Initiating Schedule III, 7-day Butrans in opioid-naïve patients

Starting the right patient at the right dose of Butrans

  • Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals
  • Butrans is for transdermal use (on intact skin) only
  • Each Butrans patch is intended to be worn for 7 days
  • Initiate treatment in opioid naive patients with Butrans with a 5 mcg/hour patch
  • Butrans doses of 7.5, 10, 15, and 20 mcg/hour are only for use in patients who are opioid experienced and in whom tolerance to an opioid of comparable potency has been established. Patients who are opioid-experienced are those receiving, for one week or longer, daily opioid doses up to 80 mg/day of oral morphine or an equianalgesic dose of another opioid
  • Monitor patients closely for respiratory depression, especially within the first 24 to 72 hours of initiating therapy with Butrans and following dosage increases
  • Butrans should be prescribed only by healthcare professionals who are knowledgeable in the use of potent opioids for the management of chronic pain
  • There is a potential for buprenorphine to precipitate withdrawal in patients who are already on opioids
  • Instruct patients not to use Butrans if the pouch seal is broken or the patch is cut, damaged, or changed in any way and not to cut Butrans
  • Instruct patients to avoid exposing Butrans to external heat sources, hot water, or prolonged direct sunlight

Use of Butrans as the first opioid analgesic (opioid-naïve patients)

Patients on NSAIDs (including COX II inhibitors), APAP, or other non-opioid medications who may be appropriate for Butrans should initiate treatment with:

5 mcg/hour, q7d
(not shown at actual size)

In a clinical trial with opioid-naïve patients, non-opioid analgesics used prior to enrollment included1,2:

  • Ibuprofen
  • Acetaminophen
  • Naproxen

Patients were suboptimally responsive to their non-opioid pain medications.

Patients with hepatic impairment

  • Butrans has not been evaluated in patients with severe hepatic impairment. As Butrans is only intended for 7-day application, consider use of an alternate analgesic that may permit more flexibility with dosing in patients with severe hepatic impairment