Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
New Pediatric Labeling Information Database - Detail
FDA Home
Pediatrics
New Pediatric Labeling Information Database
Detail
-
Please note:
JavaScript must be enabled for this application to work properly.
Check your settings
if you are unsure if your JavaScript is enabled.
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
BPCA(B):
B
Sponsor:
Purdue Pharma L.P.
NNPS:
FASLE
Therapeutic Category:
Analgesic
-
-