Spironolactone and Hydrochlorothiazide (Spironolactone / Hydrochlorothiazide) - Summary

SUMMARY

Each tablet of spironolactone and hydrochlorothiazide contains 25 mg of spironolactone, USP and 25 mg of hydrochlorothiazide, USP.

Spironolactone, an aldosterone antagonist.

Hydrochlorothiazide is a diuretic and antihypertensive.

Spironolactone has been shown to be a tumorigen in chronic toxicity studies in rats (see PRECAUTIONS section). Spironolactone and hydrochlorothiazide tablets should be used only in those conditions described below. Unnecessary use of this drug should be avoided.

Spironolactone and Hydrochlorothiazide Tablets are 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. Spironolactone and hydrochlorothiazide 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

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. Spironolactone and hydrochlorothiazide 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 indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Spironolactone and Hydrochlorothiazide (Spironolactone / Hydrochlorothiazide)

Spironolactone versus eplerenone for the treatment of idiopathic hyperaldosteronism. [2008.03]
The aim of this prospective, randomised, open-label, blinded-end point study was to compare the efficacy and safety of eplerenone versus spironolactone in patients with bilateral idiopathic hyperaldosteronism (IHA). After a 2-week washout period, 34 patients with IHA were assigned to receive either spironolactone 25 mg b.i.d...

The effect of spironolactone, cilazapril and their combination on albuminuria in patients with hypertension and diabetic nephropathy is independent of blood pressure reduction: a randomized controlled study. [2004.05]
OBJECTIVE: The effect of spironolactone, cilazapril and their combination on albuminuria was examined in a randomized prospective study in female patients with diabetes and hypertension... CONCLUSION: At the doses tested, spironolactone was superior to cilazapril in reducing albuminuria. Combined administration was more effective than either drug alone. These effects were independent of BP values. Hyperkalaemia was the main side-effect.

Spironolactone abolishes the relationship between aldosterone and plasminogen activator inhibitor-1 in humans. [2002.02]
Recent studies have defined a link between the renin-angiotensin-aldosterone system and fibrinolysis.

A comparison of the potassium and magnesium-sparing properties of amiloride and spironolactone in diuretic-treated normal subjects. [1993.04]
1. The relative potencies of amiloride (5 and 20 mg) and spironolactone (25 and 100 mg) for plasma and erythrocyte electrolytes were investigated in a double-blind, randomised, balanced, crossover study in 12 normal men treated concomitantly with hydrochlorothiazide 100 mg daily for 1 week...

Hydrochlorothiazide versus spironolactone: long-term metabolic modifications in patients with essential hypertension. [1991.05]
The metabolic side effects of thiazide diuretics are believed to be responsible for the failure of thiazide diuretics to reduce cardiovascular morbidity in patients with hypertension. However, the decrease in the incidence of osteoporotic fractures that are associated with thiazide administration may be relevant in elderly patients with arterial hypertension...

more studies >>

Clinical Trials Related to Spironolactone and Hydrochlorothiazide (Spironolactone / Hydrochlorothiazide)

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 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 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 and Insulin Resistance in Chronic Heart Failure (CHF) [Completed]
The purpose of this study is to evaluate the effects of spironolactone and furosemide on insulin resistance in patients with chronic heart failure.

more trials >>