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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:
05/20/2003
Trade Name:
Duragesic
Generic Name or Proper Name (*):
fentanyl
Indications Studied:
Management of chronic pain
Label Changes Summary:
Safety evaluated in three open-label trials in 291 patients 2 years through 18 years of age with chronic pain New Warning: Duragesic should be administered to children only if they are opioid-tolerant and age 2 years or older New information on pharmacokinetics, dosage and administration and patient information Precaution to guard against accidental ingestions by children Adverse Events: no apparent pediatric-specific risk associated with Duragesic use in children as young as 2 years old when used as directed. Most common adverse events were fever (35%), vomiting (33%), and nausea (24%)
Product Labeling:
Labeling
BPCA(B):
B
Sponsor:
Alza
Pediatric Exclusivity Granted Date:
01/29/2003
NNPS:
FALSE'
Therapeutic Category:
Anesthetic agent
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