REMS FDA Documents (opioids)

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homatropine-HYDROcodone

homatropine-HYDROcodone
Brand names: Hycodan
Form Strength
SYRUP, ORAL 1.5 mg-5 mg/5 mL
Display Antitussives Class: 480800
Medication comments:

Opioid-containing cough and cold medications are limited to patients ≥ 18 years old.
2023 American Geriatrics Society Beers Criteria® for potentially inappropriate medication use in older adults.
Medication: homatropine-HYDROcodone (Hycodan, Hydromet)
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 anticholinergics ⇄ Delirium
Rationale Avoid in older adults with or at high risk of delirium because of the potential of inducing or worsening delirium.
Recommendation Avoid
 Quality of evidence: Moderate, Strength of Recommendation: Strong
 
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 anticholinergics ⇄ Dementia or cognitive impairment
Rationale Avoid because of adverse CNS effects. If used, periodic deprescribing attempts should be considered to assess ongoing need and/or the lowest effective dose.
Recommendation Avoid
 Quality of evidence: Moderate, Strength of Recommendation: Strong
 
Drug(s) ⇆ disease or syndrome anticholinergics ⇄ 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 unless safer alternatives are not available.
 Quality of evidence: High, 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
 
Drug(s) ⇆ disease or syndrome strongly anticholinergic drugs, except antimuscarinics for urinary incontinence ⇄ Lower urinary tract symptoms, benign prostatic hyperplasia
Rationale May decrease urinary flow and cause urinary retention
Recommendation Avoid in men
 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) anticholinergics ⇄ anticholinergics
Risk Rationale Use of more than one medication with anticholinergic properties increases the risk of cognitive decline, delirium, and falls or fractures.
Recommendation Avoid; minimize the number of anticholinergic drugs Click for list.
 Quality of evidence: Moderate, Strength of Recommendation: Strong
 
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
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