Morphine/Naltrexone

DEA Class; Rx

Common Brand Names; Embeda

Oral combination opioid agonist and opioid antagonist
Used for severe pain requiring daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate
Abuse-deterrent with sequestered naltrexone intended to have no clinical effect

Known hypersensitivity to morphine, morphine slats, naltrexone, or in any situation where opioids are contraindicated

Respiratory depression

Acute or severe asthma or hypercarbia

Gastrointestinal obstruction, including paralytic ileus

• Somnolence
• Constipation
• Nausea
• Edema peripheral
• Anxiety
• Chills
• Depression
• Dizziness
• Fatigue
• Headache
• Insomnia
• Irritability
• Lethargy
• Restlessness
• Sedation
• Tremor
• Hyperhidrosis
• Pruritus
• Hot flush
• Abdominal pain
• Anorexia
• Dry mouth
• Diarrhea
• Dyspepsia
• Decreased appetite
• Flatulence
• Stomach discomfort
• Vomiting
• Arthralgia
• Muscle spasms
• Cardiac arrest
• Hypotension
• Shock
• Anaphylaxis
• Apnea
• Respiratory arrest
• Respiratory depression
• Opioid withdrawal

Abuse-deterrent properties: Releases only the morphine in the capsule when swallowed whole; when crushed, the naltrexone blocks some of the euphoric effects of the morphine and can precipitate withdrawal in persons dependent on opioids

Pharmacologic effects vary widely; in addition to its therapeutic analgesic effect, may cause adverse effects including dysphoria, euphoria, somnolence, respiratory depression, diminished gastrointestinal motility, altered circulatory dynamics, histamine release, physical dependence, & alterations of the endocrine and autonomic nervous systems

Opioids can cause sleep-related breathing disorders including central sleep apnea (CSA) and sleep-related hypoxemia; opioid use increases risk of CSA in a dose-dependent fashion; in patients who present with CSA, consider decreasing opioid dosage using best practices for opioid taper

Cases of serotonin syndrome, a potentially life-threatening condition, reported with concomitant use of serotonergic drugs; this may occur within the recommended dosage range; the onset of symptoms generally occur within several hours to a few days of concomitant use, but may occur later than that; discontinue therapy immediately if serotonin syndrome is suspected

Therapy may cause severe hypotension including orthostatic hypotension and syncope in ambulatory patients; there is increased risk in patients whose ability to maintain blood pressure has already been compromised by a reduced blood volume or concurrent administration of certain CNS depressant drugs (e.g., phenothiazines or general anesthetics); monitor patients for signs of hypotension after initiating or titrating dosage; in patients with circulatory shock, therapy may cause vasodilation that can further reduce cardiac output and blood pressure; avoid therapy in patients with circulatory shock

Prolonged use of opioid analgesics during pregnancy can cause neonatal opioid withdrawal syndrome

Morphine is present in breast milk; published lactation studies report variable concentrations of morphine in breast milk with administration of immediate-release morphine to nursing mothers in the early postpartum period with a milk-to-plasma morphine AUC ratio of 2.5:1 measured in one lactation study