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Nalbuphine

    DEA Class; Rx

    Common Brand Names; Nubain

    • Opioid Analgesics

    Parenteral opioid agonist/antagonist
    Used for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate, including preoperative, postoperative, and obstetrical analgesia, and as a supplement to balanced anesthesia
    May partially reverse or block opioid-induced respiratory depression from mu opioid agonist analgesics and may precipitate withdrawal in patients dependent on opioids

    Indicated for the treatment of severe pain requiring an opioid analgesic and for which alternative treatments are inadequate, including preoperative, postoperative, and obstetrical analgesia.

    For adjunctive use in general anesthesia induction and general anesthesia maintenance.

    Significant respiratory depression

    Diarrhea associated with toxins, gastrointestinal obstruction, including pseudomembranous colitis

    Acute or severe bronchial asthma, bradycardia, inflammatory bowel disease

    • Sedation (36%)
    • Clamminess (9%)
    • Nausea and vomiting (6%)
    • Dizziness (5%)
    • Xerostomia (4%)
    • Headache (3%)
    • Asthma
    • Bradycardia
    • Burning
    • Dyspnea
    • Hypertension
    • Hypotension
    • Itching
    • Miosis
    • Pulmonary edema
    • Respiratory depression
    • Tachycardia
    • Urticaria
    • Vertigo

    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

    In patients who may be susceptible to intracranial effects of CO2 retention (e.g., those with evidence of increased intracranial pressure or brain tumors), therapy may reduce respiratory drive, and resultant CO2 retention can further increase intracranial pressure; monitor such patients for signs of sedation and respiratory depression, particularly when initiating therapy; opioids may obscure clinical course in a patient with a head injury; avoid the use in patients with impaired consciousness or coma

    Contraindicated in patients with known or suspected gastrointestinal obstruction, including paralytic ileus; may cause spasm of sphincter of Oddi; opioids may cause increases in serum amylase; monitor patients with biliary tract disease, including acute pancreatitis, for worsening symptoms

    Therapy may increase frequency of seizures in patients with seizure disorders and in other clinical settings associated with seizures; monitor patients for worsened seizure control during therapy

    Prolonged use of opioid analgesics during pregnancy can cause neonatal opioid withdrawal syndrome; there are no available data in pregnant women to inform a drug associated risk for major birth defects and miscarriage

    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

    Adults

    20 mg/dose IV, IM, or subcutaneously and 160 mg/day IV, IM, or subcutaneously for opioid-naive patients.

    Geriatric

    20 mg/dose IV, IM, or subcutaneously and 160 mg/day IV, IM, or subcutaneously for opioid-naive patients.

    Adolescents

    Safety and efficacy have not been established.

    Children

    Safety and efficacy have not been established.

    Infants

    Safety and efficacy have not been established.

    Neonates

    Safety and efficacy have not been established.

    Nalbuphine Hydrochloride

    injectable solution

    • 10mg/mL
    • 20mg/mL