for transdermal administration
BRIEF SUMMARY OF PRESCRIBING INFORMATION
(For complete details please see the full prescribing information and
Medication Guide.)
WARNING: ABUSE POTENTIAL, LIFE-THREATENING RESPIRATORY
DEPRESSION, and ACCIDENTAL EXPOSURE
Abuse Potential
BUTRANS contains buprenorphine, an opioid agonist and
Schedule III controlled substance with an abuse liability similar
to other Schedule III opioids, legal or illicit [see Warnings and
Precautions (5.1)]. Assess each patient’s risk for opioid abuse
or addiction prior to prescribing BUTRANS. The risk for opioid
abuse is increased in patients with a personal or family history of
substance abuse (including drug or alcohol abuse or addiction) or
mental illness (e.g., major depressive disorder). Routinely monitor
all patients receiving BUTRANS for signs of misuse, abuse, and
addiction during treatment [see Drug Abuse and Dependence (9)].
Life-Threatening Respiratory Depression
Respiratory depression, including fatal cases, may occur with use
of BUTRANS, even when the drug has been used as recommended
and not misused or abused [see Warnings and Precautions (5.2)].
Proper dosing and titration are essential and BUTRANS should only
be prescribed by healthcare professionals who are knowledgeable
in the use of potent opioids for the management of chronic pain.
Monitor for respiratory depression, especially during initiation of
BUTRANS or following a dose increase.
Accidental Exposure
Accidental exposure to BUTRANS, especially in children, can
result in a fatal overdose of buprenorphine [see Warnings and
Precautions (5.3)].
1 INDICATIONS AND USAGE BUTRANS is indicated for the management of
moderate to severe chronic pain when a continuous, around-the-clock opioid
analgesic is needed for an extended period of time. Limitations of Use BUTRANS
is not for use: • As an as-needed (prn) analgesic • For pain that is mild or
not expected to persist for an extended period of time • For acute pain
• For postoperative pain unless the patient is already receiving chronic opioid
therapy prior to surgery or if the postoperative pain is expected to be moderate to severe and persist for an extended period of time 4 CONTRAINDICATIONS
BUTRANS is contraindicated in patients with: • Significant r