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; opioid REMS.
FDA dosing
Population
Start
Target
Max
Severe and persistent pain requiring an opioid, inadequately treated by alternatives
Adults, not opioid-tolerant
15 mg q8–12h
individualized
No ceiling; >60 mg single dose or >120 mg/day only if opioid-tolerant
Titration Dosage adjustments may be done every 1 to 2 days (steady state approximated in ~1 day)
Renal Altered pharmacokinetics — start with lower than usual dose and titrate slowly
Hepatic Altered pharmacokinetics in cirrhosis — start with lower than usual dose and titrate slowly
A single dose >60 mg, or total daily dose >120 mg, only for opioid-tolerant patients
Instructions
Administer orally every 8 or 12 hours
Swallow tablets whole; do not cut, break, chew, crush, or dissolve (risk of fatal dose)
Do not abruptly discontinue in physically dependent patients; taper by ~10–25% of total daily dose every 2–4 weeks
If on a CNS depressant, start at 15 mg q12h and consider lower depressant dose
Contraindications
Significant respiratory depression
Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment
Concurrent use of monoamine oxidase inhibitors (MAOIs) or use of MAOIs within the last 14 days
Known or suspected gastrointestinal obstruction, including paralytic ileus
Cautions
Opioid-induced hyperalgesia and allodynia
Life-threatening respiratory depression in chronic pulmonary disease or elderly/cachectic/debilitated patients
Adrenal insufficiency
Severe hypotension; avoid in circulatory shock
Increased intracranial pressure / head injury / impaired consciousness
Risk of seizures in seizure disorders
Serotonin syndrome with serotonergic drugs
Withdrawal on abrupt discontinuation
Adverse reactions
Constipation
Nausea
Sedation
Dizziness
Vomiting
Sweating
Dysphoria
Euphoric mood
Pregnancy Prolonged use can cause neonatal opioid withdrawal syndrome; no clear association with major birth defects; animal data show neural tube and other defects; not recommended during/immediately before labor
Lactation Morphine present in breast milk; breastfeeding not recommended due to risk of sedation and respiratory depression in infant