Spironolactone Indications and Dosage
- ascites
- bronchopulmonary dysplasia (BPD) †
- edema
- heart failure †
- hirsutism †
- hyperaldosteronism
- hyperaldosteronism diagnosis
- hypertension
- hypokalemia
- polycystic ovary syndrome †
- premenstrual syndrome (PMS) †
- pulmonary edema
† non-FDA-approved indication
Spironolactone Indications and Dosage
For the treatment of hypertension:
Oral dosage:
Adults: Initially, 50 - 100 mg/day PO in single or divided doses. Continue treatment for at least 2 weeks since the maximum response may not be observed until this time. Dosages may be titrated up to 200 mg/day PO administered in 2 - 4 divided doses.
Elderly: See adult dosage. Elderly patients may be more sensitive to the diuretic effects of the drug and are more likely to have age-associated renal impairment (see dosage for patients with renal impairment).
Children † : Doses of 1.5 - 3.3 mg/kg/day or 60 mg/m2/day PO, given once daily or in 2 - 4 divided doses, have been used.
For the treatment of diuretic-induced hypokalemia when oral potassium supplements or other potassium-sparing regimens are considered inappropriate:
Oral dosage:
Adults: 25 - 100 mg/day PO, once daily or in 2 - 4 divided doses.
Elderly: See adult dosage. Elderly patients may be more sensitive to the diuretic effects of the drug and are more likely to have age-associated renal impairment (see dosage for patients with renal impairment).
Children: Dosage has not been established.
For the treatment of severe (NYHA Class IV) heart failure † in adults to improve survival and NYHA functional class, and to reduce hospitalizations:
NOTE: Spironolactone has been shown to improve survival and NYHA Class functional class, and to reduce hospitalizations in patients with severe heart failure (NYHA Class IV) when added to conventional therapy (e.g., ACE inhibitor and a loop diuretic, with or without digoxin).
Oral dosage:
Adults: Initially, 25 mg PO once daily for 8 weeks, may increase to 50 mg once daily if the patient shows improvement in the signs or symptoms of heart failure without evidence of hyperkalemia. The dosage may be decreased to 25 mg PO every other day if hyperkalemia occurs at the initial dosage.
Elderly: See adult dosage. Elderly patients may be more sensitive to the diuretic effects of the drug and are more likely to have age-associated renal impairment (see dosage for patients with renal impairment).
For the treatment of edema (e.g., due to nephrotic syndrome, congestive heart failure or hepatic disease):
Oral dosage:
Adults: Initially, 100 mg/day PO (usual dosage range 25 - 200 mg/day) given as a single dose or in divided doses, titrated to clinical response. . If spironolactone is used alone, therapy should be continued at the initial dosage level for at least 5 days. If, after 5 days, an adequate diuretic response is not obtained, a second diuretic which acts more proximally in the renal tubule may be added to the regimen. The dosage of spironolactone should not be adjusted when other diuretics are added.
if hyperkalemia occurs at the initial dosage.
Elderly: See adult dosage. Elderly patients may be more sensitive to the diuretic effects of the drug and are more likely to have age-associated renal impairment (see dosage for patients with renal impairment).
Children: Doses of 1.5 - 3.3 mg/kg/day or 60 mg/m2/day PO, given once daily or in 2 - 4 divided doses, have been used.
Infants and neonates: Doses of 1 - 3 mg/kg/day PO, given once daily or in 2 - 4 divided doses, have been used.
For the treatment of hyperaldosteronism or for the treatment of ascites associated with hepatic cirrhosis:
Oral dosage:
Adults: Initially, 100 mg/day PO in single or divided doses, titrated to clinical response. Some clinicians determine spironolactone doses by using the urinary Na+/K+ ratio. In patients with a ratio > 1, administer 100 - 150 mg PO once daily. In patients with a ratio < 1, administer 200 - 300 mg PO once daily. The dose is adjusted until the ratio remains greater than one. One author, however, states that the diuretic dose should be increased if the urinary sodium is < 10 mmol/L and the urine volume is < 1L/day. In the treatment of ascites, although some clinicians advocate increasing the spironolactone dose to a maximum of 400 mg PO once daily before considering combination therapy with furosemide, this strategy may unnecessarily prolong achieving a therapeutic response. One author prefers to initiate therapy with a combination of spironolactone and a loop diuretic.
