Oxycodone (Oxycodone Hydrochloride) - Summary

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.)

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NEWS HIGHLIGHTS

Media Articles Related to Oxycodone

Phosphagenics Announces Positive Results From Phase 1B Study Of Transdermal Oxycodone Patch
Source: Pain / Anesthetics News From Medical News Today [2010.02.03]
Phosphagenics Limited ("Phosphagenics") (ASX: POH; OTCQX: PPGNY) today announced positive results from a Phase 1B clinical study using the Company's patented TPM™ (Targeted Penetration Matrix) for the transdermal delivery of oxycodone...

Oxycodone Linked to Rise in Opioid-Related Deaths
Source: MedicineNet codeine Specialty [2009.12.10]
Title: Oxycodone Linked to Rise in Opioid-Related Deaths
Category: Health News
Created: 12/9/2009 12:10:00 PM
Last Editorial Review: 12/10/2009

Oxycodone May Reduce Shingles Pain
Source: MedicineNet Chickenpox (Varicella) Specialty [2009.04.13]
Title: Oxycodone May Reduce Shingles Pain
Category: Health News
Created: 4/11/2009 2:00:00 AM
Last Editorial Review: 4/13/2009

Celebrating 30 Years Of Innovation In Neuromodulation, St. Jude Medical Unveils Latest Product At American Academy Of Pain Medicine Annual Meeting
Source: Health News from Medical News Today [2010.02.04]
St. Jude Medical, Inc. (NYSE:STJ) today announced the U.S. Food and Drug Administration (FDA) clearance of the Swift-Lock(TM) anchor, a new product designed to help physicians efficiently secure neurostimulation leads utilized in spinal cord stimulation (SCS) therapy for the management of chronic pain. Introduced at the American Academy of Pain Medicine (AAPM) annual meeting, the Swift-Lock anchor builds on a 30-year history of developing industry-leading neurostimulation products...

SOMA 250 MG Shown To Significantly Improve Functionality And Reduce Disability In Patients With Low Back Pain In Three Days
Source: Clinical Trials / Drug Trials News From Medical News Today [2010.02.04]
A recent analysis of two pivotal clinical trials in patients with acute low back pain (ALBP) who were treated with SOMA® (carisoprodol) 250 mg showed significantly improved functionality and reduced disability after three days of treatment, as measured by the Roland-Morris Disability Questionnaire (RMDQ)...

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Published Studies Related to Oxycodone

Dexamethasone decreases oxycodone consumption following osteotomy of the first metatarsal bone: a randomized controlled trial in day surgery. [2009.10.10]
Background: Dexamethasone may improve multimodal pain management following painful orthopedic day surgery procedures, and decrease the need for post-operative opioids. We hypothesized that dexamethasone would reduce the need for oxycodone after surgical correction of hallux valgus... Conclusion: Oral dexamethasone combined with paracetamol significantly reduced total oxycodone consumption following surgical correction of hallux valgus.

A comparison of intravenous oxycodone and intravenous morphine in patient-controlled postoperative analgesia after laparoscopic hysterectomy. [2009.10]
INTRODUCTION: In this study, we investigated the dose requirements, pain relief, and side effects of oxycodone versus morphine after surgery with visceral pain... CONCLUSIONS: Oxycodone was more potent than morphine for visceral pain relief but not for sedation.

Analgesic efficacy of peripheral kappa-opioid receptor agonist CR665 compared to oxycodone in a multi-modal, multi-tissue experimental human pain model: selective effect on visceral pain. [2009.09]
BACKGROUND: Peripherally selective opioids may be beneficial in visceral pain management due to absence of centrally mediated side effects. The objectives of this study were: (1) to assess the effects of a peripherally selective tetrapeptide kappa-opioid receptor agonist, CR665, on experimental pain from multi-modal stimulation of skin, muscle, and viscera, and (2) contrast these effects with those of oxycodone (centrally acting opioid)... CONCLUSION: CR665 had a selective effect on visceral pain. Oxycodone exhibited a generalized effect, elevating thresholds for cutaneous, deep somatic, and visceral pain stimulation.

