DILAUDID-HP

Clinical safety rating: caution

Comprehensive clinical and safety monograph for DILAUDID-HP (DILAUDID-HP).

How it works

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.

What the body does with it

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.

Classification & Brands

Dosing & administration

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.

Use during pregnancy

1st trimester	Consult provider
2nd trimester	Consult provider
3rd trimester	Consult provider

Clinical note

Comprehensive clinical and safety monograph for DILAUDID-HP (DILAUDID-HP).

Breastfeeding	Hydromorphone is excreted into breast milk. The milk-to-plasma (M/P) ratio is approximately 2.6. Limited data suggest low levels, but use caution due to potential for infant sedation and respiratory depression. The American Academy of Pediatrics considers hydromorphone compatible with breastfeeding if used short-term at low doses.
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.

Warnings & precautions

■ 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.

Side Effect Profile

Serious Effects

Absolute Contraindications

["Significant respiratory depression","Acute or severe bronchial asthma in an unmonitored setting or in absence of resuscitative equipment","Known or suspected gastrointestinal obstruction, including paralytic ileus","Hypersensitivity to hydromorphone or any component of the product"]

Clinical Precautions

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"]

Clinical Tips & Counseling

Drug interactions

Loading safety data…

DILAUDID-HP

Clinical safety rating: caution

Comprehensive clinical and safety monograph for DILAUDID-HP (DILAUDID-HP).

How it works

What the body does with it

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.

Classification & Brands

Dosing & administration

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.

Use during pregnancy

1st trimester	Consult provider
2nd trimester	Consult provider
3rd trimester	Consult provider

Clinical note

Comprehensive clinical and safety monograph for DILAUDID-HP (DILAUDID-HP).

Breastfeeding	Hydromorphone is excreted into breast milk. The milk-to-plasma (M/P) ratio is approximately 2.6. Limited data suggest low levels, but use caution due to potential for infant sedation and respiratory depression. The American Academy of Pediatrics considers hydromorphone compatible with breastfeeding if used short-term at low doses.
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.