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Dsuvia
sufentanil
Black Box Warnings .
Appropriate Use
restricted distribution program, Dsuvia REMS, to minimize risk of life-threatening resp. depression from accidental exposure; dispense only in certified medically supervised healthcare setting and D/C prior to discharge or transfer; should only be administered by healthcare professionals knowledgeable about opioid use and how to mitigate assoc. risks; reserve opioid analgesics for pts w/ inadequate tx alternatives
Accidental Exposure
accidental ingestion or exposure to even one dose, esp. in children, can result in resp. depression or fatal sufentanil overdose
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, monitor for resp. depression, esp. during tx initiation
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
CYP450 3A4 Interaction
concomitant use w/ CYP450 3A4 inhibitors or D/C of concomitant CYP450 3A4 inducers may incr. sufentanil conc. which may incr. or prolong adverse effects incl. potentially fatal resp. depression; monitor pts receiving any concomitant CYP450 3A4 inhibitor or inducer
Adult Dosing .
Dosage forms: SL TAB: 30 mcg
Restricted Distribution in US
- [1-855-925-8476 or www.DSUVIAREMS.com for more info]
pain, severe acute
- [30 mcg SL q1h prn]
- Max: 30 mcg/dose up to 360 mcg/24h; 72h; Info: use lowest effective dose, shortest effective tx duration; do not chew/swallow tab
renal dosing
- [see below]
- mild-moderate impairment: no adjustment; severe impairment: not defined, caution advised
- HD/PD: not defined
hepatic dosing
- [see below]
- hepatic impairment: not defined, caution advised
Peds Dosing .
Peds dosing is currently unavailable or not applicable for this drug.