Hydromorphone ER
EXALGO
Pronunciation: hye-droe-MOR-foen
“Dial, you did (to say) Hi (on) more phones”
pinpoint pupils → opioid
Several opioids are metabolized to hydromorphone, “All lines lead to hydro–”more phones”
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 ↗
| 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
Available strengths
- ER tab 8, 12, 16, 32 mg
- tab 2, 4, 8 mg
- sol 40 mg/20 mL
- sol 5 mg/5 mL
- supp 3 mg
- inj 0.2, 1, 2, 4, 10 mg/mL
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.
Cost
| Strength | #/mo | generic $/mo | CostPlus | |
|---|---|---|---|---|
| 8 mg | ER tab | 30 qd | $171.86 | not offered |
| 12 mg | ER tab | 30 qd | $312.64 | not offered |
| 16 mg | ER tab | 30 qd | $371.41 | not offered |
| 32 mg | ER tab | 30 qd | not offered |
Other forms: Hydromorphone (DILAUDID)
⚠ BOXED WARNINGS
- Addiction, abuse and misuse
- Life-threatening respiratory depression
- Risk from concomitant use with benzodiazepines
Classes and tags
Clinical profile
Legacy pregnancy categoryC
Defining liabilityRespiratory depression, dependence and overdose; risk rises sharply with sedatives or impaired clearance.
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