Aldactazide
Description
Clinical
Indications
Side Effects
Warnings
OverDosage
Patient Info


Spironolactone, an ingredient of Aldactazide, has been shown to be a tumorigen in chronic toxicity studies in rats (see PRECAUTIONS). Aldactazide should be used only in those conditions described under INDICATIONS AND USAGE.
Unnecessary use of this drug should be avoided.

Fixed-dose combination drugs are not indicated for initial therapy of edema or hypertension. Edema or hypertension requires therapy titrated to the individual patient. If the fixed combination represents the dosage so determined, its use may be more convenient in patient management. The treatment of hypertension and edema is not static but must be reevaluated as conditions in each patient warrant.


Aldactazide oral tablets contain:

spironolactone                  25 mg

hydrochlorothiazide           25 mg

                 or

spironolactone                  50 mg
hydrochlorothiazide           50 mg


Spironolactone (Aldactone®), an aldosterone antagonist, is 17-hydroxy-7alpha-mercapto-3-oxo-17alpha-pregn-4-ene-21-carboxylic acid gamma -lactone acetate. Spironolactone is practically insoluble in water, soluble in alcohol, and freely soluble in benzene and in chloroform.

Hydrochlorothiazide, a diuretic and antihypertensive, is 6-chloro-3, 4-dihydro-2H-1, 2, 4-benzothiadiazine-7-sulfonamide 1, 1-dioxide. Hydrochlorothiazide is slightly soluble in water and freely soluble in sodium hydroxide solution.

Inactive ingredients include calcium sulfate, corn starch, flavor, hydroxypropyl cellulose, hydroxypropyl methylcellulose, iron oxide, magnesium stearate, polyethylene glycol, povidone, and titanium dioxide.

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