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fentanyl citrate injection, USP CARPUJECT

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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.

fentanyl citrate injection, USP CARPUJECT Quick Finder

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the...
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WARNING: RISK OF ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; CYTOCHROME P450 3A4 INTERACTION; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS

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1 INDICATIONS AND USAGE

Fentanyl Citrate Injection is indicated for:

  • analgesic action of short duration during the anesthetic periods, premedication, induction and maintenance, and in the immediate...
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2 DOSAGE AND ADMINISTRATION

2.1 Important Dosage and Administration Instructions

Fentanyl Citrate Injection should be administered only by persons specifically...

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3 DOSAGE FORMS AND STRENGTHS

Fentanyl Citrate Injection, USP 50 mcg/mL (equivalent to 50 mcg/mL fentanyl base) is available as:

2 mL fill in 2.5 mL Carpuject™ Single-dose cartridge with Luer Lock for the Carpuject™...

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4 CONTRAINDICATIONS

Fentanyl Citrate Injection is contraindicated in patients with:

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5 WARNINGS AND PRECAUTIONS

5.1 Addiction, Abuse, and Misuse

Fentanyl Citrate Injection contains fentanyl, a Schedule II controlled substance. As an opioid, Fentanyl...

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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 2 includes clinically significant drug interactions with Fentanyl Citrate Injection.

Table 2: Clinically Significant Drug Interactions with Fentanyl Citrate...
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8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

Prolonged use of opioid...

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9 DRUG ABUSE AND DEPENDENCE

9.1 Controlled Substance

Fentanyl Citrate Injection contains fentanyl, a Schedule II controlled substance.

...
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10 OVERDOSAGE

Clinical Presentation

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

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11 DESCRIPTION

Fentanyl Citrate Injection is an opioid agonist, available as a solution containing fentanyl citrate equivalent to 50 mcg (0.05 mg) fentanyl base per mL adjusted to pH 4.0 to 7.5 with sodium hydroxide. The...

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12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Fentanyl Citrate Injection is an opioid agonist, whose principal actions of therapeutic value are analgesia and...

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13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

...

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16 HOW SUPPLIED/STORAGE AND HANDLING

Fentanyl Citrate Injection, USP, equivalent to 50 mcg (0.05 mg) fentanyl base per mL, is a preservative-free solution, supplied as follows:

...
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