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fentanyl transdermal
generic
Black Box Warnings .
Appropriate Use
should only be prescribed by healthcare professionals knowledgeable about ER opioid use and how to mitigate assoc. risks; reserve ER forms 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
opioid agonist Schedule II 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; due to resp. depression risk, contraindicated for use in as-needed pain mgmt, non-opioid tolerant pts, acute pain, and post-operative pain
Accidental Exposure
accidental exposure to even one dose, esp. by children, can result in fatal fentanyl overdose; death from overdose has occurred in children and adults who were accidentally exposed to transdermal fentanyl; instruct pts about strict adherence to proper patch handling and disposal
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
CYP450 3A4 Interaction
concomitant use w/ CYP450 3A4 inhibitors or D/C of concomitant CYP450 3A4 inducers may incr. fentanyl conc. which may incr. or prolong adverse effects incl. potentially fatal resp. depression; monitor pts receiving any concomitant CYP450 3A4 inhibitor or inducer
Avoid Heat Exposure
pts should avoid exposure of application site/surrounding area to external heat sources; exposure to direct external heat sources such as heating pads, electric blankets, heat/tanning lamps, sunbathing, hot baths, saunas, hot tubs, and heated water beds may incr. fentanyl absorption and has resulted in fatal overdose
Adult Dosing .
Dosage forms: PATCH: 12 mcg per hour, 25 mcg per hour, 37.5 mcg per hour, 50 mcg per hour, 62.5 mcg per hour, 75 mcg per hour, 87.5 mcg per hour, 100 mcg per hour
Special Note
- [prescribing info]
- Info: consider prescribing naloxone if risk of opioid overdose or accidental exposure
- [strength clarification]
- Info: 12 mcg patch actually delivers 12.5 mcg per hour; order this patch strength as fentanyl transdermal 12 mcg per hour to avoid misinterpretation as 125 mcg per hour
pain, severe chronic
- [individualize patch dose q72h]
- Start: individualize dose based on current opioid intake, see pkg insert for conversion tables; may adjust dose 3 days after tx start, then no more frequently than q6 days; Info: for opioid-tolerant pts only; use lowest effective dose, shortest effective tx duration; consider low start dose, titrate slowly in pts 65 yo and older; some pts may require q48h dosing; do not alter/cut patch; taper total daily dose by no more than 25% q2-4wk to D/C if long-term use; drug effects may persist >24h after patch removal
renal dosing
- [see below]
- mild-moderate impairment: decr. usual start dose by 50%; severe impairment: avoid use
- HD/PD: not defined
hepatic dosing
- [see below]
- mild-moderate impairment: decr. usual start dose by 50%; severe impairment: avoid use
Peds Dosing .
- Dosage forms: PATCH: 12 mcg per hour, 25 mcg per hour, 37.5 mcg per hour, 50 mcg per hour, 62.5 mcg per hour, 75 mcg per hour, 87.5 mcg per hour, 100 mcg per hour
Special Note
- [prescribing info]
- Info: consider prescribing naloxone if risk of opioid overdose or accidental exposure
- [strength clarification]
- Info: 12 mcg patch actually delivers 12.5 mcg per hour; order this patch strength as fentanyl transdermal 12 mcg per hour to avoid misinterpretation as 125 mcg per hour
pain, severe chronic
- [2 yo and older]
- Dose: individualize patch dose q72h; Start: individualize dose based on current opioid intake, see pkg insert for conversion tables; may adjust dose 3 days after tx start, then no more frequently than q6 days; Info: for opioid-tolerant pts only; use lowest effective dose, shortest effective tx duration; do not alter/cut patch; taper total daily dose by no more than 25% q2-4wk to D/C if long-term use; drug effects may persist >24h after patch removal
renal dosing
- [see below]
- mild-moderate impairment: decr. usual start dose by 50%; severe impairment: avoid use
- HD/PD: not defined
hepatic dosing
- [see below]
- mild-moderate impairment: decr. usual start dose by 50%; severe impairment: avoid use