REMS FDA Documents (opioids)

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meperidine

meperidine
Brand names: Demerol
Form Strength
SOLUTION, INJECTABLE 25 mg/mL; 50 mg/mL; 75 mg/mL; 100 mg/mL
TABLET, ORAL 50 mg
Display Opioid Agonists Class: 280808
High Alert Drug : Policy
Medication comments:

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
meperidine (Demerol)
Epidural Key: management only		 Y Y Y Y Y Y Y Y Y
meperidine (Demerol)
IV Push, IV Infusion for pain management		 Y Y Y Y Y Y IV Push only IV Push only IV Push only
meperidine (Demerol)
IV Push sedation / analgesia by non-ANES personnel Key: designated staff		 Y N N N N N N N N
Per policy, these drugs are subject to renal dosing adjustments by pharmacy. 
Generic + Route
(Brand)
• Indications		 Usual Adult Dose
Comments		 Renal Dosage Adjustments
meperidine IM/IV
(Demerol©)
• Analgesia		 25-150 mg q1-4h prn Avoid use in renal impairment
meperidine IV
(Demerol©)
• Post-op Shivering		 25-50 mg x1 Avoid use in renal impairment
2023 American Geriatrics Society Beers Criteria® for potentially inappropriate medication use in older adults.
Medication: meperidine (Demerol)
Criteria 1: Potentially inappropriate medication use in older adults. (Table 2)
Drug(s) meperidine
Rationale Oral analgesic not effective in dosages commonly used; may have a higher risk of neurotoxicity, including delirium, than other opioids; safer alternatives available.
Recommendation Avoid
 Quality of evidence: Moderate, Strength of Recommendation: Strong
 
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
Pediatric Pharmacy Association 2025 KIDs List of Key Potentially Inappropriate Drugs in Pediatrics 
Medication: meperidine (Demerol)
Key Potentially Inappropriate Drugs in Pediatrics (KIDs) List: Second Edition (Table 1)
Drug opioids
Risk/Rationale Acute neurotoxicity (agitation, myoclonus, hyperreflexia, tremors, delirium, seizures)
Recommendation Avoid in younger than 1 mo
Caution in 18 yr of age and younger
 Quality of evidence: High, Strength of Recommendation: Strong
Last updated: Sep. 25, 2025
UpToDate Lexidrug
Class II

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