Post-myocardial infarction cardiac failure

Initiate treatment at 25 mg once daily and titrate to the target maintenance dose of 50 mg once daily preferably within 4 weeks. Consider the serum potassium levels during titration.
Treatment should be initiated 3 to 14 days after an acute myocardial infarction.

 

 

NYHA class II (chronic) cardiac failure

Initiate treatment at 25 mg once daily and titrate to the target maintenance dose of 50 mg once daily preferably within 4 weeks. Consider the serum potassium levels during titration.

 

Patients with a serum potassium level of greater than 5 mmol/L should not be started on eplerenone. Measure serum potassium prior to therapy, within the first week and at one month after start of treatment or dose adjustment. Assess serum potassium periodically thereafter.

Once initiated, dosage should be based on the serum potassium level.

 

Serum potassium below 5 mmol/L:

Increase dose from 25 mg every other day to 25 mg once daily.
or
From 25 mg once daily increase to 50 mg once daily.

 

 

Serum potassium 5 to 5.4 mmol/L:

No dose adjustment required.

 

 

Serum potassium 5.5 to 5.9 mmol/L:

Decrease dose from
50 mg once daily to 25 mg once daily.
or
25 mg once daily to 25 mg every other day.
or
25 mg every other day to withdraw eplerenone therapy.

 

 

Serum potassium equal to or greater than 6 mmol/L:

Withdraw eplerenone therapy. This can be re-started once potassium levels fall below 5 mmol/L, at a dose of 25 mg every other day.

Moderate renal impairment (creatinine clearance 30 to 60 ml/minute)

Patients should be started at 25 mg every other day, and the dose should be adjusted based on the potassium level.
Monitor serum potassium levels periodically.

 

 

Post MI heart failure with creatinine clearance less than 50 ml/minute

Use with caution in these patients.
Doses above 25 mg once daily have not been studied.

 

The Renal Drug Handbook suggests the following doses for renal impairment:

Glomerular Filtration Rate (GFR)

GFR 20 to 50 ml/minute - Dose as in normal renal function.
GFR 10 to 20 ml/minute - Dose as in normal renal function.
GFR Less than 10 ml/minute - Dose as in normal renal function.

Contraindications

Baseline serum potassium above 5 mmol/L
Children under 18 years
Breastfeeding
Galactosaemia
Renal impairment - eGFR below 30ml/minute/1.73m sq
Severe hepatic impairment

Precautions and Warnings

Elderly
Diabetes mellitus
Glucose-galactose malabsorption syndrome
Lactose intolerance
Mild hepatic impairment
Pregnancy
Renal impairment

Advise ability to drive/operate machinery may be affected by side effects
Contains lactose
Monitor serum potassium levels before treatment
Consider dose reduction if significant rise in serum potassium occurs
Monitor serum potassium regularly
Increased risk of hyperkalaemia with K+ suppl. and K+ sparing diuretic
Advise patient not to take NSAIDs unless advised by clinician
Advise patient not to take St John's wort concurrently
Advise on problems of salt substitutes/high intake of potassium-rich food
Advise patient grapefruit products may increase plasma level

Hyperkalaemia may occur. Monitor potassium levels in all patients at initiation of therapy, within the first week and at one month after the start of treatment or dose adjustment.

One study suggested that the concurrent use of hydrochlorothiazide may offset increases in serum potassium.

Eplerenone is not dialysable.

Monitor serum electrolytes in patients with hepatic impairment.

 

Pregnancy and Lactation

Pregnancy

Use eplerenone with caution in pregnancy.

Caution when prescribing eplerenone to pregnant women as there is no adequate data.

Animal studies did not indicate direct or indirect adverse effects with respect to pregnancy, embryofoetal development, parturition and post natal development.

The use of all medication in pregnancy should be avoided whenever possible

Lactation

Eplerenone is contraindicated in breastfeeding.

It is unknown if eplerenone is excreted in breast milk.

Because of the unknown potential for adverse effects on the breastfed infant, a decision should be made whether to discontinue the drug or discontinue breastfeeding taking into account the importance of the drug to the mother.