HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the... |
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DEMEROL (Meperidine Hydrochloride Injection, USP)
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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 Quick Finder
Highlights
Boxed Warning
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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Indications and Usage
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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Dosage and Administration
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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Dosage Forms and Strengths
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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Contraindications
4 CONTRAINDICATIONS
DEMEROL Injection is contraindicated in patients with:
- •
- Significant respiratory depression [see Warnings and Precautions (5.2)] ...
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Warnings and Precautions
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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Drug Interactions
7 DRUG INTERACTIONS
Table 1 includes clinically significant drug interactions with DEMEROL Injection.
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Use in Specific Populations
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
Prolonged use of...
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Drug Abuse and Dependence
...
9 DRUG ABUSE AND DEPENDENCE
9.1 Controlled Substance
DEMEROL Injection contains meperidine, a Schedule II controlled substance.
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Overdosage
10 OVERDOSAGE
Clinical Presentation
Acute overdose with DEMEROL Injection can be manifested by respiratory depression, somnolence...
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Description
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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Clinical Pharmacology
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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Nonclinical Toxicology
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
...
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How Supplied/Storage and Handling
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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Medication Guide
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
INSTRUCTIONS FOR USE
To Use NexJect™ Syringe
...
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Report Adverse Event
To report an adverse event related to a Pfizer product and you are not part of a clinical trial* for this product, click the link below to submit your information: Pfizer Safety Reporting Site
*If you are involved in a clinical trial for either product, adverse events should be reported to your coordinating study site.
If you cannot use the above website to report an adverse event related to a Pfizer product, please call Pfizer Medical Information at (800) 438-1985.
You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatchor by calling
(800)-332-1088.
(800)-332-1088.