hydralazine hydrochloride

FDA Drug Profile — HYDRALAZINE HYDROCHLORIDE

Drug Details

Generic Name
hydralazine hydrochloride
Brand Names
HYDRALAZINE HYDROCHLORIDE
Application Number
ANDA086242
Sponsor
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
NDC Codes
15
Dosage Forms
TABLET, FILM COATED, TABLET
Routes
ORAL
Active Ingredients
HYDRALAZINE HYDROCHLORIDE

Indications and Usage

INDICATIONS AND USAGE: Essential hypertension, alone or as an adjunct.

Warnings

WARNINGS: In a few patients hydrALAZINE may produce a clinical picture simulating systemic lupus erythematosus including glomerulonephritis. In such patients hydrALAZINE should be discontinued unless the benefit-to-risk determination requires continued antihypertensive therapy with this drug. Symptoms and signs usually regress when the drug is discontinued but residua have been detected many years later. Long-term treatment with steroids may be necessary. (See PRECAUTIONS , Laboratory Tests . )