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fentanyl citrate injection, USP VIAL , AMPULE
If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents.
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 VIAL , AMPULE Quick Finder
Highlights
Boxed Warning
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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Indications and Usage
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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Dosage and Administration
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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Dosage Forms and Strengths
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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Contraindications
4 CONTRAINDICATIONS
Fentanyl Citrate Injection is contraindicated in patients with:
- Hypersensitivity to fentanyl (e.g., anaphylaxis) [see Adverse Reactions (...
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Warnings and Precautions
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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Drug Interactions
7 DRUG INTERACTIONS
Table 2 includes clinically significant drug interactions with Fentanyl Citrate Injection.
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Use in Specific Populations
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
Prolonged use of opioid...
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Drug Abuse and Dependence
...
9 DRUG ABUSE AND DEPENDENCE
9.1 Controlled Substance
Fentanyl Citrate Injection contains fentanyl, a Schedule II controlled substance.
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Overdosage
10 OVERDOSAGE
Clinical Presentation
Acute overdose with Fentanyl Citrate Injection can be manifested by respiratory depression,...
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Description
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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Clinical Pharmacology
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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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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
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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Medication Guide
17 PATIENT COUNSELING INFORMATION
Serotonin Syndrome
Inform patients that opioids could cause a rare but potentially life-threatening...
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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.