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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 associated risks; reserve ER forms for patients with inadequate tx alternatives; not indicated for prn analgesic use; proper dosing and titration essential to decr. respiratory depression risk
Addiction, Abuse, and Misuse
opioid agonist Schedule II controlled substance with 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 patients for misuse, abuse, and addiction
Respiratory Depression
serious, life-threatening, or fatal cases may occur even with recommended use, especially during tx start or after dose incr; to decr. risk, initiate and titrate dose appropriately
Accidental Ingestion
accidental ingestion of even one dose, especially by children, can result in fatal oxycodone overdose
Risks from Concomitant Use with Benzodiazepines, CNS Depressants
concomitant opioid use with benzodiazepines or other CNS depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death; reserve concomitant use for patients with inadequate alternative tx options
Neonatal Opioid Withdrawal Syndrome
advise pregnant patients with extended opioid use of risk of potentially life-threatening neonatal opioid withdrawal syndrome; ensure tx by neonatology experts available at delivery
Opioid Analgesic REMS
providers are strongly encouraged to complete risk evaluation and mitigation strategy (REMS)-compliant education program, counsel patients and/or caregivers with each Rx on serious risks, safe use, and importance of reading medication guide
CYP450 3A4 Interaction
concomitant use with CYP450 3A4 inhibitors or D/C of concomitant CYP450 3A4 inducers may incr. oxycodone concentration which may incr. or prolong adverse effects including potentially fatal respiratory depression; monitor patients 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 bioequivalent to other oxycodone ER products, reassess dose if switching between products
pain, severe chronic
- [opioid-nontolerant patients]
- Dose: individualize dose PO/NG/GT q12h; Start: 9 mg PO/NG/GT q12h, may incr. total daily dose by 25-50% q1-2 days; Info: use lowest effective dose, shortest effective tx duration; titrate slowly in patients 65 yo and older; >36 mg/dose, >72 mg/day for use in opioid-tolerant patients only; give with food; may open cap, but do not crush/chew/dissolve contents; taper dose gradually to avoid withdrawal symptoms if D/C tx in physically opioid-dependent patients; search 'opioid taper' for epocrates Opioid Tapering decision tool
- [opioid-tolerant patients]
- Dose: individualize dose PO/NG/GT q12h; Start: individualize 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 patients 65 yo and older; give with food; may open cap, but do not crush/chew/dissolve contents; taper dose gradually to avoid withdrawal symptoms if D/C tx in physically opioid-dependent patients; search 'opioid taper' for epocrates Opioid Tapering decision tool
renal dosing
- [see below]
- CrCl <60: not defined, caution advised; Info: titrate slowly; use alternative for doses <9 mg, dose adjustment not possible with ER cap
- HD/PD: not defined; Info: use alternative for doses <9 mg, dose adjustment not possible with 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 with ER cap
Peds Dosing .
Peds dosing is currently unavailable or not applicable for this drug.