Generic Name and Formulations:
Morphine sulfate, naltrexone HCl; 20mg/0.8mg, 30mg/1.2mg, 50mg/2mg, 60mg/2.4mg, 80mg/3.2mg, 100mg/4mg; ext-rel caps.
Indications for EMBEDA:
Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options 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 or open capsule and sprinkle pellets onto applesauce; do not chew pellets. Do not give via NG or gastric tubes. ≥18yrs: individualize; give on 24 hour or 12 hour schedule. Opioid-naive or opioid non-tolerant: initially 20mg/0.8mg every 24 hours. May adjust at intervals of 1–2 days. Use 100mg/4mg caps, a single dose >60mg/2.4mg, or a total daily dose >120mg/5mg in opioid-tolerant patients only. Renal failure, cirrhosis: initiate at lower dose. Conversion from other morphine formulations or other opioids: see full labeling. Concomitant CNS depressants: initiate at ⅓–½ of usual starting dose and monitor. Withdraw gradually by 25–50% every 2–4 days.
<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. Interaction with alcohol. 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. Adrenal insufficiency. Head injury. Increased intracranial pressure, brain tumors; monitor. Seizure disorders. CNS depression. Impaired consciousness, coma, shock; avoid. Biliary tract disease. Acute pancreatitis. Drug and alcohol 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.
Opioid agonist + opioid antagonist.
See Contraindications. Avoid alcohol or alcohol-containing products. 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. 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. May antagonize diuretics; monitor. Paralytic ileus may occur with anticholinergics. May be potentiated by cimetidine, P-gp inhibitors; monitor. May increase serum amylase.
Constipation, nausea, somnolence; respiratory depression, severe hypotension, syncope.
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