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Hydrocodone

    DEA Class; Rx

    Common Brand Names; Zohydro ER, Hysingla ER, Vantrela ER

    • Opioid Analgesics

    Extended-release, oral semisynthetic opioid agonist similar to other phenanthrene derivatives such as codeine
    Used for severe pain requiring daily, around-the-clock, long-term opioid treatment for which alternative treatment options are inadequate
    Abuse deterrent properties

    Indicated for the management of pain severe enough to require daily, around-the-clock, long-term treatment and for which alternative treatment options are inadequate

    For the treatment of refractory restless legs syndrome (RLS).

    Hypersensitivity

    Significant respiratory depression

    Acute or severe bronchial asthma or hypercarbia

    Suspected paralytic ileus

    Zohydro ER

    • Constipation (8-11%)
    • Nausea (7-10%)
    • Vomiting (3-5%)
    • Somnolence (1-5%)
    • UTI (1-5%)
    • Headache (4%)
    • Fatigue (1-4%)
    • Back pain (1-4%)
    • Dry mouth (3%)
    • Pruritus (3%)
    • Tremor (3%)
    • Dizziness (2-3%)
    • Peripheral edema (1-3%)
    • URI infection (1-3%)
    • Muscle spasms (1-3%)

    Hysingla ER

    • Nausea (8%)
    • Constipation (3%)
    • Vomiting (6%)
    • Dizziness (3%)
    • Insomnia (3%)
    • Influenza (3%)
    • Decreased appetite (2%)
    • Headache (2%)
    • Tinnitus (2%)
    • Somnolence (1%)
    • Fatigue (1%)

    Do not prescribe for acute pain or as needed (prn) pain relief; only for severe chronic pain requiring continuous, around-the-clock opioid analgesia

    Hydrocodone is an opioid agonist and a Schedule II controlled substance with a high potential for abuse similar to fentanyl, methadone, morphine, oxycodone, and oxymorphone

    Profound sedation, respiratory depression, coma, and death may result from concomitant administration with benzodiazepines or other CNS depressants (e.g., non-benzodiazepine sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, other opioids, alcohol); because of these risks, reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate; if concomitant use with benzodiazepine is warranted, consider prescribing naloxone for the emergency treatment of opioid overdose

    If an opioid analgesic is initiated in a patient already taking a benzodiazepine or other CNS depressant, prescribe a lower initial dose of the opioid analgesic, and titrate based on clinical response; follow patients closely for signs and symptoms of respiratory depression and sedation

    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

    Monitor carefully in elderly, cachectic, debilitated patients, and those with chronic pulmonary disease because of increased risk for life-threatening respiratory depression

    Monitor patients with head injury or increased ICP for sedation and respiratory depression; avoid use in patients with impaired consciousness or coma susceptible to intracranial effects of CO2 retention

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

    Drug is present in breast milk; published lactation studies report variable concentrations of drug in breast milk with administration of immediate-release formulation to nursing mothers in early postpartum period

    Adults

    Zohydro ER and Hysingla ER: There is no maximum dose of hydrocodone; however, careful titration of hydrocodone, especially in opioid-naive patients, is required until tolerance develops to some of the side effects (i.e., drowsiness and respiratory depression). Individualize dosage carefully.
    Vantrela ER: Do not exceed a dose of 180 mg/day PO because of a potential risk of QT prolongation.

    Geriatric

    Zohydro ER and Hysingla ER: There is no maximum dose of hydrocodone; however, careful titration of hydrocodone, especially in opioid-naive patients, is required until tolerance develops to some of the side effects (i.e., drowsiness and respiratory depression). Individualize dosage carefully.
    Vantrela ER: Do not exceed a dose of 180 mg/day PO because of a potential risk of QT prolongation.

    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.

    Hydrocodone bitartrate

    capsule, extended-release (Zohydro ER): Schedule II

    • Abuse-deterrent product (BeadTek technology)
    • 10mg
    • 15mg
    • 20mg
    • 30mg
    • 40mg
    • 50mg

    tablet, extended-release (Hysingla ER): Schedule II

    • Abuse-deterrent product (RESISTEC)
    • 20mg
    • 30mg
    • 40mg
    • 60mg
    • 80mg
    • 100mg
    • 120mg