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