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U.S. Department of Health and Human Services

Safety

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Demerol (meperidine hydrochloride)

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – April and October 2011

 

October 2011

Summary View

 

CONTRAINDICATIONS

  • Serotonin syndrome with agitation, hyperthermia, diarrhea, tachycardia, sweating, tremors and impaired consciousness may also occur
  • DEMEROL is contraindicated in patients with severe respiratory insufficiency

 

PRECAUTIONS

General
  • …or renal function; and toxic psychosis (see PRECAUTIONS, Special Risk Patients)
    Interactions with Other CNS Depressants
    • Drug-drug interactions may result in respiratory depression, hypotension, profound sedation, coma or death if...
    Interactions with Mixed Agonist/Antagonist Opioid Analgesics
    • added...may precipitate withdrawal symptoms in these patients due to competitive blocking of receptors
    Tolerance and Physical Dependence
    • added...Meperidine has the potential to produce tolerance and drug dependence
    Drug Interactions
    • CNS Depressants: Concomittant use of CNS depressants with usual doses of Demerol may result in....
    • Phenytoin: ...were increased, thus caution should be exercised when...
    Geriatric Use
    • Reducing the total daily dose of meperidine is recommended in elderly patients...

 

ADVERSE REACTIONS

  • Nervous System: Mood changes (e.g. euphoria, dysphoria), weakness, headache, agitation, tremor, involuntary muscle movements (e.g. muscle twitches, myoclonus), severe convulsions, transient hallucinations and disorientation, confusion, delirium, visual disturbances

 

April 2011

Summary View

 

WARNINGS

  • ... Prolonged meperidine use may increase the risk of toxicity (e.g., seizures) from the accumulation of the meperidine metabolite, normeperidine.

 

PRECAUTIONS

Pediatric Use:
  • ... If meperidine use is contemplated in neonates or young infants, any potential benefits of the drug need to be weighed against the relative risk to the patient.

 

ADVERSE REACTIONS

Allergic
  • Pruritus ... anaphylaxis, shock.