Clinical Information
Gen. Code and Des.
6813 spironolact/hydrochlorothiazid ORAL TABLET 25 MG-25MG
GCN and Des.
82330 spironolact/hydrochlorothiazid ORAL TABLET 25 MG-25MG
Strength
25/25MG
Dose Form
TABLET
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family
AHFS Class
24322000 MINERALOCORTICOID (ALDOSTERONE) ANTAGNTS
40281600 POTASSIUM-SPARING DIURETICS
24082416 POTASSIUM-SPARING DIURETICS (HYPOTEN)
24082420 THIAZIDE DIURETICS(HYPOTENSIVE AGENTS)
24084420 MINERALOCORTICOID(ALDOSTER.)ANTAG(HYPOT)
40282000 THIAZIDE DIURETICS
Active Ingredients
2211 spironolactone 52017
2294 hydrochlorothiazide 58935
Inactive Ingredients
2537 povidone 9003398
ALDACTAZIDE- spironolactone and hydrochlorothiazide tablet, film coated
G.D. Searle LLC Division of Pfizer Inc
WARNING
Spironolactone, an ingredient of ALDACTAZIDE, has been shown to be 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.
DESCRIPTION
ALDACTAZIDE oral tablets contain:
spironolactone . . . . . . . . . . 25 mg
hydrochlorothiazide . . . . . . . . 25 mg
or
spironolactone . . . . . . . . . . 50 mghydrochlorothiazide . . . . . . . . 50 mg
Spironolactone (ALDACTONE?), an aldosterone antagonist, is 17-hydroxy-7?-mercapto-3-oxo-17?-pregn-4-ene-21-carboxylic acid ?-lactone acetate
Spironolactone is practically insoluble in water, soluble in alcohol, and freely soluble in benzene and in chloroform.
Hydrochlorothiazide, 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, hypromellose, iron oxide, magnesium stearate, polyethylene glycol, povidone, and titanium dioxide.
Mechanism of action
ALDACTAZIDE is combination of two diuretic agents with different but complementary mechanisms and sites of action, thereby providing additive diuretic and antihypertensive effects. Additionally, the spironolactone component helps to minimize the potassium loss characteristically induced by the thiazide component.
The diuretic effect of spironolactone is mediated through its action as specific pharmacologic antagonist of aldosterone, primarily by competitive binding of receptors at the aldosterone-dependent sodium-potassium exchange site in the distal convoluted renal tubule. Hydrochlorothiazide promotes the excretion of sodium and water primarily by inhibiting their reabsorption in the cortical diluting segment of the distal renal tubule.
ALDACTAZIDE is indicated for:
Edematous conditions for patients with:
Congestive heart failure:
Cirrhosis of the liver accompanied by edema and/or ascites:
The nephrotic syndrome:
Essential hypertension:
CONTRAINDICATIONS
ALDACTAZIDE is contraindicated in patients with anuria, acute renal insufficiency, significant impairment of renal excretory function, hypercalcemia, hyperkalemia, Addison?s disease, and in patients who are allergic to thiazide diuretics or to other sulfonamide-derived drugs. ALDACTAZIDE may also be contraindicated in acute or severe hepatic failure.