DILAUDID
Clinical safety rating
cautionComprehensive clinical and safety monograph for DILAUDID (DILAUDID).
Dilaudid (hydromorphone) is a full opioid agonist with high affinity for mu-opioid receptors, producing analgesia by mimicking endogenous endorphins and enkephalins. It also activates kappa and delta opioid receptors to a lesser extent.
| Metabolism | Primarily hepatic via glucuronidation; major metabolites: hydromorphone-3-glucuronide (H3G, active) and hydromorphone-6-glucuronide (H6G); minor pathways: N-demethylation to norhydromorphone; CYP450 involvement minimal. |
| Excretion | Primarily renal (90% as hydromorphone-3-glucuronide and parent drug); <1% biliary/fecal |
| Half-life | 2.5-3.5 hours (terminal); prolonged in hepatic/renal impairment |
| Protein binding | ~20% (primarily albumin) |
| Volume of Distribution | 1.2-1.7 L/kg; indicates extensive tissue distribution |
| Bioavailability | Oral: 50-60% (first-pass); IM: ~100%; Rectal: ~50-60% |
| Onset of Action | Oral: 15-30 min; IV: 5 min; IM: 15 min; Rectal: 20-30 min |
| Duration of Action | Oral: 4-5 h; IV: 3-4 h; IM: 4-5 h; Rectal: 4-6 h; longer with extended-release formulations |
| Molecular Weight | 311.85 |
Initial: 2-4 mg orally every 4-6 hours as needed; or 1-2 mg intramuscularly, subcutaneously, or intravenously every 4-6 hours as needed.
| Dosage form | INJECTABLE |
| Renal impairment | eGFR 30-60 mL/min: Administer 75% of usual dose; eGFR <30 mL/min: Administer 50% of usual dose; avoid in severe impairment. |
| Liver impairment | Child-Pugh class A: No adjustment; Child-Pugh class B: Reduce dose by 25-50%; Child-Pugh class C: Avoid use or reduce dose by 50-75%. |
| Pediatric use | Children >12 years: 2-4 mg orally every 4-6 hours; 0.1-0.2 mg/kg intramuscularly/subcutaneously/intravenously every 4-6 hours (max single dose 4 mg). |
| Geriatric use | Initiate at 25-50% of adult dose; increase cautiously; monitor for respiratory depression, sedation, and constipation. |
| 1st trimester | Limited human data; animal studies show increased risk of neural tube defects at high doses. Use only if clearly needed. |
| 2nd trimester | Use with caution; may cause maternal dependence and neonatal withdrawal. Monitor for fetal growth restriction. |
| 3rd trimester | Prolonged use may cause neonatal opioid withdrawal syndrome (NOWS) and respiratory depression. Avoid near term. |
Clinical note
Comprehensive clinical and safety monograph for DILAUDID (DILAUDID).
| Placental transfer | Readily crosses the placenta with cord blood concentrations similar to maternal serum. |
| Breastfeeding | Enters breast milk in low concentrations; peak milk levels occur 30-60 minutes after dose. Monitor infant for drowsiness and respiratory depression. AAP considers opioid analgesics compatible with breastfeeding with caution. |
| Lactation Rating | L2 (Safer) |
| Teratogenic Risk | First trimester: Limited human data; animal studies show no consistent teratogenicity. Second and third trimesters: Chronic use may cause fetal opioid dependence and neonatal abstinence syndrome (NAS). High doses near term may cause neonatal respiratory depression. |
| Fetal Monitoring | Monitor maternal vital signs, pain scores, sedation level, and respiratory rate. Assess fetal heart rate and uterine activity if administered during labor. Monitor neonate for signs of opioid withdrawal (NAS) if chronic maternal use. |
| Fertility Effects | Opioid use may alter reproductive hormone levels, potentially affecting fertility. Chronic use can lead to menstrual cycle irregularities and reduced libido. Reversible upon discontinuation. |
■ FDA Black Box Warning
Risk of respiratory depression, particularly in opioid-naive patients and those with respiratory compromise; risk of addiction, abuse, and misuse; risk of neonatal opioid withdrawal syndrome with prolonged use during pregnancy; risk of fatal overdose when used with benzodiazepines or CNS depressants.
| Serious Effects |
Hypersensitivity to hydromorphone or any component of the formulationSignificant respiratory depression (in unmonitored settings or absence of resuscitative equipment)Acute or severe bronchial asthma (without monitoring)Known or suspected paralytic ileusConcurrent use of MAOIs or within 14 days of such therapy
| Precautions | Respiratory depression (especially with concurrent CNS depressants); addiction potential; risk of opioid-induced hyperalgesia; severe hypotension; adrenal insufficiency; androgen deficiency; impairment of mental/physical abilities; risk of serotonin syndrome with serotonergic drugs; risk of severe hypotension in hypovolemic patients; caution in elderly, cachectic, or debilitated patients. |
| Food/Dietary | Avoid grapefruit juice as it may increase hydromorphone levels via CYP3A4 inhibition. High-fat meals may delay absorption of immediate-release formulations but do not significantly alter overall exposure. Maintain adequate fluid and fiber intake to prevent constipation. |
| Clinical Pearls | Dilaudid (hydromorphone) is 5–10 times more potent than morphine. Use with caution in opioid-naive patients; start at low doses. Avoid in patients with significant respiratory depression, paralytic ileus, or acute asthma. Monitor for signs of hypotension, especially in hypovolemic patients. May cause histamine release with pruritus, but less than morphine. For breakthrough pain, immediate-release oral solution provides fastest oral onset. Not recommended for chronic pain without careful reassessment. Reversal with naloxone, but short infusion may be needed due to longer duration. |
| Patient Advice | Do not crush, chew, or break extended-release tablets; swallow whole. · Avoid alcohol and other CNS depressants (benzodiazepines, sedatives) as they increase risk of severe drowsiness, respiratory depression, coma, and death. · Do not drive or operate heavy machinery until you know how this medication affects you. · Store securely out of sight and reach of children; dispose of unused medication via take-back program or mixing with unpalatable substance and trashing. · Take exactly as prescribed; do not increase dose or frequency without consulting your doctor. · Common side effects include drowsiness, dizziness, constipation, nausea, and vomiting. Laxatives and hydration may help constipation. · Seek emergency help if you have trouble breathing, slow heartbeat, severe dizziness, or fainting. · Tell all healthcare providers you are taking this medication before any surgery or procedure. · Do not stop suddenly without doctor guidance to avoid withdrawal symptoms (anxiety, sweating, diarrhea, muscle aches). |
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