Indications for OXYCONTIN:
Management of pain severe enough to require daily, around-the-clock, long-term analgesia for which alternative opioid therapies are inadequate in adults and opioid-tolerant (already on ≥20mg/day oral oxycodone or its equivalent) children.
Limitations of Use:
Not for use as an as-needed (prn) analgesic. Use only if alternative treatment options (eg, non-opioid analgesics, immediate-release opioids) are ineffective, not tolerated, or otherwise inadequate to provide sufficient management of pain.
Swallow whole. Individualize. Usually given on a 12hr schedule. ≥18yrs: Opioid-naive, opioid non-tolerant: initially 10mg every 12hrs. May increase total daily dose by 25–50%; adjust at 1–2 day intervals. Conversion from other opioids or combinations: see full labeling. Elderly (debilitated and opioid non-tolerant), hepatic dysfunction or concomitant CNS depressants: initiate at ⅓ to ½ the usual starting dose and titrate slowly. 60mg and 80mg tabs, a single dose >40mg, or a total daily dose >80mg: for use in opioid-tolerant patients only. Withdraw gradually (esp. if opioid-dependent), taper by ≤10–25% every 2–4 weeks. See full labeling.
Swallow whole. Usually given on a 12hr schedule. ≥11yrs: Opioid-tolerant: daily dose of Oxycontin (mg) = mg/day of prior opioid x conversion factor (see full labeling). Do not initiate if total daily dose <20mg. May increase total daily dose by 25%. See full labeling.
Significant respiratory depression. Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment. Known or suspected paralytic ileus or GI obstruction.
Addiction, abuse, and misuse. Risk evaluation and mitigation strategy (REMS). Life-threatening respiratory depression. Accidental ingestion. Neonatal opioid withdrawal syndrome. Cytochrome P450 3A4 interaction. Risks from concomitant use with benzodiazepines or other CNS depressants.
Assess the potential need for access to naloxone when initiating and renewing therapy. Consider prescribing naloxone based on risk factors for overdose (eg, history of opioid use disorder, prior opioid overdose, household members or other close contacts at risk for accidental ingestion or overdose). Abuse potential (monitor). Increased risk of fatal respiratory depression (esp. when initiating therapy and during dose increases); monitor. Accidental exposure may result in fatal overdose (esp. children). Sleep-related breathing disorders (including central sleep apnea (CSA), sleep-related hypoxemia); consider dose reduction if CSA develops. Risk of neonatal opioid withdrawal syndrome. Pulmonary disease (eg, COPD, cor pulmonale); monitor for respiratory depression (esp. within the first 24–72hrs of initiating therapy and after dose increases); consider alternative non-opioid analgesics. Head injury. Impaired consciousness, coma, shock; avoid. Increased intracranial pressure, brain tumors; monitor. Convulsive disorders. Difficulty swallowing. Underlying GI disorders (eg, esophageal or colon cancer with a small GI lumen). Biliary tract disease. Acute pancreatitis. Acute alcoholism. Drug abusers. Avoid abrupt cessation. Reevaluate periodically. Impaired renal or hepatic function. Elderly. Cachectic. Debilitated. Pregnancy. Labor & delivery, nursing mothers: not recommended.
Increased risk of hypotension, respiratory depression, sedation with benzodiazepines or other CNS depressants (eg, non-benzodiazepine sedatives/hypnotics, anxiolytics, general anesthetics, phenothiazines, tranquilizers, muscle relaxants, antipsychotics, alcohol, other opioids); reserve concomitant use in those for whom alternative options are inadequate; limit dosages/durations to minimum required; monitor closely; consider prescribing naloxone if concomitant use is warranted. During or within 14 days of MAOIs: not recommended. Risk of serotonin syndrome with serotonergic drugs (eg, SSRIs, SNRIs, TCAs, triptans, 5HT3 receptor antagonists, mirtazapine, trazodone, tramadol, cyclobenzaprine, metaxalone, MAOIs, linezolid, IV methylene blue); monitor and discontinue if suspected. Avoid mixed agonist/antagonist opioids (eg, butorphanol, nalbuphine, pentazocine) or partial agonist (eg, buprenorphine); may reduce effects and/or precipitate withdrawal symptoms. May be potentiated by CYP3A4 inhibitors (eg, macrolides, azole antifungals, protease inhibitors). May be antagonized by CYP3A4 inducers (eg, rifampin, carbamazepine, phenytoin). May antagonize diuretics. Paralytic ileus may occur with anticholinergics. May increase serum amylase.
Constipation, nausea, somnolence, dizziness, vomiting, pruritus, headache, dry mouth, asthenia, sweating; orthostatic hypotension, syncope, respiratory/CNS depression, seizures, adrenal insufficiency.
Generic Drug Availability: