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CONTRAINDICATIONS
Butrans is contraindicated in patients with:
significant respiratory depression; acute or
severe bronchial asthma in an unmonitored
setting or in the absence of resuscitative
equipment; known or suspected paralytic
ileus; hypersensitivity (eg, anaphylaxis)
to buprenorphine
WARNINGS AND PRECAUTIONS
Abuse Potential
Buprenorphine can be abused in a manner
similar to other opioid agonists, legal or illicit.
Assess risk for opioid abuse or addiction prior
to prescribing. Routinely monitor all patients
for signs of misuse, abuse, and addiction.
Addiction can occur even under appropriate
medical use. Misuse or abuse of Butrans by
chewing, swallowing, snorting or injecting
buprenorphine extracted from the transdermal
system will result in the uncontrolled delivery
of the opioid and pose a significant risk that
could result in overdose and death
Life-Threatening Respiratory Depression
Respiratory depression is the primary risk
of Butrans and may lead to respiratory arrest
and death. While serious, life-threatening,
or fatal respiratory depression can occur at
any time during the use of Butrans, the risk
is greatest during the initiation of therapy or
following a dose increase. Closely monitor
patients for respiratory depression. Proper
dosing and titration of Butrans are essential.
Overestimating the Butrans dose when
converting patients from another opioid
product can result in fatal overdose with
the first dose
Accidental Exposure
Accidental exposure to Butrans, especially in
children, can result in a fatal ov