OXYCODONE
HCl CR TABLETS 10 mg 100s CII
NDC: 00591-3501-01
*Compare to: Oxycontin®, a registered trademark of Purdue
*Brand
names are the trademarks of the products' manufacturers and/or owners.
**Products illustrated may not appear at actual size and/or exact color.
OXYCODONE
HCl CR TABLETS 20 mg 100s CII
NDC: 00591-3502-01
*Compare to: Oxycontin®, a registered trademark of Purdue
*Brand
names are the trademarks of the products' manufacturers and/or owners.
**Products illustrated may not appear at actual size and/or exact color.
OXYCODONE
HCl CR TABLETS 40 mg 100s CII
NDC: 00591-3503-01
*Compare to: Oxycontin®, a registered trademark of Purdue
*Brand
names are the trademarks of the products' manufacturers and/or owners.
**Products illustrated may not appear at actual size and/or exact color.
OXYCODONE
HCl CR TABLETS 80 mg 100s CII
NDC: 00591-3504-01
*Compare to: Oxycontin®, a registered trademark of Purdue
*Brand
names are the trademarks of the products' manufacturers and/or owners.
**Products illustrated may not appear at actual size and/or exact color.
INDICATIONS AND USAGE
Oxycodone HCl Controlled-Release Tablets are a controlled-release oral formulation of oxycodone
hydrochloride 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 HCl Controlled-Release Tablets are NOT intended for use as a prn analgesic.
Physicians should individualize treatment in every case, initiating therapy at the appropriate point
along a progression from non-opioid analgesics, such as non-steroidal anti-inflammatory drugs
and acetaminophen to opioids in a plan of pain management such as outlined by the World Health
Organization, the Agency for Healthcare Research and Quality (formerly known as the Agency for
Health Care Policy and Research), the Federation of State Medical Boards Model Guidelines, or
the American Pain Society.
Oxycodone HCl Controlled-Release Tablets are not indicated for pain in the immediate postoperative
period (the first 12-24 hours following surgery), or if the pain is mild, or not expected to persist
for an extended period of time. Oxycodone HCl Controlled-Release Tablets are only indicated
for postoperative use if the patient is already receiving the drug prior to surgery or if the postoperative
pain is expected to be moderate to severe and persist for an extended period of time. Physicians
should individualize treatment, moving from parenteral to oral analgesics as appropriate. (See
American Pain Society guidelines.)
WARNINGS
OXYCODONE HCl CONTROLLED-RELEASE TABLETS ARE TO BE SWALLOWED WHOLE AND
ARE NOT TO BE BROKEN, CHEWED, OR CRUSHED. TAKING BROKEN, CHEWED, OR
CRUSHED OXYCODONE HCl CONTROLLED-RELEASE TABLETS LEADS TO RAPID RELEASE
AND ABSORPTION OF A POTENTIALLY FATAL DOSE OF OXYCODONE.
Oxycodone HCl Controlled-Release 80 mg Tablets ARE FOR USE IN OPIOID-TOLERANT
PATIENTS ONLY. This tablet strength may cause fatal respiratory depression when
administered to patients not previously exposed to opioids.
Oxycodone HCl Controlled-Release 80 mg Tablets are for use only in opioid-tolerant
patients requiring daily oxycodone equivalent dosages of 160 mg or more. Care should be
taken in the prescribing of this tablet strength. Patients should be instructed against use
by individuals other than the patient for whom it was prescribed, as such inappropriate use
may have severe medical consequences, including death.