DEMEROL Highlights

DEMEROL Injection is indicated for preoperative medication, support of anesthesia, for obstetrical analgesia, and for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. (1)

Limitations of Use (1)

Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration (5.1), reserve DEMEROL Injection for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]:

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Have not been tolerated or are not expected to be tolerated,

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Have not provided adequate analgesia or are not expected to provide adequate analgesia.

DEMEROL Injection should not be used for an extended period of time unless the ‎pain remains severe enough to require an opioid analgesic and for which ‎alternative treatment options continue to be inadequate.‎

Use of ‎DEMEROL Injection for an extended period of time may increase the risk of ‎toxicity (e.g., seizures) from the accumulation of the meperidine metabolite, ‎normeperidine.‎

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DEMEROL Injection should be prescribed only by healthcare ‎professionals who are knowledgeable about the use of ‎opioids and how to mitigate the associated risks. (2.1)‎

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Use the lowest effective dosage for the shortest duration of time consistent with individual patient treatment goals. ‎Reserve titration to higher doses of DEMEROL ‎Injection for patients in whom lower doses are ‎insufficiently effective and in whom the expected benefits ‎of using a higher dose opioid clearly outweigh the ‎substantial risks. (2.1, 5)‎

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Many acute pain conditions (e.g., the pain that occurs with ‎a number of surgical procedures or acute ‎musculoskeletal injuries) require no more than a few ‎days of an opioid analgesic. Clinical guidelines on ‎opioid prescribing for some acute pain conditions are ‎available. (2.1)‎

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Initiate the dosing regimen for each patient individually, ‎taking into account the patient’s underlying cause and ‎severity of pain, prior analgesic treatment and ‎response, and risk factors for addiction, abuse, and ‎misuse. (2.1, 5.2)‎

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Respiratory depression can occur at any time during opioid ‎therapy, especially when initiating and following dosage ‎increases with DEMEROL Injection. Consider this risk ‎when selecting an initial dose and when making dose ‎adjustments. (2.2, 5.3)‎

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For Relief of Pain:

 

Titrate the dose based upon the individual patient’s response to their ‎initial dose of DEMEROL Injection. (2.2, 5)‎
Adults: 50 mg to 150 mg intramuscularly or subcutaneously every 3 to 4 hours. (2.2)
Children: 0.5 mg/lb to 0.8 mg/lb intramuscularly or subcutaneously up to the adult dose every 3 to 4 hours. (2.2)

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Preoperative Medication:
Adults: 50 mg to 100 mg intramuscularly or subcutaneously, 30 to 90 minutes before beginning anesthesia. (2.3)
Children: 0.5 mg/lb to 1 mg/lb intramuscularly or subcutaneously up to the adult dose, 30 to 90 minutes before beginning anesthesia. (2.3)

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Obstetrical Analgesia:
50 mg to 100 mg intramuscularly or subcutaneously; may be repeated at 1 to 3 hour intervals. (2.4)

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Do not abruptly discontinue DEMEROL Injection in a physically‑dependent patient. (2.2)

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Injectable, Carpuject™ Single-Dose cartridge with Luer Lock for the Carpuject Syringe System, to be used ONLY with Carpuject™ Holder: 25 mg/mL, 50 mg/mL, 75 mg/mL, and 100 mg/mL. (3)

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Injectable, Multiple-dose vials: 1,500 mg/30 mL (50 mg/mL). (3)

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Injectable, NexJect™ Single-dose Prefilled Syringe with Luer Lock: 25 mg/mL and 50 mg/mL. (3)

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Significant respiratory depression. (4)

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Acute or severe bronchial asthma in an unmonitored setting or in absence of resuscitative equipment. (4)

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Concurrent use of monoamine oxidase inhibitors (MAOIs) or use of MAOIs within the last 14 days. (7)

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Known or suspected gastrointestinal obstruction, including paralytic ileus. (4)

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Hypersensitivity to meperidine or to any other ingredients of the product. (4)

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Opioid-Induced Hyperalgesia and Allodynia: Opioid-Induced ‎Hyperalgesia (OIH) occurs when an opioid analgesic ‎paradoxically causes an increase in pain, or an increase in ‎sensitivity to pain. If OIH is suspected, carefully consider appropriately ‎decreasing the dose of the current opioid analgesic or ‎opioid rotation. (5.7)‎

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Serotonin Syndrome with Concomitant Use of Serotonergic Drugs: Potentially life-threatening condition could result from concomitant serotonergic drug administration. Discontinue DEMEROL Injection if serotonin syndrome is suspected. (5.8)

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Life-Threatening Respiratory Depression in Patients with Chronic Pulmonary Disease or in Elderly, Cachectic, or Debilitated Patients: Monitor closely, particularly during initiation and titration. (5.9)

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Adrenal Insufficiency: If diagnosed, treat with physiologic replacement of corticosteroids, and wean patient off of the opioid. (5.10)

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Severe Hypotension: Monitor during dosage initiation and titration. Avoid use of DEMEROL Injection in patients with circulatory shock. (5.11)

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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 Injection in patients with impaired consciousness or coma. (5.12)

Most common adverse reactions were lightheadedness, dizziness, sedation, nausea, vomiting and sweating. (6)

To report SUSPECTED ADVERSE REACTIONS, contact Hospira, Inc. at 1-800-441-4100, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

 

Mixed Agonist/Antagonist and Partial Agonist Opioid Analgesics: Avoid use with DEMEROL Injection because they may reduce analgesic effect of DEMEROL Injection or precipitate withdrawal symptoms. (7)

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Pregnancy: May cause fetal harm. (8.1)

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Geriatric Patients: Use caution during dose selection, starting at the low ‎end of the dosing range while carefully monitoring for side effects. ‎‎(8.5)‎