Application Nr Approved Date Route Status External Links
ANDA077987 2007-12-28 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Therapy With Pravastatin Sodium Tablets Should Be Considered In Those Individuals At Increased Risk For Atherosclerosis-Related Clinical Events As A Function Of Cholesterol Level, The Presence Or Absence Of Coronary Heart Disease, And Other Risk Factors. Primary Prevention Of Coronary Events In Hypercholesterolemic Patients Without Clinically Evident Coronary Heart Disease, Pravastatin Sodium Is Indicated To: Reduce The Risk Of Myocardial Infarction Reduce The Risk Of Undergoing Myocardial Revascularization Procedures Reduce The Risk Of Cardiovascular Mortality With No Increase In Death From Non-Cardiovascular Causes. Hyperlipidemia Pravastatin Sodium Tablets Are Indicated As An Adjunct To Diet To Reduce Elevated Total-C, Ldl-C, Apo B, And Tg Levels And To Increase Hdl-C In Patients With Primary Hypercholesterolemia And Mixed Dyslipidemia (fredrickson Type Iia And Iib).8 Pravastatin Sodium Tablets Are Indicated As Adjunctive Therapy To Diet For The Treatment Of Patients With Elevated Serum Triglyceride Levels (fredrickson Type Iv). Pravastatin Sodium Tablets Are Indicated For The Treatment Of Patients With Primary Dysbetalipoproteinemia (fredrickson Type Iii) Who Do Not Respond Adequately To Diet. Pravastatin Sodium Tablets Are Indicated As An Adjunct To Diet And Life-Style Modification For Treatment Of Hefh In Children And Adolescent Patients Ages 8 Years And Older If After An Adequate Trial Of Diet The Following Findings Are Present. Ldl-C Remains ≥190 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 Patient. Lipid-Altering Agents Should Be Used In Addition To A Diet Restricted In Saturated Fat And Cholesterol When The Response To Diet And Other Nonpharmacological Measures Alone Has Been Inadequate (see Ncep Guidelines Below). Prior To Initiating Therapy With Pravastatin, 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 Triglycerides (tg) <400 Mg/dl (<4.5 Mmol/l), Ldl-C Can Be Estimated Using The Following Equation: Ldl-C = Total-C - Hdl-C - 1/5 Tg 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 Many Hypertriglyceridemic Patients, Ldl-C May Be Low Or Normal Despite Elevated Total-C. In Such Cases, Hmg-Coa Reductase Inhibitors Are Not Indicated. Lipid Determinations Should Be Performed At Intervals Of No Less Than Four Weeks And Dosage Adjusted According To The Patient’s Response To Therapy. The National Cholesterol Education Program’s Treatment Guidelines Are Summarized Below: Table 5: 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 Levels At Which To Consider Drug Therapy (mg/dl) Chdchd, Coronary Heart Disease. Or Chd Risk Equivalents(10-Year Risk >20%) <100 ≥100 ≥130(100-129: Drug Optional)some Authorities Recommend The Use Of Ldl-Lowering Drugs In This Category If An Ldl- C Level Of <100 Mg/dl Cannot Be Achieved By Therapeutic Lifestyle Changes. Others Prefer Use Of Drugs That Primarily Modify Triglycerides And Hdl-C, E.g., Nicotinic Acid Or Fibrate. Clinical Judgement Also May Call For Deferring Drug Therapy In This Subcategory. 2+ Risk Factors (10-Year Risk ≤20%) <130 ≥130 10-Year Risk 10%-20%:≥130 10-Year Risk <10%: ≥160 0-1 Risk Factoralmost All People With 0-1 Risk Factor Have 10-Year Risk <10%; Thus, 10-Year Risk Assessment In People With 0-1 Risk Factor Is Not Necessary. <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 Hdl-C) 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 Treatment 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. As With Other Lipid-Lowering Therapy, Pravastatin Sodium Tablets Are Not Indicated When Hypercholesterolemia Is Due To Hyperalphalipoproteinemia (elevated Hdl-C). 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

All Formulated Excipients (4 Total)

Name Structure Kind Function Status
1. Hypromelloses HYPROMELLOSES Unresolved
2. 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.
3. Mannitol MANNITOL Molecular NUTR-Nutrient GRAS-Generally recognized as safe.
4. Meglumine MEGLUMINE Molecular

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Pravastatin Sodium PRAVASTATIN SODIUM ZINC3798763