Application Nr Approved Date Route Status External Links
ANDA079245 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Fosinopril Sodium And Hydrochlorothiazide Tablets Are Indicated For The Treatment Of Hypertension. These Fixed Dose Combinations Are Not Indicated For Initial Therapy. (see Dosage And Administration . ) In Using Fosinopril Sodium 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 Fosinopril Does Not Have A Similar Risk (see Warnings: Neutropenia/agranulocytosis ). 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 (0 Total)

None

Active Ingredients ( 2 Total)

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