Application Nr Approved Date Route Status External Links
NDA021437 2002-09-27 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Eplerenone Is An Aldosterone Antagonist Indicated For: Improving Survival Of Stable Patients With Lv Systolic Dysfunction (lvef ≤40%) And Chf After An Acute Myocardial Infarction. (1.2) Hypertension, Alone Or Combined With Other Agents. (1.3) Eplerenone Is Indicated For The Treatment Of Hypertension, To Lower Blood Pressure. Lowering Blood Pressure Reduces The Risk Of Fatal And Nonfatal Cardiovascular Events, Primarily Strokes And Myocardial Infarctions. 1.1 Patient Selection Considerations Serum Potassium Levels Should Be Measured Before Initiating Eplerenone Therapy, And Eplerenone Should Not Be Prescribed If Serum Potassium Is >5.5 Meq/l. [see Contraindications (4)]. 1.2 Congestive Heart Failure Post-Myocardial Infarction Eplerenone Is Indicated To Improve Survival Of Stable Patients With Left Ventricular (lv) Systolic Dysfunction (ejection Fraction ≤40%) And Clinical Evidence Of Congestive Heart Failure (chf) After An Acute Myocardial Infarction (mi). 1.3 Hypertension Eplerenone Is Indicated For The Treatment Of Hypertension, To Lower Blood Pressure. Lowering Blood Pressure Reduces The Risk Of Fatal And Nonfatal Cardiovascular (cv) Events, Primarily Strokes And Mi. These Benefits Have Been Seen In Controlled Trials Of Antihypertensive Drugs From A Wide Variety Of Pharmacologic Classes. Control Of High Blood Pressure Should Be Part Of Comprehensive Cv Risk Management, Including, As Appropriate, Lipid Control, Diabetes Management, Antithrombotic Therapy, Smoking Cessation, Exercise, And Limited Sodium Intake. Many Patients Will Require More Than One Drug To Achieve Blood Pressure Goals. For Specific Advice On Goals And Management, See Published Guidelines, Such As Those Of The National High Blood Pressure Education Program's Joint National Committee On Prevention, Detection, Evaluation, And Treatment Of High Blood Pressure (jnc). Numerous Antihypertensive Drugs, From A Variety Of Pharmacologic Classes And With Different Mechanisms Of Action, Have Been Shown In Randomized Controlled Trials To Reduce Cv Morbidity And Mortality, And It Can Be Concluded That It Is Blood Pressure Reduction, And Not Some Other Pharmacologic Property Of The Drugs, That Is Largely Responsible For Those Benefits. The Largest And Most Consistent Cv Outcome Benefit Has Been A Reduction In The Risk Of Stroke, But Reductions In Mi And Cv Mortality Also Have Been Seen Regularly. Elevated Systolic Or Diastolic Pressure Causes Increased Cv Risk, And The Absolute Risk Increase Per Mmhg Is Greater At Higher Blood Pressures, So That Even Modest Reductions Of Severe Hypertension Can Provide Substantial Benefit. Relative Risk Reduction From Blood Pressure Reduction Is Similar Across Populations With Varying Absolute Risk, So The Absolute Benefit Is Greater In Patients Who Are At Higher Risk Independent Of Their Hypertension (for Example, Patients With Diabetes Or Hyperlipidemia), And Such Patients Would Be Expected To Benefit From More Aggressive Treatment To A Lower Blood Pressure Goal. Some Antihypertensive Drugs Have Smaller Blood Pressure Effects (as Monotherapy) In Black Patients, And Many Antihypertensive Drugs Have Additional Approved Indications And Effects (e.g., On Angina, Heart Failure, Or Diabetic Kidney Disease). These Considerations May Guide Selection Of Therapy. Eplerenone May Be Used Alone Or In Combination With Other Antihypertensive Agents.

All Formulated Excipients (10 Total)

Name Structure Kind Function Status
1. Lactose, Unspecified Form LACTOSE, UNSPECIFIED FORM Molecular
2. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
3. Croscarmellose Sodium CROSCARMELLOSE SODIUM Unresolved
4. Hypromelloses HYPROMELLOSES 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. 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.
8. Titanium Dioxide TITANIUM DIOXIDE Unresolved DYE-Dye
9. Polyethylene Glycols POLYETHYLENE GLYCOLS Unresolved
10. Polysorbate 80 POLYSORBATE 80 Unresolved AF-Antifoaming (or defoaming) agent , EMUL-Emulsifier , MISC-Miscellaneous , SDA-Solubilizing & dispersing agent REG-Food additives for which a petition has been filed and a regulation issued.

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Eplerenone EPLERENONE ZINC3985982

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