Fenofibric Acid

Fenofibric Acid

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Questions & Answers

Side Effects & Adverse Reactions

There is currently no warning information available for this product. We apologize for any inconvenience.

Legal Issues

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FDA Safety Alerts

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Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

1.1 Severe Hypertriglyceridemia

Fenofibric acid tablets are indicated as adjunctive therapy to diet for treatment of severe hypertriglyceridemia (≥ 500 mg/dL). Improving glycemic control in diabetic patients showing fasting chylomicronemia will usually obviate the need for pharmacologic intervention.

Markedly elevated levels of serum triglycerides > 2000 mg/dL may increase the risk of developing pancreatitis. The effect of fenofibrate therapy on reducing this risk has not been adequately studied.

1.2 Primary Hypercholesterolemia or Mixed Dyslipidemia

Fenofibric acid tablets 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.

1.3 Important Limitations of Use

Fenofibrate at a dose equivalent to 105 mg of fenofibric acid tablets was not shown to reduce coronary heart disease morbidity and mortality in patients with type 2 diabetes mellitus [see Warnings and Precautions (5.1)].

History

There is currently no drug history available for this drug.

Other Information

Fenofibric acid is a lipid regulating agent available as tablets for oral administration. Each tablet contains 35 mg or 105 mg of fenofibric acid. The chemical name for fenofibric acid is 2-[4-(4-chlorobenzoyl)phenoxy]-2-methylpropanoic acid with the following structural formula:

Chemical Structure

Fenofibric acid is a white to almost white crystalline powder that is stable under ordinary conditions, and has a melting point of 179 – 183°C. Its empirical formula is C17H15ClO4 and molecular weight 318.75. Fenofibric acid is insoluble in water; its solubility increases with pH in buffered media.

Inactive Ingredients: Each tablet contains copovidone, crospovidone, magnesium stearate and microcrystalline cellulose.

Fenofibric Acid Manufacturers


  • Mutual Pharmaceutical Company, Inc.
    Fenofibric Acid Tablet [Mutual Pharmaceutical Company, Inc.]
  • Global Pharmaceuticals, Division Of Impax Laboratories Inc.
    Fenofibric Acid Capsule, Delayed Release [Global Pharmaceuticals, Division Of Impax Laboratories Inc.]
  • Mylan Pharmaceuticals Inc.
    Fenofibric Acid Capsule, Delayed Release Pellets [Mylan Pharmaceuticals Inc.]
  • Mylan Institutional Inc.
    Fenofibric Acid Capsule, Delayed Release Pellets [Mylan Institutional Inc.]
  • Lupin Pharmaceuticals, Inc.
    Fenofibric Acid Capsule, Delayed Release [Lupin Pharmaceuticals, Inc.]
  • Zydus Pharmaceuticals Usa Inc
    Fenofibric Acid Capsule, Delayed Release [Zydus Pharmaceuticals Usa Inc]

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