Label Changes for:

Demerol (meperidine hydrochloride)

October 2011

Changes have been made to the CONTRAINDICATIONS and PRECAUTIONS sections of the safety label.

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

 

October 2011

 

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

 

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.

 

 

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