REMS FDA Documents (opioids)

Search results for:

HYDROmorphone

HYDROmorphone
Brand names: Dilaudid
Form Strength
SOLUTION, INJECTABLE 0.5 mg/0.5 mL; 1 mg/1 mL; 2 mg/1 mL; 40 mg/20 mL
SOLUTION, INTRAVENOUS 6 mg/30 mL PCA syringe
SUPPOSITORY, RECTAL 3 mg
TABLET, ORAL 2 mg; 4 mg
Display Opioid Agonists Class: 280808
High Alert Drug : Policy
Medication comments:

High Alert Drug: Epidural
 • Alert sticker placed on both sides of all bags of epidural infusions at the time of dispensing and on epidural lines
 • Special monitoring - flow sheet, EMR documentation, order sets
 • Guidelines for timing of anticoagulation
High Alert Drug: IV Narcotics/opiates used in PCA’s
 • Standardized concentrations.
 • Electronic order set.
 • Special monitoring required - flow sheet.
 • Two RNs independently verify pump settings and drug prior to administration.
Per policy, these medications require cardiac and/or special monitoring.
(KEY: "Y" = may be given as described on chart. "N" = may NOT be given except in Rapid Response/Code Blue situations or as otherwise described in Exceptions section of Policy.
generic (Brand) / Notes CCU, OR, PACU, CCL, ED PCU 2N (Tele) 1N (Tele), 3N (Tele) Med/Surg (1N w/o Tele, 3N w/o Tele, 4N, 5N) BirthPlace SNF ICS OPS
HYDROmorphone (Dilaudid)
Epidural Key: management only		 Y Y Y Y Y Y Y Y N
HYDROmorphone (Dilaudid)
IV Push, IV Infusion PCA for pain management		 Y Y Y Y Y Y IV Push only IV Push only IV Push only
HYDROmorphone (Dilaudid)
IV Push, IV Infusion Sedation / Analgesia by Non-ANES Personnel		 Y N N N N N N N N
2023 American Geriatrics Society Beers Criteria® for potentially inappropriate medication use in older adults.
Medication: HYDROmorphone (Dilaudid)
Criteria 2: Potentially inappropriate medication use in older adults due to drug–disease or drug–syndrome interactions that may exacerbate the disease or syndrome. (Table 3)
Drug(s) ⇆ disease or syndrome opioids ⇄ Delirium
Rationale Avoid in older adults with or at high risk of delirium because of the potential of inducing or worsening delirium.
Opioids: emerging data highlights an association between opioid administration and delirium. For older adults with pain, use a balanced approach, including the use of validated pain assessment tools and multimodal strategies that include nondrug approaches to minimize opioid use.
Recommendation Avoid, except in situations listed under the rationale statement.
 Quality of evidence: Moderate, Strength of Recommendation: Strong
 
Drug(s) ⇆ disease or syndrome opioids ⇄ History of falls or fractures
Rationale May cause ataxia, impaired psychomotor function, syncope, or additional falls
If one of the drugs must be used, consider reducing the use of other CNS-active medications that increase the risk of falls and fractures. (i.e., anticholinergics, selected antidepressants, antiepileptics, antipsychotics, sedative/hypnotics including benzodiazepines and, Nonbenzodiazepine benzodiazepine receptor agonist hypnotics, opioids) and implement other strategies to reduce fall risk.
Recommendation Avoid except for pain management in the setting if severe acute pain.
 Quality of evidence: Moderate, Strength of Recommendation: Strong
 
Criteria 4: Potentially clinically important drug-drug interactions that should be avoided in older adults. (Table 5)
Interacting drug(s) or class(es) opioids ⇄ benzodiazepines
Risk Rationale Increased risk of overdose and adverse events.
Recommendation Avoid
 Quality of evidence: Moderate, Strength of Recommendation: Strong
 
Interacting drug(s) or class(es) opioids ⇄ CNS-active agents
Risk Rationale Increased risk of falls and of fracture with the concurrent use of ≥3 CNS-active agents (antiepileptics including gabapentinoids, antidepressants, antipsychotics, benzodiazepines, Nonbenzodiazepine benzodiazepine receptor agonist hypnotics, opioids, and skeletal muscle relaxants).
Recommendation Avoid concurrent use of ≥3 CNS-active drugs Click for list; minimize the number of CNS-active drugs.
 Quality of evidence: High, Strength of Recommendation: Strong
 
Interacting drug(s) or class(es) opioids ⇄ gabapentin, pregabalin
Risk Rationale Increased risk of severe sedation-related adverse events, including respiratory depression and death.
Recommendation Avoid; exceptions are when transitioning from opioid therapy to gabapentin or pregabalin, or when using gabapentinoids to reduce opioid dose, although caution should be used in all circumstances.
 Quality of evidence: Moderate, Strength of Recommendation: Strong
Last updated: Sep. 19, 2025
UpToDate Lexidrug
Class II

Pharmacy Contact Info:

Main Inpatient Pharmacy: ext 4599, 3503
Fax: 704-878-7283

Director of Pharmacy - Randi Raynor, PharmD: ext 4501
Clinical Coordinator - Laura Rollings, PharmD: ext 4597
Pharmacy Informaticist - Stephen Pringle, PharmD: ext 7645
Pharmacy Technician Supervisor - Amy Wingler, CPhT: ext 7385
Pharmacy Automation Coordinator (Omnicell) - Melissa Fulford, CPhT: ext 3556



This site is intended for the staff of Iredell Health System. While others may view accessible pages, Iredell Health System makes no warranty, express or implied, as to the use of this information outside of Iredell Health System. The content of this policy and procedure document serves as guidance to the delivery of quality patient care. Care providers are expected to exercise critical thinking and situational awareness skills, and in specific situations to take such action as is necessary for the delivery of quality patient care.
Copyright © 2025 Rpharmy, LLC ­ All Rights Reserved