• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

New Pediatric Labeling Information Database - Detail

  • Print
  • Share
  • E-mail
-
 
Pediatric Labeling Date:  01/31/2008
 
Trade Name:  Inspra
 
Generic Name or Proper Name (*):  eplerenone
 
Indications Studied:  Hypertension
 
Label Changes Summary:  * Effectiveness was not established in a study of 304 hypertensive pediatric patients 4 - 17 years; eplerenone, at doses up to 100 mg/ day, did not lower blood pressure effectively * Therefore, it has not been studied in hypertensive patients <4 years old * Eplerenone has not been studied in hypertensive patients < 4 years or in pediatric patients with heart failure * Adverse events similar to that of adults
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B) and PREA(P):  B, P
 
Sponsor:  Pfizer
 
Pediatric Exclusivity Granted Date:  10/24/2007
 
NNPS:  FALSE
 
Therapeutic Category:  Antihypertensive
 
-
-