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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
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. 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 naloxone 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-naive or 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.