oxymorphone (Numorphan, Opana, Opana ER)
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Introduction
Tradename: Numorphan, Opana. DEA-controlled substance: class 2.
Indications
- management of moderate to severe pain
- preoperatively as a sedative & adjunct to anesthesia
Dosage
- 1-1.5 mg IM/SC every 4-6 hours
- rectal 5 mg every 4-6 hours PRN
- oral (without food)
- immediate release, start 5-20 mg every 4-6 hours
- Opana ER, start 5 mg PO BID in opiate niave patients
- start low & go slow in the elderly
Injection: 1 mg (1 mL)
Suppository: 5 mg.
Tab: 10 mg
Pharmacokinetics
- onset of analgesia:
- duration of analgesia: parenteral or rectal 3-4 hours
- food interferes with oral absorption
- plasma levels of oxymorphone are 40% higher in patients over the age of 65 years
elimination via liver
Adverse effects
- common (> 10%)
- weakness, fatigue, nausea/vomiting, hypotension, drowsiness, dizziness, histamine release, constipation
- less common (1-10%)
- ureteral spasms, pain at site of injection, nervousness, headache, restlessness, anorexia, malaise, epigastric cramps, dry mouth, biliary spasm, decreased urination, confusion, dyspnea*
- uncommon (< 1%)
- paralytic ileus, depression, hallucinations, paradoxical CNS stimulation, rash, urticaria, increased intracranial pressure, physical & psychologic dependence
- overdose:
- abuse:
- crushing & intravenously injecting Opana (extended-release) associated with thrombotic thrombocytopenic purpura[4]
- drug adverse effects of opiates
- drug adverse effects of psychotropic agents
- drug adverse effects of sedatives
Notes
- abuse-deterrent Opana ER associated with reduced risk of snorting, but increased risk of injection[5]
- FDA advisory panel concludes risks exceed benefits[5]
- FDA request Endo Pharmaceuticals remove Opana from the market[6] - Endo Pharmaceutical has not yet agreed to comply with the FDA's request
More general terms
References
- ↑ The Pharmacological Basis of Therapeutics, 9th ed. Gilman et al, eds. Permagon Press/McGraw Hill, 1996
- ↑ Kaiser Permanente Northern California Regional Drug Formulary, 1998
- ↑ Prescriber's Letter 13(8): 2006 New Drug: Opana/Opana ER (Oxymorphone) Detail-Document#: http://prescribersletter.com/(5bhgn1a4ni4cyp2tvybwfh55)/pl/ArticleDD.aspx?li=1&st=1&cs=&s=PRL&pt=3&fpt=25&dd=220806&pb=PRL (subscription needed) http://www.prescribersletter.com
- ↑ 4.0 4.1 FDA Drug Safety Alert: FDA warns about serious blood disorder resulting from misuse of Opana ER http://www.fda.gov/Drugs/DrugSafety/ucm322432.htm
- ↑ 5.0 5.1 5.2 Orciari Herman A, Sadoughi S, Saitz R FDA Advisers: Opana's Benefits Don't Outweigh Its Risks Physician's First Watch, March 16, 2017 David G. Fairchild, MD, MPH, Editor-in-Chief Massachusetts Medical Society http://www.jwatch.org
- ↑ 6.0 6.1 FDA News Release. June 8, 2017 FDA requests removal of Opana ER for risks related to abuse. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm562401.htm
endo News Release. June 8, 2017 Endo Response to June 8, 2017 FDA Meeting Related to OPANA <TM> http://phx.corporate-ir.net/phoenix.zhtml?c=231492&p=irol-newsArticle_print&ID=2279996
Database
- PubChem: http://pubchem.ncbi.nlm.nih.gov/summary/summary.cgi?cid=4639
- PubChem: http://pubchem.ncbi.nlm.nih.gov/summary/summary.cgi?cid=9646
- PubChem: http://pubchem.ncbi.nlm.nih.gov/summary/summary.cgi?cid=9645
- PubChem: http://pubchem.ncbi.nlm.nih.gov/summary/summary.cgi?cid=5284604
- PubChem: http://pubchem.ncbi.nlm.nih.gov/summary/summary.cgi?cid=6444