Oxycodone

Selected IR tablets and solution treat pain severe enough to require an opioid analgesic when alternatives are inadequate. Reserve therapy when nonopioid alternatives are ineffective, not tolerated, or otherwise inadequate; overdose and addiction risks persist at any dose or duration. The selected solution is explicitly for adults.

OxyContin and Xtampza ER treat severe and persistent pain requiring an opioid that cannot be adequately treated with alternatives, including IR opioids. Neither is an as-needed analgesic. Xtampza ER has no established pediatric use; OxyContin has a narrowly defined indication from age 11 in patients already receiving and tolerating opioids.

The 20 mg/mL solution is only for opioid-tolerant adults already titrated to a stable lower-strength oxycodone regimen who benefit from a smaller volume. High OxyContin and Xtampza doses also require established opioid tolerance; tolerance does not eliminate overdose risk.

Adult tolerance in these selected ER/liquid labels means at least 1 week of ≥60 mg/day oral morphine, ≥25 mcg/hour transdermal fentanyl, ≥30 mg/day oral oxycodone HCl, ≥8 mg/day oral hydromorphone, ≥25 mg/day oral oxymorphone, ≥60 mg/day oral hydrocodone, or an equianalgesic opioid dose. OxyContin 60/80 mg tablets, single doses >40 mg, or totals >80 mg/day require tolerance. Xtampza single doses >36 mg base or totals >72 mg base/day require tolerance; its maximum is 288 mg base/day (320 mg HCl equivalent) because higher excipient exposure is unestablished.

The OxyContin label converts other oral oxycodone formulations to half the total daily oxycodone dose every 12 hours, with close observation. Xtampza similarly divides the daily oxycodone amount every 12 hours, but uses base strengths: 9/13.5/18/27/36 mg base correspond to 10/15/20/30/40 mg HCl. Xtampza is not bioequivalent to other ER products. These are clinician-directed conversions; no universal ratio for other opioids is established by clinical trials. Methadone or fentanyl conversions need the exact label and specialist assessment.

Only age 11 or older, already receiving and tolerating opioids for at least 5 consecutive days, including at least 20 mg/day oral oxycodone or equivalent in the immediately preceding 2 days. Calculate the dose using the label’s pediatric conversion table, divide every 12 hours, and round down to an available tablet strength. Do not initiate if the calculated total is below 20 mg/day. The table is one-way into OxyContin, not an equianalgesic table for reverse conversion; other selected products do not establish pediatric dosing.

IR solution: prescribe both mg and mL; use its supplied cup for 1 mg/mL and supplied oral syringe for 20 mg/mL, never household spoons. Swallow OxyContin whole, one tablet at a time with sufficient water; do not presoak, lick, wet, cut, break, crush, chew, or dissolve. It may be taken with or without food. Take Xtampza every 12 hours with approximately the same amount of food; contents may be sprinkled on the label’s soft-food vehicles and swallowed immediately. Both ER labels allow adjustment every 1–2 days after clinical reassessment; never self-escalate.

The selected label permits NG or gastrostomy administration: flush the tube with water, open the capsule and pour microspheres directly into the tube without premixing in flushing liquid, flush with 15 mL water, then twice with 10 mL water. Milk or liquid nutritional supplement may be used instead as the label describes. Maintain the food requirement and follow the complete administration instructions; these directions do not apply to OxyContin.

IR tablets/solution: initiate lower than usual in renal or hepatic impairment and titrate carefully. ER renal impairment also requires conservative initiation. OxyContin hepatic impairment or debilitated non-tolerant geriatric patients: start at one-third to one-half the recommended starting dose; do not split ER tablets to achieve it. Xtampza hepatic impairment: one-third to one-half usual starting dose, with an alternative analgesic if <9 mg is needed. Do not abruptly stop established therapy; use an individualized gradual taper with pain and mental-health support.

Significant respiratory depression; acute or severe bronchial asthma in an unmonitored setting or without resuscitation resources; known or suspected GI obstruction including paralytic ileus; and product/oxycodone hypersensitivity. Roxicodone’s contraindication wording also specifies hypercarbia. Consult the selected product before prescribing.

Selected labels carry boxed warnings for addiction, abuse and misuse; life-threatening respiratory depression; accidental ingestion; neonatal opioid withdrawal; CYP3A4 interactions; CNS depressant combinations; and opioid REMS measures. The solution also emphasizes fatal medication errors from concentration or mg/mL confusion. ER instructions protect against dangerous administration errors and uncontrolled delivery.

Common reactions include constipation, nausea, vomiting, somnolence, dizziness, itching, headache and sweating. Serious reactions include respiratory/circulatory depression, severe hypotension, adrenal insufficiency, anaphylaxis, and serotonin syndrome with interacting agents. Pediatric OxyContin trials commonly reported vomiting, nausea, headache, fever and constipation; trial rates should not be compared across formulations.

