What it isExtended-release full mu-opioid agonist; around-the-clock chronic pain when alternatives are inadequate.
Why this oneIt is an abuse-deterrent once-daily tablet; manipulation resistance cannot prevent oral misuse or addiction.
What limits itRespiratory depression, dependence, and fatal overdose remain possible; benzodiazepines and other depressants magnify risk.
FDA-approved for
- chronic pain (around-the-clock) (2014)
FDA label
Read the full label on DailyMed ↗
BOXED WARNING Addiction, abuse, and misuse; life-threatening respiratory depression; accidental ingestion (fatal in children); neonatal opioid withdrawal syndrome; risks from concomitant benzodiazepines/CNS depressants; CYP3A4 interactions; opioid REMS
| FDA dosing | Population | Start | Target | Max |
| Severe and persistent pain requiring an opioid analgesic (not for as-needed use) | Adults (opioid-naive) | 20 mg QD | Individualized | ≥80 mg only for opioid-tolerant patients |
Titration May titrate every 3 to 5 days (increments of 10-20 mg)
Renal No adjustment for mild; moderate/severe impairment and ESRD: initiate at one-half the starting dose and titrate carefully
Hepatic No adjustment for mild/moderate; severe impairment: initiate at one-half the starting dose
Opioid-tolerant defined as ≥60 mg oral hydrocodone/day (or equivalent) for ≥1 week
Instructions
- Administer orally once daily (every 24 hours)
- Swallow tablets whole one at a time with enough water; do not crush, chew, dissolve, pre-soak, lick, or wet
- Do not abruptly discontinue in physically dependent patients; taper gradually
- Discuss opioid overdose reversal agent access
Contraindications
- Significant respiratory depression
- Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment
- Known or suspected gastrointestinal obstruction, including paralytic ileus
Cautions
- Opioid-induced hyperalgesia and allodynia
- Life-threatening respiratory depression in COPD/elderly/cachectic/debilitated patients
- Adrenal insufficiency
- Severe hypotension (avoid in circulatory shock)
- QTc prolongation (avoid in congenital long QT)
- Increased intracranial pressure/head injury
- GI obstruction risk in dysphagia/GI disorders
- Seizures
- Withdrawal on abrupt discontinuation
Adverse reactions
- Constipation
- Nausea
- Vomiting
- Fatigue
- Upper respiratory tract infection
- Dizziness
- Headache
- Somnolence
Pregnancy May cause neonatal opioid withdrawal syndrome with prolonged use; insufficient data on birth-defect risk
Lactation Hydrocodone present in human milk; breastfeeding not recommended during treatment
⚠ BOXED WARNINGS
- Addiction, abuse and misuse
- Life-threatening respiratory depression
- Risk from concomitant use with benzodiazepines
Classes and tags
Clinical profile
Direct muscarinic antagonism0 / 4
Mechanism of action: Hydrocodone ER (q24h) ballicule
Open Hydrocodone ER (q24h) in the interactive console ↗
Memory aids: mascots and interaction avatars
“Viking Hydrant code”
Viking for Vicodin (combo with acetaminophen)
Open Hydrocodone ER (q24h) in the interactive console ↗