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EPLERENONE Tablets (GREENSTONE LLC)

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EPLERENONE Tablets (GREENSTONE LLC) Quick Finder

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the...
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1 INDICATIONS AND USAGE

1.1 Heart Failure Post-Myocardial Infarction

Eplerenone is indicated to improve survival of stable patients with symptomatic heart failure...

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2 DOSAGE AND ADMINISTRATION

2.1 Heart Failure Post-Myocardial Infarction

Initiate treatment at 25 mg once daily and titrate to the recommended dose of 50 mg once...

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3 DOSAGE FORMS AND STRENGTHS

  • 25 mg tablets: yellow diamond biconvex film-coated tablets debossed with "G" on one side and "25mg" on the other
  • 50 mg tablets: yellow diamond biconvex film-coated tablets debossed...
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4 CONTRAINDICATIONS

For All Patients

Eplerenone is contraindicated in all patients with:

  • serum potassium...
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5 WARNINGS AND PRECAUTIONS

5.1 Hyperkalemia

The risk of hyperkalemia is higher in patients with impaired renal function, proteinuria, diabetes and those concomitantly...

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6 ADVERSE REACTIONS

The following adverse reactions are discussed in greater detail in other sections of the labeling:

  • Hyperkalemia [see

    6.1 Clinical Trials Experience

    ...

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7 DRUG INTERACTIONS

7.1 CYP3A Inhibitors

Eplerenone metabolism is predominantly mediated via CYP3A. Do not use eplerenone with drugs that are strong inhibitors of...

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8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

The available data from published case reports on...

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10 OVERDOSAGE

No cases of human overdosage with eplerenone have been reported. Lethality was not observed in mice, rats, or dogs after single oral doses that provided Cmax exposures at least 25 times...

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11 DESCRIPTION

Eplerenone tablets contain eplerenone, a blocker of aldosterone binding at the mineralocorticoid receptor.

Eplerenone is chemically described as Pregn-4-ene-7,21-dicarboxylic acid, 9,11-epoxy-17-hydroxy-...

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12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Eplerenone binds to the mineralocorticoid receptor and blocks the binding of aldosterone, a component of the renin-...

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13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Eplerenone was non-genotoxic in a battery of assays including in vitro bacterial...

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14 CLINICAL STUDIES

14.1 Heart Failure Post-Myocardial Infarction

The eplerenone post-acute myocardial infarction heart failure efficacy and survival study (EPHESUS...

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16 HOW SUPPLIED/STORAGE AND HANDLING

Eplerenone tablets are yellow, diamond biconvex, and film-coated. They are debossed with "G" on one side. They are supplied as follows:

...
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17 PATIENT COUNSELING INFORMATION

Advise patients receiving eplerenone:

  • Not to use potassium supplements or salt substitutes containing potassium without consulting the prescribing physician...
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