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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)

Med Boards Are Too Lax; Payment for Pain and Suffering; More
Source: Medscape Business of Medicine Headlines [2014.10.17]
Do medical boards fail to protect the public from substandard care? is a cap on payment for pain and suffering unconstitutional?; and nonclinical factors that affect cardiac testing.
Medscape Business of Medicine

Chronic Pain Malpractice Claims on the Rise
Source: Medscape Anesthesiology Headlines [2014.10.16]
More claims are now associated with chronic pain management, especially for certain procedures, such as cervical neuraxial injections, device implantations, and opioid prescriptions.
Medscape Medical News

Memories of pain during childbirth tied to intensity rather than length of labor
Source: Pain / Anesthetics News From Medical News Today [2014.10.15]
Childbirth is physically intense and, for many women, it is the most painful experience they will have.

Post-Op Pain Management Improves in Past Decade, Survey Shows
Source: MedicineNet Appendectomy Specialty [2014.10.15]
Title: Post-Op Pain Management Improves in Past Decade, Survey Shows
Category: Health News
Created: 10/14/2014 12:00:00 AM
Last Editorial Review: 10/15/2014 12:00:00 AM

Large study delivers message to expectant mothers: Epidural, spinal anesthesia safe choices for relieving pain
Source: Pain / Anesthetics News From Medical News Today [2014.10.14]
Women seeking pain relief during childbirth should be comforted to know that epidural and spinal anesthesia are extremely safe, suggests a study of more than 80,000 women that reviewed anesthesia...

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.

Effectiveness, Safety, and Tolerability Study of Oxymorphone Immediate Release (IR) Oral Liquid in Post Surgical Pediatric Subjects [Recruiting]

A Pilot Study of Ultra Rapid Opioid Rotation and Titration of Oxymorphone [Recruiting]
This project will explore the safety and feasibility of performing a successful intravenous patient controlled analgesia (IV PCA) Oxymorphone titration and conversion to oral ER Oxymorphone (extended release or OPANA ER) in the outpatient setting.

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).

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: 2014-10-17

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