DILAUDID-HP
Clinical safety rating
cautionComprehensive clinical and safety monograph for DILAUDID-HP (DILAUDID-HP).
Hydromorphone is a full mu-opioid receptor agonist with high affinity for mu-opioid receptors, producing analgesia, euphoria, and sedation. It also binds to kappa and delta opioid receptors with lower affinity.
| Metabolism | Hydromorphone is extensively metabolized in the liver via glucuronidation to hydromorphone-3-glucuronide (major metabolite) and to a lesser extent via reduction to dihydroisomorphine and dihydromorphine. Minor CYP2C9 and CYP3A4 involvement. |
| Excretion | Renal: predominantly as hydromorphone-3-glucuronide (H3G), unchanged hydromorphone (<6%), and other metabolites. Biliary/fecal: minimal. |
| Half-life | Terminal elimination half-life: 2.3–4 hours. In clinical context, consistent with dosing interval of 4–6 hours for immediate-release formulations; prolonged in hepatic or renal impairment. |
| Protein binding | Approximately 20–30%, primarily to albumin. |
| Volume of Distribution | 1.2–1.8 L/kg. Indicates extensive tissue distribution, consistent with a lipophilic opioid. |
| Bioavailability | Oral: 24–51% (first-pass metabolism); Intramuscular: 96% (relative to IV). |
| Onset of Action | Intravenous: 5–10 minutes; Intramuscular: 15–30 minutes; Oral: 30–60 minutes. |
| Duration of Action | Intravenous/Intramuscular: 4–5 hours; Oral: 3–4 hours. Clinical note: Duration may be shorter in opioid-tolerant patients. |
| Molecular Weight | 285.34 |
Initial dose: 0.2-0.6 mg IV/IM/SC every 2-4 hours as needed; usual adult dose: 0.2-0.4 mg IV/IM/SC. Oral: 1-2 mg every 3-6 hours. Dose titration based on pain severity.
| Dosage form | INJECTABLE |
| Renal impairment | GFR 30-60 mL/min: reduce dose by 25-50%; GFR 10-29 mL/min: administer 50-75% of normal dose every 6-8 hours; GFR <10 mL/min: administer 25-50% of normal dose every 8-12 hours. |
| Liver impairment | Child-Pugh Class A: no adjustment; Child-Pugh Class B: reduce initial dose by 50%; Child-Pugh Class C: avoid use or reduce dose by 75% with extended dosing interval. |
| Pediatric use | Children >2 years: 0.1-0.2 mg/kg IV/IM/SC every 4-6 hours; maximum single dose 2 mg. Neonates/infants: 0.03-0.05 mg/kg IV/IM/SC every 4-6 hours. |
| Geriatric use | Initial dose: 0.1-0.2 mg IV/IM/SC every 4-6 hours; reduce dose by 50% compared to younger adults; titrate cautiously due to increased sensitivity and risk of respiratory depression. |
| 1st trimester | Limited human data; animal studies show increased risk of malformations at high doses; avoid unless benefit outweighs risk. |
| 2nd trimester | Use with caution; may cause maternal and neonatal respiratory depression if used near term; consider benefits vs. risks. |
| 3rd trimester | Avoid prolonged use or high doses; risk of neonatal opioid withdrawal syndrome; use only if clearly needed. |
Clinical note
Comprehensive clinical and safety monograph for DILAUDID-HP (DILAUDID-HP).
| Placental transfer | Hydromorphone crosses the placenta; detected in umbilical cord blood; degree of transfer is moderate with fetal/maternal ratio approximately 0.3-0.6. |
| Breastfeeding | Hydromorphone enters breast milk in small amounts; manufacturer advises caution; monitor infant for drowsiness, feeding difficulties, and respiratory depression; use lowest effective dose for shortest duration. |
| Lactation Rating | L3 (Moderately Safe) |
| Teratogenic Risk | FDA Pregnancy Category C. First trimester: No well-controlled human studies; animal studies have shown teratogenicity at high doses. Second and third trimesters: Chronic maternal use may lead to neonatal opioid withdrawal syndrome (NOWS) and respiratory depression at birth. Avoid use during labor due to risk of neonatal respiratory depression. |
| Fetal Monitoring | Monitor maternal vital signs, respiratory rate, and sedation level. Monitor fetal heart rate and uterine activity during labor. Newborns exposed in utero should be observed for signs of neonatal opioid withdrawal syndrome and respiratory depression. |
| Fertility Effects | Opioids may impair fertility by interfering with hypothalamic-pituitary-gonadal axis, leading to reduced libido, anovulation, and menstrual irregularities. Reversible upon discontinuation. No specific human studies for hydromorphone. |
■ FDA Black Box Warning
WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS; and RISKS OF USE IN PATIENTS WITH HEAD INJURY OR INCREASED INTRACRANIAL PRESSURE.
| Serious Effects |
Hypersensitivity to hydromorphone or any componentSignificant respiratory depressionAcute or severe bronchial asthma in unmonitored settingKnown or suspected gastrointestinal obstruction including paralytic ileusConcurrent use of monoamine oxidase inhibitors (MAOIs) or within 14 days
| Precautions | Addiction, abuse, and misuse, Life-threatening respiratory depression, Accidental ingestion, Neonatal opioid withdrawal syndrome, Risks from concomitant use with benzodiazepines or other CNS depressants, Adrenal insufficiency, Severe hypotension, Gastrointestinal effects (constipation, ileus), Seizures, Withdrawal |
| Food/Dietary | Avoid alcohol while taking DILAUDID-HP, as it can potentiate CNS depression and increase the risk of respiratory depression. Grapefruit juice may inhibit CYP2D6 and CYP3A4 metabolism, potentially increasing hydromorphone levels; avoid concurrent consumption. High-fat meals may delay absorption; maintain consistent timing with or without food. |
| Clinical Pearls | DILAUDID-HP (high-potency hydromorphone) is indicated for opioid-tolerant patients only; 1 mg DILAUDID-HP is equivalent to 4 mg standard hydromorphone. Use with extreme caution in patients with respiratory compromise, COPD, or cor pulmonale. Avoid in patients with paralytic ileus or suspected GI obstruction. Monitor for serotonin syndrome when co-administered with serotonergic drugs. For PCA use, ensure proper programming to prevent overdose. Naloxone is the reversal agent; may require higher doses due to high potency. |
| Patient Advice | This is a high-potency opioid; take exactly as prescribed and never increase dose without consulting your doctor. · Do not break, crush, or chew tablets; swallow whole to avoid rapid release of the drug. · Avoid alcohol and other central nervous system depressants (e.g., benzodiazepines, sedatives) as they can increase the risk of severe drowsiness, respiratory depression, and death. · Do not stop taking abruptly; withdrawal symptoms may occur. Consult your doctor for a tapering plan. · Constipation is a common side effect; maintain adequate fluid intake, fiber, and consider stool softeners or laxatives as needed. · Store securely out of reach of children and pets; properly dispose of unused medication at a take-back location. · Seek emergency medical attention if you experience difficulty breathing, extreme drowsiness, confusion, or fainting. · This medication may impair your ability to drive or operate machinery; avoid such activities until you know how it affects you. |
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