Spironolactone has been shown to be a tumorigen in chronic toxicity studies in rats (see Precautions ). Aldactone should be used only in those conditions described under Indications and Usage . Unnecessary use of this drug should be avoided.
spironolactone tablets, USP
Aldactone oral tablets contain 25 mg, 50 mg, or 100 mg of the aldosterone antagonist spironolactone.
Aldactone (spironolactone) is indicated in the management of:
Primary hyperaldosteronism for:
Establishing the diagnosis of primary hyperaldosteronism by therapeutic trial.
Short-term preoperative treatment of patients with primary hyperaldosteronism.
Long-term maintenance therapy for patients with discrete aldosterone-producing adrenal adenomas who are judged to be poor operative risks or who decline surgery.
Long-term maintenance therapy for patients with bilateral micro- or macronodular adrenal hyperplasia (idiopathic hyperaldosteronism).
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. Aldactone is also indicated for patients with congestive heart failure taking digitalis when other therapies are considered inappropriate.
Cirrhosis of the liver accompanied by edema and/or ascites
Aldosterone levels may be exceptionally high in this condition. Aldactone 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.
Usually in combination with other drugs, Aldactone is indicated for patients who cannot be treated adequately with other agents or for whom other agents are considered inappropriate.
For the treatment of patients with hypokalemia when other measures are considered inappropriate or inadequate. Aldactone is also indicated for the prophylaxis of hypokalemia in patients taking digitalis when other measures are considered inadequate or 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.
Aldactone 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.
Published Studies Related to Aldactone (Spironolactone)
Comparison of the efficacy of 5% topical spironolactone gel and placebo in the
treatment of mild and moderate acne vulgaris: a randomized controlled trial. 
mild to moderate acne vulgaris... CONCLUSION: The 5% spironolactone topical gel resulted in a decrease in the TLC
Rationale and design of the Treatment of Preserved Cardiac Function Heart Failure with an Aldosterone Antagonist Trial: A randomized, controlled study of spironolactone in patients with symptomatic heart failure and preserved ejection fraction. [2011.12]
BACKGROUND: Despite increasing prevalence of heart failure (HF) in patients with preserved ejection fraction (PEF), there are no available therapies proven to reduce morbidity and mortality. Aldosterone, a potent stimulator of myocardial and vascular fibrosis, may be a key mediator of HF progression in this population and is therefore an important therapeutic target. OBJECTIVE: The TOPCAT trial is designed to evaluate the effect of spironolactone, an aldosterone antagonist, on morbidity, mortality, and quality of life in patients with HF-PEF... CONCLUSION: TOPCAT is designed to assess definitively the role of spironolactone in the management of HF-PEF. Copyright (c) 2011 Mosby, Inc. All rights reserved.
Addition of spironolactone in patients with resistant arterial hypertension (ASPIRANT): a randomized, double-blind, placebo-controlled trial. [2011.06]
There is currently limited data on which drug should be used to improve blood pressure (BP) control in patients with resistant hypertension. This study was designed to assess the effect of the addition of 25 mg of spironolactone on BP in patients with resistant arterial hypertension... In conclusion, spironolactone is an effective drug for lowering systolic BP in patients with resistant arterial hypertension.
A double-blind, randomized study comparing the antihypertensive effect of eplerenone and spironolactone in patients with hypertension and evidence of primary aldosteronism. [2011.05]
BACKGROUND: Eplerenone is claimed to be a more selective blocker of the mineralocorticoid receptor than spironolactone being associated with fewer antiandrogenic side-effects. We compared the efficacy, safety and tolerability of eplerenone versus spironolactone in patients with hypertension associated with primary aldosteronism... CONCLUSION: The antihypertensive effect of spironolactone was significantly greater than that of eplerenone in hypertension associated with primary aldosteronism. (c) 2011 Wolters Kluwer Health | Lippincott Williams & Wilkins
Effects of spironolactone on cardiac sympathetic nerve activity and left ventricular remodelling after reperfusion therapy in patients with first ST-segment elevation myocardial infarction. [2011.05]
OBJECTIVE: To evaluate the effects of spironolactone on cardiac sympathetic nerve activity (CSNA) and left ventricular (LV) remodelling in patients with ST-segment elevation myocardial infarction (STEMI)... CONCLUSION: Administration of spironolactone improves CSNA and prevents LV remodelling in patients with a first STEMI.
