Indicated for:

Heart Failure:

• Treatment of NYHA Class III-IV heart failure and reduced ejection fraction to increase survival, manage edema, and reduce the need for hospitalization for heart failure. ALDACTONE is usually administered in conjunction with other heart failure therapies.

Hypertension:

• As add-on therapy for the treatment of hypertension, to lower blood pressure in patients who are not adequately controlled on other agents. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.

Edema Associated with Hepatic Cirrhosis or Nephrotic Syndrome:

The management of edema in the following settings:

• Cirrhosis of the liver when edema is not responsive to fluid and sodium restriction.
• Nephrotic syndrome when treatment of the underlying disease, restriction of fluid and sodium intake, and the use of other diuretics produce an inadequate response.

Because it increases serum potassium, ALDACTONE may be useful for treating edema when administration of other diuretics has caused hypokalemia.

Primary Hyperaldosteronism:

Indicated in the following settings:

• Short-term preoperative treatment of patients with primary hyperaldosteronism.
• Long-term maintenance therapy for patients with discrete aldosterone-producing adrenal adenomas who are not candidates for surgery.
• Long-term maintenance therapy for patients with bilateral micro or macronodular adrenal hyperplasia (idiopathic hyperaldosteronism).

ALDACTONE is contraindicated for patients with:

• Hyperkalemia
• Addison’s disease
• Concomitant use of eplerenone

ALDACTONE can cause hyperkalemia. This risk is increased by impaired renal function or concomitant potassium supplementation, potassium-containing salt substitutes or drugs that increase potassium, such as ACE inhibitors, angiotensin receptor blockers, non-steroidal anti-inflammatory drugs (NSAIDs), heparin and low molecular weight heparin, and trimethoprim.

In addition to causing hyperkalemia, ALDACTONE can cause hyponatremia, hypomagnesemia, hypocalcemia, hypochloremic alkalosis, and hyperglycemia. Asymptomatic hyperuricemia can occur and rarely gout is precipitated.

ALDACTONE can cause gynecomastia.

Excessive diuresis may cause symptomatic dehydration, hypotension and worsening renal function, particularly in salt-depleted patients or those taking angiotensin converting enzyme inhibitors and angiotensin II receptor blockers. Worsening of renal function can also occur with concomitant use of nephrotoxic drugs (e.g., aminoglycosides, cisplatin, and NSAIDs).

Lithium generally should not be given with diuretics.

Spironolactone and its metabolites interfere with radioimmunoassays for digoxin and increase the apparent exposure to digoxin.

Hyperkalemic metabolic acidosis has been reported in patients given ALDACTONE concurrently with cholestyramine.

Acetylsalicylic acid may reduce the efficacy of spironolactone.

Because of the potential risk to the male fetus due to anti-androgenic properties of spironolactone and animal data, avoid spironolactone in pregnant women or advise a pregnant woman of the potential risk to a male fetus.

Spironolactone is not present in breastmilk; however, limited data from a lactating woman at 17 days postpartum reports the presence of the active metabolite, canrenone, in human breast milk in low amounts that are expected to be clinically inconsequential. In this case, there were no adverse effects reported for the breastfed infant after short term exposure to spironolactone; however, long term effects on a breastfed infant are unknown.

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• Excessive hair growth (hirsutism) in women with polycystic ovary disease. GoToSource

• Acne in women who have not responded to more conventional acne treatments. GoToSource

• Female pattern hair loss. GoToSource

• Water retention or bloating associated with premenstrual syndrome. GoToSource

• Use in patients under the age of 18. GoToSource

• Reduce risk of ventricular arrhythmia in CHF. GoToSource

Gynecomastia (male breast growth). GoToSource

Elderly patients taking both Aldactone and Septra are at increased risk of hyperkalemia (high potassium levels), more than 12 times higher than Aldactone combined with any other antibiotic. GoToSource

Severe hyperkalemia (high potassium levels). GoToSource

Acute kidney failure, dyspnea (shortness of breath), nausea and pyrexia (fever). GoToSource 

Stevens-johnson syndrome and toxic epidermal necrolysis (life-threatening skin condition). GoToSource 

Leukopenia including agranulocytosis (decreased white blood cells). GoToSource

Decreased libido, impotence and menstrual irregularity. GoToSource

Thrombocytopenia (low blood platelet count). GoToSource

Pruritus (itchy skin). GoToSource

Lawsuits filed for hyperkalemia and kidney failure.