Prescription Drug Information: DEMEROL

DEMEROL- meperidine hydrochloride injection, solution
Hospira, Inc.

Life-Threatening Respiratory Depression

Serious, life-threatening, or fatal respiratory depression may occur with use of DEMEROL Injection. Monitor for respiratory depression, especially during initiation of DEMEROL Injection or following a dose increase [see Warnings and Precautions (5.2)].

Neonatal Opioid Withdrawal Syndrome

Prolonged use of DEMEROL Injection during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available [see Warnings and Precautions (5.3)].

Cytochrome P450 3A4 Interaction

The concomitant use of DEMEROL Injection with all cytochrome P450 3A4 inhibitors may result in an increase in meperidine plasma concentrations, which could increase or prolong adverse reactions and may cause potentially fatal respiratory depression. In addition, discontinuation of a concomitantly used cytochrome P450 3A4 inducer may result in an increase in meperidine plasma concentration. Monitor patients receiving DEMEROL Injection and any CYP3A4 inhibitor or inducer [see Warnings and Precautions (5.4), Drug Interactions (7)].

Risks From Concomitant Use with Benzodiazepines Or Other CNS Depressants

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 [see Warnings and Precautions (5.5), Drug Interactions (7)].

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Reserve concomitant prescribing of DEMEROL Injection and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate.

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Limit dosage and duration to the minimum required.

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Follow patients for signs and symptoms of respiratory depression and sedation.

Concomitant Use of DEMEROL Injection with Monoamine Oxidase (MAO) Inhibitors

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 within last 14 days is contraindicated [see Contraindications (4), Warnings and Precautions (5.6), Drug Interactions (7)].

1 INDICATIONS AND USAGE

DEMEROL Injection is indicated for preoperative medication, support of anesthesia, and obstetrical analgesia.

DEMEROL Injection is 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 [see Warnings and Precautions (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 treatment of chronic pain. Prolonged DEMEROL Injection use may increase the risk of toxicity (e.g. seizures) from the accumulation of the meperidine metabolite, normeperidine.

2 DOSAGE AND ADMINISTRATION

2.1 Important Dosage and Administration Instructions

Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals [see Warnings and Precautions (5)].

Initiate the dosing regimen for each patient individually, taking into account the patient’s severity of pain, patient response, prior analgesic treatment experience, and risk factors for addiction, abuse, and misuse [see Warnings and Precautions (5.1)].

Monitor patients closely for respiratory depression, especially within the first 24–72 hours of initiating therapy and following dosage increases with DEMEROL Injection and adjust the dosage accordingly [see Warnings and Precautions (5.2)].

Parenteral drug products should be inspected visually for particulate and discoloration prior to administration whenever solution and container permit.

2.2 For Management of Pain

Initial Dosage

Dosage should be adjusted according to the severity of the pain and the response of the patient. While subcutaneous administration is suitable for occasional use, intramuscular administration is preferred when repeated doses are required. If intravenous administration is required, dosage should be decreased and the injection made very slowly, preferably utilizing a diluted solution.

Adults: The usual dosage is 50 mg to 150 mg intramuscularly or subcutaneously every 3 or 4 hours as needed for pain. Elderly patients should usually be given meperidine at the lower end of the dose range and observed closely.

Children: The usual dosage is 0.5 mg/lb to 0.8 mg/lb intramuscularly or subcutaneously up to the adult dose, every 3 or 4 hours as necessary.

Titration and Maintenance of Therapy

Individually titrate DEMEROL Injection to a dose that provides adequate analgesia and minimizes adverse reactions. Continually reevaluate patients receiving DEMEROL Injection to assess the maintenance of pain control and the relative incidence of adverse reactions, as well as monitoring for the development of addiction, abuse, or misuse [see Warnings and Precautions (5.1)]. Frequent communication is important among the prescriber, other members of the health and care team, the patient, and the caregiver/family during periods of changing analgesic requirements, including initial titration.

