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Butrans
buprenorphine transdermal
Black Box Warnings .
Appropriate Use
should only be prescribed by healthcare professionals knowledgeable about opioid use and how to mitigate assoc. risks; reserve opioid analgesics for pts w/ inadequate tx alternatives; not indicated for prn analgesic use; proper dosing and titration essential to decr. resp. depression risk
Addiction, Abuse, and Misuse
Schedule III controlled substance w/ risk of addiction, abuse, and misuse, which can lead to overdose and death; assess opioid abuse or addiction risk prior to prescribing; regularly reassess all pts for misuse, abuse, and addiction
Respiratory Depression
serious, life-threatening, or fatal cases may occur even w/ recommended use, esp. during tx start or after dose incr; to decr. risk, initiate and titrate dose appropriately; misuse or abuse by chewing, swallowing, snorting, or injecting extracted buprenorphine will result in uncontrolled drug delivery and pose significant risk of overdose and death
Accidental Exposure
accidental exposure to even one dose, esp. in children, can result in fatal buprenorphine overdose
Risks from Concomitant Use w/ Benzodiazepines, CNS Depressants
concomitant opioid use w/ benzodiazepines or other CNS depressants, incl. alcohol, may result in profound sedation, resp. depression, coma, and death; reserve concomitant use for pts w/ inadequate alternative tx options
Neonatal Opioid Withdrawal Syndrome
extended use in pregnant pts can lead to potentially life-threatening neonatal opioid withdrawal syndrome; advise pregnant pts of risks and ensure tx by neonatology experts avail. at delivery if extended opioid use required
Opioid Analgesic REMS
providers are strongly encouraged to complete risk evaluation and mitigation strategy (REMS)-compliant education program, counsel pts and/or caregivers w/ each Rx on serious risks, safe use, and importance of reading medication guide
Adult Dosing .
Dosage forms: PATCH: 5 mcg per hour, 7.5 mcg per hour, 10 mcg per hour, 15 mcg per hour, 20 mcg per hour
Special Note
- [prescribing info]
- Info: consider prescribing naloxone if risk of opioid overdose or accidental exposure
pain, mod-severe chronic
- [opioid-naive pts]
- Dose: apply 5-20 mcg patch q7 days; Start: apply 5 mcg patch, may incr. dose no more frequently than q72h; Max: 20 mcg/h qwk; Info: use lowest effective dose, shortest effective tx duration; do not alter/cut patch; taper total daily dose by no more than 10-25% q2-4wk to D/C if long-term use
- [opioid-experienced pts, oral morphine equivalent <30 mg/day]
- Dose: apply 5-20 mcg patch q7 days; Start: apply 5 mcg patch, may incr. dose no more frequently than q72h; Max: 20 mcg/h qwk; Info: use lowest effective dose, shortest effective tx duration; titrate slowly in pts 65 yo and older; do not alter/cut patch; taper total daily dose by no more than 10-25% q2-4wk to D/C if long-term use
- [opioid-experienced pts, oral morphine equivalent 30-80 mg/day]
- Dose: apply 5-20 mcg patch q7 days; Start: apply 10 mcg patch, may incr. dose no more frequently than q72h; Max: 20 mcg/h qwk; Info: taper current opioids for up to 7 days to 30 mg/day oral morphine equivalent or less prior to starting buprenorphine transdermal; use lowest effective dose, shortest effective tx duration; titrate slowly in pts 65 yo and older; do not alter/cut patch; taper total daily dose by no more than 10-25% q2-4wk to D/C if long-term use
renal dosing
- [see below]
- renal impairment: no adjustment
- HD/PD: not defined
hepatic dosing
- [see below]
- mild-moderate impairment: no adjustment; severe impairment: not defined, consider alternate tx
Peds Dosing .
Peds dosing is currently unavailable or not applicable for this drug.