TAPENTADOL TAB,SA (EXTENDED RELEASE) NEW
Clinical Criteria Summary
Transitioning Veteran/Continuity of Care
- Veteran is transitioning care from Department of Defense to VHA and has determined to continue tapentadol SA.
Exclusion Criteria
- Intended use for mild pain, acute pain, or postoperative pain (exception: may be appropriate if patient already receiving prior to surgery or postoperative pain expected moderate/severe persisting extended period).
- Intended use as an as-needed (prn) analgesic.
- Significant respiratory depression, conditions predisposing to significant respiratory depression (acute/severe bronchial asthma), or known/suspected gastrointestinal obstruction including paralytic ileus.
- Severe renal or severe hepatic impairment.
- Hypersensitivity to tapentadol or other SA tablet contents.
- Unable to swallow whole tablets/requires tablets to be crushed before administration.
- Receiving a monoamine oxidase inhibitor (MAOI) or has taken an MAOI within the last 14 days.
- Intent to consume or likelihood of consuming alcoholic beverages or products containing alcohol during therapy.
Inclusion Criteria
- Indication: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment for which alternative treatment options (non-opioid and immediate-release opioid) are inadequate.
- AND documented contraindication, history of intolerable medication-related adverse effects (to IR or SA forms), or inadequate analgesia despite appropriate upwards titration of dosage in separate trials of morphine SA and oxycodone SA.
Dosage and Administration
- Available strengths: 50, 100, 150, 200, and 250 mg.
- Tablets must be swallowed whole; not crushed, chewed, or dissolved.
- May be administered with or without food.
- Opioid-naïve/non-tolerant patients: Initiate at 50 mg every 12 hours.
- Titration: Dose increases of 50 mg no more than twice daily every 3 days.
- Maximum daily dose: 500 mg/day. Do not convert from >200 MME morphine equivalent daily dose.
- Steady state plasma concentrations achieved after third dose (24 hours after first twice-daily administration).
- Elderly patients: Recommended doses same as younger patients with normal function; consider starting at lower range due to possibility of reduced clearance.
- Renal impairment: No dosage adjustment for mild/moderate. Not recommended for severe renal impairment (CrCl < 30 ml/min).
- Hepatic impairment: No adjustment for mild (Child-Pugh Score 5 to 6). Moderate (7 to 9): Initiate 50 mg daily, max 100 mg once daily. Not recommended for severe (10 to 15).
- Conversion from fentanyl TDS: Initiate 18 hours after patch removal. Conservative initial dose: 50 mg every 12 hours per 25 mcg fentanyl TDS; titrate per pain relief and tolerability.
- Conversion from methadone: Consult clinician with expertise in methadone dosing.
- Breakthrough pain: Rescue doses of tapentadol IR or other short-acting analgesic (alone or with acetaminophen, aspirin, NSAIDs) as needed or ~1 hour before anticipated incident pain.
- Co-therapy: Consider long-duration opioid + nonopioid analgesic (acetaminophen/NSAID) for opioid-sparing effects or additive analgesia.
Safety and Monitoring Considerations
- No consistent safety/tolerability advantage over morphine SA. Serious adverse reactions include respiratory depression, apnea, respiratory arrest, circulatory depression, hypotension, shock. Non-serious events (constipation, nausea, somnolence) typically seen on initiation and decrease over time.
- Risk of addiction, abuse, misuse, overdose, and death.
- Co-ingestion with alcohol increases plasma levels and fatal overdose risk; avoid all alcohol-containing products.
- Concomitant CNS depressants (other opioids, sedative hypnotics, tranquilizers, general anesthetics, phenothiazines) increase risk of respiratory depression, profound sedation, coma, death; reduce dose of one/both if combined.
- Monitor blood pressure during initiation/titration due to hypotensive potential.
- Life-threatening respiratory depression more likely in elderly, cachectic/debilitated patients, or those with significant respiratory disease.
- Avoid in impaired consciousness/coma, head injury, or increased intracranial pressure (respiratory depressant effects may be magnified).
- Serotonin syndrome risk with serotonergic drugs (SSRIs, SNRIs, TCAs, triptans, mirtazapine, trazodone, tramadol, MAOIs).
- Seizure disorders may be aggravated/induced; use with caution in patients with history of seizures.
- Pregnancy Category C: Use only if benefit justifies risk to fetus. Not recommended during/immediately prior to labor (prolongs labor, neonatal respiratory depression/dependence/withdrawal).
- Insufficient information on breast milk excretion; monitor infants for excess sedation/respiratory depression and withdrawal symptoms.
- Crushing/chewing/dissolving causes uncontrolled delivery leading to overdose/death.
Provider Guidance and Risk Mitigation
- Implement risk mitigation strategies per VA/DOD Clinical Practice Guideline on Opioid Therapy for Chronic Pain (2017).
- Strategies include: Informed consent conversation covering risks/benefits/alternatives, ongoing random urine drug testing (with confirmatory testing), checking state PDMPs, monitoring for overdose potential/suicidality, providing overdose education, prescribing naloxone rescue with education.
- Initiation/Continuation: VA/DOD guideline recommends against initiating long-term opioid therapy for chronic pain. For existing patients, continue risk mitigation, assess for OUD, consider tapering if risks exceed benefits.
- Tapering: Screen/treat complicating conditions first (mental health disorders like PTSD/anxiety/depression, OUD/SUD, medical complications, sleep apnea). Typical taper: 5-20% dose reduction 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 period, spending 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 comfortable setting if declined.