Hydromorphone ER

EXALGO

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What it isExtended-release full mu-opioid agonist; around-the-clock severe chronic pain in opioid-tolerant patients.

Why this oneIts once-daily osmotic tablet may leave an empty shell that appears intact in stool.

What limits itCrushing can release a fatal load; respiratory depression, addiction, and benzodiazepine co-use are the central hazards.

FDA-approved for

chronic pain (around-the-clock) (2010)

FDA label

Read the full label on DailyMed ↗

BOXED WARNING Abuse potential; life-threatening respiratory depression (greatest at initiation and dose increases); for opioid-tolerant patients only; crushing/dissolving/chewing can release a fatal dose; accidental exposure (especially in children) can be fatal.

FDA dosing	Population	Start	Target	Max
Moderate to severe pain requiring continuous, around-the-clock opioid analgesia	Opioid-tolerant adults	Individualize by converting prior opioid; start at 50% of calculated 24-hour oral hydromorphone requirement, QD	Titrate to adequate analgesia

Titration Dosage adjustments every 3 to 4 days

Renal Moderate impairment: start at 50% of the usual dose; severe impairment: start at 25% (consider an alternate analgesic)

Hepatic Moderate impairment: start at 25% of the usual dose; severe impairment: use an alternate analgesic

For use in opioid-tolerant patients only; once-daily (every 24 hours) administration.

Instructions

Swallow tablets whole and intact; do not crush, dissolve, or chew
Administer once daily, at about the same time, with or without food
When discontinuing, taper by 25%–50% every 2–3 days down to 8 mg before stopping; do not abruptly discontinue
For opioid-tolerant patients only; do not use as the first opioid

Contraindications

Opioid non-tolerant patients (fatal respiratory depression could occur)
Patients with significant respiratory depression
Patients with acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment
Patients with known or suspected paralytic ileus
Patients with surgical procedures and/or underlying disease resulting in narrowing of the gastrointestinal tract, or with 'blind loops' of the gastrointestinal tract or gastrointestinal obstruction

Cautions

Respiratory depression — increased risk in elderly, cachectic, debilitated, and chronic pulmonary disease patients
Additive effects with alcohol, other CNS depressants, and illicit drugs
Severe hypotension including orthostatic hypotension/syncope
Head injury or increased intracranial pressure
Sulfites (contains sodium metabisulfite) — allergic-type reactions
Seizure/convulsive disorders
Avoid mixed agonist/antagonist analgesics; avoid abrupt withdrawal
Impairment of ability to drive/operate machinery

Adverse reactions

Constipation
Nausea, vomiting
Somnolence
Headache
Dizziness

Pregnancy Use during pregnancy only if potential benefit justifies potential risk; prolonged use can cause neonatal opioid withdrawal syndrome, which may be life-threatening.

Lactation Hydromorphone is excreted in human milk; nursing not recommended; monitor infants for withdrawal when maternal use stops.

⚠ BOXED WARNINGS