Label: FENOFIBRATE tablet, film coated

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated November 12, 2024

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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use FENOFIBRATE TABLETS safely and effectively. See full prescribing information for FENOFIBRATE TABLETS. FENOFIBRATE tablets USP ...
  • Table of Contents
    Table of Contents
  • 1 INDICATIONS & USAGE
    1.1 Primary Hypercholesterolemia or Mixed Dyslipidemia - Fenofibrate tablets are indicated as adjunctive therapy to diet to reduce elevated low-density lipoprotein cholesterol (LDL-C), total ...
  • 2 DOSAGE & ADMINISTRATION
    2.1 General Considerations - Patients should be placed on an appropriate lipid-lowering diet before receiving fenofibrate tablets, and should continue this diet during treatment with ...
  • 3 DOSAGE FORMS & STRENGTHS
    • 48 mg tablets are yellow, oval, biconvex film coated tablets, debossed with 'J' on one side and '137' on other side. • 145 mg tablets are white to off-white, oval, biconvex film coated ...
  • 4 CONTRAINDICATIONS
    Fenofibrate tablets are contraindicated in: • patients with severe renal impairment, including those receiving dialysis - [see Clinical Pharmacology ( 12.3)].   ...
  • 5 WARNINGS AND PRECAUTIONS
    5.1 Mortality and Coronary Heart Disease Morbidity - The effect of fenofibrate tablets on coronary heart disease morbidity and mortality and non-cardiovascular mortality has not been ...
  • 6 ADVERSE REACTIONS
    6.1 Clinical Trials Experience - Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly ...
  • 7 DRUG INTERACTIONS
    7.1 Coumarin Anticoagulants - Potentiation of coumarin-type anticoagulant effects has been observed with prolongation of the PT/INR. Caution should be exercised when coumarin ...
  • 8 USE IN SPECIFIC POPULATIONS
    8.1 Pregnancy - Teratogenic Effects - Pregnancy Category C - Safety in pregnant women has not been established. There are no adequate and well controlled studies of ...
  • 10 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 ...
  • 11 DESCRIPTION
    Fenofibrate tablets, USP are lipid regulating agent available as tablets for oral administration. Each tablet contains 48 mg or 145 mg of fenofibrate USP. The chemical name for fenofibrate USP is ...
  • 12 CLINICAL PHARMACOLOGY
    12.1 Mechanism of Action - The active moiety of fenofibrate tablets is fenofibric acid. The pharmacological effects of fenofibric acid in both animals and humans have been extensively studied ...
  • 13 NONCLINICAL TOXICOLOGY
    13.1 Carcinogenesis & Mutagenesis & Impairment Of Fertility - Two dietary carcinogenicity studies have been conducted in rats with fenofibrate. In the first 24-month study, Wistar rats were ...
  • 14 CLINICAL STUDIES
    14.1 Primary Hypercholesterolemia (Heterozygous Familial and Nonfamilial) and Mixed Dyslipidemia - The effects of fenofibrate at a dose equivalent to 145 mg fenofibrate tablets per day were ...
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    Fenofibrate tablets, USP are available in two strengths: 48 mg tablets are yellow, oval, biconvex film coated tablets, debossed with 'J' on one side and '137' on other side, available in ...
  • 17 PATIENT COUNSELING INFORMATION
    Patients should be advised: • of the potential benefits and risks of fenofibrate tablets. • not to use fenofibrate tablets if there is a known hypersensitivity to fenofibrate or ...
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