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, even at recommended doses, reserve DEMEROL Injection for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: (1)

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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

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Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals. (2.1)

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Individualize dosing based on the severity of pain, patient response, prior analgesic experience, and risk factors for addiction, abuse, and misuse. (2.1)

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For Relief of Pain:
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 150 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 stop DEMEROL Injection abruptly in a physically dependent patient. (2.2)

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Injectable, Carpuject Single-Dose cartridge with Luer Lock for the Carpuject Syringe System: 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, 50 mg/mL, 75 mg/mL, and 100 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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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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Life-Threatening Respiratory Depression in Patients with Chronic Pulmonary Disease or in Elderly, Cachectic, or Debilitated Patients: Monitor closely, particularly during initiation and titration. (5.7)

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Serotonin Syndrome: 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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Adrenal Insufficiency: If diagnosed, treat with physiologic replacement of corticosteroids, and wean patient off of the opioid. (5.9)

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Severe Hypotension: Monitor during dosage initiation and titration. Avoid use of DEMEROL Injection in patients with circulatory shock. (5.10)

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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. (5.11)

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.

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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)