Application Nr Approved Date Route Status External Links
ANDA205566 2017-04-07 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

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 Hypercholesterolemia Or Mixed Dyslipidemia (fredrickson Types Iia And Iib). Lipid Altering Agents Should Be Used In Addition To A Diet Restricted In Saturated Fat And Cholesterol When Response To Diet And Non-Pharmacological Interventions Alone Has Been Inadequate (see National Cholesterol Education Program [ncep] Treatment Guidelines, Below). Treatment Of Hypertriglyceridemia Fenofibrate Capsules Are Also Indicated As Adjunctive Therapy To Diet For Treatment Of Adult Patients With Hypertriglyceridemia (fredrickson Types Iv And V Hyperlipidemia). Improving Glycemic Control In Diabetic Patients Showing Fasting Chylomicronemia Will Usually Reduce Fasting Triglycerides And Eliminate Chylomicronemia Thereby Obviating The Need For Pharmacologic Intervention. Markedly Elevated Levels Of Serum Triglycerides (e.g. > 2,000 Mg/dl) May Increase The Risk Of Developing Pancreatitis. The Effect Of Fenofibrate Therapy On Reducing This Risk Has Not Been Adequately Studied. Drug Therapy Is Not Indicated For Patients With Type I Hyperlipoproteinemia, Who Have Elevations Of Chylomicrons And Plasma Triglycerides, But Who Have Normal Levels Of Very Low Density Lipoprotein (vldl). Inspection Of Plasma Refrigerated For 14 Hours Is Helpful In Distinguishing Types I, Iv And V Hyperlipoproteinemia2. The Initial Treatment For Dyslipidemia Is Dietary Therapy Specific For The Type Of Lipoprotein Abnormality. Excess Body Weight And Excess Alcoholic Intake May Be Important Factors In Hypertriglyceridemia And Should Be Addressed Prior To Any Drug Therapy. Physical Exercise Can Be An Important Ancillary Measure. Diseases Contributory To Hyperlipidemia, Such As Hypothyroidism Or Diabetes Mellitus Should Be Looked For And Adequately Treated. Estrogen Therapy, Like Thiazide Diuretics And Beta-Blockers, Is Sometimes Associated With Massive Rises In Plasma Triglycerides, Especially In Subjects With Familial Hypertriglyceridemia. In Such Cases, Discontinuation Of The Specific Etiologic Agent May Obviate The Need For Specific Drug Therapy Of Hypertriglyceridemia. The Use Of Drugs Should Be Considered Only When Reasonable Attempts Have Been Made To Obtain Satisfactory Results With Non-Drug Methods. If The Decision Is Made To Use Drugs, The Patient Should Be Instructed That This Does Not Reduce The Importance Of Adhering To Diet (see Warnings And Precautions). Fredrickson Classification Of Hyperlipoproteinemias Lipid Elevation Type Lipoprotein Elevated Major Minor I (rare) Chylomicrons Tg ↑↔c Iia Ldl C - Iib Ldl, Vldl C Tg Iii (rare) Idl C, Tg - Iv Vldl Tg ↑↔c V (rare) Chylomicrons, Vldl Tg ↑↔ C = Cholesterol Tg = Triglycerides Ldl = Low Density Lipoprotein Vldl = Very Low Density Lipoprotein Idl = Intermediate Density Lipoprotein The Ncep Treatment Guidelines Ldl-Cholesterol Mg/dl (mmol/l) Definite Atherosclerotic Disease Coronary Heart Disease Or Peripheral Vascular Disease (including Symptomatic Carotid Artery Disease). Two Or More Other Risk Factors Other Risk Factors For Coronary Heart Disease (chd) Include: Age (males: ≥ 45 Years; Females: ≥ 55 Years Or Premature Menopause Without Estrogen Replacement Therapy); Family History Of Premature Chd; Current Cigarette Smoking; Hypertension; Confirmed Hdl-C < 35 Mg/dl (< 0.91 Mmol/l); And Diabetes Mellitus. Subtract 1 Risk Factor If Hdl-C Is ≥ 60 Mg/dl (≥ 1.6 Mmol/l). Initiation Level Goal No No ≥ 190 (≥ 4.9) < 160 (< 4.1) No Yes ≥ 160 (≥ 4.1) < 130 (< 3.4) Yes Yes Or No ≥ 130in Chd Patients With Ldl-C Levels 100 To 129 Mg/dl, The Physician Should Exercise Clinical Judgement In Deciding Whether To Initiate Drug Treatment. (≥ 3.4) < 160 (< 2.6)

All Formulated Excipients (9 Total)

Name Structure Kind Function Status
1. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.
2. Lactose Monohydrate LACTOSE MONOHYDRATE Molecular
3. Magnesium Stearate MAGNESIUM STEARATE Molecular AF-Antifoaming (or defoaming) agent , MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
4. Povidones POVIDONES Unresolved
5. Sodium Lauryl Sulfate SODIUM LAURYL SULFATE Molecular AF-Antifoaming (or defoaming) agent , CTG-Component or coating , EMUL-Emulsifier , SANI-Sanitizing agent , SDA-Solubilizing & dispersing agent REG-Food additives for which a petition has been filed and a regulation issued.
6. Talc TALC Unresolved DYE-Dye GRAS-Generally recognized as safe.
7. Titanium Dioxide TITANIUM DIOXIDE Unresolved DYE-Dye
8. Gelatin GELATIN Unresolved
9. Ferrosoferric Oxide FERROSOFERRIC OXIDE Molecular

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Fenofibrate FENOFIBRATE ZINC584092