Elderly: See adult dosage. Elderly patients may be more sensitive to the diuretic effects of the drug and are more likely to have age-associated renal impairment (see dosage for patients with renal impairment).
Children: Dosage has not been established.
For primary hyperaldosteronism diagnosis:
Oral dosage:
Adults: Short test: 400 mg PO per day for 4 days. If potassium concentration rises initially during spironolactone therapy but decreases when the drug is discontinued, then primary hyperaldosteronism may be inferred. Long test: 400 mg PO for 3 - 4 weeks. If potassium concentration rises to within normal limits and hypertension is corrected, then this is presumptive evidence for primary hyperaldosteronism.
Children: Doses of 125 - 375 mg/m2/day PO, given in divided doses, have been used.
For the treatment of pulmonary edema due to heart failure or bronchopulmonary dysplasia (BPD) † in children:
Oral dosage:
Children: Doses of 1.5 - 3.3 mg/kg/day or 60 mg/m2/day PO, given once daily or in 2 - 4 divided doses, have been used.
Infants and neonates: Doses of 1 - 3 mg/kg/day PO, given once daily or in 2 - 4 divided doses, have been used.
For the treatment of symptoms of bloating and weight gain associated with premenstrual syndrome (PMS) † :
Oral dosage:
Adult females: Initially, 25 mg PO administered 2 - 4 times per day. Alternatively, 100mg PO once daily from day 12 of the cycle until menstruation was found to be statistically superior to placebo in relieving the feeling of bloatedness. Diuretic use should be limited to patients who demonstrate a premenstrual weight gain of > 1.4 kg. Individualize dosage to achieve desired diuresis and minimize weight gain.
For the treatment of polycystic ovary syndrome † :
Oral dosage:
Adult females: Doses of 50 - 200 mg/day PO, given in 1 - 2 divided doses, have been used.
For the treatment of female hirsutism † :
Oral dosage:
Adults and adolescent females: Doses of 50 - 200 mg/day PO, given in 1 - 2 divided doses, have been used.
Maximum Dosage Limits:
- Adults: 400 mg/day PO. Doses > 200 mg/day PO are generally not needed except in patients receiving spironolactone for conditions associated with hyperaldosteronism.
- Elderly: 400 mg/day PO. Doses > 200 mg/day PO are generally not needed except in patients receiving spironolactone for conditions associated with hyperaldosteronism.
- Adolescents: Maximum dosage information is not available. Consider the dosage for adults or children, depending on the age and weight of the adolescent.
- Children: 3.3 mg/kg/day PO or 60 mg/m2/day PO for hypertension; 375 mg/m2/day PO for hyperaldosteronism diagnosis.
Patients with hepatic impairment:
No dosage adjustment is needed; spironolactone is often a preferred agent in the management of cirrhotic ascites. However, diuretics should be used with caution in patients with hepatic disease since minor alterations of fluid and electrolyte balance may precipitate hepatic coma.
Patients with renal impairment:
CrCl > 50 ml/min: no dosage adjustment needed.
CrCl 10 - 50 ml/min: extend dosage interval to every 24 hours.
CrCl < 10 ml/min: avoid use of drug.
† non-FDA-approved indication
[ Last revised: 4/1/2003 11:05:00 AM ]
References
. Runyon BA. Care of patients with ascites. N Engl J Med 1994;330:337 - 42.
. Smith S, Schiff I. The premenstrual syndrome - diagnosis and management. Fertility and Sterility 1989;52:527 - 43.
. Pitt B, Zannad F, Remme WJ. The effect of spironolactone on morbidity and mortality in patients with severe heart failure. N Engl J Med 1999;341:709 - 17.
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