WARNING: POTENTIAL FOR ABUSE, IMPORTANCE OF PROPER PATIENT SELECTION AND LIMITATIONS OF USE
Potential for Abuse
OPANA ER contains oxymorphone, which is a morphine-like opioid agonist and a Schedule II controlled substance, with an abuse liability similar to other opioid analgesics. (9)
Oxymorphone can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing OPANA ER in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse, or diversion. (9.2)
Proper Patient Selection
OPANA ER is an extended-release oral formulation of oxymorphone indicated for the management of moderate to severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. (1)
Limitations of Use
OPANA ER is NOT intended for use as an as needed analgesic. (1)
OPANA ER TABLETS are to be swallowed whole and are not to be broken, chewed, dissolved, or crushed. Taking broken, chewed, dissolved, or crushed OPANA ER TABLETS leads to rapid release and absorption of a potentially fatal dose of oxymorphone. (2)
Patients must not consume alcoholic beverages, or prescription or non-prescription medications containing alcohol, while on OPANA ER therapy. The co-ingestion of alcohol with OPANA ER may result in increased plasma levels and a potentially fatal overdose of oxymorphone. (2)
OPANA ER SUMMARY
OPANA ER (oxymorphone hydrochloride) extended-release is a semi-synthetic opioid analgesic supplied in 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 30 mg, and 40 mg tablet strengths for oral administration. The tablet strength describes the amount of oxymorphone hydrochloride per tablet.
1 INDICATIONS AND USAGE
OPANA ER is indicated for the relief of moderate to severe pain in patients requiring continuous, around-the-clock opioid treatment for an extended period of time.
Limitations of Usage
OPANA ER is not intended for use as an as needed analgesic.
OPANA ER is not indicated for pain in the immediate post-operative period if the pain is mild, or not expected to persist for an extended period of time.
OPANA ER is 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 or 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).
Media Articles Related to Opana ER (Oxymorphone)
A Man With Fever and Leg Pain: Osmosis Question of the Week
Source: Medscape Emergency Medicine Headlines [2016.10.21]
A 67-year-old man presents to the urgent care clinic following several days of fever and dull pain in his left leg. Do you know the diagnosis?
Positive pivotal Phase 3 data announced demonstrating investigational Elagolix reduced endometriosis-associated pain
Source: Clinical Trials / Drug Trials News From Medical News Today [2016.10.20]
AbbVie, a global biopharmaceutical company in cooperation with Neurocrine Biosciences, Inc.
'Fake Pills' May Help Ease Back Pain
Source: MedicineNet Chronic Pain Specialty [2016.10.20]
Title: 'Fake Pills' May Help Ease Back Pain
Category: Health News
Created: 10/19/2016 12:00:00 AM
Last Editorial Review: 10/20/2016 12:00:00 AM
Pregabalin may lessen pain from irritable bowel syndrome, Mayo Clinic study finds
Source: Irritable Bowel Syndrome News From Medical News Today [2016.10.19]
A pilot study by researchers at Mayo Clinic has found that patients suffering from pain related to irritable bowel syndrome (IBS) may benefit from taking pregabalin, a neuro-pain inhibitor commonly...
FDA Places Regeneron and Teva's Pain-Drug Study on Hold
Source: Medscape Orthopaedics Headlines [2016.10.18]
Regeneron Pharmaceuticals Inc and partner Teva Pharmaceutical Industries Ltd said the U.S. health regulator placed a clinical hold on a mid-stage study of their experimental drug for chronic lower back pain.
Reuters Health Information
Published Studies Related to Opana ER (Oxymorphone)
Positive and negative subjective effects of extended-release oxymorphone versus controlled-release oxycodone in recreational opioid users. [2011.05]
OBJECTIVE: To compare the subjective effects of oxymorphone extended release (OM-ER) versus oxycodone controlled release (OC-CR)... CONCLUSIONS: At equianalgesic doses, single oral intact OM-ER produced lower positive, negative, and balance subjective effects than OC-CR, indicating that analgesic potency may not necessarily be reflected in subjective/objective effects.
