Application Nr Approved Date Route Status External Links
NDA202331 2011-12-20 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Edarbyclor Contains An Angiotensin Ii Receptor Blocker (arb) And A Thiazide-Like Diuretic And Is Indicated For The Treatment Of Hypertension, To Lower Blood Pressure. Edarbyclor May Be Used In Patients Whose Blood Pressure Is Not Adequately Controlled On Monotherapy. Edarbyclor May Be Used As Initial Therapy If A Patient Is Likely To Need Multiple Drugs To Achieve Blood Pressure Goals. Lowering Blood Pressure Reduces The Risk Of Fatal And Nonfatal Cardiovascular Events, Primarily Strokes And Myocardial Infarctions. These Benefits Have Been Seen In Controlled Trials Of Antihypertensive Drugs From A Wide Variety Of Pharmacologic Classes Including Thiazide-Like Diuretics Such As Chlorthalidone And Arbs Such As Azilsartan Medoxomil. There Are No Controlled Trials Demonstrating Risk Reduction With Edarbyclor. Control Of High Blood Pressure Should Be Part Of Comprehensive Cardiovascular 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 Of High Blood Pressure, 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 Cardiovascular 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 Cardiovascular Outcome Benefit Has Been A Reduction In The Risk Of Stroke, But Reductions In Myocardial Infarction And Cardiovascular Mortality Also Have Been Seen Regularly. Elevated Systolic Or Diastolic Pressure Causes Increased Cardiovascular 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; However, The Blood Pressure Effect Of Edarbyclor In Blacks Is Similar To That In Non-Blacks. 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. The Choice Of Edarbyclor As Initial Therapy For Hypertension Should Be Based On An Assessment Of Potential Benefits And Risks Including Whether The Patient Is Likely To Tolerate The Starting Dose Of Edarbyclor. Patients With Moderate-To-Severe Hypertension Are At A Relatively High Risk Of Cardiovascular Events (e.g., Stroke, Heart Attack, And Heart Failure), Kidney Failure, And Vision Problems, So Prompt Treatment Is Clinically Relevant. Consider The Patient's Baseline Blood Pressure, Target Goal And The Incremental Likelihood Of Achieving The Goal With A Combination Product, Such As Edarbyclor, Versus A Monotherapy Product When Deciding Upon Initial Therapy. Individual Blood Pressure Goals May Vary Based On The Patient's Risk. Data From An 8-Week, Active-Controlled, Factorial Trial Provide Estimates Of The Probability Of Reaching A Target Blood Pressure With Edarbyclor Compared With Azilsartan Medoxomil Or Chlorthalidone Monotherapy [see Clinical Studies (14)]. Figures 1.a-1.d Provide Estimates Of The Likelihood Of Achieving Target Clinic Systolic And Diastolic Blood Pressure Control With Edarbyclor 40/25 Mg Tablets After 8 Weeks, Based On Baseline Systolic Or Diastolic Blood Pressure. The Curve For Each Treatment Group Was Estimated By Logistic Regression Modeling And Is More Variable At The Tails. Figure 1.a Probability Of Achieving Systolic Blood Pressure <140 Mmhg At Week 8 Figure 1.b Probability Of Achieving Systolic Blood Pressure <130 Mmhg At Week 8 Figure 1.c Probability Of Achieving Diastolic Blood Pressure <90 Mmhg At Week 8 Figure 1.d Probability Of Achieving Diastolic Blood Pressure <80 Mmhg At Week 8 For Example, A Patient With A Baseline Blood Pressure Of 170/105 Mm Hg Has Approximately A 48% Likelihood Of Achieving A Goal Of <140 Mm Hg (systolic) And 48% Likelihood Of Achieving <90 Mm Hg (diastolic) On Azilsartan Medoxomil 80 Mg. The Likelihood Of Achieving These Same Goals On Chlorthalidone 25 Mg Is Approximately 51% (systolic) And 40% (diastolic). These Likelihoods Rise To 85% (systolic) And 85% (diastolic) With Edarbyclor 40/25 Mg. Edarbyclor Is An Angiotensin Ii Receptor Blocker (arb) And A Thiazide-Like Diuretic Combination Product Indicated For The Treatment Of Hypertension, To Lower Blood Pressure: •in Patients Not Adequately Controlled With Monotherapy (1) •as Initial Therapy In Patients Likely To Need Multiple Drugs To Help Achieve Blood Pressure Goals (1) Lowering Blood Pressure Reduces The Risk Of Fatal And Nonfatal Cardiovascular Events, Primarily Strokes And Myocardial Infarctions (1) Figure1a Figure1b Figure1c Figure1d

All Formulated Excipients (9 Total)

Name Structure Kind Function Status
1. Mannitol MANNITOL Molecular NUTR-Nutrient GRAS-Generally recognized as safe.
2. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
3. Fumaric Acid FUMARIC ACID Molecular DS-Dietary supplement REG-Food additives for which a petition has been filed and a regulation issued.
4. Sodium Hydroxide SODIUM HYDROXIDE Unresolved BC-Boiler compound , B&N-Buffer & neutralizing agent , MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
5. 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.
6. Talc TALC Unresolved DYE-Dye GRAS-Generally recognized as safe.
7. Titanium Dioxide TITANIUM DIOXIDE Unresolved DYE-Dye
8. Ferric Oxide Red FERRIC OXIDE RED Molecular
9. Polyethylene Glycol 8000 POLYETHYLENE GLYCOL 8000 Unresolved

Active Ingredients ( 2 Total)

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