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Spironolactone (Spironolactone) - Summary

 
 



BOXED WARNING

Spironolactone has been shown to be a tumorigen in chronic toxicity studies in rats (see PRECAUTIONS). Spironolactone should be used only in those conditions described under INDICATIONS AND USAGE. Unnecessary use of this drug should be avoided.

 

SPIRONOLACTONE SUMMARY

Spironolactone oral tablets contain 25 mg, 50 mg, or 100 mg of the aldosterone antagonist spironolactone, 17-hydroxy-7α-mercapto-3-oxo-17α-pregn-4-ene-21-carboxylic acid γ-lactone acetate.

Spironolactone tablets are 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. Spironolactone tablets are 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. Spironolactone tablets are 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

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.

Hypokalemia

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.

Spironolactone tablets are 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.


See all Spironolactone indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Spironolactone

Race influences the safety and efficacy of spironolactone in severe heart failure. [2013]
CONCLUSIONS: AAs with HF exhibited less hyperkalemia and more hypokalemia with

Comparison of the efficacy of 5% topical spironolactone gel and placebo in the treatment of mild and moderate acne vulgaris: a randomized controlled trial. [2012]
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

more studies >>

Clinical Trials Related to Spironolactone

Hemodynamic Effects of Chronic Administration of Spironolactone and/or Propranolol in Alcoholic Cirrhotic Patients [Terminated]
The aim of this study was assesment of splanchnic and systemic hemodynamic effects of chronic administration (2 month) of spironolactone or propranolol, alone or in association in alcoholic cirrhotic patients. The patients were randomized in 4 groups (aldactone 150 mg/day, propranolol 160 mg/day, aldactone 150 mg/day + propranolol 160 mg/day, placebo). Systemic and splanchnic hemodynamic effect were evaluated by hepatic venous pressure gradient measurements before and after 2 month of treatment.

The Efficacy of Spironolactone in Patients With Resistant Hypertension [Not yet recruiting]
To determine the efficacy of the addition of spironolactone to modern blood pressure lowering treatment regimens in patients with resistant hypertension (whose blood pressure is uncontrolled despite three blood pressure lowering drugs)

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.

Spironolactone in Patients With Single Ventricle Heart [Active, not recruiting]
Ultrasound is a technique that can provide images of the blood vessels such as arteries. The size of the arteries, such as the main blood vessel in the arm, can change under different conditions. Using ultrasound we can see how arteries change with movement or even drugs. We want to use ultrasound to see how blood vessels look in patients with Congestive Heart Failure (CHF) and to also see how a drug called Spironolactone, commonly prescribed for patients with this disease, effects blood vessel function in patients with congestive heart failure. This information may be used to change the standard of care for patients with heart failure especially if we show that Spironolactone has a positive effect on vessel function in patients with CHF.

Is Spironolactone Safe and Effective in the Treatment of Cardiovascular Disease in Mild Chronic Renal Failure? [Completed]
Patients with kidney failure have a poor survival rate that is due to a much higher than average rate of heart and vascular disease. The reason that kidney failure causes heart disease is unknown but recent research suggests that a hormone called aldosterone, which is increased in patients with kidney disease may damage the heart and blood vessels.

The investigators propose, using a randomized blinded trial, to find out whether drugs that inhibit the actions of aldosterone have beneficial effects on the cardiovascular system in patients with kidney failure

more trials >>

Reports of Suspected Spironolactone Side Effects

Hyperkalaemia (117)Renal Failure Acute (104)Blood Creatinine Increased (49)Dyspnoea (42)Hypotension (41)Atrial Fibrillation (36)Drug Interaction (35)Nausea (34)Dehydration (32)Oedema Peripheral (31)more >>


PATIENT REVIEWS / RATINGS / COMMENTS

Based on a total of 20 ratings/reviews, Spironolactone has an overall score of 7.50. The effectiveness score is 7.70 and the side effect score is 7.50. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.
 

Spironolactone review by 33 year old female patient

  Rating
Overall rating:  
Effectiveness:   Considerably Effective
Side effects:   No Side Effects
  
Treatment Info
Condition / reason:   acne
Dosage & duration:   100mg taken once a day for the period of 1 yr and continuing
Other conditions:   small acne also
Other drugs taken:   retinol A
  
Reported Results
Benefits:   the spironolactone has prevented the large cycst types of acne from forming. My skin looks a lot smoother.
Side effects:   if not taken daily it will not work. you can not miss a day or there will be some cycsts that will form.
Comments:   spironolactone is a water pill that has the side effect of clearer skin. the spironolactone only is effective on the large cycst types of acne. If not taken daily there will be some cycsts that will form the week before you cycle. The small acne is taken care of with a retinol A cream.

 

Spironolactone review by 39 year old female patient

  Rating
Overall rating:  
Effectiveness:   Considerably Effective
Side effects:   Mild Side Effects
  
Treatment Info
Condition / reason:   adult moderate hormone related acne
Dosage & duration:   50mgs taken once a day for the period of 4mths
Other conditions:   hair loss middle of the scalp, thinning mainly
Other drugs taken:   none
  
Reported Results
Benefits:   my usually oily skin dried up considerably and as a result the frequency of spots reduced.
Side effects:   in the first week i experienced headaces, pulpitations,nausea,insomnia and halusinations,dry mouth and lips along with frequent urination. i almost stopped taking the drug but i gave it a little more time and eventually felt better..most side effects disappeared and i remained with dry mouth lips and sorish throat.drinking alot of water helped.
Comments:   50mg tab once a day for 4 months

 

Spironolactone review by 30 year old female patient

  Rating
Overall rating:  
Effectiveness:   Ineffective
Side effects:   Severe Side Effects
  
Treatment Info
Condition / reason:   POCS, elevated testosterone, hirsutism
Dosage & duration:   50mg reduced to 25mg taken twice a day for the period of 2 months
Other conditions:   none
Other drugs taken:   none
  
Reported Results
Benefits:   No benefits in 2 months, no reduction in body hair
Side effects:   Tiredness, thinning of the hair, hair loss, stomach ache
Comments:   Not effective for me at all, wanted to reduce body hair - no change after two months. But noticed hair thinning and some hair loss on the top of my scalp, have to stop it.

See all Spironolactone reviews / ratings >>

Page last updated: 2014-11-30

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