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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OXYCODONE NEWS HIGHLIGHTS

Media Articles Related to Oxycodone

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

New Treatment For Receding Gums: No Pain, Lots Of Gain
Source: Cosmetic Medicine / Plastic Surgery News From Medical News Today [2009.07.02]
Tufts dental researchers conducted a three-year follow-up study that examined the stability of a treatment option for receding gums and found that complete root coverage the goal of the surgery had been maintained. This specific tissue regeneration application, developed at Tufts, reduces the considerable pain and recovery time of gum grafting surgery. The case study of six patients is published in the July 2009 issue of the Journal of Periodontology.

Increasing Age Of Mothers In Spain Leads To Rise In Mortality Rates
Source: Seniors / Aging News From Medical News Today [2009.07.02]
A new study examining the evolution of maternal mortality rates in Spain since 1996 shows a 17% increase in deaths. This trend is linked to the widespread increase in maternal age. The highest death rates are among foreign women and those who live in the province of Malaga. Medicine has taken giant strides during the 20th Century. However, European studies show a clear and constant increase in maternal mortality rates over recent years.

Health Tip: What's Causing My Neck Pain?
Source: MedicineNet Arthritis Specialty [2009.07.02]
Title: Health Tip: What's Causing My Neck Pain?
Category: Health News
Created: 7/2/2009 7:00:00 AM
Last Editorial Review: 7/2/2009

Laughter - The Best Medicine? Spain Hosts The Most Renowned International Symposium On Sense Of Humor And Its Applications
Source: Conferences News From Medical News Today [2009.07.01]
Spain hosts this week, for the first time in history, this event, the most renowned international symposium on humour and laughter, where scientists and experts from four continents will discuss the latest advances and research of this field of study.

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Published Studies Related to Oxycodone

A randomized, placebo-controlled trial of oxycodone and of gabapentin for acute pain in herpes zoster. [2009.02.03]
Although acute pain in patients with herpes zoster can be severe and has a substantial impact on health-related quality of life, there have been no randomized clinical trials of oral medications specifically for its ongoing treatment. A randomized clinical trial was conducted in which 87 subjects 50 years of age with herpes zoster within 6 calendar days of rash onset and with worst pain in the past 24h3 on a 0-10 rating scale initiated 7 days of treatment with famciclovir in combination with 28 days of treatment with either controlled-release (CR) oxycodone, gabapentin, or placebo...

Analgesic efficacy and safety of oxycodone in combination with naloxone as prolonged release tablets in patients with moderate to severe chronic pain. [2008.12]
This randomized, double-blind, placebo- and active-controlled, parallel-group study was designed to demonstrate the superiority of oxycodone in combination with naloxone in a prolonged release (PR) formulation over placebo with respect to analgesic efficacy. The active control group was included for sensitivity and safety analyses, and furthermore to compare the analgesic efficacy and bowel function of oxycodone PR/naloxone PR with oxycodone PR alone.

Oxycodone versus codeine for triage pain in children with suspected forearm fracture: a randomized controlled trial. [2008.09]
OBJECTIVE: To compare the efficacy of pain reduction of triage oxycodone (O) versus codeine (C) to children with suspected forearm fractures... CONCLUSIONS: Triage-administered O tended toward greater pain reduction compared with C in children with suspected forearm fractures. Although minor adverse effects occurred in both groups, itching occurred more in C. Identification of radiography as the most painful part of fracture evaluation underscores the need for early triage administration of analgesia for suspected fractures.

Pharmacokinetic-pharmacodynamic modeling of morphine and oxycodone concentrations and analgesic effect in a multimodal experimental pain model. [2008.05]
Analgesia from most opioids is mediated by mu receptors located mainly in the central nervous system. Previous studies have shown a different pharmacological profile of oxycodone in respect to visceral analgesia... Oxycodone and morphine showed different pharmacodynamic/pharmacokinetic relationships for the visceral analgesia, whereas relationships were alike for somatic analgesia.

The effect of single-dose tramadol on oxycodone clearance. [2007.11]
We have noticed increased prescribing of tramadol by emergency physicians for breakthrough pain in patients chronically taking oxycodone. Both oxycodone and tramadol undergo oxidative metabolism by CYP2D6 and CYP3A4, suggesting the possibility that tramadol may compete with oxycodone for metabolism...

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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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OXYCODONE 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 46 year old female patient
		Rating
Overall rating:
Effectiveness:		Considerably Effective
Side effects:		Mild Side Effects
		Treatment Info
Condition / reason:		possible lymphoma/kidney pain
Dosage & duration:		5MG-50MG caps taken 1 cap/4-6 h for the period of 1 mo
Other conditions:		ulcerative colitis/kidney infection
Other drugs taken:		cipro, Asacol, doxycycline,promethazine
		Reported Results
Benefits:		The drug was pretty good for pain. They had me on morphine, which was horrible. The pain was preferable to the crazy dreams and paranoia I had. They then tried oxycontin, which was the best pain drug they gave me, but too addictive... so they moved me to vicodin products, which worked pretty well, with surprisingly few side effects.
Side effects:		Sleepiness, dizziness, light-headedness & nausea. I only took them when the pain was unbearable, so I might have gotten used to the side effects if I had kept the levels up in my system.
Comments:		I just took the pills every 4-6 hours when the kidney pain was too bad. I tried to only take them at night as the conditions improved since they made me sleep. I stopped takeing them long before the infections and colon problems were resolved, as I don't like takeing drugs.

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!