Abuse Potential
• Schedule II controlled substance with abuse liability similar to morphine.
• Potential for abuse in a manner similar to other legal or illicit opiates. Consider abuse potential when prescribing or dispensing oxycodone extended-release tablets (e.g., OxyContin^®) in situations where the clinician or pharmacist is concerned about increased risk of misuse, abuse, or diversion.

Intended Uses of Extended-release Tablets (e.g., OxyContin^®)
• Oxycodone hydrochloride extended-release tablets (e.g., OxyContin^®) are a controlled-release oral formulation indicated for the management of moderate to severe pain when a continuous, around-the-clock analgesic is needed for an extended period of time.
• Oxycodone hydrochloride extended-release tablets (e.g., OxyContin^®) are not intended for use as a prn analgesic.
• Only use the 80-mg formulation in opiate-tolerant patients. This strength may cause fatal respiratory depression when administered to patients not previously exposed to opiates. (See Dosage and Administration.)

Overdose Risk with Improper Administration of Extended-release Tablets (e.g., OxyContin^®)
• Oxycodone hydrochloride extended-release tablets are to be swallowed whole and are not to be broken.
• Chewing, crushing, or dissolving the extended-release tablets could result in rapid release and absorption of a potentially fatal dose of oxycodone hydrochloride.

REMS:

FDA approved a REMS for oxycodone to ensure that the benefits of a drug outweigh the risks. The REMS may apply to one or more preparations of oxycodone and consists of the following: medication guide and elements to assure safe use. See the FDA REMS page ([Web]) or the ASHP REMS Resource Center ([Web]).