Eplerenone contraindications

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]

Contraindications

For All Patients

INSPRA is contraindicated in all patients with:

serum potassium >5.5 mEq/L at initiation, creatinine clearance ≤30 mL/min, or concomitant administration of strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, nefazodone, troleandomycin, clarithromycin, ritonavir, and nelfinavir). [SeeDRUG INTERACTIONS (7.1), CLINICAL PHARMACOLOGY (12.3).]

For Patients Treated for Hypertension

INSPRA is contraindicated for the treatment of hypertension in patients with:

type 2 diabetes with microalbuminuria, serum creatinine >2.0 mg/dL in males or >1.8 mg/dL in females, creatinine clearance <50 mL/min, or concomitant administration of potassium supplements or potassium-sparing diuretics (e.g., amiloride, spironolactone, or triamterene). [See WARNINGS AND PRECAUTIONS (5.1), ADVERSE REACTIONS (6.2), DRUG INTERACTIONS (7), and CLINICAL PHARMACOLOGY (12.3).]