Relationship between rate of infusion and reinforcing strength of oxycodone in humans. [2009.07]
The rate of drug delivery to the central nervous system is believed to be an important predictor of the reinforcing strength of a drug. However, only a few studies have directly examined the relationship between drug-taking behavior and rate of drug administration... Specifically, these "abuse-deterrent formulations" could prevent patients from tampering with their medications to enhance their euphoric and reinforcing effects.

Rifampin greatly reduces the plasma concentrations of intravenous and oral oxycodone. [2009.06]
BACKGROUND: Oxycodone is a mu-opioid receptor agonist that is metabolized mainly in the liver by cytochrome P450 3A and 2D6 enzymes. Rifampin is a strong inducer of several drug-metabolizing enzymes. The authors studied the interaction of rifampin with oxycodone. Their hypothesis was that rifampin enhances the CYP3A-mediated metabolism of oxycodone and attenuates its pharmacologic effect... CONCLUSIONS: Induction of cytochrome P450 3A by rifampin reduced the area under the oxycodone concentration-time curve of intravenous and oral oxycodone. The pharmacologic effects of oxycodone were modestly attenuated. To maintain adequate analgesia, dose adjustment of oxycodone may be necessary, when used concomitantly with rifampin.

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Clinical Trials Related to Oxycodone

Oxycodone-Naloxone in Relieving Opioid-Related Constipation [Active, not recruiting]
The primary objective of this study is to demonstrate that subjects with moderate to severe non-malignant pain taking oxycodone/naloxone prolonged release tablets have improvement in symptoms of constipation compared to subjects taking oxycodone prolonged release tablets alone.

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

OXY-1: The Pharmacogenetics of Oxycodone Analgesia in Postoperative Pain [Completed]
Patients undergoing surgery (thyroidectomy and hysterectomy) will postoperatively receive oxycodone intravenously (IV) as pain management with morphine as an escape medicine, if there is insufficient pain relief with oxycodone. Patients' pain and side effects will be registered and after 24 hours they will answer a questionnaire. All included patients will be genotyped accordingly to CYP2D6 and relevant single nucleotide polymorphisms (SNPs), and measures of plasma levels of oxycodone will be performed.

OXY-2: The Pharmacogenetics of Oxycodone Analgesia in Human Experimental Pain Models [Completed]
Thirty-two healthy volunteers will be submitted to experimental pain and on the 2 study days receive Oxycodone 20 mg po vs. placebo. Half of the volunteers will be poor metabolizers according to CYP2D6 genotype and half will be extensive metabolizers (EM) and have an enzyme with normal function. The study hypothesis is that PM will experience less pain relief than EM.

Safety/Efficacy Study of Oxycodone HCl/Niacin to Treat Pain After Bunionectomy [Completed]
The purpose of this study is to determine whether oxycodone HCl and niacin are effective in the treatment of pain following bunionectomy surgery.

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PATIENT REVIEWS / RATINGS / COMMENTS

Oxycodone review by 37 year old female patient
		Rating
Overall rating:
Effectiveness:		Highly Effective
Side effects:		Moderate Side Effects
		Treatment Info
Condition / reason:		scoliosis
Dosage & duration:		30mg 6x daily taken 3-6 per day for the period of 2+ yrs.
Other conditions:		c/spine hnp & cervical arthritis
Other drugs taken:		xanax
		Reported Results
Benefits:		reduce pain levels and resume daily life without interferance from pain. Reduce pain in order to proceed with physical therapy.
Side effects:		tired at times & upset stomache
Comments:		Take up to 6 times a day for pain

Oxycodone review by care giver of 36 year old female patient
		Rating
Overall rating:
Effectiveness:		Considerably Effective
Side effects:		Moderate Side Effects
		Treatment Info
Condition / reason:		Pain
Dosage & duration:		APAP 5MG-325MG taken 1 to 2 tablets every 4 to 6 hours for the period of 3 days
Other conditions:		None
Other drugs taken:		None
		Reported Results
Benefits:		Reduced pain, helped with sleep
Side effects:		Mild nausea, dizziness, fuzzy thinking. Very weird feeling
Comments:		Medication to be taken as needed for pain after arthroscopic shoulder surgery. Would not want to take this medication unless in severe pain due mainly to the fuzzy headed/dizzy effect. Certainly could not drive or operate machinery while on the medication.

