Usual Adult Dose for Edema

25 to 200 mg orally per day in single or divided doses

Duration of therapy: When given as the sole diuretic, continue the initial dose for at least 5 days, after which the initial dose may be adjusted to an optimal maintenance dose.

Comments:

• A second diuretic that acts more proximally at the renal tubule may be added if adequate diuresis has not been achieved after 5 days. The dose of this drug should remain unchanged if a second diuretic is added.

Uses:

• Treatment of edematous conditions in patients with congestive heart failure who are only partially responsive to or intolerant of other therapeutic measures or who are taking digitalis when other therapies are considered inappropriate.
• Treatment of edematous conditions in patients with liver cirrhosis accompanied by edema and/or ascites.
• Treatment of edematous conditions in patients with nephrotic syndrome when treatment of the underlying disease, restriction of fluid and sodium intake, and the use of other diuretics do not provide an adequate response.

Usual Adult Dose for Hypertension

Initial dose: 50 to 100 mg orally per day in single or divided doses

Duration of therapy: Treatment should be continued for at least 2 weeks to achieve a maximum response. Subsequently, the dose may be adjusted according to patient response.

Usual Adult Dose for Congestive Heart Failure

Initial dose: 25 mg orally once a day assuming serum potassium is less than or equal to 5 mEq/L and serum creatinine is less than or equal to 2.5 mg/dL

Maintenance dose:

• Patients tolerant of initial dose: May increase to 50 mg orally once a day as clinically indicated
• Patients intolerant of initial dose: May decrease to 25 mg orally every other day

Use: To increase survival and reduce the need for hospitalization of severe heart failure patients (New York Heart Association [NYHA] class III to IV) when used in addition to standard therapy.

Usual Adult Dose for Primary Hyperaldosteronism

Diagnostic dose:

• Long test: 400 mg orally per day for 3 to 4 weeks
• Short test: 400 mg orally per day for 4 days

Maintenance dose: 100 to 400 mg orally per day until surgery; may be used long-term at the lowest effective dose in patients deemed unsuitable for surgery.

Comments:

• For the long test, correction of hypokalemia and hypertension provides presumptive evidence of primary hyperaldosteronism.
• For the short test, increased serum potassium with this drug and a decrease upon discontinuation provide presumptive evidence of primary hyperaldosteronism.

Uses:

• Initial diagnostic measure to provide presumptive evidence of primary hyperaldosteronism while patients are on normal diets.
• Short-term preoperative treatment of patients with primary hyperaldosteronism.
• Long-term maintenance therapy for patients deemed unsuitable for surgery or those with idiopathic hyperaldosteronism.

Usual Adult Dose for Hypokalemia

25 to 100 mg orally per day

Uses:

• Treatment of patients with hypokalemia when other measures are considered inappropriate or inadequate.
• Prophylaxis of hypokalemia in patients taking digitalis when other measures are considered inadequate or inappropriate.

Renal Dose Adjustments

Contraindicated in patients with anuria, acute renal insufficiency, or significant impairment of renal excretory function.

Liver Dose Adjustments

Use with caution

Dose Adjustments

In patients with severe heart failure (New York Heart Association [NYHA] class III to IV), discontinue or interrupt treatment for serum potassium greater than 5 mEq/L or for serum creatinine greater than 4 mg/dL.

Precautions

US BOXED WARNING:

• TUMORIGENICITY: This drug has been shown to be a tumorigen in chronic toxicity studies of rats. This drug should be used only for its indicated conditions and unnecessary use should be avoided.

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Monitoring:

• Metabolic: Monitor fluids and electrolytes regularly in all patients. In patients with severe heart failure, monitor potassium and creatinine one week after initiation or a dose increase, monthly for the first 3 months, then quarterly for a year, and then every 6 months.

Patient advice: Advise patients to avoid potassium supplements and foods containing high levels of potassium, including salt substitutes.

Frequently asked questions

• What is the strength of CaroSpir (spironolactone) oral suspension?