Application Nr Approved Date Route Status External Links
ANDA075788 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Enalapril Maleate And Hydrochlorothiazide Is Indicated For The Treatment Of Hypertension. This Fixed Dose Combination Is Not Indicated For Initial Treatment (see Dosage And Administration ). In Using Enalapril Maleate 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, And That Available Data Are Insufficient To Show That Enalapril Does Not Have A Similar Risk (see Warnings ). In Considering Use Of Enalapril Maleate And Hydrochlorothiazide, 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 (0 Total)

None

Active Ingredients ( 2 Total)

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