Label Changes for:

Inspra (eplerenone) 25 mg and 50 mg Tablets

May 2013

Changes have been made to the WARNINGS and PRECAUTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)

 

The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary.


 

 

May 2013

WARNINGS AND PRECAUTIONS

5.1 Hyperkalemia
  • ..... The risk of hyperkalemia 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)]

DRUG INTERACTIONS

7.2 ACE Inhibitors and Angiotensin II Receptor Antagonists
  • The risk of hyperkalemia 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. [see WARNINGS AND PRECAUTIONS (5.1)]
     

 

May 2008

Summary View

Sections Modified

USE IN SPECIFIC POPULATIONS

  • Pediatric Use

 

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