Application Nr Approved Date Route Status External Links
ANDA078296 2008-03-14 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Therapy With Lovastatin Tablets Should Be A Component Of Multiple Risk Factor Intervention In Those Individuals With Dyslipidemia At Risk For Atherosclerotic Vascular Disease. Lovastatin Tablets Should Be Used In Addition To A Diet Restricted In Saturated Fat And Cholesterol As Part Of A Treatment Strategy To Lower Total-C And Ldl-C To Target Levels When The Response To Diet And Other Nonpharmacological Measures Alone Has Been Inadequate To Reduce Risk. Primary Prevention Of Coronary Heart Disease In Individuals Without Symptomatic Cardiovascular Disease, Average To Moderately Elevated Total-C And Ldl-C, And Below Average Hdl-C, Lovastatin Tablets Are Indicated To Reduce The Risk Of: - Myocardial Infarction - Unstable Angina - Coronary Revascularization Procedures (see Clinical Pharmacology, Clinical Studies.) Coronary Heart Disease Lovastatin Tablets Are Indicated To Slow The Progression Of Coronary Atherosclerosis In Patients With Coronary Heart Disease As Part Of A Treatment Strategy To Lower Total-C And Ldl-C To Target Levels. Hypercholesterolemia Therapy With Lipid-Altering Agents Should Be A Component Of Multiple Risk Factor Intervention In Those Individuals At Significantly Increased Risk For Atherosclerotic Vascular Disease Due To Hypercholesterolemia. Lovastatin Tablets Are Indicated As An Adjunct To Diet For The Reduction Of Elevated Total-C And Ldl-C Levels In Patients With Primary Hypercholesterolemia (types Iia And Iib***), When The Response To Diet Restricted In Saturated Fat And Cholesterol And To Other Nonpharmacological Measures Alone Has Been Inadequate. *** Classification Of Hyperlipoproteinemias Idl = Intermediate-Density Lipoprotein Type Lipoproteins Elevated Lipid Elevations Major Minor I 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 Adolescent Patients With Heterozygous Familial Hypercholesterolemia Lovastatin Tablets Are Indicated As An Adjunct To Diet To Reduce Total-C, Ldl-C And Apolipoprotein B Levels In Adolescent Boys And Girls Who Are At Least One Year Post-Menarche, 10-17 Years Of Age, With Hefh If After An Adequate Trial Of Diet Therapy The Following Findings Are Present: Ldl-C Remains >189 Mg/dl Or Ldl-C Remains >160 Mg/dl And: • There Is A Positive Family History Of Premature Cardiovascular Disease Or • Two Or More Other Cvd Risk Factors Are Present In The Adolescent Patient General Recommendations Prior To Initiating Therapy With Lovastatin, Secondary Causes For Hypercholesterolemia (e.g., Poorly Controlled Diabetes Mellitus, Hypothyroidism, Nephrotic Syndrome, Dysproteinemias, Obstructive Liver Disease, Other Drug Therapy, Alcoholism) Should Be Excluded, And A Lipid Profile Performed To Measure Total-C, Hdl-C, And Tg. For Patients With Tg Less Than 400 Mg/dl (<4.5 Mmol/l), Ldl-C Can Be Estimated Using The Following Equation: Ldl-C = Total-C – [0.2 X (tg) + Hdl-C] For Tg Levels >400 Mg/dl (>4.5 Mmol/l), This Equation Is Less Accurate And Ldl-C Concentrations Should Be Determined By Ultracentrifugation. In Hypertriglyceridemic Patients, Ldl-C May Be Low Or Normal Despite Elevated Total-C. In Such Cases, Lovastatin Tablets Are Not Indicated. The National Cholesterol Education Program (ncep) Treatment Guidelines Are Summarized Below: Ncep Treatment Guidelines: Ldl-C Goals And Cutpoints For Therapeutic Lifestyle Changes And Drug Therapy In Different Risk Categories Risk Category Ldl Goal (mg/dl) Ldl Level At Which To Initiate Therapeutic Lifestyle Changes (mg/dl) Ldl Level At Which To Consider Drug Therapy (mg/dl) Chd Or Chd Risk Equivalence (10-Year Risk >20%) <100 ≥100 ≥130(100-129: Drug Optional) 2+ Risk Factors(10-Year Risk ≤20%) <130 ≥130 10-Year Risk 10-20%: ≥13010-Year Risk<10%: ≥160 0-1 Risk Factor <160 ≥160 ≥190(160-189: Ldl-Lowering Drug Optional) After The Ldl-C Goal Has Been Achieved, If The Tg Is Still ≥200 Mg/dl, Non-Hdl-C (total-C Minus Hdlc) Becomes A Secondary Target Of Therapy. Non-Hdl-C Goals Are Set 30 Mg/dl Higher Than Ldl-C Goals For Each Risk Category. At The Time Of Hospitalization For An Acute Coronary Event, Consideration Can Be Given To Initiating Drug Therapy At Discharge If The Ldl-C Is ≥130 Mg/dl (see Ncep Guidelines Above). Since The Goal Of Treatment Is To Lower Ldl-C, The Ncep Recommends That Ldl-C Levels Be Used To Initiate And Assess Treatment Response. Only If Ldl-C Levels Are Not Available, Should The Total-C Be Used To Monitor Therapy. Although Lovastatin Tablets May Be Useful To Reduce Elevated Ldl-C Levels In Patients With Combined Hypercholesterolemia And Hypertriglyceridemia Where Hypercholesterolemia Is The Major Abnormality (type Iib Hyperlipoproteinemia), It Has Not Been Studied In Conditions Where The Major Abnormality Is Elevation Of Chylomicrons, Vldl Or Idl (i.e., Hyperlipoproteinemia Types I, Iii, Iv, Or V).*** The Ncep Classification Of Cholesterol Levels In Pediatric Patients With A Familial History Of Hypercholesterolemia Or Premature Cardiovascular Disease Is Summarized Below: Category Total-C (mg/dl) Ldl-C (mg/dl) Acceptable <170 <110 Borderline 170-199 110-129 High ≥200 ≥130 Children Treated With Lovastatin In Adolescence Should Be Re-Evaluated In Adulthood And Appropriate Changes Made To Their Cholesterol-Lowering Regimen To Achieve Adult Goals For Ldl-C.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Lovastatin LOVASTATIN ZINC3812841

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