Generic Name and Formulations:
Oxycodone HCl 10mg, 15mg, 20mg, 30mg, 40mg, 60mg, 80mg; ext-rel tabs.
Purdue Pharma L.P.
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. 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.
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). 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.
Initiation of CYP3A4 inhibitors (or discontinuation of CYP3A4 inducers) can result in fatal overdose. May be potentiated by CYP3A4 inhibitors (eg, macrolides, azole antifungals, protease inhibitors), CYP2D6 inhibitors (eg, quinidine, fluoxetine); monitor. May be antagonized by CYP3A4 inducers (eg, rifampin, carbamazepine, phenytoin); monitor. During or within 14 days of MAOIs: not recommended. Avoid mixed agonist/antagonist opioids (eg, butorphanol, nalbuphine, pentazocine) or partial agonist (eg, buprenorphine); may reduce effects and precipitate withdrawal symptoms. Increased CNS effects with concomitant alcohol, benzodiazepines, or other CNS depressants (eg, sedatives, hypnotics, anxiolytics, neuroleptics, tranquilizers, anesthetics, phenothiazines, other opioids); consider reducing dose for one or both drugs. May antagonize diuretics. Increased risk of urinary retention and/or severe constipation with anticholinergics; monitor. Potentiates muscle relaxants; monitor. Risk of serotonin syndrome with serotonergic drugs (eg, SSRIs, SNRIs, TCAs, triptans, 5HT3 receptor antagonists, mirtazapine, trazodone, tramadol, MAOIs, linezolid, IV methylene blue). May increase serum amylase.
Constipation, nausea, somnolence, dizziness, vomiting, pruritus, headache, dry mouth, asthenia, sweating; orthostatic hypotension, syncope, respiratory/CNS depression, seizures, adrenal insufficiency.
Hepatic (CYP3A4, CYP2D6).