Select therapeutic use:
Indications for BUTRANS:
Management of pain severe enough to require daily, around-the-clock, long-term analgesia for which alternative opioid therapies are inadequate.
Limitations Of use:
Not for use as an as-needed (prn) analgesic. Use only if alternative treatment options (eg, non-opioid analgesics, immediate-release opioids) are ineffective, not tolerated, or otherwise inadequate to provide sufficient management of pain.
≥18yrs: Apply one patch to clean, dry, hairless, intact skin on upper outer arm, upper chest, upper back, or side of chest every 7 days. Cleanse application site with water only. Do not cut patch. Rotate sites (allow ≥21 days before reapplication to same site). Individualize. Opioid-naive, or oral morphine <30mg/day or equivalent: one 5mcg/hr patch. Converting from oral morphine equivalents 30–80mg/day: Taper current opioids for up to 7 days to ≤30mg/day oral morphine equivalents before starting, then initiate with Butrans 10mcg/hr patch; may use short-acting analgesics until Butrans efficacy is attained. Conversion from higher opioid doses: not recommended; see full labeling. Increase dose only after patient is exposed to previous dose for at least 72hrs. Max one 20mcg/hr patch per week. Severe hepatic impairment: use alternative therapy. Monitor use. Reevaluate periodically. Withdraw gradually.
<18yrs: not established.
Significant respiratory depression. Acute or severe bronchial asthma. Paralytic ileus.
Increased risk of fatal respiratory depression (esp. when initiating therapy and during dose increases); monitor. Abuse potential (monitor routinely). Accidental exposure may result in fatal overdose (esp. children). Risk of neonatal opioid withdrawal syndrome. Not for management of addictive disorders. Pulmonary disease (eg, COPD, cor pulmonale); monitor for respiratory depression (esp. within the first 24–72hrs of initiating therapy and after dose increases) and consider alternative non-opioid analgesic. CNS depression. Long QT syndrome or history thereof: avoid; doses >20mcg/hr increase risk of QT prolongation. Unstable cardiac disease. Unstable atrial fibrillation. Unstable CHF. Active MI. Bradycardia. Hypokalemia. Hypovolemia. Head injury. Brain tumors. Increased intracranial pressure. Impaired consciousness or coma; avoid. Fever. Seizure disorders. Biliary tract disease. GI obstruction; avoid. Acute pancreatitis. Severe hepatic impairment; consider alternate analgesic. If at risk for hepatotoxicity (eg, history of alcohol or substance abuse, liver disease); obtain baseline liver enzyme levels and monitor periodically. Avoid external heat (eg, thermal wraps, sunlamps); risk of overdose. Dispose properly. Elderly. Cachectic. Debilitated. Pregnancy (Cat.C). Labor and delivery, nursing mothers: not recommended.
Avoid concomitant Class 1A (eg, quinidine, procainamide, disopyramide) or Class III antiarrhythmics (eg, sotalol, amiodarone, dofetilide). Potentiated by other CNS depressants, sedatives, hypnotics, tranquilizers, general anesthetics, phenothiazines, other opioids, alcohol; monitor and reduce dose of one or both drugs. Potentiates benzodiazepines, skeletal muscle relaxants; monitor. Potentiated by CYP3A4 inhibitors; monitor and consider adjusting dose. Antagonized by CYP3A4 inducers; monitor for opioid withdrawal and consider adjusting dose. Increased risk of urinary retention and/or severe constipation with anticholinergics; monitor. May increase serum amylase.
Opioid (partial agonist-antagonist).
Nausea, headache, application site reactions (pruritus, erythema, rash), dizziness, constipation, somnolence, vomiting, dry mouth, peripheral edema; CNS and respiratory depression, orthostatic hypotension (monitor), syncope, neonatal withdrawal syndrome.
Hepatic (CYP3A4); 96% protein bound.
Biliary, fecal, renal.
Patch—4 (w. disposal units)