REMS FDA Documents (opioids)

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morphine

morphine
Brand names: AVINza, Duramorph, morphine PCA, morphine sulfate, MS Contin, MS IR, Oramorph SR
Form Strength
SOLUTION, INJECTABLE 2 mg/1 mL; 4 mg/1 mL; 10 mg/1 mL; 10 mg/10 mL PF (Duramorph)
SOLUTION, INTRAVENOUS 30 mg/30 mL (PCA syringe)
SOLUTION, ORAL 10 mg/0.5 mL (CONC); 10 mg/5 mL (oral soln)
TABLET, EXTENDED RELEASE, ORAL 15 mg/12 hr; 30 mg/12 hr; 100 mg/12 hours
TABLET, ORAL 15 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
morphine
Epidural management only		 Y Y Y Y Y Y Y Y N
morphine
IV Push,IV Infusion PCA for pain management		 Y Y Y Y Y Y IV Push only IV Push only IV Push only
morphine
IV Push sedation / analgesia by non-ANES personnel Key: designated staff		 Y N N N N N N N N
morphine (Roxanol oral concentrate 20 mg/ml)
Oral		 Y Y Y Y Y N Y Y Y
Per policy, orders for these non-formulary agents will be changed to formulary equivalents.
Non-Formulary Agent Formulary Equivalent
morphine (Oramorph SR) morphine (MS Contin)
2023 American Geriatrics Society Beers Criteria® for potentially inappropriate medication use in older adults.
Medication: morphine (Oramorph SR, Roxanol)
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

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