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Opana ER (Oxymorphone Hydrochloride) - Summary

 
 



WARNING:

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.

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.

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.

OPANA ER is NOT intended for use as a prn analgesic.

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.

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.

 

OPANA ER SUMMARY

OPANA® ER
(Oxymorphone Hydrochloride) Extended-Release Tablets
5mg, 10mg, 20mg, and 40mg
CII
Rx Only

OPANA ER (oxymorphone hydrochloride) extended-release, is a semi-synthetic opioid analgesic supplied in 5 mg, 10 mg, 20 mg, and 40 mg tablet strengths for oral administration. The tablet strength describes the amount of oxymorphone hydrochloride per tablet.

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.

OPANA ER is not intended for use as a prn analgesic.

OPANA ER is not indicated for pain in the immediate post-operative period (12-24 hours following surgery) for patients not previously taking opioids because of the risk of oversedation and respiratory depression requiring reversal with opioid antagonists.

OPANA ER is not indicated for pain in the post-operative period if the pain is mild or not expected to persist for an extended period of time.


See all Opana ER indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Opana ER (Oxymorphone)

Exercise Stimulates Pain Modulation in Fibromyalgia
Source: Medscape Medical News Headlines [2015.05.22]
Exercise activates areas of the brain associated with pain modulation, suggesting it could be an effective treatment for fibromyalgia.
Medscape Medical News

Subconscious learning shapes pain responses
Source: Pain / Anesthetics News From Medical News Today [2015.05.22]
In a new study led from Sweden's Karolinska Institutet, researchers report that people can be conditioned to associate images with particular pain responses - such as improved tolerance to pain ...

More Babies Born to Mothers Addicted to Pain Meds
Source: MedicineNet Pregnancy Drug Dangers Specialty [2015.05.22]
Title: More Babies Born to Mothers Addicted to Pain Meds
Category: Health News
Created: 5/22/2015 12:00:00 AM
Last Editorial Review: 5/22/2015 12:00:00 AM

By the Book: How to Roll Out a New Chest Pain Pathway
Source: MedPageToday.com - medical news plus CME for physicians [2015.05.21]
(MedPage Today) -- A new chest pain protocol?

Oral steroids for acute sciatica produce limited improvement in function and pain
Source: Pain / Anesthetics News From Medical News Today [2015.05.20]
Among patients with acute sciatica caused by a herniated lumbar disk (a condition also known as "acute radiculopathy"), a short course of oral steroids resulted in only modest improvement in...

more news >>

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.

more studies >>

Clinical Trials Related to Opana ER (Oxymorphone)

Effect of Extended-Release Oxymorphone Taking With or Without Food on Cognitive Functioning [Recruiting]
The purpose of the study is to determine whether extended-release oxymorphone hydrochloride taken orally with a high-fat meal, generating an approximately 50% higher Cmax, impacts cognitive functioning, using Cambridge Neuropsychological Test Automated Battery (CANTAB) tests, to a greater extent than when taking under conditions of fasting.

Open-Label Safety and Tolerability of Oxymorphone IR and ER in Opioid Tolerant Pediatric Subjects [Recruiting]
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.

Open-Label Safety and Tolerability Study of Oxymorphone for Acute Postoperative Pain in Pediatric Subjects. [Recruiting]
When post-operative parenteral analgesia is discontinued, oral dosing with study medication may begin once the subject has developed a moderate level of pain as defined by a 100 mm VAS (pain intensity score greater than or equal to 40).

Lumbar Stenosis Outcomes Research II [Recruiting]
The primary objective of the proposed pilot study is to determine the efficacy of oxymorphone hydrochloride and propoxyphene/acetaminophen combination in prolonging the time to onset of pain and reducing the severity of pain associated with walking in patients with neurogenic intermittent claudication. The secondary objective is to examine the functional benefit of oxymorphone hydrochloride and propoxyphene/acetaminophen combination with respect to improvement in duration and distance of walking tolerance.

The proposed study will also provide the foundation for a treadmill-based methodology for assessing the analgesic efficacy of drugs for low back pain provoked by standing and walking associated with lumbar spinal stenosis.

A Pilot Study of Switching From One Pain Medication to Another (Opioid Rotation) [Recruiting]
he purpose of this study is to see if changing from one pain medication like morphine or oxycodone to another pain medication, oxymorphone (OPANAŽ), will be helpful to patients. This study will examine if the swithcing from one pain medication to another can be done over a 24 hour period. Oxymorhone, the drug being studied, is an FDA approved drug for treatment of severe pain.

more trials >>

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: 2015-05-22

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