![Fenofibric Acid Delayed-release (Fenofibric Acid) Capsule, Delayed Release [American Health Packaging]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Fenofibric Acid Delayed-release | American Health Packaging
2.1 General ConsiderationsPatients should be placed on an appropriate lipid-lowering diet before receiving Fenofibric Acid Delayed-Release Capsules as monotherapy or coadministered with a statin, and should continue this diet during treatment. Fenofibric acid delayed-release capsules can be taken without regard to meals. Patients should be advised to swallow fenofibric acid delayed-release capsules whole. Do not open, crush, dissolve, or chew capsules. Serum lipids should be monitored periodically.
2.2 Coadministration Therapy with Statins for the Treatment of Mixed DyslipidemiaFenofibric acid delayed-release capsules 135 mg may be coadministered with an HMG-CoA reductase inhibitor (statin) in patients with mixed dyslipidemia. For convenience, the daily dose of fenofibric acid delayed-release capsules may be taken at the same time as a statin, according to the dosing recommendations for each medication. Coadministration with the maximum dose of a statin has not been evaluated in clinical studies and should be avoided unless the benefits are expected to outweigh the risks.
2.3 Severe HypertriglyceridemiaThe initial dose of fenofibric acid delayed-release capsules is 45 to 135 mg once daily. 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 135 mg once daily.
2.4 Primary Hypercholesterolemia or Mixed DyslipidemiaThe dose of fenofibric acid delayed-release capsules is 135 mg once daily.
2.5 Impaired Renal FunctionTreatment with fenofibric acid delayed-release capsules should be initiated at a dose of 45 mg once daily in patients with mild to moderate renal impairment and should only be increased after evaluation of the effects on renal function and lipid levels at this dose. The use of fenofibric acid delayed-release capsules should be avoided in patients with severely impaired renal function [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].
2.6 Geriatric PatientsDose selection for the elderly should be made on the basis of renal function [see Use In Specific Populations (8.5)].
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Par Pharmaceutical, Inc.
Fenofibric Acid Delayed-release | Par Pharmaceutical, Inc.
2.1 General ConsiderationsPatients should be placed on an appropriate lipid-lowering diet before receiving fenofibric acid delayed-release capsules, and should continue this diet during treatment. Fenofibric acid delayed-release capsules can be taken without regard to meals. Patients should be advised to swallow fenofibric acid delayed-release capsules whole. Do not open, crush, dissolve, or chew capsules. Serum lipids should be monitored periodically.
2.2 Severe HypertriglyceridemiaThe initial dose of fenofibric acid delayed-release capsules is 45 to 135 mg once daily. 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 135 mg once daily.
2.3 Primary Hypercholesterolemia or Mixed DyslipidemiaThe dose of fenofibric acid delayed-release capsules is 135 mg once daily.
2.4 Impaired Renal FunctionTreatment with fenofibric acid delayed-release capsules should be initiated at a dose of 45 mg once daily in patients with mild to moderate renal impairment and should only be increased after evaluation of the effects on renal function and lipid levels at this dose. The use of fenofibric acid delayed-release capsules should be avoided in patients with severely impaired renal function [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].
2.5 Geriatric PatientsDose selection for the elderly should be made on the basis of renal function [see Use In Specific Populations (8.5)].
![Fenofibric Acid Delayed-release (Fenofibric Acid) Capsule, Delayed Release [Par Pharmaceutical, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=ef784203-4dcd-4b7e-985c-70b0033e48e8&name=bottle-label-135mg.jpg)
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