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DEMEROL Tablets and Oral Solution are opioid agonists indicated for the
management of pain, severe enough to require an opioid analgesic and for which
alternative treatments are inadequate.
Limitations of Use
Because of the risks of addiction, abuse, and misuse with opioids, even at
recommended doses, reserve DEMEROL Tablets and Oral Solution for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]:
• Have not been tolerated, or are not expected to be tolerated,
• Have not provided adequate analgesia, or are not expected to provide
adequate analgesia.
- Most common adverse reactions were lightheadedness, dizziness, sedation, nausea, vomiting, and sweating.
• Mixed Agonist/Antagonist and Partial Agonist Opioid Analgesics: Avoid use with DEMEROL Tablets or Oral Solution because they may reduce analgesic effect of DEMEROL Tablets or Oral Solution or precipitate withdrawal symptoms.
• Life-Threatening Respiratory Depression in Patients with Chronic Pulmonary
Disease or in Elderly, Cachectic, or Debilitated Patients: Monitor closely,
particularly during initiation and titration.
• Serotonin Syndrome: Potentially life-threatening condition could result from
concomitant serotonergic drug administration. Discontinue DEMEROL
Tablets or Oral Solution if serotonin syndrome is suspected.
• Adrenal Insufficiency: If diagnosed, treat with physiologic replacement of
corticosteroids, and wean patient off of the opioid.
• Severe Hypotension: Monitor during dosage initiation and titration. Avoid use
of DEMEROL Tablets or Oral Solution in patients with circulatory shock.
• Risks of Use in Patients with Increased Intracranial Pressure, Brain Tumors,
Head Injury, or Impaired Consciousness: Monitor for sedation and respiratory
depression. Avoid use of DEMEROL Tablets or Oral Solution in patients with
impaired consciousness or coma.
