Pain severe enough to require an opioid analgesic, when alternative treatments are inadequate (non-ocular; the only labeled use)
Tablets 2 mg to 4 mg PO q4-6h PRN; oral solution 2.5 mg to 10 mg (2.5 mL to 10 mL) PO q3-6h PRN
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.
Hypersensitivity to hydromorphone, its salts, any other component of the product, or sulfite-containing medications.
Available Forms
2 mg, 4 mg and 8 mg tablets; oral solution 5 mg/5 mL (1 mg/mL) in 473 mL bottles
Mechanism of Action
Full opioid agonist, relatively selective for the mu-opioid receptor, binding other opioid receptors at higher doses; analgesia is its principal action and, as with all full agonists, there is no analgesic ceiling. Ocularly relevant pharmacodynamics: miosis occurs even in total darkness, while marked mydriasis rather than miosis may appear with hypoxia in overdose.
Warnings & Precautions
Addiction, abuse, and misuse: Boxed warning. Schedule II opioid; addiction can occur at recommended doses. Assess risk before prescribing and reassess throughout therapy.
Life-threatening respiratory depression: Boxed warning. Risk is greatest at initiation and after any dosage increase; opioids also raise the risk of central sleep apnea in a dose-dependent fashion.
Benzodiazepines and CNS depressants: Boxed warning. Concomitant use, including alcohol, gabapentinoids, muscle relaxants, and other opioids, may cause profound sedation, respiratory depression, coma, and death.
Accidental ingestion: Boxed warning. A single dose, especially in a child, can produce a fatal overdose.
Oral solution dosing errors: Boxed warning. Confusion between mg and mL, or with other hydromorphone solution concentrations, has caused fatal overdose; write both the mg dose and the volume.
Neonatal opioid withdrawal syndrome: Boxed warning. Extended use in pregnancy can cause neonatal withdrawal, which may be life-threatening if not recognized and treated.
Opioid analgesic REMS: Boxed warning. Prescribers are strongly encouraged to complete a REMS-compliant education program and to counsel on risks, storage, and disposal at every prescription.
Increased intracranial pressure: CO2 retention from reduced respiratory drive can further raise intracranial pressure in susceptible patients, including those with brain tumors, and opioids may obscure the clinical course of head injury; avoid in impaired consciousness or coma.
Sodium metabisulfite content: May cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes; sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.
Common Side Effects
Ocular: Blurred vision, diplopia, miosis, and visual impairment, all listed as less frequently observed; no frequency figures given.
Common reactions: Lightheadedness, dizziness, sedation, nausea, vomiting, sweating, flushing, dysphoria, euphoria, dry mouth, pruritus; more prominent in ambulatory patients and in those not experiencing severe pain.
Serious reactions: Respiratory depression and apnea, and to a lesser degree circulatory depression, respiratory arrest, shock, and cardiac arrest.
Postmarketing: Serotonin syndrome with serotonergic drugs, adrenal insufficiency (more often after more than one month of use), anaphylaxis, hyperalgesia and allodynia, hypoglycemia, opioid-induced esophageal dysfunction.
Pregnancy & Lactation
Pregnancy: No human data to inform a drug-associated risk of major birth defects or miscarriage; animal studies showed neural tube defects in hamsters, soft tissue and skeletal malformations in mice, and reduced pup survival and body weight in rats. Extended use in pregnancy can cause neonatal opioid withdrawal syndrome; not recommended during or immediately prior to labor, when other analgesic techniques are more appropriate.
Lactation: Low levels of opioid analgesics have been detected in human milk; monitor the breastfed infant for excess sedation and respiratory depression, and for withdrawal when maternal use or breastfeeding stops.
Opioid-induced hyperalgesia and allodynia: Paradoxical increase in pain or pain sensitivity, reported with both short-term and longer-term use; consider dose reduction or opioid rotation rather than escalation.
Severe hypotension: Orthostatic hypotension and syncope in ambulatory patients; avoid in circulatory shock, where vasodilation can further reduce cardiac output.
Adrenal insufficiency: Reported with opioid use, more often after more than one month; confirm by testing, give physiologic corticosteroid replacement, and wean the opioid.
MAO inhibitors: Not recommended in patients taking an MAOI or within 14 days of stopping one; the interaction may present as serotonin syndrome or opioid toxicity.
Withdrawal: Do not abruptly discontinue or rapidly reduce in a physically dependent patient; taper by no more than 10% to 25% of the total daily dose at intervals of every 2 to 4 weeks.
Seizure disorders: May increase seizure frequency in patients with a seizure disorder and the risk of seizures in other settings associated with them.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established.