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Oxycodone 5 mg Controlled-release products are indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
Initial dosing
Oxycodone 5 mg Opioid-naïve patients: 30 mg PO q12hr initially; titrate gradually every 1-2 days, increasing by 25-50% increments, with q12hr dosing interval maintained
A single dose >40 mg ER or total dose >80 mg ER are for use only in opioid-tolerant patients
Xtampza ER Opioid-naïve patients: 9 mg PO q12hr with food
Dosage Modifications
Coadministration with other CNS depressants: Initiate long-acting Oxycodone 5 mg with one-third to one-half the recommended starting dose; monitor for signs of respiratory depression, sedation, and hypotension
Conversion from other opioids to Oxycodone 5 mg Provide immediate-release opioids for breakthrough pain
Monitor patient closely for adverse effects or breakthrough pain during conversion and for several days following
Conversion from other oral Oxycodone 5 mg formulations
Conversion from other oral Oxycodone 5 mg formulations: Administer one-half of the patient's total daily PO Oxycodone 5 mg dose as q12hr
Conversion from fentanyl transdermal: Wait 18 hr after patch removed, then initiate conservative dose of ~10 mg q12hr Oxycodone 5 mg controlled-release for each 25 mcg/hr fentanyl transdermal patch
Conversion from fentanyl transdermal
Wait 18 hr after patch removed, then initiate conservative dose of ~10 mg q12hr Oxycodone 5 mg controlled-release for each 25 mcg/hr fentanyl transdermal patch
Conversion from other opioids to Xtampza ER
Conversion from other oral Oxycodone 5 mg formulations
Administer one-half of the patient's total daily PO Oxycodone 5 mg dose as q12hr with food
Because Xtampza ER is not bioequivalent to other Oxycodone 5 mg extended-release products
Monitor patients for possible dosage adjustment
Conversion from other opioids
Discontinue all other around-the -clock opioid drugs
There are no established conversion ratios for conversion from other opioids to Xtampza ER defined by clinical trials
Initiate dosing using 9 mg PO q12hr with food and provide immediate-release rescue medication while stabilizing patient on Xtampza ER
Conversion from methadone
Close monitoring is of particular importance when converting from methadone to other opioid agonists; the ratio between methadone and other opioid agonists may vary widely as a function of previous dose exposure and methadone has a long half-life and can accumulate in the plasma
Conversion from fentanyl transdermal
18 hr following the removal of the transdermal fentanyl patch, initiate Xtampza ER; there has been no systematic assessment of such conversion, a conservative Oxycodone 5 mg dose, ~9 mg (equivalent to 30 mg Oxycodone 5 mg HCl) q12hr should be initially substituted for each 25 mcg/hr fentanyl transdermal patch
Renal impairment
CrCl <60 mL/min: Serum concentration may increase by 50%; adjust dosage to response Hepatic impairment Reduce dosage in liver disease; decrease dosage of extended release form to 1/3 or 1/2 of usual starting dosage; titrate to response Alternative analgesics are recommended for patients who require a dose of Xtampza ER <9 mg Dosing Considerations Access to naloxone for opioid overdose Assess need for naloxone upon initiating and renewing treatment Consider prescribing naloxone Based on patient’s risk factors for overdose (eg, concomitant use of CNS depressants, a history of opioid use disorder, prior opioid overdose); presence of risk factors should not prevent proper pain management Household members (including children) or other close contacts at risk for accidental ingestion or overdose Consult patients and caregivers on the following: Availability of naloxone for emergency treatment of opioid overdose Ways differ on how to obtain naloxone as permitted by individual state dispensing and prescribing requirements or guidelines (eg, by prescription, directly from a pharmacist, as part of a community-based program) Discontinuation Use a gradual downward titration of the dosage to avoid signs and symptoms of withdrawal in the physically-dependent patient Do not abruptly discontinue Xtampza ER Opioid-tolerant definition Use of higher starting doses in patients who are not opioid tolerant may cause fatal respiratory depression Patients who are opioid tolerant are those receiving, for 1 week or longer, at least 60 mg/day PO morphine, 25 mcg/hr transdermal fentanyl, 30 mg/day PO oxycodone, 8 mg/day PO hydromorphone, 25 mg/day PO oxymorphone, or an equianalgesic dose of another opioid Limitations of use Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve for patients whom alternative treatment options (eg, nonopioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain Long-acting opioids are not indicated as a PRN analgesic