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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:  02/23/2001
 
Trade Name:  Diprivan
 
Generic Name or Proper Name (*):  propofol
 
Indications Studied:  Induction and/or maintenance of anesthesia
 
Label Changes Summary:  Maintenance of anesthesia- age decreased down to 2 months from 3 years Induction of anesthesia remains the same- 3 years of age and above Concomitant administration with fentanyl may result in serious bradycardia Abrupt discontinuation following prolonged infusion may result in flushing of hands and feet, agitation, tremulousness and hyperirritability Propofol is not indicated for pediatric ICU sedation as safety has not been established. In a single multicenter trial of ICU sedation in critically ill pediatric patients (patients with upper respiratory tract infections excluded), the incidence of mortality (causality not established) was 9% in the propofol arm versus 4% in the standard sedative agents arm
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B):  B
 
Sponsor:  AstraZeneca
 
Pediatric Exclusivity Granted Date:  08/11/1999
 
NNPS:  FALSE'
 
Therapeutic Category:  Anesthetic agent
 
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