Label: FENOFIBRATE capsule

  • NDC Code(s): 62332-084-30, 62332-084-31, 62332-084-71, 62332-085-30, view more
  • Packager: Alembic Pharmaceuticals Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated May 12, 2022

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  • DESCRIPTION
    Fenofibrate, USP (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, USP. The chemical ...
  • CLINICAL PHARMACOLOGY
    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 ...
  • INDICATIONS AND USAGE
    Treatment of Hypercholesterolemia - Fenofibrate capsules are indicated as adjunctive therapy to diet for the reduction of LDL-C, Total-C, Triglycerides and Apo B in adult patients with primary ...
  • CONTRAINDICATIONS
    Fenofibrate capsules are contraindicated in patients who exhibit hypersensitivity to fenofibrate. Fenofibrate capsules are contraindicated in patients with hepatic or severe renal dysfunction ...
  • WARNINGS
    Hepatotoxicity: Serious drug-induced liver injury (DILI), including liver transplantation and death, have been reported postmarketing with fenofibrate. DILI has been reported within the first ...
  • PRECAUTIONS
    Initial Therapy: Laboratory studies should be done to ascertain that the lipid levels are consistently abnormal before instituting fenofibrate therapy. Every attempt should be made to control ...
  • ADVERSE REACTIONS
    Clinical Studies Experience: Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared ...
  • OVERDOSAGE
    There is no specific treatment for overdose with fenofibrate. General supportive care of the patient is indicated, including monitoring of vital signs and observation of clinical status, should an ...
  • DOSAGE AND ADMINISTRATION
    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 ...
  • HOW SUPPLIED
    Fenofibrate capsules, USP (micronized) is available as hard gelatin capsules in three strengths: Fenofibrate capsules, USP (micronized),67 mg are Opaque pale Yellow / Opaque pale Yellow, Size ...
  • REFERENCES
    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 ...
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - 67 mg
    NDC 62332-084-30 - Fenofibrate - Capsules, USP - 67 mg - Rx only - 30 Capsules - Alembic
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - 134 mg
    NDC 62332-085-30 - Fenofibrate - Capsules, USP - 134 mg - Rx only - 30 Capsules - Alembic
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - 200 mg
    NDC 62332-086-30 - Fenofibrate - Capsules, USP - 200 mg - Rx only - 30 Capsules - Alembic
  • INGREDIENTS AND APPEARANCE
    Product Information