Application Nr Approved Date Route Status External Links
ANDA075480 2000-08-22 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Hypertension Enalapril Maleate Tablets, Usp Are Indicated For The Treatment Of Hypertension. Enalapril Maleate Tablets Are Effective Alone Or In Combination With Other Antihypertensive Agents, Especially Thiazide-Type Diuretics. The Blood Pressure Lowering Effects Of Enalapril Maleate Tablets And Thiazides Are Approximately Additive. Heart Failure Enalapril Maleate Tablets Are Indicated For The Treatment Of Symptomatic Congestive Heart Failure, Usually In Combination With Diuretics And Digitalis. In These Patients Enalapril Maleate Tablets Improve Symptoms, Increases Survival, And Decreases The Frequency Of Hospitalization (see Clinical Pharmacology: Heart Failure, Mortality Trials For Details And Limitations Of Survival Trials). Asymptomatic Left Ventricular Dysfunction In Clinically Stable Asymptomatic Patients With Left Ventricular Dysfunction (ejection Fraction ≤ 35%), Enalapril Maleate Tablets Decrease The Rate Of Development Of Overt Heart Failure And Decrease The Incidence Of Hospitalization For Heart Failure (see Clinical Pharmacology: Heart Failure, Mortality Trials For Details And Limitations Of Survival Trials). In Using Enalapril Maleate 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 Enalapril Maleate Tablets Do Not Have A Similar Risk. (see Warnings.) In Considering Use Of Enalapril Maleate 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, It Should Be Noted That Black Patients Receiving Ace Inhibitors Have Been Reported To Have A Higher Incidence Of Angioedema Compared To Non-Blacks. (see Warnings: Head And Neck Angioedema.)

All Formulated Excipients (5 Total)

Name Structure Kind Function Status
1. Anhydrous Lactose ANHYDROUS LACTOSE Molecular
2. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.
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. Maleic Acid MALEIC ACID Molecular
5. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Enalapril Maleate ENALAPRIL MALEATE ZINC3791297

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