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.
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ALDACTAZIDE SUMMARY
Aldactazide®
spironolactone and
hydrochlorothiazide tablets
Aldactazide oral tablets contain:
spironolactone. .. .. .. .. .. .. .. .. .. . 25 mg
hydrochlorothiazide. .. .. .. .. .. .. .. . 25 mg
or
spironolactone. .. .. .. .. .. .. .. .. .. . 50 mg
hydrochlorothiazide. .. .. .. .. .. .. .. . 50 mg
Spironolactone (Aldactone®) is an aldosterone antagonist diuretic.
Hydrochlorothiazide is a diuretic and antihypertensive.
Spironolactone, an ingredient of Aldactazide, has been shown to be a tumorigen in chronic toxicity studies in rats (see Precautions section). Aldactazide should be used only in those conditions described below. Unnecessary use of this drug should be avoided.
Aldactazide is indicated for:
Edematous conditions for patients with:
Congestive heart failure: For the management of edema and sodium retention when the patient is only partially responsive to, or is intolerant of, other therapeutic measures. The treatment of diuretic-induced hypokalemia in patients with congestive heart failure when other measures are considered inappropriate. The treatment of patients with congestive heart failure taking digitalis when other therapies are considered inadequate or inappropriate.
Cirrhosis of the liver accompanied by edema and/or ascites: Aldosterone levels may be exceptionally high in this condition. Aldactazide is indicated for maintenance therapy together with bed rest and the restriction of fluid and sodium.
The nephrotic syndrome: For nephrotic patients when treatment of the underlying disease, restriction of fluid and sodium intake, and the use of other diuretics do not provide an adequate response.
Essential hypertension
For patients with essential hypertension in whom other measures are considered inadequate or inappropriate. In hypertensive patients for the treatment of a diuretic-induced hypokalemia when other measures are considered inappropriate.
Usage in Pregnancy
The routine use of diuretics in an otherwise healthy woman is inappropriate and exposes mother and fetus to unnecessary hazard. Diuretics do not prevent development of toxemia of pregnancy, and there is no satisfactory evidence that they are useful in the treatment of developing toxemia.
Edema during pregnancy may arise from pathologic causes or from the physiologic and mechanical consequences of pregnancy. Aldactazide is indicated in pregnancy when edema is due to pathologic causes just as it is in the absence of pregnancy (however, see Precautions: Pregnancy ). Dependent edema in pregnancy, resulting from restriction of venous return by the expanded uterus, is properly treated through elevation of the lower extremities and use of support hose; use of diuretics to lower intravascular volume in this case is unsupported and unnecessary. There is hypervolemia during normal pregnancy which is not harmful to either the fetus or the mother (in the absence of cardiovascular disease), but which is associated with edema, including generalized edema, in the majority of pregnant women. If this edema produces discomfort, increased recumbency will often provide relief. In rare instances, this edema may cause extreme discomfort which is not relieved by rest. In these cases, a short course of diuretics may provide relief and may be appropriate.
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NEWS HIGHLIGHTS
Published Studies Related to Aldactazide (Spironolactone / Hydrochlorothiazide)
Effect of spironolactone-hydrochlorothiazide on lung function in infants with chronic bronchopulmonary dysplasia. [1989.04]
To test the hypothesis that spironolactone-hydrochlorothiazide (Aldactazide) will improve urine output and lung function in infants with bronchopulmonary dysplasia, we studied 21 hospitalized, spontaneously breathing, oxygen-dependent infants with chronic bronchopulmonary dysplasia... We speculate that diuresis per se is not responsible for lung function improvement during treatment with other drugs with diuretic properties.
Clinical Trials Related to Aldactazide (Spironolactone / Hydrochlorothiazide)
Spironolactone Plus Metformin in Polycystic Ovary Syndrome [Completed]
The investigators examined whether a combined therapy with low-dose spironolactone plus
metformin is more effective than metformin alone in 52 overweight/obese Polycystic Ovary
Syndrome (PCOS) patients.
Spironolactone Versus Spironolactone Plus Furosemide (SVSSF) [Completed]
The question whether the sequential diuretic therapy, that means using an antialdosteronic
drug at first and adding a loop diuretic in nonresponders, is better than the combination of
the two diuretics from the beginning (combined diuretic therapy) in the treatment of ascites
in patients with cirrhosis is still open. Therefore, the aim of the study is to compare
sequential versus combined diuretic therapy in these patients. One hundred patients will be
randomized into two groups. Group A will receive potassium canrenoate at the initial dose of
200 mg/day, then increased up to 400 mg/day. Non responders will be treated with 400 mg/day
of potassium canrenoate and furosemide at an initial dose of 50 mg/day, then increased up to
150 mg/day. Group B will receive at first 200 mg/day of potassium canrenoate and 50 mg/day
of furosemide, then increased up to 400 mg/day and 150 mg/day, respectively.
The percentage of responders to dthe diuretic treatment, the time to get the resolution of
ascites and the rate of adverse effects will be compared between the two Groups of Patients.
Safety And Efficacy Of Spirinolactone Plus Hydroflumethiazide In The Treatment Of Filipino Patients With Hypertension [Withdrawn]
Aldazide 25 mg OD will be given to Filipino hypertensive patients, and there will be 2
follow-up visits on week 4 and week 8 to monitor for safety and efficacy as primary and
secondary outcomes, respectively.
High-Dose Aldactone for Treatment of Diuretic Resistant Heart Failure [Recruiting]
Prospective, open-label, randomized cohort study comparing adding high-dose spironolactone
to usual heart failure care versus usual care in patients with acute decompensated heart
failure. Patients will be randomized in a 1: 1 fashion to either usual care or high-dose
spironolactone plus usual care. Both arms of the study will continue with treatment of ADHF
until euvolemia as defined as the resolution of pulmonary edema, peripheral edema, abdominal
bloating and/or jugular venous distention. Assessment of clinical status and serum
electrolytes, symptoms and renal function will be performed in accordance to standard of
care.
Reports of Suspected Aldactazide (Spironolactone / Hydrochlorothiazide) Side Effects
Cardiac Disorder (6),
Implantable Defibrillator Insertion (3),
Impaired Work Ability (3),
Fatigue (3),
Myocardial Infarction (3),
Dyspnoea (3),
Vascular Purpura (2),
Renal Injury (1),
Creatinine Renal Clearance Decreased (1),
Hyperkalaemia (1), more >>
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Page last updated: 2007-05-02
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