Seglentis

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; proper dosing and titration essential to decr. resp. depression risk

Addiction, Abuse, and Misuse

opioid agonist Schedule IV 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

Accidental Ingestion

accidental ingestion of even one dose, esp. by children, can result in fatal tramadol 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

Cardiovascular Thrombotic Event

NSAIDs incr. risk of serious and potentially fatal cardiovascular thrombotic events, incl. MI and stroke; risk may occur early in tx and may incr. w/ duration of use; contraindicated in CABG periop setting

GI Bleeding, Ulceration, and Perforation

NSAIDs incr. risk of serious and potentially fatal GI adverse events incl. bleeding, ulcer, and stomach or intestine perforation; GI events may occur at any time during use and w/o warning sx; elderly pts and pts w/ hx of PUD or GI bleeding at greater risk for serious GI events

Ultra-Rapid Metabolism of Tramadol and Other Respiratory Depression Risk in Children

resp. depression and death have occurred in children; some cases involved tramadol use post-tonsillectomy and/or adenoidectomy and at least one case had evidence of being a CYP2D6 ultra-rapid metabolizer; contraindicated in pts <12 yo and in pts <18 yo post-tonsillectomy and/or adenoidectomy; avoid use in pts 12-18 yo w/ risk factors that incr. sensitivity to resp. depressant effects of tramadol

CYP450 Interactions

effects of concomitant use or D/C of concomitant CYP450 3A4 inducers, 3A4 inhibitors, or 2D6 inhibitors are complex requiring careful consideration of the effects on tramadol and its active metabolite