Eplerenone warnings and precautions

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]

Warnings and Precautions

5.1 Hyperkalemia

Minimize the risk of hyperkalemiawith proper patient selection and monitoring, and avoidance of certain concomitant medications [See CONTRAINDICATIONS (4),ADVERSE REACTIONS (6.2), and DRUG INTERACTIONS (7)]. Monitor patients for the development of hyperkalemiauntil the effect of INSPRA is established. Patients who develop hyperkalemia(>5.5 mEq/L) may continue INSPRA therapy with proper dose adjustment. Dose reduction decreases potassium levels. [SeeDOSAGE AND ADMINISTRATION (2.1).]

The rates of hyperkalemiaincrease with declining renal function. [See ADVERSE REACTIONS (6.2).] Patients with hypertension who have serum creatinine levels >2.0 mg/dL (males) or >1.8 mg/dL (females) or creatinine clearance ≤50 mL/min should not be treated with INSPRA. [See CONTRAINDICTIONS (4).] Patients with CHF post-MI who have serum creatinine levels >2.0 mg/dL (males) or >1.8 mg/dL (females) or creatinine clearance ≤50mL/min should be treated with INSPRA with caution.

Diabetic patients with CHF post-MI should also be treated with caution, especially those with proteinuria. The subset of patients in the EPHESUS study with both diabetes and proteinuria on the baseline urinalysis had increased rates of hyperkalemiacompared to patients with either diabetes or proteinuria. [See ADVERSE REACTIONS (6.2).]

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). [See DRUG INTERACTIONS (7.2)]

5.2 Impaired Hepatic Function

Mild-to-moderate hepatic impairment did not increase the incidence of hyperkalemia. In 16 subjects with mild-to-moderate hepatic impairment who received 400 mg of eplerenone, no elevations of serum potassium above 5.5 mEq/L were observed. The mean increase in serum potassium was 0.12 mEq/L in patients with hepatic impairment and 0.13 mEq/L in normal controls. The use of INSPRA in patients with severe hepatic impairment has not been evaluated. [See CLINICAL PHARMACOLOGY (12.3).]

5.3 Impaired Renal Function

Patients with decreased renal function are at increased risk of hyperkalemia. [See CONTRAINDICATIONS (4),WARNINGS AND PRECAUTIONS (5.1), ADVERSE REACTIONS (6.1).]