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fentanyl citrate injection, USP VIAL, AMPULE

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fentanyl citrate injection, USP VIAL, AMPULE Quick Finder

HIGHLIGHTS OF PRESCRIBING INFORMATION

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WARNING: 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...
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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

  • Injection: 50 mcg (0.05 mg)/mL in single-dose Fliptop vial.
  • Injection: 50 mcg (0.05 mg)/mL in single-dose ampule.
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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 CII 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,...

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11 DESCRIPTION

Fentanyl Citrate Injection is an opioid agonist. Fentanyl Citrate Injection, is a sterile, nonpyrogenic solution of fentanyl citrate in water for injection, available as 50 mcg (0.05 mg) per mL which is...

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12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Fentanyl is an opioid agonist whose principal actions of therapeutic value are analgesic and sedation.

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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 per mL, is supplied in single-dose glass containers as follows:

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

PRINCIPAL DISPLAY PANEL

LAB-0843-5.0...

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