Aldactone (Spironolactone) - Summary

ALDACTONE SUMMARY

Aldactone^®
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.

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.

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.

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NEWS HIGHLIGHTS

Published Studies Related to Aldactone (Spironolactone)

Treatment with spironolactone for 24 weeks decreases the level of matrix metalloproteinases and improves cardiac function in patients with chronic heart failure of ischemic etiology. [2009.09]
CONCLUSIONS: Biomarkers of collagen degradation were elevated and correlated with depressed heart function; spironolactone may partially reverse the dysregulation in collagen metabolism.

Effect of spironolactone on left ventricular mass and aortic stiffness in early-stage chronic kidney disease: a randomized controlled trial. [2009.08.04]
OBJECTIVES: We sought to determine whether the addition of spironolactone to angiotensin-converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARBs) improves left ventricular mass and arterial stiffness in early-stage chronic kidney disease (CKD). BACKGROUND: Chronic kidney disease is associated with a high risk of cardiovascular disease and a high prevalence of left ventricular hypertrophy and arterial stiffness that confer an adverse prognosis. It is believed that these abnormalities are in part a result of activation of the renin-angiotensin-aldosterone system... CONCLUSIONS: The use of spironolactone reduces left ventricular mass and improves arterial stiffness in early-stage CKD. These effects suggest that aldosterone exerts adverse cardiovascular effects in CKD and that spironolactone is worthy of further study as a treatment that could reduce adverse cardiovascular events. (Is Spironolactone Safe and Effective in the Treatment of Cardiovascular Disease in Mild Chronic Renal Failure; NCT00291720).

Spironolactone in chronic hemodialysis patients improves cardiac function. [2009.05]
We performed this study to assess whether low dose spironolactone could be administered in hemodialysis (HD) patients with moderate to severe heart failure to improve cardiovascular function and reduce hospitalization without inducing hyperkalemia. We enrolled 16 chronic HD patients with moderate to severe heart failure and left ventricle ejection fraction :5 45%...

Differential effects of chlorthalidone versus spironolactone on muscle sympathetic nerve activity in hypertensive patients. [2009.04]
CONTEXT: Previous studies in rats indicated that thiazide-type diuretics reduced blood pressure (BP) and triggered baroreflex-mediated increase in sympathetic nerve activity (SNA), whereas spironolactone exerted central sympathoinhibitory action in addition to diuretic effects. OBJECTIVES: The objectives were to determine effects of spironolactone and chlorthalidone on SNA and the role of SNA on diuretic-induced insulin resistance in human hypertension... CONCLUSIONS: Our data suggest that chlorthalidone, the first-line drug therapy for hypertension, causes persistent activation of sympathetic nervous system and insulin resistance in hypertensive patients. These side effects, however, are avoided by spironolactone despite similar reduction in BP.

Effects of additive therapy with spironolactone on proteinuria in diabetic patients already on ACE inhibitor or ARB therapy: results of a randomized, placebo-controlled, double-blind, crossover trial. [2008.04]
CONCLUSIONS: Addition of a modest dose of spironolactone to a regimen of ACEI or ARB in patients with diabetic proteinuria causes further reduction in proteinuria and also lowers the systolic BP. As with ACEI or ARB, spironolactone modestly reduces the glomerular filtration rate and raises serum potassium.

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Clinical Trials Related to Aldactone (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.

Spironolactone for Reducing Proteinuria in Diabetic Nephropathy [Completed]
Introduction: Aldosterone seems to have deleterious effects on the kidneys. Many animal studies and few clinical trials now have shown that suppression of aldosterone by aldosterone receptor blockers ameliorated these effects.

Method: In a double-blind, cross over study, 24 patients with diabetic nephropathy who were already receiving either ACE inhibitor(lisinopril 20-40 mg/day ) or ARB( losartan 25-100 mg/day )were given spironolactone( 25 mg during the first month and 50 mg during the second and third month if serum K remained ok) or matching placebo with 1 month of washout in between. All patients were from a single center and exclusively male veterans. Blood pressure, serum creatinine, serum K and spot urine protein/creatinine were measured at the beginning and end of each study period. The study was started in May of 2003 and completed in May 2006.

Result: Of 30 patients who were randomized 6 patients did not complete the study. Data were analyzed on the 24 patients who completed the study . The mean systolic BP on placebo was 149. 9mmHg(s. d. 20. 5) and 150. 9(s. d. 24. 7)at the beginning and at the end of 3 months study period. Diastolic BP was 76. 9 (13. 9) and 79. 2 (13. 6) respectively(p=0. 103 and 0. 502); mean BP on spironolactone was systolic 152. 0(23. 8) and 140. 1(17. 2) at the beginning and at the end (p=.002). Diastolic BP during spironolactone therapy was 80. 16(112. 3) and 76. 1(9. 7) respectively (p=0. 092). The urine pr/cr increased from 1. 24(1. 13) to 1. 54 (2. 1) while on placebo and decreased from 1. 83(1. 83) to 0. 79(0. 9) during spironolactone period. (p=0. 218 for placebo and p=.007 for spironolactone). In other words proteinuria increased by 24% during the placebo treatment period while decreased by half ( 57% ) during the active treatment. Mean serum K did not change during the period of placebo treatment. (4. 3(0. 48) to 4. 3(0. 43) but went from 4. 3(0. 47) to 4. 6(0. 56) during spironolactone therapy (p=0. 023).

Conclusion: Addition of a modest dose of spironolactone to a regimen of ace inhibitor or ARB in patients with diabetic proteinuria causes further reduction in proteinuria and also lowers the systolic BP.

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

Spironolactone for Paroxysmal Atrial Fibrillation [Recruiting]
To determine whether or not spironolactone can prevent or delay the occurrence of atrial fibrillation.

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PATIENT REVIEWS / RATINGS / COMMENTS

Aldactone review by 57 year old female patient
		Rating
Overall rating:
Effectiveness:		Highly Effective
Side effects:		Moderate Side Effects
		Treatment Info
Condition / reason:		Adult acne
Dosage & duration:		1000mg taken once per day for the period of 14 years
Other conditions:		none
Other drugs taken:		pv caroine
		Reported Results
Benefits:		My acne cleared within one to two months and did not return while I was taking the drug.
Side effects:		I noticed thinning of my hair. This is the only reason I stopped taking the drug, because my hair is naturally very fine iin texture and the thinning was more noticable than if my hair was of a thicker texture.
Comments:		Interestingly, if I took four 250mg doses per day, the drug was not as effective in treating my acne.

Aldactone review by 34 year old female patient
		Rating
Overall rating:
Effectiveness:		Marginally Effective
Side effects:		Mild Side Effects
		Treatment Info
Condition / reason:		hormonal acne
Dosage & duration:		100 mg taken 1 time a day for the period of 2 month and still taking it
Other conditions:		none
Other drugs taken:		none
		Reported Results
Benefits:		Not much improvement in hormonal acne.
Side effects:		Dry mouth and lips
Comments:		I started taking Spironolactone for hormonal acne about two months ago along with tazorac and a sulfur face wash. My acne remains the same with only a small change. I still have cysts but but not as many (reduced by 30%).

Aldactone review by 50 year old female patient
		Rating
Overall rating:
Effectiveness:		Highly Effective
Side effects:		Extremely Severe Side Effects
		Treatment Info
Condition / reason:		acne
Dosage & duration:		100mg taken daily for the period of 12 months
Other conditions:		none
Other drugs taken:		none
		Reported Results
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?