Application Nr Approved Date Route Status External Links
ANDA075752 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. It May Be Used Alone As Initial Therapy Or Concomitantly With Other Classes Of 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 Tablets Do Not Have A Similar Risk (see Warnings). In Considering Use Of Lisinopril Tablets, 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. Starch, Corn STARCH, CORN Unresolved
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