Eplerenone drug interactions: Difference between revisions
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=Drug Interactions== | ==Drug Interactions== | ||
===7.1 CYP3A4 Inhibitors=== | ===7.1 CYP3A4 Inhibitors=== | ||
Revision as of 00:02, 3 March 2014
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.[1]
References
- ↑ "INSPRA (EPLERENONE) TABLET, FILM COATED [G.D. SEARLE LLC DIVISION OF PFIZER INC]". Retrieved 28 February 2014.