Application Nr Approved Date Route Status External Links
ANDA074505 1996-02-13 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Hypertension: Captopril Tablets, Usp Are Indicated For The Treatment Of Hypertension. In Using Captopril Tablets, Usp, Consideration Should Be Given To The Risk Of Neutropenia/agranulocytosis (see Warnings ). Captopril Tablets, Usp May Be Used As Initial Therapy For Patients With Normal Renal Function, In Whom The Risk Is Relatively Low. In Patients With Impaired Renal Function, Particularly Those With Collagen Vascular Disease, Captopril Should Be Reserved For Hypertensives Who Have Either Developed Unacceptable Side Effects On Other Drugs, Or Have Failed To Respond Satisfactorily To Drug Combinations. Captopril Tablets, Usp Are Effective Alone And In Combination With Other Antihypertensive Agents, Especially Thiazide-Type Diuretics. The Blood Pressure Lowering Effects Of Captopril And Thiazides Are Approximately Additive. Heart Failure: Captopril Tablets, Usp Are Indicated In The Treatment Of Congestive Heart Failure Usually In Combination With Diuretics And Digitalis. The Beneficial Effect Of Captopril In Heart Failure Does Not Require The Presence Of Digitalis, However, Most Controlled Clinical Trial Experience With Captopril Has Been In Patients Receiving Digitalis, As Well As Diuretic Treatment. Left Ventricular Dysfunction After Myocardial Infarction: Captopril Tablets, Usp Are Indicated To Improve Survival Following Myocardial Infarction In Clinically Stable Patients With Left Ventricular Dysfunction Manifested As An Ejection Fraction ≤ 40% And To Reduce The Incidence Of Overt Heart Failure And Subsequent Hospitalizations For Congestive Heart Failure In These Patients. Diabetic Nephropathy: Captopril Tablets, Usp Are Indicated For The Treatment Of Diabetic Nephropathy (proteinuria > 500 Mg/day) In Patients With Type I Insulin-Dependent Diabetes Mellitus And Retinopathy. Captopril Tablets, Usp Decreases The Rate Of Progression Of Renal Insufficiency And Development Of Serious Adverse Clinical Outcomes (death Or Need For Renal Transplantation Or Dialysis). In Considering Use Of Captopril Tablets, Usp, It Should Be Noted That In Controlled Trials Ace Inhibitors Have An Effect On Blood Pressure That Is Less In Black Patients Than In Non-Blacks. In Addition, Ace Inhibitors (for Which Adequate Data Are Available) Cause A Higher Rate Of Angioedema In Black Than In Non-Black Patients (see Warnings: Head And Neck Angioedema And Intestinal Angioedema ).

All Formulated Excipients (3 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. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Captopril CAPTOPRIL ZINC57001