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Roxicodone (Oxycodone Hydrochloride) - Summary

 
 



ROXICODONE SUMMARY

ROXICODONE®
(Oxycodone Hydrochloride
Tablets USP)

ROXICODONE® (oxycodone hydrochloride tablets USP) is an opioid analgesic. Each tablet for oral administration contains 5 mg, 15 mg or 30 mg of oxycodone hydrochloride USP. Oxycodone hydrochloride is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride dissolves in water (1 g in 6 to 7 mL) and is considered slightly soluble in alcohol (octanol water partition coefficient is 0.7).

ROXICODONE® tablets are an immediate-release oral formulation of oxycodone hydrochloride indicated for the management of moderate to severe pain where the use of an opioid analgesic is appropriate.


See all Roxicodone indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Roxicodone (Oxycodone)

DPP-4 Inhibitors Can Cause Severe Joint Pain, FDA Says
Source: Medscape Diabetes & Endocrinology Headlines [2015.08.28]
However, the pain associated with dipeptidyl peptidase-4 inhibitors for type 2 diabetes goes away once patients stop taking the medicine, according to the agency.
News Alerts

Group Offers Guidelines to Lessen Vaccination Pain
Source: Medscape Pediatrics Headlines [2015.08.28]
Clinicians can shuffle the order of vaccine injections, leverage the calming influence of parents and breast-feeding, and routinely apply topical anesthetic to ease vaccination pain for patients.
Medscape Medical News

DPP-4 Inhibitors Linked to Severe Joint Pain, FDA Warns
Source: MedPageToday.com - medical news plus CME for physicians [2015.08.28]
(MedPage Today) -- The agency has identified 33 cases since 2006

Low Back Pain and GI Symptoms on the Swiss Alps
Source: Medscape Gastroenterology Headlines [2015.08.26]
Dr Paget discusses a recent patient of his who presented with a 5-year history of recurrent severe low back pain and gastrointestinal symptoms.
Medscape Rheumatology

Is There Sex After Low Back Pain?
Source: Medscape Orthopaedics Headlines [2015.08.26]
For many people with low back pain, sex is excruciating. But the recommended position for the past 25 years--'side-lying' (ie, 'spooning')--is contraindicated by two new biomechanical studies.
Medscape Orthopedics

more news >>

Published Studies Related to Roxicodone (Oxycodone)

Comparison of subjective effects of extended-release versus immediate-release oxycodone/acetaminophen tablets in healthy nondependent recreational users of prescription opioids: a randomized trial. [2014]
[APAP]) formulation with those of immediate-release (IR) OC/APAP... CONCLUSIONS: Extended-release OC/APAP produced lower subjective drug effects than

A randomized, double-blind, placebo-controlled study of oral oxycodone plus acetaminophen for the treatment of pain in photodynamic therapy on port wine stains. [2014]
efficacy and safety of an oral analgesic for the treatment of pain in PDT on PWS... CONCLUSIONS: The time of the pain beginning was 8.31 ± 4.58 min in

Safety and efficacy of once-daily hydromorphone extended-release versus twice-daily oxycodone hydrochloride controlled-release in chinese patients with cancer pain: a phase 3, randomized, double-blind, multicenter study. [2014]
Noninferiority of the efficacy of once-daily hydromorphone hydrochloride extended-release (hydromorphone ER) compared with twice-daily oxycodone hydrochloride controlled-release (oxycodone CR) was investigated in this randomized, double-blind study in Chinese patients with moderate to severe cancer pain requiring strong oral opioid analgesics.

Oral oxycodone plus intravenous acetaminophen versus intravenous morphine sulfate in acute bone fracture pain control: a double-blind placebo-controlled randomized clinical trial. [2014]
control efforts efficacy and decrease the adverse effects of each medication... CONCLUSION: Intravenous acetaminophen plus oral oxycodone is as effective as

Bowel function after tapentadol and oxycodone immediate release (IR) treatment in patients with low back or osteoarthritis pain. [2013]
OBJECTIVES: Constipation is a common side effect of opioid therapy. Tapentadol immediate release (IR) was better tolerated than oxycodone IR in 2 clinical trials involving patients with low back or osteoarthritis pain... DISCUSSION: Patient-reported bowel function associated with tapentadol IR treatment was similar to that associated with placebo (10-d trial) and significantly better than that associated with oxycodone IR treatment (10- and 90-d trials).

more studies >>

Clinical Trials Related to Roxicodone (Oxycodone)

