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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:
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
PREA(P):
P
Sponsor:
Adapt Pharma Operations Limited
NNPS:
FALSE
Therapeutic Category:
Opioid antagonist
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