Meperidine (injection)

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Meperidine (injection)
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Kiran Singh, M.D. [2]

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Overview

Meperidine (injection) is an analgesic that is FDA approved for the treatment of moderate to severe pain and for preoperative medication,. Common adverse reactions include .

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

  • For the relief of moderate to severe pain
  • For preoperative medication
  • For support of anesthesia
  • For obstetrical analgesia

Dosage

For Relief of Pain

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

For Preoperative Medication

  • 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.

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.

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

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Meperidine (injection) in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Meperidine (injection) in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding FDA-Labeled Use of Meperidine (injection) in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Meperidine (injection) in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Meperidine (injection) in pediatric patients.

Contraindications

There is limited information regarding Meperidine (injection) Contraindications in the drug label.

Warnings

  • Prolonged meperidine use may increase the risk of toxicity (e.g., seizures) from the accumulation of the meperidine metabolite, normeperidine.

Drug Dependence

  • Meperidine can produce drug dependence of the morphine type and therefore has the potential for being abused. Psychic dependence, physical dependence, and tolerance may develop upon repeated administration of meperidine, and it should be prescribed and administered with the same degree of caution appropriate to the use of morphine. Like other narcotics, meperidine is subject to the provisions of the Federal narcotic laws.

Head Injury and Increased Intracranial Pressure

  • The respiratory depressant effects of meperidine and its capacity to elevate cerebrospinal fluid pressure may be markedly exaggerated in the presence of head injury, other intracranial lesions, or a preexisting increase in intracranial pressure. Furthermore, narcotics produce adverse reactions which may obscure the clinical course of patients with head injuries. In such patients, meperidine must be used with extreme caution and only if its use is deemed essential.

Intravenous Use

  • If necessary, meperidine may be given intravenously, but the injection should be given very slowly, preferably in the form of a diluted solution. Rapid intravenous injection of narcotic analgesics, including meperidine, increases the incidence of adverse reactions; severe respiratory depression, apnea, hypotension, peripheral circulatory collapse, and cardiac arrest have occurred. Meperidine should not be administered intravenously unless a narcotic antagonist and the facilities for assisted or controlled respiration are immediately available. When meperidine is given parenterally, especially intravenously, the patient should be lying down.

Asthma and Other Respiratory Conditions

  • Meperidine should be used with extreme caution in patients having an acute asthmatic attack, patients with chronic obstructive pulmonary disease or cor pulmonale, patients having a substantially decreased respiratory reserve, and patients with preexisting respiratory depression, hypoxia, or hypercapnia. In such patients, even usual therapeutic doses of narcotics may decrease respiratory drive while simultaneously increasing airway resistance to the point of apnea.

Hypotensive Effect

  • The administration of meperidine may result in severe hypotension in the postoperative patient or any individual whose ability to maintain blood pressure has been compromised by a depleted blood volume or the administration of drugs such as the phenothiazines or certain anesthetics.

Usage in Ambulatory Patients

  • Meperidine may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery. The patient should be cautioned accordingly.
  • Meperidine, like other narcotics, may produce orthostatic hypotension in ambulatory patients.

Usage in Pregnancy

  • Meperidine should not be used in pregnant women prior to the labor period, unless in the judgment of the physician the potential benefits outweigh the possible risks, because safe use in pregnancy prior to labor has not been established relative to possible adverse effects on fetal development.

Labor and Delivery

  • When used as an obstetrical analgesic, meperidine crosses the placental barrier and can produce depression of respiration and psychophysiologic functions in the newborn. Resuscitation may be required. Therefore meperidine is not recommended during labor.
  • Meperidine appears in the milk of nursing mothers receiving the drug. Due to the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the potential benefits of the drug to the nursing woman.

Adverse Reactions

Clinical Trials Experience

  • The most frequently observed adverse reactions include lightheadedness, dizziness, sedation, nausea, vomiting, and sweating. These effects seem to be more prominent in ambulatory patients and in those who are not experiencing severe pain. In such individuals, lower doses are advisable. Some adverse reactions in ambulatory patients may be alleviated if the patient lies down.
  • Other adverse reactions include:
  • Allergic. Pruritus, urticaria, other skin rashes, wheal and flare over the vein with intravenous injection.
  • Other. Pain at injection site; local tissue irritation and induration following subcutaneous injection, particularly when repeated; antidiuretic effect.

