XARTEMIS XR CII
Generic Name and Formulations:
Oxycodone HCl, acetaminophen 7.5mg/325mg; bilayer ext-rel tabs.
Indications for XARTEMIS XR:
Acute pain severe enough to require opioid treatment and for which alternative treatment options are inadequate. Limitations of use: reserve for use in patients for whom alternative treatment options (eg, non-opioid analgesics) are ineffective, not tolerated, or would be otherwise inadequate.
Not interchangeable with other oxycodone/acetaminophen products. Use lowest effective dose for shortest duration. Swallow whole, one tab at a time. ≥18yrs: individualize. Opioid-naïve: 2 tabs every 12hrs; may give 2nd dose as early as 8hrs after initial dose if analgesia required at that time. Give subsequent doses of 2 tabs every 12hrs. Max acetaminophen dose: 4g/day. Hepatic or renal impairment: initially 1 tab and adjust dose as needed. Concomitant CNS depressants: initially 1 tab every 12hrs; consider using lower CNS depressant dose and monitor. Concomitant use or discontinuation of CYP3A4 inhibitors or inducers: monitor closely and consider dose adjustments (see full labeling). Withdraw gradually by 25–50% every 2–4 days.
<18yrs: not recommended.
Significant respiratory depression. Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment. Known or suspected GI obstruction, including paralytic ileus.
Life-threatening respiratory depression; monitor within first 24–72hrs of initiating therapy and following dose increases. Accidental exposure may cause fatal overdose (esp. in children). COPD, cor pulmonale, decreased respiratory reserve, hypoxia, hypercapnia, or pre-existing respiratory depression; monitor and consider non-opioid analgesics. Abuse potential (monitor). Increased risk of hepatotoxicity with underlying liver disease, concomitant alcohol, acetaminophen doses >4g/day or involving >1 acetaminophen-containing product. Adrenal insufficiency. Head injury. Increased intracranial pressure, brain tumors; monitor. Seizure disorders. CNS depression. Impaired consciousness, coma, shock; avoid. Difficulty swallowing, underlying GI disorders (eg, small GI lumen); consider alternatives. Biliary tract disease. Acute pancreatitis. Drug abusers. Renal or hepatic impairment; monitor. Reevaluate periodically. Avoid abrupt cessation. Elderly. Cachectic. Debilitated. Pregnancy; potential neonatal opioid withdrawal syndrome during prolonged use. Labor & delivery, nursing mothers: not recommended.
Avoid concomitant other acetaminophen-containing drugs. 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. During or within 14 days of MAOIs: not recommended. Risk of serotonin syndrome with serotonergic drugs (eg, SSRIs, SNRIs, TCAs, triptans, 5-HT3 antagonists, mirtazapine, trazodone, tramadol, MAOIs, linezolid, IV methylene blue); monitor and discontinue if suspected. Avoid concomitant mixed agonist/antagonist opioids (eg, butorphanol, nalbuphine, pentazocine) or partial agonist (eg, buprenorphine); may reduce effects and precipitate withdrawal symptoms. Potentiated by CYP3A4 inhibitors (eg, macrolides, azole antifungals, protease inhibitors). Antagonized by CYP3A4 inducers (eg, rifampin, carbamazepine, phenytoin). May antagonize diuretics; monitor. Paralytic ileus may occur with anticholinergics. May increase serum amylase.
Opioid + analgesic.
Nausea, dizziness, headache, vomiting, constipation, somnolence; respiratory depression, severe hypotension, syncope, hepatotoxicity; rare: serious skin reactions or anaphylaxis; discontinue if occurs.
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