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oxymorphone (Numorphan, Opana, Opana ER)

Tradename: Numorphan, Opana. DEA-controlled substance: class 2. Indications: 1) management of moderate to severe pain 2) preoperatively as a sedative & adjunct to anesthesia Dosage: 1) 1-1.5 mg IM/SC every 4-6 hours 2) rectal 5 mg every 4-6 hours PRN 3) oral (without food) a) immediate release, start 5-20 mg every 4-6 hours b) Opana ER, start 5 mg PO BID in opiate niave patients 5) start low & go slow in the elderly Injection: 1 mg (1 mL) Suppository: 5 mg. Tab: 10 mg Pharmacokinetics: 1) onset of analgesia: a) IV/IM/SC: within 5-10 minutes b) rectal: within 15-30 minutes 2) duration of analgesia: parenteral or rectal 3-4 hours 3) food interferes with oral absorption 4) plasma levels of oxymorphone are 40% higher in patients over the age of 65 years Adverse effects: 1) common (> 10%) - weakness, fatigue, nausea/vomiting, hypotension, drowsiness, dizziness, histamine release, constipation 2) 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* 3) uncommon (< 1%) - paralytic ileus, depression, hallucinations, paradoxical CNS stimulation, rash, urticaria, increased intracranial pressure, physical & psychologic dependence 4) overdose: - management: - airway support - IV administration of naloxone - 2 mg (0.01 mg/kg in children) - may repeat up to a total of 10 mg 5) abuse: - crushing & intravenously injecting Opana (extended-release) associated with thrombotic thrombocytopenic purpura [4] 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

Interactions

drug interactions drug adverse effects (more general classes)

Related

noroxymorphone

General

opiate opioid receptor agonist (narcotic)

Properties

MISC-INFO: elimination route LIVER pregnancy-category C safety in lactation ?

Database Correlations

PUBCHEM correlations

References

  1. The Pharmacological Basis of Therapeutics, 9th ed. Gilman et al, eds. Permagon Press/McGraw Hill, 1996
  2. Kaiser Permanente Northern California Regional Drug Formulary, 1998
  3. Prescriber's Letter 13(8): 2006 New Drug: Opana/Opana ER (Oxymorphone) Detail-Document#: 220806 (subscription needed) http://www.prescribersletter.com
  4. 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. 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. 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 http://phx.corporate-ir.net/phoenix.zhtml?c=231492&p=irol-newsArticle_print&ID=2279996