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Oxycodone (Oxycodone Hydrochloride) - Summary

 

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WARNING

Oxycodone hydrochloride extended-release tablets are an opioid agonist and a Schedule II controlled substance with an abuse liability similar to morphine.

Oxycodone can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing oxycodone hydrochloride extended-release tablets in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse, or diversion.

Oxycodone hydrochloride extended-release tablets are an extended-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 hydrochloride extended-release tablets are NOT intended for use as a prn analgesic.

Oxycodone Hydrochloride Extended-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 HYDROCHLORIDE EXTENDED-RELEASE TABLETS ARE TO BE SWALLOWED WHOLE AND ARE NOT TO BE BROKEN, CHEWED, OR CRUSHED. TAKING BROKEN, CHEWED, OR CRUSHED OXYCODONE HYDROCHLORIDE EXTENDED-RELEASE TABLETS LEADS TO RAPID RELEASE AND ABSORPTION OF A POTENTIALLY FATAL DOSE OF OXYCODONE.

 

OXYCODONE SUMMARY

OXYCODONE HYDROCHLORIDE EXTENDED-RELEASE TABLETS, 80 mg CII

Oxycodone Hydrochloride Extended-Release Tablets are an opioid analgesic supplied in 80 mg tablet strength for oral administration. The tablet strength describes the amount of oxycodone per tablet as the hydrochloride salt.

Oxycodone hydrochloride extended-release tablets are an extended-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 hydrochloride extended-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 Health 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 hydrochloride extended-release tablets are not indicated for pain in the immediate post-operative period (the first 12 to 24 hours following surgery), or if the pain is mild, or not expected to persist for an extended period of time. Oxycodone hydrochloride extended-release tablets are only indicated for post-operative use if the patient is already receiving the drug prior to surgery or if the post-operative 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.)

OXYCODONE NEWS HIGHLIGHTS

Media Articles Related to Oxycodone

Pain More a Cause of Arthritis Than a Symptom (HealthDay)
Source: Y! Health Arthritis News [2008.09.29]

Many cancer patients forgo painkillers (Reuters)
Source: Y! Health Cancer & Chemotherapy News [2008.09.29]

UCB Pharma Withdraws Its Marketing Authorisation Application For Lacosamide Pain UCB Pharma, Europe
Source: Diabetes News From Medical News Today [2008.09.28]

Painkiller May Prevent Diabetes-Related Retinal Damage
Source: MedicineNet Diabetes Mellitus Specialty [2008.09.25]

FDA Warns Companies To Stop Marketing Unapproved Ophthalmic Balanced Salt Solution Drug Products And Topical Drug Products Containing Papain
Source: Eye Health / Blindness News From Medical News Today [2008.09.24]

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Published Studies Related to Oxycodone

The effect of single-dose tramadol on oxycodone clearance. [2007.11]

Postoperative intravenous morphine consumption, pain scores, and side effects with perioperative oral controlled-release oxycodone after lumbar discectomy. [2007.07]

Efficacy and tolerability of once-daily OROS hydromorphone and twice-daily extended-release oxycodone in patients with chronic, moderate to severe osteoarthritis pain: results of a 6-week, randomized, open-label, noninferiority analysis. [2007.05]

PTI-821: sustained-release oxycodone using gel-cap technology. [2007.03]

A randomized, open-label, multicenter trial comparing once-a-day AVINZA (morphine sulfate extended-release capsules) versus twice-a-day OxyContin (oxycodone hydrochloride controlled-release tablets) for the treatment of chronic, moderate to severe low back pain: improved physical functioning in the ACTION trial. [2007.01]

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Clinical Trials Related to Oxycodone

Oxycodone-Naloxone in Relieving Opioid-Related Constipation [Active, not recruiting]

Oxycodone-Naloxone Prolonged Release Tablets in Relieving Opioid-Related Constipation [Active, not recruiting]

OXY-1: The Pharmacogenetics of Oxycodone Analgesia in Postoperative Pain [Completed]

OXY-2: The Pharmacogenetics of Oxycodone Analgesia in Human Experimental Pain Models [Completed]

Safety/Efficacy Study of Oxycodone HCl/Niacin to Treat Pain After Bunionectomy [Completed]

more>>

Page last updated: 2008-09-29

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