Safety

Inspra (eplerenone) Tablets

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

May 2016

Summary View

WARNINGS AND PRECAUTIONS

Hyperkalemia
  • The risk of hyperkalemia is higher in patients with impaired renal function, proteinuria , diabetes and those concomitantly treated with ACEs, ARBs, NSAIDs and moderate CYP3A inhibitors.
  • Patients on moderate CYP3A inhibitors that cannot be avoided should have their dose of eplerenone reduced.

ADVERSE REACTIONS

Clinical Trials Experience
  • Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in clinical trials of another drug and may not reflect the rates observed in practice.

DRUG INTERACTIONS

CYP3A4 Inhibitors
  • CYP3A4 replaces CYP3A in all instances in this section
  • In post-MI CHF patients taking a moderate CYP3A inhibitor, do not exceed 25 mg once daily. In patients with hypertension taking a moderate CYP3A inhibitor, initiate at 25 mg once daily. For inadequate blood pressure response, dosing may be increased to a maximum of 25 mg twice daily.

USE IN SPECIFIC POPULATIONS

Pediatric Use
  • pediatric patients age 4 to 16 years (replaces 4 to 17 years)
  • 149 patients … (age range 5 to 17 years)
Geriatric Use

Hypertension

  • younger subjects… however due to age-related decreases in creatine clearance, the risk of hyperkalemia may be increased.

 

May 2013

Summary View

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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