OXYMORPHONE TAB
Clinical Criteria Summary
Indications & Inclusion Criteria
- Intended use for treatment of moderate to severe acute pain where opioid use is appropriate
- Documented intolerance, contraindication, or lack of sufficient analgesic response to other formulary short-acting immediate-release opioids (tramadol, codeine, codeine/acetaminophen, hydrocodone/acetaminophen, oxycodone/acetaminophen, oxycodone, hydromorphone, and morphine)
- Patient approved for oxymorphone SA tabs requiring oxymorphone IR for breakthrough pain
- Transitioning Veteran care from Department of Defense to VHA, with VA prescriber determination that continuation is safe and clinically appropriate
Exclusion Criteria
- Intended use for treatment of mild pain
- Opioid naïve patient with initial single dosage > 20mg
- Significant respiratory depression, condition predisposing to significant respiratory depression (acute or severe bronchial asthma), or known/suspected paralytic ileus
- Moderate or severe hepatic impairment
- Hypersensitivity to oxymorphone
Dosing & Administration
- Available strengths: 5 and 10 mg
- Administer on empty stomach (at least 1 hour before or 2 hours after eating); high-fat meal increases CMAX
- Opioid naïve patients: Initiate at doses up to 10-20 mg every 4 to 6 hours; use higher starting doses cautiously due to risk of fatal respiratory depression
- Initiate with 5mg dose in opioid-naïve patients with mild hepatic impairment, impaired renal function (creatinine clearance < 50 ml/min), or age ≥ 65 years
- Opioid tolerant definition: Receiving for one week or longer at least 60 mg oral morphine per day, 25 mcg transdermal fentanyl per hour, 30 mg oral oxycodone per day, 8 mg oral hydromorphone per day, 25 mg oral oxymorphone per day, or equianalgesic dose of another opioid
- Conversion: Use standard equianalgesic dosage estimates; new opioid typically dosed at 33 to 50% less than calculated MME dose to avoid accidental overdose due to incomplete cross-tolerance
Safety & Adverse Effects
- Adverse effect profile includes nausea, somnolence, vomiting, pruritus, headache, dizziness, constipation, and confusion
- May cause severe hypotension in patients with compromised blood pressure maintenance (depleted blood volume or concurrent drugs compromising vasomotor tone)
- Avoid in patients with impaired consciousness/coma, head injury, or increased intracranial pressure (respiratory depressant effects may be magnified)
- Avoid co-administration with alcohol (significantly increases CMAX)
- Concomitant use with other CNS depressants (other opioids, sedative hypnotics, tranquilizers, general anesthetics, phenothiazines) increases risk of respiratory depression, profound sedation, coma, and death
- Concurrent use with benzodiazepines is not recommended; consider tapering if risks exceed benefits and obtain specialty consultation
Special Populations
- Renal impairment: Effect on pharmacokinetics not studied for IR; SA formulation shows increased bioavailability in mild (26%), moderate (57%), and severe (65%) renal impairment
- Hepatic impairment: Contraindicated in moderate or severe hepatic impairment
- Pregnancy: Category C; use only if potential benefit justifies potential risk to fetus. Not recommended during/immediately prior to labor (may prolong labor, cause neonatal respiratory depression, physical dependence, and withdrawal syndrome)
- Lactation: Unknown if excreted in breast milk; monitor exposed infants for excess sedation and respiratory depression
Risk Mitigation & Provider Guidance
- Implement risk mitigation strategies including informed consent conversation covering risks/benefits of opioid therapy and alternatives
- Ongoing, random urine drug testing (including appropriate confirmatory testing)
- Checking state prescription drug monitoring programs
- Monitoring for overdose potential and suicidality
- Providing overdose education
- Prescribing naloxone rescue kit with accompanying education
- Initiation/Continuation: Do not initiate long-term opioid therapy for chronic pain; for existing long-term therapy, conduct ongoing risk mitigation, assess for OUD, and consider tapering when risks exceed benefits
- Tapering: Screen/treat complicating conditions first (mental health disorders, OUD/SUD, medical complications, sleep disorders including sleep apnea); typical taper involves dose reductions of 5% to 20% every 4 weeks
- OUD Management: Suspected OUD requires addiction-focused medical management in PACT, referral to Interdisciplinary Pain Management Team with Addiction Medicine/MAT expertise, or Primary Care Mental Health/specialty care; DSM-5 criteria include craving, tolerance, withdrawal, using larger amounts/longer periods than intended, spending excessive time obtaining/using/recovering, and continued use despite physical/psychological problems