oxycodone-apap (wattson labs)


This combination medication is used to help relieve moderate to severe pain. It contains a opioid (narcotic) pain reliever (oxycodone) and a non-opioid pain reliever (acetaminophen). Oxycodone works in the brain to change how your body feels and responds to pain. Acetaminophen can also reduce a fever.

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Each tablet of OXY/APAP XR consists of 7.5mg of OXY and 325mg of APAP. When taken as a
single dose of two tablets, the IR layer delivers approximately 3.75/325mg of OXY/APAP,
followed by the release of approximately 11.25/325 mg of OXY/APAP over the remainder of the
dosing interval.

The XR component of OXY/APAP XR contains a proprietary formulation (AcuForm™ by
Depomed) primarily consisting of high molecular weight polyethylene oxide (PEO) designed to
promote gastric retention and extend the duration of drug release.

Oxycodone HCl is a pure opioid agonist and is relatively selective for the mu receptor,
although it can interact with other opioid receptors at higher doses. The principal
therapeutic action of oxycodone is analgesia.

Acetaminophen is a non-opiate, non-salicylate analgesic, and antipyretic. The site and
mechanism for the analgesic effect of acetaminophen has not been determined

FDA-approved Indication(s): Management of acute pain severe enough to require opioid
treatment and for which alternative treatment options are inadequate.

Limitations of Use: Because of the risks of addiction, abuse, misuse, overdose, and death with
opioids, even at recommended doses, OXY/APAP XR should be reserved for use in patients for
whom alternative treatment options (e.g., non-opioid analgesics) have been ineffective, not
tolerated, or otherwise inadequate.

OXY/APAP XR is not interchangeable with other combination oxycodone and acetaminophen
products because of differing pharmacokinetic profiles that affect the frequency of administration.

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