Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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:  11/18/2015
 
Trade Name:  Narcan Nasal Spray
 
Generic Name or Proper Name (*):  naloxone hydrochloride
 
Indications Studied:  Emergency treatment of known or suspected opioid overdose
 
Label Changes Summary:  *Safety and effectiveness of naloxone nasal spray have been established in adults and pediatric patients of all ages *Use of naloxone hydrochloride in pediatric patients is supported by evidence from adequate and well-controlled studies of naloxone hydrochloride in adults with additional data from 15 clinical studies (controlled and uncontrolled) in neonates and pediatric patients *Absorption of naloxone hydrochloride following intranasal administration in pediatric patients may be erratic or delayed. *Even when the opiate-intoxicated pediatric patient responds appropriately to naloxone hydrochloride, he/she must be carefully monitored for at least 24 hours, as a relapse may occur as naloxone is metabolized. *Use in patients who are opioid dependent may precipitate opioid withdrawal. In neonates, opioid withdrawal may be life-threatening if not recognized and properly treated. Monitor for the development of opioid withdrawal. *Information on dosing *New dosage form
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Adapt Pharma Operations Limited
 
NNPS:  FALSE
 
Therapeutic Category:  Opioid antagonist
 
-
-