Hydrocodone ER

Class
Narcotic analgesics
Subclass
Semisynthetic opioids
Substance name
HYDROcodone bitartrate, dihydrocodeinone ER
Brand names
Hysingla ER®
Common formulations
Tablet
Dosage and administration
Adults patients
Symptomatic relief of pain • Severe, requiring opioids
•
10-20 mg PO daily, in 1-2 divided doses
Titrate in 10-20 mg increments every 3-7 days to achieve adequate pain relief.
Other off-label uses
•
Treatment of restless legs syndrome
Indications for use
Labeled indications
Adults
•
Symptomatic relief of pain (severe, requiring opioids)
Off-label indications
Adults
•
Treatment of restless legs syndrome
Safety risks
Boxed warnings
Drug misuse, drug abuse, opioid use disorder
•
Use extreme caution in all patients, especially with a personal or family history of substance abuse or mental illness.
Increased serum hydrocodone levels, respiratory depression
•
Use extreme caution in patients taking CYP3A4 inhibitors (such as macrolide antibiotics, azole antifungals, or protease inhibitors) or discontinuing CYP3A4 inducers (such as rifampin, carbamazepine, or phenytoin).
Neonatal abstinence syndrome
•
Use extreme caution in pregnant patients.
Profound sedation, respiratory depression, coma
•
Use extreme caution in patients receiving benzodiazepines or other CNS depressants, including alcohol.
Respiratory depression
•
Use extreme caution in all patients, especially in elderly, malnourished, or frail patients or patients with significant pulmonary disease.
•
Use extreme caution for accidental ingestion, especially in children.
Contraindications
Hypersensitivity to hydrocodone or its components
Acute or severe asthma
•
Do not use hydrocodone in patients with acute or severe asthma in an unmonitored setting or in the absence of resuscitative equipment.
Gastrointestinal obstruction
•
Do not use hydrocodone in patients with known or suspected gastrointestinal obstruction, including paralytic ileus.
Significant respiratory depression
Warnings and precautions
Adrenal insufficiency
•
Use caution in patients taking the drug for a prolonged period (> 1 month).
Central sleep apnea
•
Use caution in patients taking higher doses.
Decreased serum hydrocodone level
•
Use caution in patients taking CYP3A4 inducers (such as rifampin, carbamazepine, or phenytoin) or discontinuing CYP3A4 inhibitors (such as macrolide antibiotics, azole antifungals, or protease inhibitors).
Erectile dysfunction, infertility
•
Use caution in patients taking the drug for a prolonged period.
Exacerbation of increased ICP
•
Use caution in patients with increased ICP, brain tumor, or head injury.
Growth suppression
•
Use caution with chronic corticosteroid therapy. Monitor growth regularly in pediatric patients receiving chronic corticosteroid therapy. Reassess the need for hydrocodone regularly and adjust the corticosteroid therapy as appropriate.
Hypotension, syncope
•
Use caution in patients with reduced blood volume or taking other CNS depressants. Monitor BP after initiation and dose titration. Avoid use in patients with circulatory shock.
Mask symptoms of head injury
•
Use caution in patients with head injury. Avoid use in patients with impaired consciousness or coma.
Opioid overdose
•
Use caution in patients taking CNS depressants or with a history of opioid use disorder or prior opioid overdose. Consider prescribing naloxone based on the patient's risk factors for overdose.
Opioid withdrawal syndrome
•
Use extreme caution in patients taking mixed agonist/antagonist analgesics (such as pentazocine, nalbuphine, or butorphanol) or partial agonist analgesics (such as buprenorphine).
•
Use caution in patients taking CYP3A4 inducers (such as rifampin, carbamazepine, or phenytoin) or discontinuing CYP3A4 inhibitors (such as macrolide antibiotics, azole antifungals, or protease inhibitors).
•
Do not discontinue abruptly in patients physically dependent on opioids.
Prolonged QT interval
•
Use caution in patients with congestive HF, bradyarrhythmia, electrolyte abnormalities, or taking drugs prolonging QT interval. Avoid use in patients with congenital long QT syndrome. Do not exceed 90 mg BID in patients developing QT prolongation.
Seizure
•
Use caution in patients with seizure disorder.
Serotonin syndrome
•
Use extreme caution in patients taking MAOIs or within 14 days of stopping treatment.
•
Use caution in patients taking serotonergic drugs.
Somnolence
•
Use extreme caution in patients performing activities requiring mental alertness, such as driving or operating machinery.
Sphincter of Oddi dysfunction
•
Use caution in patients with biliary tract disease and acute pancreatitis.
Specific populations
Renal impairment
eGFR ≥ 60 mL/min/1.73 m²
•
Use acceptable. No dose adjustment required.
eGFR < 60 mL/min/1.73 m²
•
Reduce dose by 50%. Monitor for respiratory depression, sedation and hypotension.
Renal replacement therapy
Any modality
•
No guidance available.
Hepatic impairment
Child-Pugh A (mild)
•
Use acceptable. No dose adjustment required.
Child-Pugh B (moderate)
•
Use acceptable. No dose adjustment required.
Child-Pugh C (severe)
•
Reduce dose. Titrate slowly. Patients with severe hepatic impairment may display higher plasma concentrations of hydrocodone.
Pregnancy and breastfeeding
Pregnancy
All trimesters
•
Use only if no alternatives are available. Evidence of fetal harm in animals. Monitor for neonatal opioid withdrawal syndrome. Do not use long-acting opioids during or immediately before labor when short-acting analgesics or other analgesic techniques are more appropriate.
Breastfeeding
Consider alternative agents that may be safer.
Unknown drug levels in breastfed infants.
May potentially cause adverse effects in breastfed infants.
No overt adverse effects on lactation reported.
Adverse reactions
Very common > 10%
•
Constipation, nausea
Common 1-10%
•
Bronchitis, ↓ serum potassium, dehydration, gastroenteritis, gastroesophageal reflux, hypercholesterolemia, hyperhidrosis, hypertension, influenza, lethargy, migraine, muscle strains, nasopharyngitis, peripheral edema, pharyngitis, abdominal pain, anxiety, arthralgia, chest pain, chills, confusion, cough, depression, diarrhea, dizziness, drowsiness, dry mouth, dyspepsia, dysphagia, dyspnea, falls, fatigue, fever, headache, indigestion, insomnia, irritability, limb pain, loss of appetite, low back pain, muscle cramps, muscle spasms, musculoskeletal pain, myalgia, nasal congestion, neck pain, night sweats, palpitations, paresthesia, pruritus, skin flushing, skin rash, throat pain, tinnitus, tremor, vomiting, sedation, sinusitis, urinary tract infections, upper respiratory tract infections
Uncommon < 1%
•
Drug hypersensitivity reaction, hypogonadism, hypotension, opioid withdrawal syndrome, orthostatic hypotension, pancreatitis, dysphagia, respiratory depression
Unknown frequency
•
Adrenal insufficiency, adrenocortical insufficiency, anaphylaxis, apnea, bowel obstruction, ↓ serum potassium, ↑ ICP, neonatal abstinence syndrome, ↑QTc interval, infertility, seizure, syncope, respiratory arrest, serotonin syndrome, serotonin syndrome
Interactions
Drug(s)
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