Aldactone (spironolactone)

In patients with cirrhosis, spironolactone should be initiated with the lowest dose and titrated slowly; patients with cirrhosis and ascites should have therapy initiated in the hospital. (See Cautions: Precautions and Contraindications.)

The manufacturer states, for the treatment of heart failure in patients with an eGFR of 30-50 mL/minute per 1.73 m2, initiation of spironolactone at a dosage of 25 mg every other day (as oral tablets) should be considered because of the risk of hyperkalemia. Alternatively, ACCF and AHA state that the dosage of spironolactone should be reduced in heart failure patients with marginal renal function (eGFR 30-49 mL/minute per 1.73 m2); an initial dosage of 12.5 mg once daily or every other day and a maintenance dosage of 12.5-25 mg once daily as tablets (after 4 weeks of therapy and if serum potassium is 5 mEq/L or less) has been recommended. The manufacturer of the commercially available spironolactone oral suspension (CaroSpir(R)) states in patients with heart failure and an eGFR of 30-50 mL/minute per 1.73 m2, a reduced initial dosage of 10 mg once daily (as the oral suspension) should be considered because of the risk of hyperkalemia. The use of an aldosterone antagonist may be harmful in patients with an eGFR less than 30 mL/minute per 1.73 m2 because of potentially life-threatening hyperkalemia or renal insufficiency. (See Cautions: Electrolyte and Metabolic Effects.)

Spironolactone is administered orally.

Administration of spironolactone with food increases the bioavailability of the drug by approximately 90-100%. The manufacturers state that patients should establish a routine time for taking the drug with regard to meals.

Spironolactone tablets should be stored in tight, light-resistant containers at a temperature less than 25degreesC.

The commercially available oral suspension (CaroSpir(R)) is not therapeutically equivalent to spironolactone oral tablets (e.g., Aldactone(R)). In patients who require a dose exceeding 100 mg, tablets should be used; doses of CaroSpir(R) suspension exceeding 100 mg may result in higher than expected serum spironolactone concentrations. The oral suspension (CaroSpir(R)) should be stored at a controlled room temperature of 20-25degreesC but may be exposed to temperatures ranging from 15-30degreesC.

Although it has frequently been recommended that spironolactone tablets be administered in 3 or 4 doses daily, more recent information suggests that 1 or 2 doses daily may be adequate.

No dosing information is available for this tab.

No dosing information is available for this tab.

There is no enhanced messaging for this drug.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

There is no enhanced messaging for this drug.

There are no contraindication contraindications for this drug.

There are no severe contraindications for this drug.

There are no moderate contraindications for this drug.

There is no enhanced messaging for this drug.

There are no severe adverse reactions for this drug.

There are no less severe adverse reactions for this drug.

No enhanced messaging available.

No enhanced messaging available.

The use of spironolactone during pregnancy may affect the sex differentiation of a male fetus during embryogenesis. Studies in rats indicate that spironolactone may cause feminization of male fetuses and endocrine dysfunction in female fetuses exposed to the drug in utero. Data from published case reports and case series have not demonstrated an association of major malformations or other adverse pregnancy outcomes with spironolactone use. Because of the potential risk to the male fetus due to the antiandrogenic properties of spironolactone, the drug should be avoided during pregnancy; pregnant women who receive spironolactone should be advised of the potential risk to a male fetus.

Spironolactone is not distributed into milk; however, the active metabolite, canrenone, is distributed into milk in low amounts that are expected to be clinically inconsequential. The developmental and health benefits of breastfeeding along with the mother's clinical need for spironolactone and any potential adverse effects on the breastfed child from spironolactone or from the underlying maternal condition should be considered.

No enhanced messaging available.