TAPENTADOL TAB

Clinical Criteria Summary

Veteran is transitioning care from the Department of Defense to VHA, and a VA prescriber has determined continuation of tapentadol IR tablets is safe and clinically appropriate (remainder of criteria not applicable)

Intended use for treatment of moderate to severe acute pain where opioid use is appropriate
Patient has documented intolerance, contraindication, or lack of sufficient analgesic response to at least 4 other formulary short-acting immediate-release opioids (tramadol, codeine, codeine/acetaminophen, hydrocodone/acetaminophen, oxycodone/acetaminophen, oxycodone, hydromorphone, morphine)
OR Patient is approved for tapentadol SA tabs and tapentadol IR is required for breakthrough pain

Intended use is for treatment of mild pain
Patient is opioid naïve and initial single dosage is > 100 mg
Significant respiratory depression, conditions predisposing to significant respiratory depression (acute or severe bronchial asthma), or known/suspected gastrointestinal obstruction including paralytic ileus
Severe renal or hepatic impairment
Receiving a monoamine oxidase inhibitor (MAOI) or has taken an MAOI within 14 days
Hypersensitivity to tapentadol

Available strengths: 50, 75, and 100 mg
First day of dosing: Second dose may be administered as soon as one hour after first dose if adequate pain relief not attained; subsequent dosing is 50, 75, or 100 mg up to every 4 to 6 hours, adjusted for adequate analgesia with acceptable tolerability
Daily doses > 700 mg on day 1 and > 600 mg on subsequent days are not recommended
Consider starting elderly patients at the lower range of recommended dosages
No FDA-approved dosing instructions exist for conversion from another opioid; use provided conversion factors to estimate dose, but reduce calculated MME to 50–67% to avoid accidental overdose due to incomplete cross-tolerance and individual variability

Does not offer consistent advantages over morphine IR regarding safety or tolerability
Serious adverse reactions: potentially life-threatening respiratory depression, profound sedation, hypotension
Non-serious adverse events: nausea, vomiting, constipation, dry mouth, fatigue, dizziness, somnolence, pruritus
Concomitant use with other CNS depressants (other opioids, alcohol, sedative hypnotics, tranquilizers, general anesthetics, phenothiazines, skeletal muscle relaxants) increases risk of respiratory depression, profound sedation, coma, death, and hypotension
VA/DOD guideline recommends against concurrent use of opioids and benzodiazepines; consider tapering one or both when risks exceed benefits and obtain specialty consultation if combined therapy is contemplated
Avoid in patients with impaired consciousness or coma, head injury, or increased intracranial pressure (respiratory depressant effects may be magnified)
Potentially life-threatening serotonin syndrome may occur when combined with serotonergic drugs (SSRIs, SNRIs, TCAs, triptans, mirtazapine, trazodone, tramadol, MAOIs)
Seizure disorders may be aggravated or induced; use with caution in patients with history of seizures
Abuse potential via crushing, chewing, snorting, or injecting poses significant risk of overdose and death; consider provision of naloxone rescue kit as risk mitigation

Pregnancy: Category C; use only if potential benefit to mother justifies potential risk to fetus
Labor/Delivery: Not recommended during or immediately prior to labor (can prolong labor and cause neonatal respiratory depression, physical dependence, and withdrawal syndrome)
Lactation: Insufficient information on excretion in breast milk; monitor infants for excess sedation, respiratory depression, and withdrawal symptoms when therapy is stopped

Implement risk mitigation strategies per VA/DOD Clinical Practice Guideline on Management of Opioid Therapy (2017): informed consent conversation, ongoing random urine drug testing, checking state PDMPs, monitoring for overdose potential and suicidality, providing overdose education, prescribing naloxone rescue kit with accompanying education
Do not initiate long-term opioid therapy for chronic pain; for patients already on long-term therapy, continue risk mitigation, assess for OUD, and consider tapering when risks exceed benefits
Opioid Tapering: Screen and treat complicating conditions before initiating taper (mental health disorders like PTSD/anxiety/depression, OUD/SUD, medical complications, sleep disorders including sleep apnea); typical taper involves dose reductions of 5% to 20% every 4 weeks
OUD Management: Monitor for aberrant behaviors; if OUD suspected, provide addiction-focused medical management in PACT or refer to Interdisciplinary Pain Management Team with Addiction Medicine expertise/MAT, or Primary Care Mental Health/specialty care

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