Reduced cognitive and psychomotor impairment with extended-release oxymorphone versus controlled-release oxycodone. [2010.11]
BACKGROUND: Opioids provide effective pain control, yet have risks including adverse events (AEs) (e.g., constipation, nausea/vomiting, sedation) and cognitive/psychomotor effects. OBJECTIVE: To compare cognitive and psychomotor effects of oxymorphone extended release (OM-ER) versus oxycodone controlled release (OC-CR)... CONCLUSION: Single oral intact low and high doses of OM-ER produced less cognitive and psychomotor impairment plus less sedation than equianalgesic OC-CR in this exploratory study. ClinicalTrials.gov registration NCT00955110.
Long-term tolerability and effectiveness of oxymorphone extended release in patients with cancer. [2010.05]
OBJECTIVE: To evaluate the long-term safety, tolerability, and effectiveness of oxymorphone extended release (ER) in patients with cancer-related pain... CONCLUSIONS: In these patients with pain related to cancer, oxymorphone ER was generally well tolerated and provided stable long-term pain control.
The pain quality response profile of oxymorphone extended release in the treatment of low back pain. [2009.02]
OBJECTIVE: In controlled trials of analgesics, the primary outcome variable is most often a measure of global pain intensity. However, because pain is associated with a variety of pain sensations, the effects of analgesic treatments on different sensations could go undetected if specific pain qualities are not assessed...
Oxymorphone extended release for the treatment of chronic low back pain: a retrospective pooled analysis of enriched-enrollment clinical trial data stratified according to age, sex, and prior opioid use. [2009.02]
OBJECTIVE: This study assessed the potential effects of age, sex, and prior opioid use on the response to oxymorphone extended release (ER) in patients with moderate to severe chronic low back pain... CONCLUSION: In the enriched population of patients who successfully titrated to oxymorphone ER, oxymorphone ER was effective and generally well tolerated, independent of patients' age, sex, or previous opioid use.
Clinical Trials Related to Opana ER (Oxymorphone)
Bioavailability of Oxymorphone Hydrochloride 40 mg Extended Release Tablets Under Fasted Conditions [Completed]
The purpose of this study is to demonstrate the relative bioequivalence of oxymorphone
hydrochloride extended-release tablets (Sandoz) with Opana extended release oxymorphone
Open-Label Safety and Tolerability of Oxymorphone IR and ER in Opioid Tolerant Pediatric Subjects [Terminated]
Patients will convert from current opioid to Oxymorphone ER and undergo titration. During
the Titration Period, subjects will receive daily oxymorphone Extended Release tablets(s)
every 12 hours. Dosing adjustments will be based on the review of the subject's pain
scores. Oxymorphone IR 5 mg will be provided to be used as supplemental "breakthrough" pain
medication (as needed). Titration Period will end when the fixed dose of study medication
is tolerated and the subject achieves adequate analgesia. Subjects will then proceed to the
open-label 3-month maintenance period on the fixed dose of study medication established
during the Titration Period.
Study to Compare Oxymorphone Extended-Release (Opana ER) Versus Oxycodone Controlled-Release (Oxycontin) [Completed]
Bioavailability of Oxymorphone Hydrochloride 40 mg Extended Release Tablets Under Fed Conditions [Completed]
The purpose of this study is to demonstrate the relative bioequivalence of oxymorphone
hydrochloride extended release tablets (Sandoz) with Opana extended release oxymorphone
Bioequivalency Study of Oxymorphone Hydrochloride 10 mg Tablets Under Fasted Conditions [Completed]
The objective of this study was to prove the bioequivalence of Oxymorphone Hydrochloride 10
mg Tablets under fasting conditions
Reports of Suspected Opana ER (Oxymorphone) Side Effects
Drug Ineffective (127),
Drug Abuse (99),
Intentional Drug Misuse (71),
Wrong Technique in Drug Usage Process (51),
Drug Effect Decreased (42),
Inappropriate Schedule of Drug Administration (40),
Withdrawal Syndrome (37),
Medication Residue (33),
Foreign Body (26),
Nausea (24), more >>
Page last updated: 2016-10-21