Medical Information
United States
 

In order to provide you with relevant and meaningful content we need to know more about you.

Please choose the category that best describes you.

Existe información en español para pacientes y cuidadores, para acceder, haga clic sobre “Select” al lado de “I am a U.S. Patient / Caregiver”.

This content is intended for U.S. Healthcare Professionals. Would you like to proceed?

If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents.

Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.

DEMEROL Highlights (Meperidine Hydrochloride Injection, USP)

HIGHLIGHTS OF PRESCRIBING INFORMATION

These 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: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; NEONATAL OPIOID WITHDRAWAL SYNDROME; CYTOCHROME P450 3A4 INTERACTION; RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS; and MONOAMINE OXIDASE (MAO) INHIBITORS INTERACTIONS

See full prescribing information for complete boxed warning.

  • DEMEROL Injection exposes users to risks of addiction, abuse, and misuse, which can also lead to overdose and death. Assess patient's risk before prescribing and monitor regularly for these behaviors and conditions. (5.1)
  • Serious, life-threatening, or fatal respiratory depression may occur. Monitor closely, especially upon initiation or following a dose increase. (5.2)
  • Prolonged use of DEMEROL Injection during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated. If prolonged opioid use is required in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available. (5.3)
  • Concomitant use with CYP3A4 inhibitors (or discontinuation of CYP3A4 inducers) can result in fatal overdose of meperidine. (5.4, 7)
  • 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; limit dosages and durations to the minimum required; and follow patients for signs and symptoms of respiratory depression and sedation. (5.5, 7).
  • 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)

INDICATIONS AND USAGE

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)

  • Have not been tolerated, or are not expected to be tolerated,
  • Have not provided adequate analgesia, or are not expected to provide adequate analgesia

DOSAGE AND ADMINISTRATION

  • Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals. (2.1)
  • Individualize dosing based on the severity of pain, patient response, prior analgesic experience, and risk factors for addiction, abuse, and misuse. (2.1)
  • 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)
  • 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 stop DEMEROL Injection abruptly in a physically dependent patient. (2.2)

DOSAGE FORMS AND STRENGTHS

  • 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)
  • Injectable, Multiple-dose vials: 1,500 mg/30 mL (50 mg/mL) and 2,000 mg/20 mL (100 mg/mL). (3)
  • Injectable, NexJect™ Single-dose Prefilled Syringe with Luer Lock: 25 mg/mL, 50 mg/mL, 75 mg/mL, and 100 mg/mL. (3)

CONTRAINDICATIONS

  • Significant respiratory depression. (4)
  • Acute or severe bronchial asthma in an unmonitored setting or in absence of resuscitative equipment. (4)
  • Known or suspected gastrointestinal obstruction, including paralytic ileus. (4)
  • Hypersensitivity to meperidine or to any other ingredients of the product. (4)

WARNINGS AND PRECAUTIONS

  • 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)
  • Serotonin Syndrome: Potentially life-threatening condition could result from concomitant serotonergic drug administration. Discontinue DEMEROL Injection if serotonin syndrome is suspected. (5.8)
  • Adrenal Insufficiency: If diagnosed, treat with physiologic replacement of corticosteroids, and wean patient off of the opioid. (5.9)
  • Severe Hypotension: Monitor during dosage initiation and titration. Avoid use of DEMEROL Injection in patients with circulatory shock. (5.10)
  • 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)

ADVERSE REACTIONS

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.

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)

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 4/2022

Did you find an answer to your question? Yes No
Didn’t find what you were looking for? Contact us.
Report Adverse Event