Manufacturer:

Purdue Pharma L.P.

Pharmacological Class:

Opioid analgesic.

Active Ingredient(s):

Buprenorphine 5mcg/hour, 10mcg/hour, 20mcg/hour; transdermal patch.

Indication(s):

Moderate to severe chronic pain when continuous opioid analgesia is needed for extended time period. Not for as-needed use.

Pharmacology:

Buprenorphine is a partial agonist at mu opioid receptors. It is also an antagonist at kappa opioid receptors, an agonist at delta opioid receptors, and a partial agonist at ORL-1 (nociceptin) receptors.

Clinical Trials:

Two clinical studies in patients with moderate to severe low back pain showed that Butrans improved pain scores in both ­opioid-naive and opioid-experienced patients who needed continuous treatment for an extended period of time. These studies included open-label titration periods followed by randomized, double-blind, 12-week study periods.

Another study in patients with low back pain, as well as a study in patients with osteoarthritis, failed to demonstrate efficacy.

Legal Classification:

CIII

Adults:

≥18years: 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/hour patch. Converting from oral mor­phine equivalents 30–80mg/day: one 10mcg/hour patch. Conversion from higher opioid doses: not recommended; see literature. Previously on oral morphine >30mg/day or equivalent: taper it down to no more than 30mg/day oral morphine equivalents before starting; use short-acting analgesics until Butrans takes effect. Increase dose only after patient is exposed to previous dose for at least 72 hours. Max one 20mcg/hour patch per week. Mild to moderate hepatic impairment: initially one 5mcg/hour patch. Monitor use. Reevaluate periodically. Withdraw gradually.

Children:

<18years: not recommended.

Contraindication(s):

Acute or post-op pain, or mild or intermittent pain that can be managed by lesser means. Significant respiratory impairment. Asthma (acute or severe). Paralytic ileus.

Warnings/Precautions:

Respiratory depression (COPD, cor pulmonale, asthma, obesity, sleep apnea, myxedema, kyphoscoliosis, CNS depression). Long QT syndrome or history thereof: avoid; doses >20mcg/hour increase risk of QT prolongation. Unstable cardiac disease. Active MI. Bradycardia. Hypokalemia. Circulatory shock. Hypovolemia. Avoid external heat (eg, thermal wraps, sunlamps); risk of overdose. Fever. Head injury. Increased intracranial pressure. Seizure disorders. Delirium tremens. Toxic psychosis. Severe hepatic, renal, thyroid, adrenocortical, or pulmonary impairment. Acute abdomen. Gallbladder disease. Biliary disease. GI or GU obstruction. Acute pancreatitis. Drug abusers. Monitor liver function in susceptible patients (eg, alcohol or substance abuse, liver disease). Dispose properly. Elderly. Debilitated. Labor and delivery, pregnancy (Cat.C), nursing mothers: not recommended.

Interaction(s):

Not recommended within 14 days of MAOIs. 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, tricyclics, pheno­thiazines). Caution with CYP3A4 inhibitors. Monitor with CYP3A4 inducers (eg, phenobarbital, carbamazepine, rifampin).

Adverse Reaction(s):

CNS and respiratory depression, hypotension, GI upset, headache, application site reactions (eg, pruritus, erythema, rash), dizziness, constipation, somnolence, peripheral edema, dry mouth.

How Supplied:

Patch—4 (w. disposal units)

Last Updated:

1/6/2011