CYP3A4 inhibitors such as macrolides, azoles or ritonavir may increase oxycodone and require dose reduction; stopping an inhibitor may reduce effect or trigger withdrawal. Inducers such as rifampin, carbamazepine or phenytoin reduce exposure; stopping an inducer can cause respiratory toxicity. Combined CYP3A4/CYP2D6 inhibition may amplify effects. Monitor closely and let the prescriber adjust doses.

Benzodiazepines, alcohol, gabapentinoids, sedatives, muscle relaxants and other opioids can cause profound sedation, coma and death. Reserve necessary combinations for patients without adequate alternatives; minimize doses/duration, monitor respiration, and discuss a reversal agent.

Serotonergic medicines including SSRIs, SNRIs, TCAs, triptans, trazodone and tramadol can contribute to serotonin syndrome. MAOI use or use within 14 days is not recommended; this is an interaction precaution in the selected labels, not a universal §4 contraindication. Suspected serotonin toxicity requires urgent assessment and discontinuation of the implicated opioid under clinical care.

Mixed agonist/antagonist or partial agonist opioids may reduce analgesia or precipitate withdrawal; coordinate any change with pain/addiction clinicians. Anticholinergics raise retention and ileus risk. Muscle relaxants increase respiratory depression, and opioids may reduce diuretic efficacy; assess clinical response and blood pressure.

Available human pregnancy data are insufficient to define risk. Prolonged opioid exposure can cause neonatal withdrawal; placental transfer can cause neonatal respiratory depression, especially around delivery. ER use during/immediately before labor is not recommended when alternatives are appropriate. Oxycodone enters milk. OxyContin/Xtampza labels advise against breastfeeding; current IR tablet/solution labels instead call for maternal benefit–risk assessment and infant monitoring, with limited postpartum data suggesting low exposure at studied IR doses. Monitor exposed infants for unusual sleepiness, poor feeding or breathing difficulty; seek urgent care for toxicity. Chronic opioid exposure may reduce fertility, with uncertain reversibility.

Only selected OxyContin establishes the restricted opioid-tolerant pediatric regimen from age 11. Roxicodone, selected solution, and Xtampza have no established pediatric dosing. Older, cachectic or debilitated patients require cautious initiation and frequent respiratory/sedation assessment; apply the specific OxyContin reduced-starting-dose rule when relevant.

Follow the reduced/conservative initiation directions above rather than a universal renal dose table. Selected ER studies found increased oxycodone exposure with CrCl <60 mL/min. Hepatic impairment reduces clearance; monitor respiratory depression, sedation and hypotension, and choose an alternative formulation when an intact available ER strength cannot deliver a safely reduced dose.

Oxycodone acts principally through μ-opioid receptors to produce analgesia. The parent drug accounts for most activity. Full-agonist analgesia has no pharmacologic ceiling, but toxicity limits clinical dosing and does not permit unrestricted escalation.

CYP3A-mediated metabolism to noroxycodone is predominant; CYP2D6 also forms oxymorphone. Oxycodone and metabolites are eliminated mainly through the kidneys. Roxicodone’s apparent elimination half-life is approximately 3.5–4 hours; organ dysfunction can increase exposure.

OxyContin and Xtampza deliver oxycodone over about 12 hours, but are not bioequivalent to each other. Food does not significantly change OxyContin’s extent of absorption. Xtampza’s absorption depends substantially on food, explaining the mandatory consistent-food administration. The salt/base difference changes the printed milligram strength without establishing automatic product interchangeability.

Assess pain/function, sedation, respiratory rate, mental health, misuse risk, constipation, blood pressure, interactions, and organ function at initiation, conversion, titration and renewal. Investigate paradoxical worsening pain, swallowing symptoms, or adrenal insufficiency. If urine testing is used, confirm the assay detects oxycodone; a generic opiate screen can miss it.

Take only the prescribed release type and concentration, never share doses, and avoid alcohol or unapproved sedatives. Store securely away from children and visitors. Discuss naloxone/nalmefene access and train caregivers using the actual reversal product’s directions. Follow product-specific take-back/disposal advice; do not drive until effects are known or abruptly stop established treatment.

Call emergency services for slow or absent breathing, inability to awaken, or suspected excess dosing. Give the available opioid reversal agent according to its directions while obtaining help; repeated doses and airway support may be needed. ER products can continue adding drug for 24–48 hours or longer after overdose, requiring prolonged professional observation.

Selected product

Roxicodone IR15 mg · SpecGx LLC

Appearance

Green, scored tablet

Imprint

54 710

Example NDC

23635-581-10 · bottle of 100

Selected Roxicodone supply:15 and 30 mg IR tablets. Selected solution:1 mg/mL and 20 mg/mL. OxyContin ER tablets:10,15,20,30,40,60,80 mg HCl. Xtampza ER capsules:9,13.5,18,27,36 mg oxycodone base. Combination products and other delivery systems require separate review.

Selected products:25°C, excursions 15–30°C. Roxicodone and OxyContin use tight, light-resistant containers; protect Roxicodone from moisture. Solution:protect from moisture and light. Xtampza:tight, light-resistant container with child-resistant closure. Store all securely and follow the specific Medication Guide’s disposal instructions.