Uses
Edema
Management of edema associated with excessive aldosterone including cirrhosis of the liver and nephrotic syndrome.
Used as an adjunct to thiazide therapy when diuresis is inadequate or reduction of potassium excretion is necessary.
Hypertension
Management of hypertension (alone or in combination with other classes of antihypertensive agents); used for patients who cannot be treated adequately with other agents or for whom other agents are considered inappropriate.
One of several initial preferred therapies in hypertensive patients with heart failure and in those with ischemic heart disease (e.g., MI).
Can be used as monotherapy for initial management of uncomplicated hypertension; however, thiazide diuretics are preferred by JNC 7.
CHF
Management of edema and sodium retention in CHF in patients only partially responsive to, or intolerant of, other therapeutic measures.
Has been used in conjunction with ACE inhibitors, loop diuretics, and occasionally cardiac glycosides in patients with severe CHF whose condition was inadequately controlled by an ACE inhibitor and a loop diuretic.
Consider adding spironolactone to standard therapy in patients with severe (i.e., NYHA class IV) CHF.
Safety and efficacy in mild or moderate CHF not determined.
Primary Aldosteronism
Diagnosis of primary aldosteronism by therapeutic trial; test results may be equivocal and additional diagnostic studies often required.
Short-term preoperative treatment of primary aldosteronism.
Long-term maintenance therapy in patients with discrete aldosterone-producing adrenal adenomas who cannot undergo adrenalectomy or who decline surgery.
Long-term maintenance therapy for patients with bilateral micronodular or macronodular adrenal hyperplasia (idiopathic hyperaldosteronism).
Hypokalemia
Treatment of hypokalemia when oral potassium supplements or other measures are inappropriate or inadequate.
Prophylaxis of hypokalemia in patients taking digitalis when other measures are inappropriate or inadequate.
Precocious Puberty
Management of certain forms of gonadotropin releasing hormone (GnRH)-independent (peripheral) precocious puberty† (e.g., familial male precocious puberty [testotoxicosis]).
Hirsutism
Treatment of hirsutism† in women with polycystic ovary syndrome or idiopathic hirsutism.
Dosage and Administration
Administration
Administer orally.
Oral Administration
Administer as single or divided doses; 2 doses daily may be adequate.
For administration in children†, tablets may be pulverized and administered as an oral suspension in cherry syrup.
When used with a thiazide diuretic in edema associated with cirrhosis of the liver, administer spironolactone for 2–3 days prior to the thiazide diuretic in order to prevent potassium depletion and precipitation of hepatic coma.
Dosage
Pediatric Patients
Edema
Oral
3.3 mg/kg (up to 100 mg) daily as a single dose or in divided doses.†
Alternatively, initial dosage of 60 mg/m2 daily in divided doses.†
Hypertension
Oral
Initially, 1 mg/kg daily as a single dose or in 2 divided doses. Increase dosage as necessary up to a maximum of 3.3 mg/kg (up to 100 mg) daily as a single dose or in 2 divided doses.†
Primary Aldosteronism
Diagnosis
Oral
125–375 mg/m2 in divided doses over 24 hours.†
If serum potassium concentration increases during therapy but decreases when the drug is discontinued, a presumptive diagnosis of primary aldosteronism should be considered.†
Adults
Edema
Oral
Initially, 100 mg daily. Range: 25–200 mg daily.
As monotherapy, administer usual initial dosage for ≥5 days; if response is satisfactory, titrate dosage to optimal dosage.
If response is not satisfactory after initial 5 days of therapy, add a thiazide or loop diuretic. Do not adjust spironolactone dosage during combined diuretic therapy.
Spironolactone in combination with hydrochlorothiazide: spironolactone 100 mg daily and hydrochlorothiazide 100 mg daily as a single dose or in divided doses. Range: spironolactone 25–200 mg daily and hydrochlorothiazide 25–200 mg daily as a single dose or in divided doses.
Initial use of fixed-combination preparations is not recommended; adjust by administering each drug separately, then use the fixed combination if the optimum maintenance dosage corresponds to the ratio of drugs in the combination preparation. Administer separately for subsequent dosage adjustment.
Hypertension
Lower dosage and combination therapy recommended by JNC 7; higher spironolactone dosage may result in intolerable adverse effects.
Carefully monitor BP during initial titration or subsequent upward adjustment in dosage.
Adjust dosage at approximately monthly intervals.
Monotherapy
Oral
Usual initial dosage: 50–100 mg daily as a single dose or in divided doses. Full hypotensive response may require 2 weeks.
Usual dosage recommended by JNC 7: 25–50 mg daily.
Spironolactone/Hydrochlorothiazide Combination Therapy
Oral
Spironolactone 50–100 mg daily and hydrochlorothiazide 50–100 mg daily as a single dose or in divided doses.
Initial use of fixed-combination sprionolactone/hydrochlorothiazide preparations is not recommended; adjust by administering each drug separately, then use the fixed combination if the optimum maintenance dosage corresponds to the ratio of drugs in the combination preparation. Administer separately for subsequent dosage adjustment.
CHF
Oral
Initially, 12.5–25 mg daily used in patients receiving an ACE inhibitor and a loop diuretic with or without a cardiac glycoside.
Increase to 50 mg daily after 8 weeks in patients who exhibit signs and symptoms of progressive heart failure and have serum potassium concentrations <5.5 mEq/L.
Decrease to 25 mg every other day if hyperkalemia occurs.
Primary Aldosteronism
Diagnosis
Oral
400 mg daily for 3–4 weeks. Correction of hypokalemia and hypertension provides presumptive evidence for the diagnosis of primary aldosteronism.
Alternatively, 400 mg daily for 4 days. If serum potassium concentration increases during spironolactone therapy but decreases when the drug is discontinued, consider presumptive diagnosis of primary aldosteronism.
Medical Therapy Prior to Adrenalectomy
Oral
Patients with a definitive diagnosis: 100–400 mg daily before surgery.
Treatment Of Primary Aldosteronism
Oral
Initially, 400 mg daily.
Maintenance dosage: 100–300 mg daily. Use lowest effective dosage for long-term maintenance therapy.
Hypokalemia
Oral
25–100 mg daily.
Hirsutism
Oral
50–200 mg daily. Regression of hirsutism evident within 2 months, maximal within 6 months, and has been maintained for ≥16 months with continued therapy.†
Prescribing Limits
Pediatric Patients
Hypertension
Oral
Maximum 3.3 mg/kg (up to 100 mg) daily.†
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