Indications for ARYMO ER:
Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment for which alternative therapies are inadequate.
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.
Use lowest effective dose for shortest duration. Swallow whole. Individualize. Opioid-naive or opioid non-tolerant: Initially 15mg every 8hrs or 12hrs. Dosage adjustments may be made every 1–2 days. Single dose >60mg or total daily dose >120mg: for use in opioid-tolerant patients only. Withdraw gradually (esp. if opioid-dependent), taper by ≤10–25% every 2–4 weeks. Converting from other morphine formulations, other opioids: see full labeling.
<18yrs: not established.
Significant respiratory depression. Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment. During or within 14 days of MAOIs. 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. 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). Sleep-related breathing disorders (including central sleep apnea (CSA), sleep-related hypoxemia); consider dose reduction if CSA develops. COPD, cor pulmonale, decreased respiratory reserve, hypoxia, hypercapnia, or pre-existing respiratory depression; monitor and consider non-opioid analgesics. Adrenal insufficiency. Head injury. Increased intracranial pressure, brain tumors; monitor. Seizure disorders. CNS depression. Impaired consciousness, coma, shock; avoid. Difficulty swallowing or risk for small GI lumen: consider alternative analgesic. Biliary tract disease. Acute pancreatitis. Drug abusers. Renal or hepatic impairment. Reevaluate periodically. Avoid abrupt cessation. Elderly. Cachectic. Debilitated. Pregnancy; potential neonatal opioid withdrawal syndrome during prolonged use. Labor & delivery, nursing mothers: not recommended.
See Contraindications. 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. Avoid concomitant mixed agonist/antagonist opioids (eg, butorphanol, nalbuphine, pentazocine) or partial agonist (eg, buprenorphine); may reduce effects and/or precipitate withdrawal symptoms. Risk of serotonin syndrome with serotonergic drugs (eg, SSRIs, SNRIs, TCAs, triptans, 5-HT3 antagonists, mirtazapine, trazodone, tramadol, cyclobenzaprine, metaxalone, MAOIs, linezolid, IV methylene blue); monitor and discontinue if suspected. Monitor for respiratory depression with muscle relaxants, cimetidine, or P-gp inhibitors (eg, quinidine). Paralytic ileus may occur with anticholinergics. May antagonize diuretics; monitor. May increase serum amylase.
Constipation, nausea, sedation, vomiting, sweating, dysphoria, euphoria; respiratory depression, orthostatic hypotension, syncope, hypersensitivity reactions.