If the level of pain increases after dosage stabilization, attempt to identify the source of increased pain before increasing the DEMEROL Injection dosage. If unacceptable opioid-related adverse reactions are observed, consider reducing the dosage. Adjust the dosage to obtain an appropriate balance between management of pain and opioid-related adverse reactions.

Discontinuation of DEMEROL Injection

When a patient who has been taking DEMEROL Injection regularly and may be physically dependent no longer requires therapy with DEMEROL Injection, taper the dose gradually, by 25% to 50% every 2 to 4 days, while monitoring carefully for signs and symptoms of withdrawal. If the patient develops these signs or symptoms, raise the dose to the previous level and taper more slowly, either by increasing the interval between decreases, decreasing the amount of change in dose, or both. Do not abruptly discontinue DEMEROL Injection in a physically-dependent patient [see Warnings and Precautions (5.13), Drug Abuse and Dependence (9.3)].

2.3 For Preoperative Medication

Adults: The usual dosage is 50 mg to 100 mg intramuscularly or subcutaneously, 30 to 90 minutes before the beginning of anesthesia. Elderly patients should usually be given meperidine at the lower end of the dose range and observed closely.

Children: The usual dosage is 0.5 mg/lb to 1 mg/lb intramuscularly or subcutaneously up to the adult dose, 30 to 90 minutes before the beginning of anesthesia.

2.4 For Support of Anesthesia

Repeated slow intravenous Injections of fractional doses (e.g., 10 mg/mL) or continuous intravenous infusion of a more dilute solution (e.g., 1 mg/mL) should be used. The dose should be titrated to the needs of the patient and will depend on the premedication and type of anesthesia being employed, the characteristics of the particular patient, and the nature and duration of the operative procedure. Elderly patients should usually be given meperidine at the lower end of the dose range and observed closely.

2.5 For Obstetrical Analgesia

The usual dosage is 50 mg to 100 mg intramuscularly or subcutaneously when pain becomes regular, and may be repeated at 1- to 3-hour intervals.

2.6 Dosage Modifications with Concomitant Phenothiazines

The dose of DEMEROL Injection should be proportionately reduced (usually by 25 to 50 percent) when administered concomitantly with phenothiazines and many other tranquilizers since they potentiate the action of DEMEROL Injection.

2.7 Instructions for Use of the Syringe Systems

Instructions for using the Carpuject Syringe are available with the reusable Carpuject Holder. Carpuject Single-dose cartridges are to be used ONLY with Carpuject Holders.

To prevent needlestick injuries, needles should not be recapped, purposely bent, or broken by hand.

Blunt cannulas should not be recapped, purposely bent or broken by hand.

3 DOSAGE FORMS AND STRENGTHS

DEMEROL Injection is a clear, colorless, sterile aqueous solution, available in the following dosage forms and strengths:

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Single-dose Carpuject cartridge with Luer Lock for the Carpuject Syringe System, available in the following strengths: 25 mg/mL, 50 mg/mL, 75 mg/mL, and 100 mg/mL.

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Multiple-dose vials containing 0.1% metacresol as a preservative, available in the following strength: 1,500 mg/30 mL (50 mg/mL).

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Single-dose NexJect^TM Prefilled Syringe with Luer Lock, available in the following strengths: 25 mg/mL, 50 mg/mL, 75 mg/mL, and 100 mg/mL.

4 CONTRAINDICATIONS

DEMEROL Injection is contraindicated in patients with:

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Significant respiratory depression [see Warnings and Precautions (5.2)]

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Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see Warnings and Precautions (5.2)]

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Concomitant use of monoamine oxidase inhibitors (MAOIs) or within 14 days of having taken an MAOI [see Warnings and Precautions (5.6), Drug Interactions (7)]

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Known or suspected gastrointestinal obstruction, including paralytic ileus [see Warnings and Precautions (5.12)]

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Hypersensitivity to meperidine (e.g., anaphylaxis) [see Adverse Reactions (6)]