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.
Addiction, abuse, and misuse. Risk evaluation and mitigation strategy (REMS). Life-threatening respiratory depression. Accidental ingestion. Neonatal opioid withdrawal syndrome. Cytochrome P450 3A4 interaction. Hepatotoxicity. Risks from concomitant use with benzodiazepines or other CNS depressants.
Abuse potential (monitor). 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. 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.
Opioid + analgesic.
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.
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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