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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:  08/13/2015
 
Trade Name:  Oxycontin extended release tablets
 
Generic Name or Proper Name (*):  oxycodone hydrochloride
 
Indications Studied:  Management of pain severe enough to require daily, around the-clock, long-term opioid treatment in pediatric patients 11 years and older
 
Label Changes Summary:  *Safety and efficacy have been established in pediatric patients 11 to 16 years. Use is supported by evidence from adequate and well-controlled trials in adults as well as an open-label study in pediatric patients ages 6 to 16 years. *There were insufficient numbers of patients less than 11 years of age enrolled in this study to establish the safety of the product in this age group. *The safety in pediatric patients was evaluated in 155 patients previously receiving and tolerating opioids for at least 5 consecutive days. *The most frequent adverse reactions observed in pediatric patients were vomiting, nausea, headache, pyrexia, and constipation. *Information on dosing, adverse reactions, and clinical trial
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B):  B
 
Sponsor:  Purdue Pharma L.P.
 
NNPS:  FASLE
 
Therapeutic Category:  Analgesic
 
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