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.
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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 HIGHLIGHTSMedia Articles Related to Oxycodone
Reformulated OxyContin To Receive Abuse-Deterrent Labelling Source: Pain / Anesthetics News From Medical News Today [2013.04.17] A new reformulated form of Oxycontin (a highly addictive oxycodone hydrochloride) has received a unique labeling update by the U.S. Food and Drug Administration regarding its abuse potential. People most commonly abuse Oxycontin by injecting or snorting it. However, with Purdue Pharma L.P.'s new reformulated version, abuse is much harder. OxyContin abuse is a huge problem in the U.S...
Erectile Dysfunction Tied To Long Term Painkiller Use Source: Erectile Dysfunction / Premature Ejaculation News From Medical News Today [2013.05.16] A new study suggests that long term use of opioid prescription painkillers for back pain is tied to a higher risk of erectile dysfunction (ED). The findings are published in the 15 May online issue of the journal Spine. Lead author Richard A...
Painkillers Increase Risk of Erectile Dysfunction Source: Erectile Dysfunction / Premature Ejaculation News From Medical News Today [2013.05.15] Regularly taking prescription painkillers, commonly called opioids, is linked to a greater risk of erectile dysfunction (ED) in men, according to a new study published in Spine. Over 11,000 men suffering from back pain were involved in the research...
Retooling Pain Assessment for Older Adults Source: Medscape Emergency Medicine Headlines [2013.05.14] Current pain assessment tools for older adults are inadequate, and education for healthcare professionals falls short in meeting the unique challenges posed by pain management for elderly patients. Medscape Medical News
Tanezumab Makes Good in Chronic Back Pain (CME/CE) Source: MedPage Today Neurology [2013.05.14] NEW ORLEANS (MedPage Today) -- The controversial agent tanezumab, which was once put on an FDA regulatory hold, offered durable reduction of chronic low back pain, a long-term safety and efficacy study showed.
Published Studies Related to Oxycodone
Tolerability and efficacy of two synergistic ratios of oral morphine and
oxycodone combinations versus morphine in patients with chronic noncancer pain. [2012] SETTING: Clinical study centers in Australia... CONCLUSION: A 3:2 or 1:2 fixed ratio combination of morphine and oxycodone (MOX)
Liver cancer: effects, safety, and cost-effectiveness of controlled-release
oxycodone for pain control after TACE. [2012] liver cancer who are undergoing transarterial chemoembolization... CONCLUSION: CRO is effective, safe, and cost-effective in the control of
A randomized, double-blind, active-controlled, double-dummy, parallel-group study
to determine the safety and efficacy of oxycodone/naloxone prolonged-release
tablets in patients with moderate/severe, chronic cancer pain. [2012] prolonged-release tablets (OxyPR) in patients with moderate/severe cancer pain... CONCLUSIONS: OXN PR provides superior bowel function in cancer pain patients,
Oxycodone lengthens reproductions of suprasecond time intervals in human research volunteers. [2011.08] Oxycodone, a popularly used opioid for treating pain, is widely abused. Other drugs of abuse have been shown to affect time perception, which, in turn, may affect sensitivity to future consequences.
Clinical outcomes during opioid titration following initiation with or conversion to Remoxy(R), an extended-release formulation of oxycodone. [2011.07] Intra- and interpatient variability in opioid response usually necessitates opioid therapy titration to optimally balance analgesia and side effects, whether initiating therapy or converting from another opioid. Remoxy(R) (King Pharmaceuticals, Inc., Bristol, TN, which was acquired by Pfizer Inc in March 2011) is an extended-release formulation of oxycodone designed to maintain its rate-controlling mechanism following physical and chemical manipulation...
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]
Oxycodone for Labor Pain - Pharmacokinetics (PK), Safety and Efficacy [Not yet recruiting]
Childbirth is one of the most painful events that a woman is likely to experience, and thus
is a major concern for most parturient. Severe pain releases stress mediators and may thus
compromise fetus well-being if placental perfusion is decreased. Epidural analgesia is the
golden standard for the management of severe labor pain. However, it could not always be
used both due the parturient related factors and the organizational reasons. However, the
knowledge on safety and efficacy of oxycodone involving mother, fetus and newborn is
limited.
Aim of the study is firstly, to evaluate the efficacy and safety of oxycodone in labor pain
healthy parturients. Secondly, to measure parturient's blood oxycodone concentration during
labour and fetal concentration from placental umbilical vein and artery right after birth.
Controlled-Release Oxycodone For Postoperative Analgesia After Video-Assisted Thoracic Surgery [Recruiting]
The main hypothesis of this study is that preoperative administration of controlled-release
(CR) oxycodone may reduce acute postoperative pain and improve time to discharge from the
post-anesthesia care unit in patients undergoing video-assisted thoracoscopy for spontaneous
pneumothorax.
The study drug will be compared with intravenous morphine administered 30 minutes before the
end of anesthesia.
Efficacy of Oxycodone/Naloxone, Compared to Oxycodone, for the Reduction of Intensity of Opioid-induced Constipation in Pain Patients [Recruiting]
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PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 13 ratings/reviews, Oxycodone has an overall score of 7.31. The effectiveness score is 9.08 and the side effect score is 6.62. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.
| | Oxycodone review by 49 year old female patient | | | Rating |
| Overall rating: | |           |
| Effectiveness: | | Highly Effective |
| Side effects: | | Mild Side Effects | | | Treatment Info |
| Condition / reason: | | Metastasized ovarian cancer/chemotherapy |
| Dosage & duration: | | 5 mg taken two to three times daily, as needed. for the period of One year; am still taking it. |
| Other conditions: | | None |
| Other drugs taken: | | Lorazepam 1 mg, 2x daily; occasional acetaminophen; Gemsar (chemotherapy); Carboplatinum (chemo). | | | Reported Results |
| Benefits: | | One year after diagnosis, surgery and beginning chemotherapy for stage IIIc ovarian cancer, I am working 35+ hours per week and living more or less normally while receiving biweekly chemotherapy treatments. Taking oxycodone makes all the difference in my quality of life, because it allows me to live without otherwise constant pain in my back, ribcage and belly. In the absence of this pain, my mobility/activity level is excellent, I can think and focus clearly, and I am free of the depression and frustration of what could be a debilitating illness. |
| Side effects: | | Occasional fogginess if otherwise fatigued; otherwise, I am surprised at the absence of noticeable side effects. |
| Comments: | | As I am aware of the addictive potential of narcotics/opioids, I have deliberately requested a continued low dose (5 mg) and have made a point of not increasing frequency to more than three tablets a day. During the week after chemo, I will sometimes experience a bit of breakthrough pain between doses, and will then take a low (325 mg) dose of acetaminophen. |
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| | Oxycodone review by 42 year old female patient | | | Rating |
| Overall rating: | |           |
| Effectiveness: | | Highly Effective |
| Side effects: | | Moderate Side Effects | | | Treatment Info |
| Condition / reason: | | post-surgical pain |
| Dosage & duration: | | can't recall (dosage frequency: every 4 to 6 hours) for the period of 8 weeks |
| Other conditions: | | none |
| Other drugs taken: | | none | | | Reported Results |
| Benefits: | | immediate relief from acute, severe post-surgical spinal pain following three-level lumbar fusion. minimized discomfort so that i was ambulatory, which was a key factor in my recuperation (physical movement was encouraged) |
| Side effects: | | severe constipation, only relieved by taking milk of magnesia on a daily basis. |
| Comments: | | took oxycodone for two months every 4 to 6 hours for pain relief, then weaned down to propoxyphene |
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| | 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! |
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Page last updated: 2013-05-16
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