Spironolactone, an ingredient of spironolactone and hydrochlorothiazide tablets, has been shown to be a tumorigen in chronic toxicity studies in rats (see Precautions ). Spironolactone and hydrochlorothiazide tablets 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.
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.
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.
Published Studies Related to Spironolactone and Hydrochlorothiazide (Spironolactone / Hydrochlorothiazide)
Spironolactone and hydrochlorothiazide decrease vascular stiffness and blood pressure in geriatric hypertension. [2010.07]
OBJECTIVES: To determine the efficacy of spironolactone (SPIRO) and hydrochlorothiazide (HCTZ) as monotherapy in older patients with hypertension in blood pressure (BP) control and measures of vascular stiffness... CONCLUSIONS: Six months of therapy with HCTZ or SPIRO resulted in comparable reductions in 24-hour average and nocturnal SBP and DBP, PP, and PWV in older subjects with hypertension.
Spironolactone and hydrochlorothiazide decrease vascular stiffness and blood
pressure in geriatric hypertension. 
blood pressure (BP) control and measures of vascular stiffness... CONCLUSIONS: Six months of therapy with HCTZ or SPIRO resulted in comparable
Comparison of effects of low dose of spironolactone and a thiazide diuretic in patients with hypertension treated with an angiotensin-converting enzyme inhibitor or an angiotensin type 1 receptor blocker. [2009.11]
This study was performed to investigate the additional anti-hypertensive effects and safety of low-dose thiazide diuretic, trichlormethiazide (TCTZ), and a mineralocorticoid receptor blocker, spironolactone (SPI), as add-on therapy in 64 patients whose blood pressure (BP) at office were over 140/90 mmHg, while receiving anti-hypertensive medication including an angiotensin-converting enzyme inhibitor or angiotensin II type I receptor antagonist...
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.
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.
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
Reports of Suspected Spironolactone and Hydrochlorothiazide (Spironolactone / Hydrochlorothiazide) Side Effects
Renal Failure Acute (7),
Myocardial Infarction (6),
Cerebrovascular Accident (6),
Loss of Employment (3),
Confusional State (1),
Personality Change (1),
Breast Enlargement (1),
Suicidal Ideation (1), more >>
Page last updated: 2013-02-10