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NDC 53489-0144-01

Spironolactone and Hydrochlorothiazide 25 mg/1, 25 mg/1 TABLET

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NDC
53489-0144-01
Generic Name
Spironolactone and Hydrochlorothiazide
Brand Name
Spironolactone and Hydrochlorothiazide
Strength
25 mg/1, 25 mg/1
Dosage Form
TABLET
Route
ORAL
Package Size
—
Labeler
Sun Pharmaceutical Industries, Inc.

FDA Drug Information

Indications & Usage

INDICATIONS AND USAGE Spironolactone, an ingredient of spironolactone and hydrochlorothiazide tablets, has been shown to be a tumorigen in chronic toxicity studies in rats (see Precautions section). Spironolactone and hydrochlorothiazide tablets should be used only in those conditions described below. Unnecessary use of this drug should be avoided. Spironolactone and hydrochlorothiazide tablets are indicated for: Edematous conditions for patients with: Congestive heart failure: •For the manageme…

Important Warnings

WARNINGS Potassium supplementation, either in the form of medication or as a diet rich in potassium, should not ordinarily be given in association with spironolactone and hydrochlorothiazide tablets therapy. Excessive potassium intake may cause hyperkalemia in patients receiving spironolactone and hydrochlorothiazide tablets (see Precautions : General ). Concomitant administration of spironolacton…

Source: FDA. For professional use only. Not a substitute for prescribing information.

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