What it isExtended-release mu-opioid agonist; severe chronic pain requiring continuous opioid therapy.
Why this oneIts capsules may be opened and the pellets sprinkled on applesauce (never crushed), an option when intact extended-release tablets cannot be swallowed.
What limits itRenal accumulation, respiratory depression, and benzodiazepine co-use markedly increase overdose risk.
BOXED WARNING Opioid agonist (Schedule II) with abuse liability; risk of fatal respiratory depression. 100 mg and 200 mg capsules for opioid-tolerant patients only. Swallow whole or sprinkle pellets on applesauce; do not chew/crush/dissolve.
FDA dosing
Population
Start
Target
Max
Moderate to severe pain requiring continuous around-the-clock opioid (not PRN)
Opioid-naive
10-20 mg QD or BID
Individualized
No maximum defined
Moderate to severe pain (conversion from other oral morphine)
Half total daily oral morphine dose q12h, or total daily dose q24h
Individualized
No maximum defined
Titration No more frequently than every other day (opioid-naive: increase by ~20 mg every other day)
Renal Use with caution; reduced dosage in severe renal insufficiency
Hepatic Use with caution; reduced dosage in severe hepatic insufficiency
Do not dose more frequently than every 12 hours
Instructions
Swallow capsules whole; do not chew, crush, or dissolve
May sprinkle pellets on a small amount of room-temperature applesauce; use immediately, do not divide
May give via 16 French gastrostomy tube; do NOT give via nasogastric tube
100 mg and 200 mg capsules for opioid-tolerant patients only
Taper gradually on discontinuation to prevent withdrawal
Contraindications
Respiratory depression (in the absence of resuscitative equipment or in unmonitored settings)
Acute or severe bronchial asthma or hypercarbia
Known or suspected paralytic ileus
Any situation where opioids are contraindicated
Cautions
Respiratory depression is the chief hazard; extreme caution in COPD, cor pulmonale, decreased respiratory reserve, hypoxia/hypercapnia
Additive CNS depression with alcohol, sedatives, other opioids, MAOIs (do not use within 14 days of MAOI)
Severe hypotension/orthostatic hypotension
Head injury/increased intracranial pressure
Spasm of sphincter of Oddi; caution in biliary tract/pancreatic disease
Misuse, abuse, addiction, diversion potential
Neonatal withdrawal with prolonged maternal use
Tolerance and physical dependence
Adverse reactions
Drowsiness
Constipation
Nausea
Dizziness
Anxiety
Vomiting
Pregnancy Pregnancy Category C; use only if benefit justifies fetal risk. Prolonged use can cause neonatal opioid withdrawal syndrome.
Lactation Low levels of morphine detected in human milk; withdrawal can occur in breastfed infant when maternal drug stopped; weigh benefits vs discontinuing.