Simvastatin

Product manufactured by Cardinal Health

Application Nr Approved Date Route Status External Links
ANDA078103 2009-04-14 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Simvastatin Is An Hmg-Coa Reductase Inhibitor (statin) Indicated As An Adjunctive Therapy To Diet To: •reduce The Risk Of Total Mortality By Reducing Chd Deaths And Reduce The Risk Of Non-Fatal Myocardial Infarction, Stroke, And The Need For Revascularization Procedures In Patients At High Risk Of Coronary Events. (1.1) •reduce Elevated Total-C, Ldl-C, Apo B, Tg And Increase Hdl-C In Patients With Primary Hyperlipidemia (heterozygous Familial And Nonfamilial) And Mixed Dyslipidemia. (1.2) •reduce Elevated Tg In Patients With Hypertriglyceridemia And Reduce Tg And Vldl-C In Patients With Primary Dysbetalipoproteinemia. (1.2) •reduce Total-C And Ldl-C In Adult Patients With Homozygous Familial Hypercholesterolemia. (1.2) •reduce Elevated Total-C, Ldl-C, And Apo B In Boys And Postmenarchal Girls, 10 To 17 Years Of Age With Heterozygous Familial Hypercholesterolemia After Failing An Adequate Trial Of Diet Therapy. (1.2, 1.3) Limitations Of Use Simvastatin Has Not Been Studied In Fredrickson Types I And V Dyslipidemias. (1.4) Therapy With Lipid-Altering Agents Should Be Only One Component Of Multiple Risk Factor Intervention In Individuals At Significantly Increased Risk For Atherosclerotic Vascular Disease Due To Hypercholesterolemia. Drug Therapy Is Indicated As An Adjunct To Diet When The Response To A Diet Restricted In Saturated Fat And Cholesterol And Other Nonpharmacologic Measures Alone Has Been Inadequate. In Patients With Coronary Heart Disease (chd) Or At High Risk Of Chd, Simvastatin Tablets Usp Can Be Started Simultaneously With Diet. 1.1 Reductions In Risk Of Chd Mortality And Cardiovascular Events In Patients At High Risk Of Coronary Events Because Of Existing Coronary Heart Disease, Diabetes, Peripheral Vessel Disease, History Of Stroke Or Other Cerebrovascular Disease, Simvastatin Tablets Usp Are Indicated To: •reduce The Risk Of Total Mortality By Reducing Chd Deaths. •reduce The Risk Of Non-Fatal Myocardial Infarction And Stroke. •reduce The Need For Coronary And Non-Coronary Revascularization Procedures. 1.2 Hyperlipidemia Simvastatin Tablets Usp Are Indicated To: •reduce Elevated Total Cholesterol (total-C), Low-Density Lipoprotein Cholesterol (ldl-C), Apolipoprotein B (apo B), And Triglycerides (tg), And To Increase High-Density Lipoprotein Cholesterol (hdl-C) In Patients With Primary Hyperlipidemia (fredrickson Type Iia, Heterozygous Familial And Nonfamilial) Or Mixed Dyslipidemia (fredrickson Type Iib). •reduce Elevated Tg In Patients With Hypertriglyceridemia (fredrickson Type Lv Hyperlipidemia). •reduce Elevated Tg And Vldl-C In Patients With Primary Dysbetalipoproteinemia (fredrickson Type Iii Hyperlipidemia). •reduce Total-C And Ldl-C In Patients With Homozygous Familial Hypercholesterolemia (hofh) As An Adjunct To Other Lipid-Lowering Treatments (e.g., Ldl Apheresis) Or If Such Treatments Are Unavailable. 1.3 Adolescent Patients With Heterozygous Familial Hypercholesterolemia (hefh) Simvastatin Tablets Usp Are Indicated As An Adjunct To Diet To Reduce Total-C, Ldl-C, And Apo 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 Cholesterol Remains ≥190 Mg/dl; Or •ldl Cholesterol Remains ≥160 Mg/dl And •there Is A Positive Family History Of Premature Cardiovascular Disease (cvd) Or •two Or More Other Cvd Risk Factors Are Present In The Adolescent Patient. The Minimum Goal Of Treatment In Pediatric And Adolescent Patients Is To Achieve A Mean Ldl-C <130 Mg/dl. The Optimal Age At Which To Initiate Lipid-Lowering Therapy To Decrease The Risk Of Symptomatic Adulthood Cad Has Not Been Determined. 1.4 Limitations Of Use Simvastatin Tablets Usp Have Not Been Studied In Conditions Where The Major Abnormality Is Elevation Of Chylomicrons (i.e., Hyperlipidemia Fredrickson Types I And V).

All Formulated Excipients (7 Total)

Name Structure Kind Function Status
1. Ascorbic Acid ASCORBIC ACID Molecular DS-Dietary supplement , MISC-Miscellaneous , NUTR-Nutrient , PRES-Chemical preservative FS-Substances permitted as optional ingredient in a standardized food.
2. Citric Acid Monohydrate CITRIC ACID MONOHYDRATE Molecular
3. Hypromelloses HYPROMELLOSES Unresolved
4. Ferric Oxide Red FERRIC OXIDE RED Molecular
5. Lactose Monohydrate LACTOSE MONOHYDRATE Molecular
6. 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.
7. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Simvastatin SIMVASTATIN ZINC3780893

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