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Meperidine (injection) in the drug label.

Drug Interactions

Acyclovir: Plasma concentrations of meperidine and its metabolite, normeperidine, may be increased by acyclovir, thus caution should be used with concomitant administration.

Cimetidine: Cimetidine reduced the clearance and volume of distribution of meperidine and also the formation of the metabolite, normeperidine, in healthy subjects and thus, caution should be used with concomitant administration.

CNS Depressants: Concomitant use of CNS depressants with usual doses of Demerol may result in respiratory depression, hypotension, profound sedation, coma or death.

Phenytoin: The hepatic metabolism of meperidine may be enhanced by phenytoin. Concomitant administration resulted in reduced half-life and bioavailability with increased clearance of meperidine in healthy subjects, however, blood concentrations of normeperidine were increased, thus exercise caution when phenytoin is used concomitantly with meperidine.

Ritonavir: Plasma concentrations of the active metabolite normeperidine may be increased by ritonavir, thus concomitant administration should be avoided.

Opioid analgesics, including DEMEROL, may enhance the neuromuscular blocking action of skeletal muscle relaxants and produce an increased degree of respiratory depression.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

  • Pregnancy Category


Pregnancy Category (AUS):

  • Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Meperidine (injection) in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Meperidine (injection) during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Meperidine (injection) with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Meperidine (injection) with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Meperidine (injection) with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Meperidine (injection) with respect to specific gender populations.

Race

There is no FDA guidance on the use of Meperidine (injection) with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Meperidine (injection) in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Meperidine (injection) in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Meperidine (injection) in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Meperidine (injection) in patients who are immunocompromised.

Administration and Monitoring

Administration

  • Intravenous

Monitoring

There is limited information regarding Monitoring of Meperidine (injection) in the drug label

IV Compatibility

There is limited information regarding IV Compatibility of Meperidine (injection) in the drug label.

Overdosage

Symptoms

Treatment

  • Primary attention should be given to the reestablishment of adequate respiratory exchange through provision of a patent airway and institution of assisted or controlled ventilation. The narcotic antagonist, naloxone hydrochloride, is a specific antidote against respiratory depression which may result from overdosage or unusual sensitivity to narcotics, including meperidine. Therefore, an appropriate dose of this antagonist should be administered, preferably by the intravenous route, simultaneously with efforts at respiratory resuscitation.
  • An antagonist should not be administered in the absence of clinically significant respiratory or cardiovascular depression.
  • Oxygen, intravenous fluids, vasopressors, and other supportive measures should be employed as indicated.
  • NOTE: In an individual physically dependent on narcotics, the administration of the usual dose of a narcotic antagonist will precipitate an acute withdrawal syndrome. The severity of this syndrome will depend on the degree of physical dependence and the dose of antagonist administered. The use of narcotic antagonists in such individuals should be avoided if possible. If a narcotic antagonist must be used to treat serious respiratory depression in the physically dependent patient, the antagonist should be administered with extreme care and only one-fifth to one-tenth the usual initial dose administered.

Pharmacology

There is limited information regarding Meperidine (injection) Pharmacology in the drug label.

Mechanism of Action

Structure

File:Meperidine (injection)01.png
This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Meperidine (injection) in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Meperidine (injection) in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Meperidine (injection) in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Meperidine (injection) in the drug label.

How Supplied

  • For Parenteral Use
  • Solutions of DEMEROL for parenteral use are clear and colorless and are available as follows:
This image is provided by the National Library of Medicine.
  • Carpuject™ are packaged in a Slim-Pak™ tamper detection package. To prevent needle-stick injuries, needles should not be recapped, purposely bent, or broken by hand. Blunt cannulas should not be recapped, purposely bent or broken by hand.

NOTE: The pH of DEMEROL solutions is adjusted between 3.5 and 6 with sodium hydroxide or hydrochloric acid. Multiple-dose vials contain metacresol 0.1 percent as preservative. No preservatives are added to the ampuls or Carpuject™ sterile cartridge units.

Storage

  • Store at 20 to 25°C (68 to 77°F).

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Patient Counseling Information of Meperidine (injection) in the drug label.

Precautions with Alcohol

  • Alcohol-Meperidine (injection) interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

Look-Alike Drug Names

There is limited information regarding Meperidine (injection) Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

  1. ↑ "meperidine hydrochloride injection, solution".

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