ALDACTONE® Dosage and Administration

(spironolactone)

2 DOSAGE AND ADMINISTRATION

2.1 General Considerations

ALDACTONE can be taken with or without food, but should be taken consistently with respect to food [see Clinical Pharmacology (12.3)].

2.2 Treatment of Heart Failure

In patients with serum potassium ≤5.0 mEq/L and eGFR >50 mL/min/1.73 m2, initiate treatment at 25 mg once daily. Patients who tolerate 25 mg once daily may have their dosage increased to 50 mg once daily as clinically indicated. Patients who develop hyperkalemia on 25 mg once daily may have their dosage reduced to 25 mg every other day [see Warnings and Precautions (5.1)]. In patients with an eGFR between 30 and 50 mL/min/1.73 m2, consider initiating therapy at 25 mg every other day because of the risk of hyperkalemia [see Use in Specific Populations (8.6)].

2.3 Treatment of Essential Hypertension

The recommended initial daily dose is 25 to 100 mg of ALDACTONE administered in either single or divided doses is recommended. Dosage can be titrated at two-week intervals. Doses greater than 100 mg/day generally do not provide additional reductions in blood pressure.

2.4 Treatment of Edema

In patients with cirrhosis, initiate therapy in a hospital setting and titrate slowly [see Use in Specific Populations (8.7)]. The recommended initial daily dosage is 100 mg of ALDACTONE administered in either single or divided doses, but may range from 25 to 200 mg daily. When given as the sole agent for diuresis, administer for at least five days before increasing dose to obtain desired effect.

2.5 Treatment of Primary Hyperaldosteronism

Administer ALDACTONE in doses of 100 to 400 mg daily in preparation for surgery. For patients who are considered unsuitable for surgery, ALDACTONE can be used as long-term maintenance therapy at the lowest effective dosage determined for the individual patient.

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Dosage and Administration

2 DOSAGE AND ADMINISTRATION

2.1 General Considerations

ALDACTONE can be taken with or without food, but should be taken consistently with respect to food [see Clinical Pharmacology (12.3)].

2.2 Treatment of Heart Failure

In patients with serum potassium ≤5.0 mEq/L and eGFR >50 mL/min/1.73 m2, initiate treatment at 25 mg once daily. Patients who tolerate 25 mg once daily may have their dosage increased to 50 mg once daily as clinically indicated. Patients who develop hyperkalemia on 25 mg once daily may have their dosage reduced to 25 mg every other day [see Warnings and Precautions (5.1)]. In patients with an eGFR between 30 and 50 mL/min/1.73 m2, consider initiating therapy at 25 mg every other day because of the risk of hyperkalemia [see Use in Specific Populations (8.6)].

2.3 Treatment of Essential Hypertension

The recommended initial daily dose is 25 to 100 mg of ALDACTONE administered in either single or divided doses is recommended. Dosage can be titrated at two-week intervals. Doses greater than 100 mg/day generally do not provide additional reductions in blood pressure.

2.4 Treatment of Edema

In patients with cirrhosis, initiate therapy in a hospital setting and titrate slowly [see Use in Specific Populations (8.7)]. The recommended initial daily dosage is 100 mg of ALDACTONE administered in either single or divided doses, but may range from 25 to 200 mg daily. When given as the sole agent for diuresis, administer for at least five days before increasing dose to obtain desired effect.

2.5 Treatment of Primary Hyperaldosteronism

Administer ALDACTONE in doses of 100 to 400 mg daily in preparation for surgery. For patients who are considered unsuitable for surgery, ALDACTONE can be used as long-term maintenance therapy at the lowest effective dosage determined for the individual patient.
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