Classes
DEA Class; Rx
Common Brand Names; Zohydro ER, Hysingla ER, Vantrela ER
- Opioid Analgesics
Description
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
Indications
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
Contraindications
Hypersensitivity
Significant respiratory depression
Acute or severe bronchial asthma or hypercarbia
Suspected paralytic ileus
Adverse Effects
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%)
Warnings
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
Pregnancy and Lactation
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
Maximum Dosage
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.
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.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
How supplied
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