Clinical Trials Related to Aldactone (Spironolactone)
Interest of Topical Spironolactone's Administration to Prevent Corticoid-induced Epidermal Atrophy [Recruiting]
The purpose of this study is to determine whether spironolactone could significantly reduce
cutaneous atrophy due to corticosteroids.
Effects of Spironolactone on Collagen Metabolism in Patients With Pulmonary Arterial Hypertension [Recruiting]
The purpose of this study is to determine the effects of spironolactone on collagen
markers in a large number of patients with pulmonary hypertension. In addition, safety and
tolerability of spironolactone, an aldosterone receptor antagonist, in patients with
pulmonary arterial hypertension, will be determined.
Determining the Effect of Spironolactone on Electrolyte Supplementation in Preterm Infants With Chronic Lung Disease [Recruiting]
Bronchopulmonary dysplasia (BPD), also known as chronic lung disease (CLD), is a major
complication of premature birth and is associated with a significant increased risk of
complications including death. Diuretics have been used for decades in babies with BPD and
are considered a standard of care. Patients receive electrolyte supplementation to replace
the electrolytes removed by the diuretics. Spironolactone is not as good as other diuretics
at removing extra fluid, but it is different from chlorothiazide and furosemide because
instead of removing potassium, it actually can increase potassium levels in our body.
Spironolactone is used with chlorothiazide to try to minimize the potassium lost; therefore,
reduce the electrolyte supplementation needed. However, studies have suggested that preterm
babies aren´t developed enough to appropriately respond to spironolactone. Also, one study
has shown that adding spironolactone to chlorothiazide in patients with BPD has no effect on
whether or not patients receive electrolyte supplementation. This study will examine whether
there is a difference in the amount of electrolyte supplementation between patients
receiving chlorothiazide only or chlorothiazide plus spironolactone. the investigators
hypothesize there will be no difference in the amount of electrolyte supplementation between
the two groups.
Spironolactone for Paroxysmal Atrial Fibrillation [Recruiting]
To determine whether or not spironolactone can prevent or delay the occurrence of atrial
Effects of Spironolactone in Dialysis [Recruiting]
Several studies indicate that chronic kidney disease patients give a high cardiovascular
risk and have an intrinsic relationship with hypertension and cardiomyopathy: characterized
by left ventricular hypertrophy and interstitial fibrosis. The reversal of left ventricular
hypertrophy is associated with increased life expectancy in these patients. The renin
angiotensin aldosterone system plays an important role in blood pressure control. Even
patients using converting enzyme inhibitors inhibitors or angiotensin II blockers may
experience the so called aldosterone breakthrough phenomenon (inappropriately called
aldosterone escape). This phenomenon is documented in patients with heart disease and in
chronic kidney disease. Spironolactone is a synthetic steroid that acts as an antagonist of
aldosterone, which has historically avoided in chronic kidney disease patients, given the
risk of hyperkalemia. However, its active metabolite, canrenone and spironolactone, are able
to antagonize the binding of ouabain, a Na+/K+ATPase inhibitor, to its receptor. The
Na+/K+-ATPase inhibition results in changes in sodium gradients, and increases the calcium
influx through the transporter Na+/Ca+ in specific regions of the membrane. Spironolactone
and canrenone in previous research were able to reverse left ventricular hypertrophy in
chronic kidney disease patients on conservative treatment, which turn this drug and its
metabolite potential tools for reversion of left ventricular hypertrophy in chronic kidney
disease. The aim of this study is to verify the safety, tolerability and efficacy in the
reversal of target organ damage from the use of spironolactone added to conventional
antihypertensive therapy in chronic kidney disease patients on hemodialysis, in addition to
measuring its ability to reduce left ventricular hypertrophy and arterial stiffness indices.