Oxycodone review by 43 year old female patient
		Rating
Overall rating:
Effectiveness:		Moderately Effective
Side effects:		Severe Side Effects
		Treatment Info
Condition / reason:		pain management
Dosage & duration:		10mg taken 3 times daily for the period of 2 yrs
Other conditions:		Degenerative disk disease (C2-C7, L5, S1), pinched nerves C5 & 6.
Other drugs taken:		Percocette, Toradol, Topamax, Gabapentin
		Reported Results
Benefits:		Initially the treatment benefits were -increased mobility/ activity level due to experiencing less pain - sleep ( was able to sleep longer while the medication was still active) - better mood (because of less pain)
Side effects:		The level of pain control quickly decreased (with the prescribed amount of medication(10 mg)) resulting in having to steadily increase the dosage for the same amount of pain relief. However the worst side effects were severe constipation(even while taking stool softeners/extra fiber, water, etc), depression, insomnia, weight loss, hair loss, muscle wasting, my skin became completely dehydrated and wrinkled. Became physically and mentally addicted to the medication, when I tried to reduce the dosage /stop taking the medication I experienced severe withdrawal symptoms (fever,chills, nausea, vomiting, severe bone muscle and joint pain) to name a few.
Comments:		I was in an MVA in 2002 in which I suffered a whiplash type injury which caused/accelerated the DDD. I was prescribed Percocette 5mg on an as needed basis for pain control. After 3 years (of constant agonizing pain)of being on the Percocette they became ineffective at relieving pain and I was referred to a PAIN CLINIC specializing in chronic pain. The doctors there decided that I had built up a tolerance/dependence on the Percocette and that it would be best to put me on a longer acting narcotic (Oxycontin 10mg,time released, supposed to provide pain relief for 12 hrs) with Percocette (Oxycodone 5mg/Acetaminophen 325 mg)for break through pain. In the beginning the medication seemed to help but over time I built up a tolerance to the Oxycodone(they became less effective) which meant I had to keep increasing the dosage to get the same amount of pain relief. For example I started out with Oxycontin 10mg/3x day and approx 3 Percocette/daily a couple of months later as my tolerance increased I had to take Oxycontin 20mg/3X day and 5-6 Percocette as the months passed by my tolerance grew and my dosage was increased. After about 8 months on the Oxycontin I started to experience all of the side effects mentioned above, not only did I notice the negative effects the drug was having on me but friends and family noticed too, and mentioned (not to me but amongst themselves) that my appearance/demeanor over the past 2 yrs had dramatically changed. A couple of months ago my Sister took me aside and asked me what was wrong to which I replied nothing why? She then explained to me how my behavior(depression, moodiness, etc.) and appearance(drastic weight loss) had been getting worse and worse and told me that she was worried. Being under the influence of these drugs for so long I felt like I was in a fog and really had no idea as to the extent of how bad it really was/ how I looked. So I stepped back and examined the last 4-5 yrs of my life while on these medications and realized that they had taken a considerable toll on me emotionally, physically, mentally. I strongly advise that before anyone decides to go this route for pain management that you have a long talk with your Physician on the pros and cons of this medication specifically the Oxycontin. If I would have known then what I know now about all the negative side effects I would never, never had started taking it. I feel that it deteriorated my body (especially my muscle mass and skin). When I started taking the medication I was 37 and felt 25 and was told I looked like I was in my late 20's, I am now 42, I feel 50 and now in an effort to spare my feelings people don't mention anything about how old I look . I wish that my Physicians would have told me about ALL of the negative effects of this medication instead of just the positive (which are few). In my opinion the negative far outweigh the positive. I'm still in constant pain but will continue to search for pain management without drugs. PLEASE USE WITH CAUTION!