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DEMEROL (Meperidine Hydrochloride Injection, USP)

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DEMEROL Quick Finder

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the...
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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 (...

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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...

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2 DOSAGE AND ADMINISTRATION

2.1 Important Dosage and Administration Instructions

Use the lowest effective dosage for the shortest duration consistent with individual...

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3 DOSAGE FORMS AND STRENGTHS

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

Single-dose Carpuject cartridge with Luer Lock for...
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5 WARNINGS AND PRECAUTIONS

5.1 Addiction, Abuse, and Misuse

DEMEROL Injection contains meperidine, a Schedule II controlled substance. As an opioid, DEMEROL Injection...

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6 ADVERSE REACTIONS

The following serious adverse reactions are described, or described in greater detail, in other sections:

Addiction, Abuse, and Misuse [see ...
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7 DRUG INTERACTIONS

Table 1 includes clinically significant drug interactions with DEMEROL Injection.

Table 1: Clinically Significant Drug Interactions with DEMEROL Injection...
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8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

Prolonged use of...

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9 DRUG ABUSE AND DEPENDENCE

9.1 Controlled Substance

DEMEROL Injection contains meperidine, a Schedule II controlled substance.

...
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10 OVERDOSAGE

Clinical Presentation

Acute overdose with DEMEROL Injection can be manifested by respiratory depression, somnolence...

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11 DESCRIPTION

DEMEROL (meperidine hydrochloride injection) is an opioid agonist available as a sterile aqueous solution, for intramuscular, intravenous, or subcutaneous administration. It contains meperidine hydrochloride...

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12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Meperidine hydrochloride is an opioid agonist with multiple actions qualitatively similar to those of morphine; the...

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13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

...

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16 HOW SUPPLIED/STORAGE AND HANDLING

For Parenteral Use

DEMEROL (meperidine hydrochloride injection), for subcutaneous, intramuscular, and intravenous use, is clear and colorless, and...

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17 PATIENT COUNSELING INFORMATION

Serotonin Syndrome

Inform patients that opioids could cause a rare but potentially life-threatening...

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INSTRUCTIONS FOR USE

To Use NexJect™ Syringe

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Distributed by Hospira, Inc., Lake Forest, IL 60045 USA

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