INDICATIONS AND USAGE

Eplerenone tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular (CV) events, primarily strokes and MI. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes.

DOSAGE

Hypertension

The recommended starting dose of eplerenone tablets are 50 mg administered once daily. The full therapeutic effect of eplerenone tablet is apparent within 4 weeks. For patients with an inadequate blood pressure response to 50 mg once daily increase the dosage of eplerenone tablets to 50 mg twice daily. Higher dosages of eplerenone tablets are not recommended because they have no greater effect on blood pressure than 100 mg and are associated with an increased risk of hyperkalemia.

Recommended Monitoring

Measure serum potassium before initiating eplerenone tablets therapy, within the first week, and at one month after the start of treatment or dose adjustment. Assess serum potassium periodically thereafter.

Check serum potassium and serum creatinine within 3 to 7 days of a patient initating a moderate CYP3A inhibitor, angiotensin-II blockers or non-steroidal-anti-inflammatories.

ADVERSE REACTIONS

Hyperkalemia

For full information, please refer to:

https://nctr-crs.fda.gov/fdalabel/services/spl/set-ids/b0886e4e-5710-4053-9270-4d7de34068e7/spl-doc?hl=eplerenone

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