Application Nr Approved Date Route Status External Links
ANDA076059 2002-07-01 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Hypertension: Lisinopril Tablets Are Indicated For The Treatment Of Hypertension To Lower Blood Pressure. Lowering Blood Pressure Lowers The Risk Of Fatal And Non-Fatal 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 Lisinopril. 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 1 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. Lisinopril Tablets May Be Administered Alone Or With Other Antihypertensive Agents. Heart Failure: Lisinopril Tablets Are Indicated As Adjunctive Therapy In The Management Of Heart Failure In Patients Who Are Not Responding Adequately To Diuretics And Digitalis. Acute Myocardial Infarction: Lisinopril Tablets Are Indicated For The Treatment Of Hemodynamically Stable Patients Within 24 Hours Of Acute Myocardial Infarction, To Improve Survival. Patients Should Receive, As Appropriate, The Standard Recommended Treatments Such As Thrombolytics, Aspirin And Beta-Blockers. In Using Lisinopril Tablets, Consideration Should Be Given To The Fact That Another Angiotensin-Converting Enzyme Inhibitor, Captopril, Has Caused Agranulocytosis, Particularly In Patients With Renal Impairment Or Collagen Vascular Disease, And That Available Data Are Insufficient To Show That Lisinopril Does Not Have A Similar Risk (see Warnings ). In Considering The Use Of Lisinopril, It Should 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. In Addition, Ace Inhibitors Have Been Associated With A Higher Rate Of Angioedema In Black Than In Non-Black Patients (see Warnings, Anaphylactoid And Possibly Related Reactions ).

All Formulated Excipients (4 Total)

Name Structure Kind Function Status
1. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.
2. Calcium Phosphate, Dibasic, Anhydrous CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS Molecular
3. 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.
4. Mannitol MANNITOL Molecular NUTR-Nutrient GRAS-Generally recognized as safe.

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Lisinopril LISINOPRIL ZINC3812863

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