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Basic Drug Info
Drug Name:HydrALAzine Hydrochloride
Manufacturer:Barr Laboratories, Inc.
Other Info:

Manufactured by PLIVA Krakow Pharmaceutical Company S.A.,Krakow, Poland for PLIVA®, Inc., Pomona, NY 10970Distributed by Barr Laboratories, Inc.

Pomona, NY 10970Revised APRIL 2007BR 398,327,328,397K21-032711001203



Clinical Trials:


Indications and Usage
Essential hypertension, alone or as an adjunct.
Essential Hypertension -- hypertension occurring without preexisting renal disease or known organic cause.

Contraindications
Hypersensitivity to hydrALAzine; coronary artery disease; mitral valvular rheumatic heart disease.
Hypersensitivity -- Altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen.

Rheumatism -- Disorders of connective tissue, especially the joints and related structures, characterized by inflammation, degeneration, or metabolic derangement.

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.)
Branded Drugs
The following US Branded drugs contain HydrALAzine Hydrochloride


APRESOLINE -- NOVARTIS PHARMACEUTICALS CORP

DRALZINE -- TEVA PHARMACEUTICALS USA INC

APRESAZIDE -- NOVARTIS PHARMACEUTICALS CORP

HYDRALAZINE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE -- SOLVAY PHARMACEUTICALS

HYDRALAZINE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE -- SUPERPHARM CORP

HYDRALAZINE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE -- WATSON LABORATORIES INC

HYDRALAZINE HYDROCHLORIDE W/ HYDROCHLOROTHIAZIDE 100/50 -- IVAX PHARMACEUTICALS INC

HYDRALAZINE HYDROCHLORIDE W/ HYDROCHLOROTHIAZIDE 25/25 -- IVAX PHARMACEUTICALS INC

HYDRALAZINE HYDROCHLORIDE W/ HYDROCHLOROTHIAZIDE 50/50 -- IVAX PHARMACEUTICALS INC

HYDRA-ZIDE -- PAR PHARMACEUTICAL INC

APRESOLINE-ESIDRIX -- NOVARTIS PHARMACEUTICALS CORP

HYDRALAZINE AND HYDROCHLORTHIAZIDE -- WATSON LABORATORIES INC

HYDROCHLOROTHIAZIDE W/ HYDRALAZINE -- WATSON LABORATORIES INC

CAM-AP-ES -- TG UNITED LABS LLC

HYDRALAZINE HYDROCHLORIDE, HYDROCHLOROTHIAZIDE AND RESERPINE -- IVAX PHARMACEUTICALS INC

HYDRALAZINE HYDROCHLORIDE-HYDROCHLOROTHIAZIDE-RESERPINE -- MYLAN PHARMACEUTICALS INC

HYDRALAZINE, HYDROCHLOROTHIAZIDE W/ RESERPINE -- WATSON LABORATORIES INC

HYDRAP-ES -- SANDOZ INC

HYDROCHLOROTHIAZIDE W/ RESERPINE AND HYDRALAZINE -- WATSON LABORATORIES INC

HYDROSERPINE PLUS (R-H-H) -- IVAX PHARMACEUTICALS INC

RESERPINE, HYDRALAZINE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE -- MUTUAL PHARMACEUTICAL CO INC

RESERPINE, HYDRALAZINE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE -- SOLVAY PHARMACEUTICALS

RESERPINE, HYDRALAZINE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE -- WATSON LABORATORIES INC

RESERPINE, HYDROCHLOROTHIAZIDE, AND HYDRALAZINE HYDROCHLORIDE -- LEDERLE LABORATORIES DIV AMERICAN CYANAMID CO

SER-A-GEN -- SOLVAY PHARMACEUTICALS

SER-AP-ES -- NOVARTIS PHARMACEUTICALS CORP

UNIPRES -- SOLVAY PHARMACEUTICALS

BIDIL -- NITROMED INC

DRALSERP -- SANDOZ INC

SERPASIL-APRESOLINE -- NOVARTIS PHARMACEUTICALS CORP


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