OXYCODONE TAB,SA
Clinical Criteria Summary
Transitioning Veteran Criteria
- Veteran is transitioning care from the Department of Defense to VHA
- VA prescriber has assessed and consulted with the Veteran, determining that continuation of oxycodone SA tablets is safe and clinically appropriate
- If this criterion is met, the remainder of the criteria for use is not applicable
- Exclusion Criteria (Patient should NOT receive if ANY are met)
- Intended use is for treatment of mild pain
- Intended use is for treatment of acute pain
- Intended use is for 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 is as an as-needed (prn) analgesic
- Patient has significant respiratory depression, condition predisposing to significant respiratory depression (e.g., acute or severe bronchial asthma), or known/suspected paralytic ileus
- Patient has hypersensitivity to oxycodone or other tablet contents
- Patient is unable to swallow whole tablets/requires tablets to be crushed before administration
- Inclusion Criteria (Must be fulfilled)
- Indication is management of moderate to severe chronic pain requiring a continuous, around-the-clock opioid analgesic for an extended period of time
- Patient has a documented contraindication to morphine, history of intolerable medication-related adverse effects to morphine, or documentation of inadequate analgesia despite appropriate upwards titration of morphine SA tablets
Therapeutic Alternatives
- Methadone oral tablet is a long-acting opioid alternative; only clinicians familiar with its pharmacological characteristics, appropriate titration, risk profile, and prepared to educate/monitor patients should initiate or titrate
- Fentanyl TDS has safety concerns regarding dosing/absorption; only clinicians familiar with its properties and prepared to educate patients should initiate or titrate
Dosage and Administration
- Available strengths: 10, 15, 20, 30, 40, 60, 80, 160 mg
- Opioid naïve patients: Use low-dose short-acting as-needed opioids to establish tolerance/efficacy and for dose finding prior to long-acting initiation
- Opioid tolerant definition: Receiving ≥1 week at least 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
- Conversion from other opioids: Use standard equianalgesic dosage estimates; new opioid typically dosed 33 to 50% less than calculated MME to avoid overdose due to incomplete cross-tolerance and individual variability
- Fentanyl TDS conversion: Initiate oxycodone SA 18 hours after patch removal; start with approximately 10 mg every 12 hours per 25 mcg/hr fentanyl TDS
- Methadone conversion: No widely accepted strategy; consult clinician with expertise in methadone dosing
- Titration/Conversion monitoring: Monitor and individualize to patient response; lower initial doses indicated for age >65, hepatic impairment, renal impairment, or concurrent CNS depressants; follow closely during conversion/titration
- Breakthrough pain: Rescue doses of oxycodone IR or other short-acting analgesic (alone or with acetaminophen/aspirin/NSAIDs) may be given as needed or ~1 h before anticipated incident pain; supplemental dose ~1/4 to 1/3 of the 12-h SA dose
- Co-therapy: Consider long-duration opioid + nonopioid analgesic (acetaminophen/NSAID) for opioid-sparing effects or additive analgesia
Safety and Monitoring
- Adverse effect profile similar to morphine SA; no consistent safety/tolerability advantage over morphine SA
- Serious adverse reactions: Respiratory depression, apnea, respiratory arrest, circulatory depression, hypotension, shock
- Non-serious events (typically on initiation, decrease over time): Constipation, nausea, somnolence
- Monitor blood pressure during dose initiation/titration due to hypotensive potential
- Avoid in impaired consciousness/coma, head injury, or increased intracranial pressure (respiratory depressant effects may be magnified)
- Initiating/discontinuing CYP3A4 inducers may alter oxycodone plasma concentrations
- Pregnancy: Category B; use only if clearly indicated; may prolong labor and cause neonatal respiratory depression, physical dependence, and withdrawal syndrome
- Lactation: Excreted in breast milk; discontinue nursing or drug due to risk of infant sedation/respiratory depression/withdrawal
- Crushing tablets: Cannot be crushed; results in immediate release of full dose, risking fatal overdose
- Abuse hazard: Crushed tablet abuse increases overdose/death risk, especially with alcohol/substances; parenteral abuse risks local tissue necrosis, infection, pulmonary granulomas, endocarditis, and valvular heart injury
- CNS depressants: Concomitant use (other opioids, sedatives, hypnotics, tranquilizers/benzodiazepines, anesthetics, phenothiazines, muscle relaxants, alcohol) may cause respiratory depression, hypotension, profound sedation, or coma; concurrent opioids and benzodiazepines is recommended against
Provider-Related Guidance and Risk Mitigation
- Implement risk mitigation strategies per VA/DOD Clinical Practice Guideline; include informed consent conversation covering risks/benefits of opioid therapy and alternatives
- Strategies and frequency should be commensurate with risk factors: ongoing random urine drug testing (with confirmatory testing), state PDMP checks, monitoring for overdose potential/suicidality, overdose education, naloxone rescue prescribing/education
- Initiation/Continuation: Guideline recommends against initiating long-term opioid therapy for chronic pain; for existing patients, continue risk mitigation, assess for OUD, consider tapering when risks exceed benefits
- Tapering: Screen/treat complicating conditions first (mental health disorders like PTSD/anxiety/depression, OUD/SUD, medical complications like lung/hepatic/renal disease, sleep disorders/apnea); typical taper involves 5% to 20% dose reductions every 4 weeks
- OUD Management: Aberrant behaviors may emerge during taper/discontinuation or as tolerance develops; DSM-5 criteria include craving, tolerance, withdrawal, using larger amounts/longer periods, spending excessive time obtaining/using/recovering, continued use despite problems; 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; offer treatment in setting patient feels most comfortable if initial options are declined