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New Pediatric Labeling Information Database - Detail
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Pediatrics
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
BPCA(B) and PREA(P):
B, P
Sponsor:
Pfizer
Pediatric Exclusivity Granted Date:
10/24/2007
NNPS:
FALSE'
Therapeutic Category:
Antihypertensive
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