Interventional randomized, double-blind, placebo-controlled study comprising two groups: one
that will take 25mg of spironolactone associated with conventional antihypertensive therapy
and another that will take spironolactone placebo associated with conventional
antihypertensive therapy. Each group will consist of 30 patients. Clinical and laboratory
investigations, as well as home monitoring of blood pressure, echocardiography,
determination of pulse wave velocity, augmentation index, and central blood pressure
measurement of serum aldosterone will be are evaluated before and after treatment that will
last 12 months.
Reports of Suspected Aldactone (Spironolactone) Side Effects
Renal Failure Acute (124),
Drug Interaction (62),
Renal Failure (30),
Lactic Acidosis (28),
Hepatic Encephalopathy (24), more >>
PATIENT REVIEWS / RATINGS / COMMENTS
Based on a total of 8 ratings/reviews, Aldactone has an overall score of 6.62. The effectiveness score is 8.25 and the side effect score is 7.25. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.
Aldactone review by 62 year old female patient
|Overall rating:|| || |
|Effectiveness:|| || Highly Effective|
|Side effects:|| || No Side Effects|
|Condition / reason:|| || swollen knee|
|Dosage & duration:|| || 50mg taken 2x per day for the period of 2 yrs|
|Other conditions:|| || none|
|Other drugs taken:|| || vitamin supplements|
|Benefits:|| || NO LONGER ANY KNEE SWELLING.....TOTAL KNEE MOBILITY... NO PAIN...|
|Side effects:|| || THERE WERE NO NOTICABLE SIDE EFFECTS...SPIRALACTONE ACTS AS A WATER PILL SO THERE WAS AN INCREASE OF URINATION. THATS ALL...|
|Comments:|| || after two shots of cortisone to my knee, I had an mri done...this showed no problems yet the cortisone injections lasted only about four months. My dr did not want to give additional injections and prescribed physical therapy, which I did, but it only aleviated the pain for a short time and never for an entire day. My job requires me to be on my feet and I needed more relief. I went to an internist (the first doctor was a bone and joint specialist) who prescribed spiralactone. OK, I didnt have much faith in a water pill, but it worked and still continues to work. I do not take many medications but I do make sure I never run out of this miracle.|
Aldactone review by 33 year old female patient
|Overall rating:|| || |
|Effectiveness:|| || Marginally Effective|
|Side effects:|| || Moderate Side Effects|
|Condition / reason:|| || hair loss/ facial hair|
|Dosage & duration:|| || 100mg day taken 2 daily for the period of 2 months|
|Other conditions:|| || acne|
|Other drugs taken:|| || yasmin|
|Benefits:|| || so far combo of spirolonactone and yasmin has regulate my periods, however i have not seen any improvement on acne nor any decrease in facial hair|
|Side effects:|| || frequent urination, always thristy, dizziness.|
|Comments:|| || sprioloctone has been prescibed to help with hair loss of the scalp, but so far has not shown to be of much effectiveness..second month on it and hair sill falls out a lot. |
Aldactone review by 50 year old female patient
|Overall rating:|| || |
|Effectiveness:|| || Highly Effective|
|Side effects:|| || Extremely Severe Side Effects|
|Condition / reason:|| || acne|
|Dosage & duration:|| || 100mg taken daily for the period of 12 months|
|Other conditions:|| || none|
|Other drugs taken:|| || none|
|Benefits:|| || Takes about 3 months to show results, but cleared up my skin, reduced overall oiliness and enlarged pores, and eliminated my very greasy hair, caused by excess oil on my scalp. My skin looked hydrated, clarity was good and the improvement was constant with no variations after the first 3 months. Also contributed a significant improvement to my libido. |
|Side effects:|| || Periods about every 14 days. After 12 months of use, DCIS detected in my right breast. No history of breast cancer in the family at all, and I was in good health otherwise. Malignant tumour of the breast was one of the side effects I located on the internet. |
|Comments:|| || I am happy to complete this but dont know what you mean, I have already given the dosage. Can you email me what it is you want here?|
Page last updated: 2013-02-10