Early Postoperative Administration of Oxycodone +/- Naloxone and Duration of Epidural Analgesia [Not yet recruiting]
Cystectomy with urinary diversion (ileal conduit, ileal orthotopic neobladder, catheterizable ileal pouch) is major abdominal surgery, which is associated with a high incidence of gastrointestinal complications. Perioperative techniques aiming at an early return of bowel function are to be pursued. Optimal postoperative pain management is one of the key factors leading to enhanced recovery after surgery. The perioperative use of an epidural analgesia for major abdominal surgery is established, not only because of its excellent analgesic properties, but also because it can accelerate the return of bowel function. However, epidural analgesia is associated with additional costs, need for close monitoring and nursing. In addition each supplemental day with an indwelling epidural catheter increases the risk of infection. So it is recommended to re-assess the risk/benefit ratio of an epidural analgesia after 4 days, if not sooner. Therefore, it is important to develop strategies that reduce its duration without impairing the benefits. Systemic analgesics with prolonged-release oral formulation like oral oxycodone (Oxycontin®) or combined drug mixture (oral oxycodone/naloxone (Targin®)) could be a valuable alternative pain treatment as a second analgesic step, starting on postoperative day (POD) 3, so that the epidural catheter could be removed earlier without impairing postoperative enhanced recovery including return of the bowel function. Both oxycodone and naloxone orally administered are a recognized and accepted treatment option. The objective of this study is to evaluate the implementation of an oral opioid with or without naloxone in the early postoperative period in patients undergoing open radical cystectomy with urinary diversion and intraoperative and early postoperative use of epidural analgesia. The investigators expect an unchanged early return of the bowel function and equal analgesia with a reduced length of stay of the epidural catheter (primary endpoint), thus potentially reducing epidural catheter associated complications and lowering costs (nursing and pain service).

Pharmacokinetics And Relative Bioavailability Study Of Oxycodone [Completed]

Comparison of the Effects of Tapentadol and Oxycodone on Gastrointestinal and Colonic Transit in Humans [Completed]
Tapentadol is FDA approved for the treatment of moderate to severe acute pain. Due to the dual mechanism of action as an opioid agonist and norepinephrine reuptake inhibitor, there is potential for off label use in chronic pain. Tapentadol is a new molecular entity that is structurally similar to tramadol. Tapentadol is a centrally-acting analgesic with a dual mode of action as an agonist at the mu-opioid receptor and as a norepinephrine reuptake inhibitor. These two actions are synergistic in pain relief. While its action reflects aspects of tramadol and morphine, its ability to control pain is more on the order of hydrocodone and oxycodone. Its dual mode of action provides analgesia at similar levels of more potent narcotic analgesics such as hydrocodone, oxycodone, and meperidine with a more tolerable side effect profile. Clinical studies showed that tapentadol effectively relieves moderate to severe pain in various pain care settings. In addition, it was reported to be associated with significantly fewer treatment discontinuations due to a significantly lower incidence of gastrointestinal-related adverse events compared with equivalent doses of oxycodone. The combination of these reduced treatment discontinuation rates and tapentadol efficacy for the relief of moderate to severe nociceptive and neuropathic pain may offer an improvement in pain therapy by increasing patient compliance with their treatment regimen.

Pharmacokinetics Study of ALO-02 and OxyContin [Completed]
To characterize the single- and multiple-dose pharmacokinetics of oxycodone following the administration of ALO-02 40 Mg Twice Daily, ALO-02 80 Mg Once Daily or Oxycontin 40 Mg Twice Daily in Healthy Volunteers

Abuse Liability of Controlled-Release Oxycodone Formulations [Completed]
The objective of this study is to examine the abuse liability of a single 40mg dose of 2 controlled release oxycodone formulations (Apo-Oxycodone CR and OxyNEO) in non-dependent recreational opioid users by assessing the self-reported acute effects of the drugs and taking blood samples to measure drug concentrations. The investigators think there may be differences in how well these drugs are liked when swallowed whole due to differences in how the products are formulated.

more trials >>

Reports of Suspected Roxicodone (Oxycodone) Side Effects

Respiratory Arrest (25)Completed Suicide (23)Cardiac Arrest (18)Pain (17)Drug Dependence (14)Substance Abuse (12)Drug Withdrawal Syndrome (12)Dizziness (11)Confusional State (9)Multiple Drug Overdose (9)more >>


Page last updated: 2015-08-28

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