Spironolactone has been shown to be a tumorigen in chronic
toxicity studies in rats (see PRECAUTIONS).
Spironolactone and hydrochlorothiazide should be used only in those conditions
described under INDICATIONS AND USAGE. Unnecessary use of this drug should be
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 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:
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)
Short Term Spironolactone for Prevention of Acute Kidney Injury After Cardiac Surgery [Recruiting]
Our aim is to test whether short term perioperative administration of oral spironolactone
could reduce incidence of postoperative acute kidney injury (AKI) in cardiac surgical
The Combination Ambrisentan Plus Spironolactone in Pulmonary Arterial Hypertension Study [Not yet recruiting]
The purpose of this study is to find out if spironolactone added to ambrisentan for
Pulmonary Arterial Hypertension (PAH) will increase exercise capacity. We also want to find
out if spironolactone and ambrisentan effect the cardiac output (amount of blood the heart
pumps every minute), right ventricle function and quality of life.
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.
High-Dose Aldactone for Treatment of Diuretic Resistant Heart Failure [Recruiting]
Prospective, open-label, randomized cohort study comparing adding high-dose spironolactone
to usual heart failure care versus usual care in patients with acute decompensated heart
failure. Patients will be randomized in a 1: 1 fashion to either usual care or high-dose
spironolactone plus usual care. Both arms of the study will continue with treatment of ADHF
until euvolemia as defined as the resolution of pulmonary edema, peripheral edema, abdominal
bloating and/or jugular venous distention. Assessment of clinical status and serum
electrolytes, symptoms and renal function will be performed in accordance to standard of
Interest of Topical Spironolactone's Administration to Prevent Corticoid-induced Epidermal Atrophy [Completed]
The purpose of this study is to determine whether spironolactone could significantly reduce
cutaneous atrophy due to corticosteroids.
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