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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:  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  Opens a new window
Sponsor:  Alza
Pediatric Exclusivity Granted Date:  01/29/2003
Therapeutic Category:  Anesthetic agent