Product manufactured by Remedyrepack Inc.

Application Nr Approved Date Route Status External Links
ANDA078384 2007-09-05 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Carvedilol Tablet Is An Alpha/beta-Adrenergic Blocking Agent Indicated For The Treatment Of: Mild To Severe Chronic Heart Failure ( 1.1) Left Ventricular Dysfunction Following Myocardial Infarction In Clinically Stable Patients ( 1.2) Hypertension ( 1.3) 1.1 Heart Failure Carvedilol Tablets Is Indicated For The Treatment Of Mild-To-Severe Chronic Heart Failure Of Ischemic Or Cardiomyopathic Origin, Usually In Addition To Diuretics, Ace Inhibitors, And Digitalis, To Increase Survival And, Also, To Reduce The Risk Of Hospitalization [see Clinical Studies ( 14.1)]. 1.2 Left Ventricular Dysfunction Following Myocardial Infarction Carvedilol Tablet Is Indicated To Reduce Cardiovascular Mortality In Clinically Stable Patients Who Have Survived The Acute Phase Of A Myocardial Infarction And Have A Left Ventricular Ejection Fraction Of Less Than Or Equal To 40% (with Or Without Symptomatic Heart Failure) [ See Clinical Studies ( 14.2) ]. 1.3 Hypertension Carvedilol Tablet Is Indicated For The Management Of Essential Hypertension [ See Clinical Studies ( 14.3, 14.4) ]. It Can Be Used Alone Or In Combination With Other Antihypertensive Agents, Especially Thiazide-Type Diuretics [ See Drug Interactions ( 7.2) ].

All Formulated Excipients (7 Total)

Name Structure Kind Function Status
1. Hypromelloses HYPROMELLOSES Unresolved
2. Lactose Monohydrate LACTOSE MONOHYDRATE 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. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
5. Polyethylene Glycols POLYETHYLENE GLYCOLS Unresolved
6. Trisodium Citrate Dihydrate TRISODIUM CITRATE DIHYDRATE Molecular
7. Sucrose SUCROSE Molecular NUTRS-Nutritive Sweetener GRAS-Generally recognized as safe.

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Carvedilol CARVEDILOL ZINC1530579