Pediatric Use Approved for OxyContin
August 17, 2015 – The U.S. Food and Drug Administration (FDA) approved pediatric use of OxyContin extended release tablets C11. After analysis of requested studies, the FDA gave its approval for the treatment of patients who are at least eleven years old, with pain severe enough to need continuous, long term treatment, which is not managed by current drug therapy.
Patients taking OxyContin must have had daily doses of another opioid drug for a minimum of five days before OxyContin can be started. Before treatment with OxyContin can be initiated, any other opioid in use for at least two days prior to the OxyContin must have a dose that is equivalent to 20mg or more of Oxycodone. Dosage of OxyContin is dependent on the drug and dose the patient previously received, and may be adjusted to provide adequate pain control once the patient has transitioned.
Several box warnings including risks for abuse, addiction, overdose, and respiratory depression must be part of the labeling for OxyContin. OxyContin is dispensed with a medication guide, and under a Risk Evaluation and Mitigation Strategy (REMS).
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and a availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability. All trademarks are the property of their respective owners.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.