HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the information needed to use DEMEROL™ INJECTION safely and effectively. See full prescribing information for DEMEROL INJECTION.
DEMEROL™ (meperidine hydrochloride injection), for subcutaneous, intramuscular, and intravenous use, CII
Initial U.S. Approval: 1942 WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF DEMEROL INJECTION See full prescribing information for complete boxed warning.- •
- DEMEROL Injection exposes users to risks of addiction, abuse, and misuse, which can lead to overdose and death. Assess patient’s risk before prescribing and reassess regularly for these behaviors and conditions. (5.1)
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- Serious, life-threatening, or fatal respiratory depression may occur with use of DEMEROL Injection, especially during initiation or following a dosage increase. To reduce the risk of respiratory depression, proper dosing and titration of DEMEROL Injection are essential. (5.2)
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- Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing for use in patients for whom alternative treatment options are inadequate. (5.3, 7)
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- If opioid use is required for an extended period of time in a pregnant woman, advise the patient of the risk of Neonatal Opioid Withdrawal Syndrome, which may be life-threatening if not recognized and treated. Ensure that management by neonatology experts will be available at delivery. (5.4)
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- Concomitant use with CYP3A4 inhibitors (or discontinuation of CYP3A4 inducers) can result in a fatal overdose of meperidine. (5.5, 7)
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- Concomitant use of DEMEROL Injection with Monoamine oxidase (MAO) inhibitors can result in coma, severe respiratory depression, cyanosis and hypotension. Use of DEMEROL Injection with MAO inhibitors is contraindicated. (4, 5.6, 7)
RECENT MAJOR CHANGESBoxed Warning | 12/2023 | Indications and Usage (1) | 12/2023 | Dosage and Administration (2.1, 2.2) | 12/2023 | Warnings and Precautions (5.7) | 12/2023 |
INDICATIONS AND USAGEDEMEROL 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]: - •
- 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. DOSAGE AND ADMINISTRATION- •
- 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:
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- 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) - •
- 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) - •
- Obstetrical Analgesia:
50 mg to 100 mg intramuscularly or subcutaneously; may be repeated at 1 to 3 hour intervals. (2.4) - •
- Do not abruptly discontinue DEMEROL Injection in a physically‑dependent patient. (2.2)
DOSAGE FORMS AND STRENGTHS- •
- 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)
CONTRAINDICATIONS- •
- 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)
WARNINGS AND PRECAUTIONS- •
- 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)
ADVERSE REACTIONSMost 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. DRUG INTERACTIONS-
- 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)
USE IN SPECIFIC POPULATIONS- •
- 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)
See 17 for PATIENT COUNSELING INFORMATION. Revised: 4/2024 |