Application Nr Approved Date Route Status External Links
ANDA077690 2006-06-20 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Hypertension Quinapril Tablets Usp Are 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. These Benefits Have Been Seen In Controlled Trials Of Antihypertensive Drugs From A Wide Variety Of Pharmacologic Classes Including The Class To Which This Drug Principally Belongs. There Are No Controlled Trials Demonstrating Risk Reduction With Quinapril Tablets Usp. 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, 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, 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. Quinapril Tablets Usp May Be Used Alone Or In Combination With Thiazide Diuretics. Heart Failure Quinapril Tablets Usp Is Indicated In The Management Of Heart Failure As Adjunctive Therapy When Added To Conventional Therapy Including Diuretics And/or Digitalis. In Using Quinapril Tablets Usp, Consideration Should Be Given To The Fact That Another Ace Inhibitor, Captopril, Has Caused Agranulocytosis, Particularly In Patients With Renal Impairment Or Collagen Vascular Disease. Available Data Are Insufficient To Show That Quinapril Tablets Usp Does Not Have A Similar Risk (see Warnings). Angioedema In Black Patients Black Patients Receiving Ace Inhibitor Monotherapy Have Been Reported To Have A Higher Incidence Of Angioedema Compared To Non-Blacks. It Should Also Be Noted That In Controlled Clinical Trials Ace Inhibitors Have An Effect On Blood Pressure That Is Less In Black Patients Than In Non-Blacks.

All Formulated Excipients (8 Total)

Name Structure Kind Function Status
1. Ferric Oxide Yellow FERRIC OXIDE YELLOW Molecular
2. Lecithin LECITHIN Unresolved
3. Magnesium Carbonate MAGNESIUM CARBONATE Molecular B&N-Buffer & neutralizing agent FS-Substances permitted as optional ingredient in a standardized food.
4. 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.
5. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
6. Polyvinyl Alcohol POLYVINYL ALCOHOL Unresolved
7. Povidones POVIDONES Unresolved
8. Talc TALC Unresolved DYE-Dye GRAS-Generally recognized as safe.

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Quinapril Hydrochloride QUINAPRIL HYDROCHLORIDE ZINC3801163

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