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Aldactazide®
(spironolactone and hydrochlorothiazide) Tablets
WARNING
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-7αmercapto-3-oxo-17α-pregn-4-ene-21-carboxylic acid &gama;-lactone acetate and has the following structural formula:
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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-1,2,4benzothiadiazine-7-sulfonamide 1,1-dioxide and has the following structural formula:
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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.
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop using this medication and call your doctor at once if you have a serious side effect such as:
Read All Potential Side Effects and See Pictures of Aldactazide »
Before taking this product, tell your doctor or pharmacist if you are allergic to either spironolactone or hydrochlorothiazide; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: untreated salt/mineral imbalance (such as high potassium, low sodium level), kidney disease, liver disease, diabetes, loss of too much body water (dehydration), lupus, gout, high levels of fats in the blood (cholesterol/triglycerides).
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Last reviewed on RxList: 6/21/2011
This monograph has been modified to include the generic and brand name in many instances.
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