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Aldactazide

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Aldactazide

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.

DRUG DESCRIPTION

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 γ-lactone acetate and has the following structural formula:

Spironolactone - Structural Formula Illustration

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:

Hydrochlorothiazide - Structural Formula Illustration

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.

What are the possible side effects of hydrochlorothiazide and spironolactone (Aldactazide)?

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:

  • eye pain, vision problems;
  • numbness or tingly feeling;
  • muscle pain or weakness;
  • slow, fast, or uneven heartbeat;
  • feeling drowsy, restless, or light-headed;
  • urinating less than usual or not at all;
  • shallow breathing;
  • tremors,...

Read All Potential Side Effects and See Pictures of Aldactazide »

What are the precautions when taking spironolactone and hydrochlorothiazide (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), decreased adrenal gland function (Addison's disease).

Before having surgery, tell your doctor or dentist about all the products you use...

Read All Potential Precautions of Aldactazide »

Last reviewed on RxList: 3/21/2014
This monograph has been modified to include the generic and brand name in many instances.

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Aldactazide - User Reviews

Aldactazide User Reviews

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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