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U.S. Department of Health and Human Services

New Pediatric Labeling Information Database - Detail

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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
Therapeutic Category:  Antihypertensive