Application Nr Approved Date Route Status External Links
ANDA078211 2009-03-04 Oral DISCN Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Quinapril Hydrochloride And Hydrochlorothiazide Tablets Are Indicated For The Treatment Of Hypertension. This Fixed Combination Is Not Indicated For The Initial Therapy Of Hypertension (see Dosage And Administration). In Using Quinapril Hydrochloride And Hydrochlorothiazide, 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. Available Data Are Insufficient To Show That Quinapril Does Not Have A Similar Risk (see Warnings: Neutropenia/agranulocytosis). Angioedema In Black Patients: Black Patients Receiving Ace Inhibitor Monotherapy Have Been Reported To Have A Higher Incidence Of Angioedema Compared To Non-Blacks. It Should Also 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.

All Formulated Excipients (10 Total)

Name Structure Kind Function Status
1. Ferric Oxide Red FERRIC OXIDE RED Molecular
2. Lecithin LECITHIN Unresolved
3. Magnesium Carbonate MAGNESIUM CARBONATE Molecular B&N-Buffer & neutralizing agent FS-Substances permitted as optional ingredient in a standardized food.
4. 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.
5. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
6. Polyvinyl Alcohol POLYVINYL ALCOHOL Unresolved
7. Povidones POVIDONES Unresolved
8. Talc TALC Unresolved DYE-Dye GRAS-Generally recognized as safe.
9. Titanium Dioxide TITANIUM DIOXIDE Unresolved DYE-Dye
10. Xanthan Gum XANTHAN GUM Unresolved EMUL-Emulsifier FS-Substances permitted as optional ingredient in a standardized food.

Active Ingredients ( 2 Total)

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