OXYMORPHONE TAB,SA
Clinical Criteria Summary
Transitioning Veteran Criteria
- Veteran is transitioning care from the Department of Defense to VHA and has determined with a VHA health care prescriber to continue oxymorphone SA. If met, remainder of criteria for use is not applicable.
Exclusion Criteria
- Intended use for treatment of mild pain, acute pain, or postoperative pain (unless patient is already receiving the drug prior to surgery or postoperative pain is expected to be moderate to severe and persist for an extended period).
- Intended use as an as-needed (prn) analgesic.
- Significant respiratory depression, condition predisposing to significant respiratory depression (e.g., acute or severe bronchial asthma), or known/suspected paralytic ileus.
- Moderate or severe hepatic impairment.
- Hypersensitivity to oxymorphone or other tablet contents.
- Inability to swallow whole tablets or requirement for tablets to be crushed before administration.
- Intent to consume or likelihood of consuming alcoholic beverages or prescription/non-prescription products containing alcohol during therapy.
Inclusion Criteria
- Indication is management of moderate to severe chronic pain requiring a continuous, around-the-clock opioid analgesic for an extended period.
- Documented contraindication, history of intolerable medication-related adverse effects (to IR or SA forms), or inadequate analgesia despite appropriate upward titration in separate trials of morphine SA tabs and oxycodone SA tabs.
Therapeutic Alternatives
- Methadone oral tablet is a long-acting opioid alternative; initiation/titration only for clinicians familiar with its pharmacological characteristics, appropriate titration, risk profile, and prepared to educate/monitor closely.
- Fentanyl TDS: Initiation/titration only for clinicians familiar with dosing/absorption properties and prepared to educate patients about use.
Practice Standards & Risk Mitigation
- Utilize CDC and VA/DoD Clinical Practice Guidelines for prescribing opioids for chronic pain.
- Obtain informed consent explaining risks, benefits, and obligatory terms of long-term opioid treatment.
- Follow all federal and state guidelines on prescribing and dispensing opioids.
- Perform initial and periodic checks of State Prescription Drug Monitoring System (if available).
- Consider provision of naloxone rescue and other risk mitigation strategies commensurate with patient risk factors.
Dosage & Administration
- Available strengths: 5, 7.5, 10, 15, 20, 30, 40 mg.
- Administer on empty stomach (1 hour before or 2 hours after eating); food increases CMAX.
- Tablets must not be wetted prior to placing in mouth.
- Opioid naïve: Initial dose 5 mg q 12 h; higher starting doses may cause fatal respiratory depression.
- Opioid tolerant definition: Receiving ≥60 mg oral morphine/day, ≥25 mcg transdermal fentanyl/hour, ≥30 mg oral oxycodone/day, ≥8 mg oral hydromorphone/day, ≥25 mg oral oxymorphone/day, or equianalgesic dose of another opioid for ≥1 week.
- Opioid-tolerant patients with mild hepatic impairment, impaired renal function (CrCl < 50 ml/min), or age ≥65 years: Initiate at 50% lower than usual doses and titrate slowly.
- Steady-state reached within 3 days; dosage adjustments preferably in increments of 5-10 mg every 12 hours, performed every 3 to 7 days.
- Conversion from fentanyl TDS: Initiate 18 hours after patch removal; conservative initial dose 5 or 7.5 mg q 12 h per 25 mcg fentanyl TDS, then titrate based on pain relief/tolerability.
- Conversion from methadone: Use 0.5 conversion factor (10 mg oral methadone/day ≈ 5 mg oral oxymorphone/day); consult clinician with methadone expertise.
- Rescue doses of oxymorphone IR or other short-acting analgesic may be administered for breakthrough pain as needed or ~1 hour before anticipated incident pain.
- Co-therapy with long-duration opioid and nonopioid analgesic (acetaminophen/NSAID) should be considered for opioid-sparing effects or additive analgesia.
Safety & Adverse Effects
- Adverse effect profile similar to morphine SA; serious reactions include respiratory depression, apnea, respiratory arrest, circulatory depression, hypotension, shock. Non-serious events typically occur on initiation and decrease over time (constipation, nausea, somnolence).
- Co-ingestion of alcohol may increase plasma levels and cause potentially fatal overdose; patients must not consume alcohol or alcohol-containing products.
- Concomitant use with other CNS depressants increases risk of respiratory depression, profound sedation, coma, and death; reduce dose of one or both agents.
- VA/DOD guideline recommends against concurrent use of opioids and benzodiazepines; consider tapering if risks exceed benefits and obtain specialty consultation.
- Bioavailability increased in renal impairment (mild 26%, moderate 57%, severe 65%); monitor blood pressure during initiation/titration due to hypotensive potential.
- Avoid in patients with impaired consciousness/coma, head injury, or increased intracranial pressure (respiratory depressant effects may be magnified).
- Pregnancy Category C; use only if maternal benefit justifies fetal risk. Not for use during/immediately prior to labor (may prolong labor and cause neonatal respiratory depression, physical dependence, and withdrawal syndrome).
- Unknown excretion in breast milk; monitor exposed infants for excess sedation and respiratory depression.
- Tablets cannot be crushed (causes immediate release of full dose, risking fatal overdose); do not pre-soak, lick, or wet tablets (swells/sticks, risk of GI obstruction/choking, particularly with prior GI surgery or structural abnormalities).
- Abuse of crushed tablets poses overdose/death hazard; parenteral abuse risks local tissue necrosis, infection, pulmonary granulomas, endocarditis, and valvular heart injury.
Provider Guidance & Opioid Use Disorder Management
- Implement risk mitigation strategies: informed consent conversation, ongoing random urine drug testing (with confirmatory testing), PDMP checks, monitoring for overdose potential/suicidality, overdose education, and prescribing naloxone rescue with education.
- Initiation/Continuation: Recommend against initiating long-term opioid therapy for chronic pain; for existing patients, continue 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). Typically involves dose reductions of 5% to 20% every 4 weeks.
- OUD Management: Aberrant behaviors may emerge during taper/discontinuation or as tolerance develops. DSM-5 criteria include craving/urge, tolerance, withdrawal, using larger amounts/longer periods than intended, spending excessive time obtaining/using/recovering, and continued use despite physical/psychological problems. Refer to addiction-focused medical management (PACT, Interdisciplinary Pain Management Team with Addiction Medicine/MAT, Primary Care Mental Health/specialty care).