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Xtampza ER
oxycodone
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
Accidental Ingestion
accidental ingestion of even one dose, esp. by children, can result in fatal oxycodone 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
advise pregnant pts w/ extended opioid use of risk of potentially life-threatening neonatal opioid withdrawal syndrome; ensure tx by neonatology experts avail. at delivery
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. oxycodone 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: ER CAP: 9 mg, 13.5 mg, 18 mg, 27 mg, 36 mg
Dosage Form Details
- [formulation clarification]
- Info: abuse-deterrent formulation to reduce potential abuse or misuse
Special Note
- [prescribing info]
- Info: consider prescribing opioid overdose reversal agent (e.g., naloxone, nalmefene), especially if risk of opioid overdose or accidental ingestion
- [equivalency or interchangeability info]
- Info: not interchangeable w/ other oxycodone ER products, do not substitute on a mg to mg basis
pain, severe chronic
- [opioid-nontolerant pts]
- Dose: individualize dose PO q12h; Start: 9 mg PO q12h, may incr. total daily dose by 25-50% q1-2 days; Info: use lowest effective dose, shortest effective tx duration; titrate slowly in pts 65 yo and older; >36 mg/dose, >72 mg/day for use in opioid-tolerant pts only; give w/ food; may open cap, but do not crush/chew/dissolve contents; taper total daily dose by no more than 10-25% q2-4wk to D/C if long-term use
- [opioid-tolerant pts]
- Dose: individualize dose PO q12h; Start: individualize start dose based on current opioid intake, see pkg insert for conversion; may incr. total daily dose by 25-50% q1-2 days; Max: 288 mg/day; Info: use lowest effective dose, shortest effective tx duration; consider low start dose, titrate slowly in pts 65 yo and older; give w/ food; may open cap, but do not crush/chew/dissolve contents; taper total daily dose by no more than 10-25% q2-4wk to D/C if long-term use
renal dosing
- [see below]
- CrCl <60: not defined, titrate slowly; Info: use alternative for doses <9 mg, dose adjustment not possible w/ ER cap
- HD/PD: not defined; Info: use alternative for doses <9 mg, dose adjustment not possible w/ ER cap
hepatic dosing
- [see below]
- hepatic impairment: decr. usual start dose by 50-66%, titrate slowly; Info: use alternative for doses <9 mg, dose adjustment not possible w/ ER cap
Peds Dosing .
Peds dosing is currently unavailable or not applicable for this drug.