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INSPRA (eplerenone) Dosage And Administration

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Dosage And Administration

Glomerular filtration rate should be estimated (eGFR) and serum potassium measured before initiating INSPRA (eplerenone) therapy since INSPRA dosing depends on these variables.

INSPRA should not be administered to heart failure patients with initial serum potassium >5.0 mmol/L, serum creatinine >221 umol/L and/or eGFR <30 mL/min/1.73 m2.

Serum potassium should be measured before initiating INSPRA (eplerenone) therapy, within the first week and at one month after the start of treatment or after a dose adjustment. Serum potassium should be measured periodically thereafter, as clinically warranted. Hyperkalemia can be expected at any time during treatment with INSPRA.

Efforts should be made to decrease the dietary potassium intake. Patients should be asked about their use of potassium containing salt substitutes and dietary supplements. Factors, such as patient characteristics, serum potassium levels and concomitant medications, may indicate that additional monitoring of serum potassium is appropriate (see WARNINGS AND PRECAUTIONS - Hyperkalemia, ADVERSE REACTIONS, and DRUG INTERACTIONS). INSPRA may be administered with or without food.

Recommended Dose and Dosage Adjustment

Heart failure

Renal Impairment

Patients with eGFR of ≥50 mL/min/1.73 m2:

For chronic heart failure NYHA Class II and post-myocardial infarction heart failure patients with serum potassium ≤ 5 mmol/L, treatment should be initiated at a dose of 25 mg once daily and titrated to the target dose of 50 mg once daily preferably within 4 weeks, taking into account the serum potassium level (see Table 16). Following myocardial infarction INSPRA should be initiated 3 – 14 days after MI.

The maximum daily dose in patients with eGFR of ≥50 ml/min/1.73 m2 is 50 mg daily. In patients using a mild to moderate CYP3A4 inhibitor, the maximum daily dose of INSPRA is 25 mg.

Patients with eGFR of 30-49 mL/min/1.73 m2 :
For chronic heart failure NYHA Class II and post-myocardial infarction heart failure patients with serum potassium ≤ 5 mmol/L, treatment should be initiated at a dose of 25 mg once every other day and titrated to the target dose of 25 mg once daily preferably within 4 weeks, taking into account the serum potassium level (see Table 16). Following myocardial infarction INSPRA should be initiated 3 – 14 days after MI.

The maximum dose in patients with an eGFR 30-49 mL/min/1.73 m2 is 25 mg once daily. INSPRA should not be given to patients on a mild to moderate CYP3A4 inhibitor because a lower dose than 25 mg once daily has not been studied.

Patients with eGFR of <30 mL/min/1.73 m2: INSPRA is contraindicated in patients with severe renal impairment.

Hepatic Impairment

Mild-to-Moderate Hepatic Impairment: No initial dosage adjustment is necessary. Severe Hepatic Impairment (see CONTRAINDICATIONS and WARNINGS and PRECAUTIONS).

Dose adjustment based on serum potassium levels for heart failure patients

Patients who develop hyperkalemia (>5.5 mmol/L) may still benefit from INSPRA with proper dose adjustment. The dose should be adjusted based on the serum potassium level and the dose adjustment table shown in Table 16.

Table 16 Dose Adjustment recommendations after initiation
 
*QOD: every other day; **QD: every day

Serum Potassium (mmol/L)

Action

Dose Adjustment

< 5.0

Increase

If 25 mg QOD* to 25 mg QD**

If 25 mg QD to 50 mg QD; except (no increase) if:

- concurrent mild-moderate CYP3A4 inhibitor or

- patients with an eGFR 30-49 mL/min/1.73 m2

5.0-5.4

Maintain

No adjustment

5.5-5.9

Decrease

If 50 mg QD to 25 mg QD

If 25 mg QD to 25 mg QOD

If 25 mg QOD to withhold; restart ONLY if K+ falls <5.0

≥ 6.0

Withhold

Restart at a lower dose ONLY when K+ falls <5.0

Following withholding INSPRA due to serum potassium ≥ 6.0 mmol/L and the return of potassium levels within acceptable limits, INSPRA can be restarted at a test dose of 25 mg every other day. There are no data to demonstrate that 25 mg every other day is effective and such dosing should be considered to be only a temporary situation. After a test period of one week on 25 mg every other day, serum potassium levels should be measured. If potassium levels return within acceptable limits, the dose can be increased to 25 mg every day and serum potassium should be measured after one week. It could then be determined if INSPRA therapy should be continued or stopped.

Hypertension

INSPRA should not be administered to hypertensive patients with initial serum potassium >5.0 mmol/L, serum creatinine >132 µmol/L in males or >115 µmol/L in females, and/or eGFR <50 mL/min/1.73 m2.

In patients with hypertension who have reduced eGFR, serum potassium concentrations should be closely monitored when treated with INSPRA, especially when co-administrated with other antihypertensive drugs).

For hypertension, the recommended starting dose of INSPRA is 50 mg administered once daily. The full therapeutic effect of INSPRA is apparent within 4 weeks. For patients with an inadequate blood pressure response to 50 mg once daily the dosage of INSPRA should be increased to 50 mg twice daily. Higher dosages of INSPRA are not recommended because they have no greater effect on blood pressure and are associated with an increased risk of adverse reactions, including hyperkalemia. (See CLINICAL TRIALS)

Specific Populations

Patients with hypertension: for patients with hypertension receiving mild to moderate CYP3A4 inhibitors (e.g.erythromycin, saquinavir, verapamil, and fluconazole), the dose of INSPRA should be reduced to 25 mg once daily. (See DRUG INTERACTIONS).

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