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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:  11/22/2013
 
Trade Name:  Nitropress
 
Generic Name or Proper Name (*):  sodium nitroprusside
 
Indications Studied:  Immediate reduction of blood pressure in hypertensive crisis
 
Label Changes Summary:  *Efficacy in the pediatric population was established based on adult trials and supported by a dose-ranging trial and an open label trial that achieved adequate mean arterial pressure control in pediatric patients. *No novel safety issues were found in these two studies. *Information on dosing, PK parameters and clinical trials. *Off-patent Written Request.
 
BPCA(B):  B
 
Sponsor:  Hospira
 
NNPS:  FALSE
 
Therapeutic Category:  Antihypertensive
 
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