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Roxicodone
oxycodone
Black Box Warnings .
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 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: TAB: 15 mg, 30 mg
Special Note
- [prescribing info]
- Info: consider prescribing opioid overdose reversal agent (e.g., naloxone, nalmefene), especially if risk of opioid overdose or accidental ingestion
pain, mod-severe
- [opioid-naive pts]
- Dose: individualize dose PO q4-6h prn; Start: 5-15 mg PO q4-6h prn; Info: use lowest effective dose, shortest effective tx duration; consider low start dose, titrate slowly in pts 65 yo and older; taper total daily dose by no more than 10-25% q2-4wk to D/C if prolonged or long-term use
- [opioid-experienced pts]
- Dose: individualize dose PO q4-6h prn; Start: individualize based on current opioid intake, see pkg insert for conversion; Info: use lowest effective dose, shortest effective tx duration; consider low start dose, titrate slowly in pts 65 yo and older; taper total daily dose by no more than 10-25% q2-4wk to D/C if prolonged or long-term use
renal dosing
- [adjust dose amount]
- CrCl <60: decr. usual start dose, amount not defined; Info: titrate slowly
- HD/PD: not defined
hepatic dosing
- [see below]
- hepatic impairment: decr. usual start dose, amount not defined; Info: titrate slowly
Peds Dosing .
Peds dosing is currently unavailable or not applicable for this drug.