Generic Name and Formulations:
Buprenorphine 5mcg/hr, 7.5mcg/hr, 10mcg/hr, 15mcg/hr, 20mcg/hr; transdermal patch.
Purdue Pharma L.P.
|Additional 7.5mcg/hr dosing strength.|
Moderate to severe chronic pain when continuous opioid analgesia is needed for extended time period. Not for use: as an as-needed (prn) analgesic; for mild or acute pain; or post-op pain unless previously on chronic opioid therapy, or if pain expected to be persistent.
≥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 literature. 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 recommended.
Significant respiratory depression. Acute or severe bronchial asthma. Paralytic ileus.
Pulmonary disease (eg, COPD, cor pulmonale); monitor for respiratory depression (esp. within the first 24–72hrs of initiating therapy and after dose increases). CNS depression. Long QT syndrome or history thereof: avoid; doses >20microgram/hr increase risk of QT prolongation. Unstable cardiac disease. Unstable atrial fibrillation. Unstable CHF. Active MI. Bradycardia. Hypokalemia. Hypovolemia. Head injury. Increased intracranial pressure. Impaired consciousness or coma; avoid. Fever. Seizure disorders. Biliary tract disease. GI obstruction. Acute pancreatitis. Abuse potential (monitor). Monitor liver function in susceptible patients (eg, alcohol or substance abuse, liver disease). Avoid external heat (eg, thermal wraps, sunlamps); risk of overdose. Dispose properly. Elderly. Cachectic. Debilitated. Accidental exposure (esp. children). Labor and delivery, pregnancy (Cat.C), nursing mothers: not recommended.
Avoid concomitant Class 1A (eg, quinidine, procainamide, disopyramide) or Class III antiarrhythmics (eg, sotalol, amiodarone, dofetilide). Potentiation with alcohol, CNS and respiratory depressants (eg, benzodiazepines, muscle relaxants, sedatives, hypnotics, general anesthetics, antiemetics, other tranquilizers, phenothiazines). Caution with CYP3A4 inhibitors. Monitor with CYP3A4 inducers (eg, phenobarbital, carbamazepine, phenytoin, rifampin). Increased risk of urinary retention and/or severe constipation with anticholinergics; monitor.
CNS and respiratory depression, hypotension, GI upset, headache, application site reactions (eg, pruritus, erythema, rash), dizziness, constipation, somnolence, peripheral edema, dry mouth.
Hepatic (CYP3A4); 96% protein bound.
Biliary, fecal, renal.
Patch—4 (w. disposal units)