Eplerenone drug interactions

Eplerenone
INSPRA® FDA Package Insert
Indications and Usage
Dosage and Administration
Dosage Forms and Strengths
Contraindications
Warnings and Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Overdosage
Description
Clinical Pharmacology
Nonclinical Toxicology
Clinical Studies
How Supplied/Storage and Handling
Labels and Packages
Clinical Trials on Eplerenone
ClinicalTrials.gov

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Sheng Shi, M.D. [2]

Drug Interactions=

7.1 CYP3A4 Inhibitors

Because eplerenone metabolism is predominantly mediated via CYP3A4, do not use INSPRA with drugs that are strong inhibitors of CYP3A4. [SeeCONTRAINDICATIONS (4) and CLINICAL PHARMACOLOGY (12.3).]

In patients with hypertension taking moderate CYP3A4 inhibitors, reduce the starting dose of INSPRA to 25 mg once daily. [See DOSAGE AND ADMINISTRATION (2.3, 2.4) and CLINICAL PHARMACOLOGY (12.3).]

7.2 ACE Inhibitors and Angiotensin II Receptor Antagonists

The risk of hyperkalaemia may increase when eplerenone is used in combination with an angiotensin converting enzyme (ACE) inhibitor and/or an angiotensin receptor blocker (ARB). A close monitoring of serum potassium and renal function is recommended, especially in patients at risk for impaired renal function, e.g., the elderly. [seeWARNINGS AND PRECAUTIONS (5.1)]

Congestive Heart Failure Post-Myocardial Infarction

In EPHESUS [see CLINICAL STUDIES (14.1)], 3020 (91%) patients receiving INSPRA 25 to 50 mg also received ACE inhibitors or angiotensin II receptor antagonists (ACEI/ARB). Rates of patients with maximum potassium levels >5.5 mEq/L were similar regardless of the use of ACEI/ARB.

Hypertension

In clinical studies of patients with hypertension, the addition of INSPRA 50 to 100 mg to ACE inhibitors and angiotensin II receptor antagonists increased mean serum potassium slightly (about 0.09–0.13 mEq/L). In a study in diabetics with microalbuminuria, INSPRA 200 mg combined with the ACE inhibitor enalapril 10 mg increased the frequency of hyperkalemia (serum potassium >5.5 mEq/L) from 17% on enalapril alone to 38%.

7.3 Lithium

A drug interaction study of eplerenone with lithiumhas not been conducted. lithiumtoxicity has been reported in patients receiving lithiumconcomitantly with diuretics and ACE inhibitors. Serum lithiumlevels should be monitored frequently if INSPRA is administered concomitantly with lithium.

7.4 Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)

A drug interaction study of eplerenone with an NSAID has not been conducted. The administration of other potassium-sparing antihypertensives with NSAIDs has been shown to reduce the antihypertensive effect in some patients and result in severe hyperkalemia in patients with impaired renal function. Therefore, when INSPRA and NSAIDs are used concomitantly, patients should be observed to determine whether the desired effect on blood pressure is obtained and monitored for changes in serum potassium levels.